A Study to Compare the Efficacy of Guselkumab to Fumaric... | NCT02951533 | Trialant
NCT02951533
Sponsor
Janssen-Cilag G.m.b.H
Status
Completed
Last Update Posted
Feb 28, 2020Actual
Enrollment
119Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Guselkumab
Fumaric Acid Esters
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT02951533
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108220
Secondary IDs
ID
Type
Description
Link
2016-002135-15
EudraCT Number
CNTO1959PSO3008
Other Identifier
Janssen-Cilag G.m.b.H, Germany
Brief Title
A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Official Title
Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded, Active Comparator-Controlled Phase 3b Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters (Fumaderm Initial/ Fumaderm) for Adult Patients With Moderate to Severe Plaque Psoriasis Who Are Candidates for and Naive to Systemic Treatment
Acronym
POLARIS
Organization
Janssen-Cilag G.m.b.HINDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 12, 2016Actual
Primary Completion Date
Sep 13, 2017Actual
Completion Date
Feb 6, 2019Actual
First Submitted Date
Oct 28, 2016
First Submission Date that Met QC Criteria
Oct 28, 2016
First Posted Date
Nov 1, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 13, 2018
Results First Submitted that Met QC Criteria
Oct 3, 2018
Results First Posted Date
Feb 15, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 27, 2020
Last Update Posted Date
Feb 28, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen-Cilag G.m.b.HINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
119Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group I: Guselkumab
Experimental
Participants will receive Guselkumab 100 milligram (mg) administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) by single-use prefilled syringe (PFS) at weeks 0, 4, 12 and 20.
Drug: Guselkumab
Group II: Fumaric Acid Esters (FAE)
Active Comparator
Participants will receive Fumaderm initial/Fumaderm tablets by self administration at week 0. The individual FAE dose representing the optimal efficacy/tolerability ratio needs to be determined for each participant according to local prescription information. To this aim, FAE doses will be slowly increased beginning with increasing doses of Fumderm initial (containing 30 mg dimethylfumarate) over the first 3 weeks. Thereafter, participants will be switched to Fumaderm tablets (containing 120 mg dimethylfumarate) starting with 1 tablet per day. Fumaderm dose may be increased to a maximum of 3*2 tablets per day. The decision to maintain, increase or decrease the FAE dose depends on efficacy, safety and tolerability.
Drug: Fumaric Acid Esters
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Guselkumab
Drug
Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.
Group I: Guselkumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
At Week 24
Secondary Outcomes
Measure
Description
Time Frame
Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
Have a Psoriasis Area and Severity Index (PASI) greater than (>)10 or Body Surface Area (BSA) >10 at screening and at baseline
Have a Dermatology Life Quality Index (DLQI) >10 at screening and at baseline
No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analyzed centrally. Here, protein and glucose levels must not exceed trace levels, example, <=(+); one re-test (central urine analysis) is allowed
Exclusion Criteria:
Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients
Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug
Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen-Cilag G.m.b.H, Germany Clinical Trial
Janssen-Cilag G.m.b.H
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Augsburg
Germany
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Total of 119 participants were enrolled and randomized, 118 (GUS [60], FAE [58 participants]) were treated in this study. Out of them, 42 participants completed study in Part III.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Guselkumab (GUS)
Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.
Periods
Title
Milestones
Reasons Not Completed
Part I (Week 0 Through Week 24)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 22, 2018
Feb 5, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Fumaric Acid Esters
Drug
Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.
Group II: Fumaric Acid Esters (FAE)
At Week 24
Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
At Week 24
Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
At Week 24
Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
Baseline and Week 24
Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24
The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
Baseline and Week 24
Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=<) 1 were assessed.
At Week 24
Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
At Week 24
Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Baseline and Week 24
Part I: Change From Baseline in DLQI Score at Week 24
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Baseline and Week 24
Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
At Week 24
Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Baseline and Week 24
Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Week 56
Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Week 56
Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Week 56
Part IIb: Percentage of Participants With a PASI 75 Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Week 56
Part IIb: Percentage of Participants With a PASI 90 Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Week 56
Part IIb: Percentage of Participants With a PASI 100 Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Week 56
Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Week 56
Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).
Week 32
Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
Week 32
Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
Week 32
Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32
DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
Week 32
Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Week 100
Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100
The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI >5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Week 100
Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100
The time to PASI>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI >3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Week 100
Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100
The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI >5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Week 100
Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100
The time to PASI>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI >3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Week 100
Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Week 100
Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Week 100
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Week 100
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
Baseline (Week 56) and Week 100
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 100
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 100
Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Baseline (Week 56) and Week 100
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Week 100
Part III: Change From Baseline in DLQI Score at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Baseline (Week 56) and Week 100
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Week 100
Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Week 100
Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Week 100
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Baseline (Week 56) and Week 100
Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Up to Week 32
Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.
Week 32 to Week 64
Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability
ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.
Week 64 to Week 100
Berlin
Germany
Bielefeld
Germany
Dresden
Germany
Dülmen
Germany
Düsseldorf
Germany
Erlangen
Germany
Essen
Germany
Frankfurt
Germany
Gera
Germany
Hamburg
Germany
Heidelberg
Germany
Jena
Germany
Kiel
Germany
Leipzig
Germany
Lübeck
Germany
Mahlow
Germany
Mainz
Germany
Memmingen
Germany
München
Germany
Münster
Germany
Neu-Ulm
Germany
Osnabrück
Germany
Selters
Germany
Stuttgart
Germany
Tübingen
Germany
Witten
Germany
Wuppertal
Germany
FG001
Fumaric Acid Esters (FAE)
Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
FG002
FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Weeks 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who received GUS in Study Part II (participants who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
FG00060 subjects
FG00159 subjects
FG0020 subjects
Treated
FG00060 subjects
FG00158 subjects
FG0020 subjects
COMPLETED
FG00056 subjects
FG00136 subjects
FG0020 subjects
NOT COMPLETED
FG0004 subjects
FG00123 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG00116 subjects
FG0020 subjects
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0020 subjects
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0020 subjects
Noncompliance with Study Drug
FG0000 subjects
FG0011 subjects
FG0020 subjects
Part IIa (Week 24 Through Week 32)
Type
Comment
Milestone Data
STARTED
FG00056 subjects
FG00135 subjects1 participant did not sign informed consent form (ICF) for Study Part II but completed Study Part I.
FG0020 subjects
PASI 75 Responder at Week 32
FG00054 subjects
FG00114 subjects
FG0020 subjects
PASI 75 Non-responder at Week 32
FG0001 subjects
FG00120 subjects
FG0020 subjects
COMPLETED
FG00055 subjects
FG00134 subjects
FG0020 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG000
Part IIb (Week 32 Through Week 56)
Type
Comment
Milestone Data
STARTED
FG00055 subjects
FG00114 subjectsOut of 34 participants in the FAE group, 14 PASI 75 responders remained on FAE treatment.
FG00220 subjectsOut of 34 participants in FAE group, 20 PASI 75 non-responders switched to GUS group.
COMPLETED
FG00054 subjects
FG00110 subjects
FG00220 subjects
NOT COMPLETED
FG0001 subjects
FG0014 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
Lost to Follow-up
FG000
Part III (Week 64 Through Week 100)
Type
Comment
Milestone Data
STARTED
FG00036 subjects18 participants were not eligible to enter Part III.
FG0010 subjects10 participants in the FAE group were not eligible to enter Part III.
FG00212 subjects8 participants were not eligible to enter Part III.
COMPLETED
FG00032 subjects
FG0010 subjects
FG00210 subjects
NOT COMPLETED
FG0004 subjects
FG0010 subjects
FG0022 subjects
Type
Comment
Reasons
Prohibited Medication Therapy
FG0001 subjects
FG0010 subjects
FG0020 subjects
Lost to Follow-up
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Guselkumab (GUS)
Participants received guselkumab (GUS) 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Participants who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52 (Part IIb). Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Participants who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and followed-up until loss of response/ until Week 100.
BG001
Fumaric Acid Esters (FAE)
Participants received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Participants who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm switched to 100 mg GUS at Week 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For participants who discontinued study, safety follow-up was done at Week 32 (Part I) / Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00159
BG002119
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00039± 13.98
BG00145.8± 13.72
BG00242.4± 14.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00117
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Germany
Title
Measurements
BG00060
BG00159
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Efficacy analysis set (EAS) included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using non-responder imputation (NRI) (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00081.7
OG00113.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-squared
<0.0001
Superiority
Secondary
Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Secondary
Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Secondary
Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
EAS included all participants who were randomized to one of two treatment groups (GUS or FAE) at Week 0 regardless of treatment they received. Missing data was imputed using last observed carried forward (LOCF) imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24
The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=<) 1 were assessed.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Secondary
Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using LOCF imputation method. Here "N" (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Change in BSA (% points)
Baseline and Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Change From Baseline in DLQI Score at Week 24
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
EAS: participants randomized to one of two treatments (GUS or FAE) at Week 0 regardless of treatment received and SP, ss-IGA Score>=2 at Baseline. Missing data was imputed using NRI (participants with missing data at Week 4,16, 24 were non-responders).
Posted
Number
Percentage of Participants
At Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF. Here "N" (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 24
ID
Title
Description
OG000
Part I: Guselkumab (GUS)
Participants received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Secondary
Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With a PASI 75 Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With a PASI 90 Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With a PASI 100 Response at Week 56
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).
Posted
Number
Percentage of Participants
Week 56
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Part I/IIa: Guselkumab (GUS)
In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Part I/IIa: Guselkumab (GUS)
In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Part I/IIa: Guselkumab (GUS)
In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32
DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.
EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).
Posted
Number
Percentage of Participants
Week 32
ID
Title
Description
OG000
Part I/IIa: Guselkumab (GUS)
In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).
Posted
Number
Percentage of Participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100
The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI >5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.
Posted
Median
95% Confidence Interval
Days
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100
The time to PASI>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI >3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.
Posted
Median
95% Confidence Interval
Days
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100
The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI >5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.
Posted
Median
95% Confidence Interval
Days
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100
The time to PASI>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI >3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.
Posted
Median
95% Confidence Interval
Days
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).
Posted
Number
Percentage of Participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).
Posted
Number
Percentage of Participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.
Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).
Posted
Number
Percentage of Participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100
The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using last observed carried forward (LOCF) imputation method.
Posted
Mean
Standard Deviation
Units on a scale
Baseline (Week 56) and Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64, 76,88 and 100 were considered non-responders).
Posted
Number
Percentage of participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Secondary
Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100
The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64, 76,88 and 100 were considered non-responders).
Posted
Number
Percentage of participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Secondary
Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100
BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.
Posted
Mean
Standard Deviation
Change in BSA (% points)
Baseline (Week 56) and Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Secondary
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.
Posted
Number
Percentage of participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Change From Baseline in DLQI Score at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.
Posted
Mean
Standard Deviation
Units on a scale
Baseline (Week 56) and Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).
Posted
Number
Percentage of participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64, 76, 88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp psoriasis and ss-IGA score >=2 at Baseline (Week 0).
Posted
Number
Percentage of participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Secondary
Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).
Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp Psoriasis and an ss-IGA Score >=2 (at least mild disease) at Baseline (Week 0).
Posted
Number
Percentage of participants
Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Secondary
Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100
SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.
Part III analysis set included all participants treated with GUS during Part IIb (Weeks 32 to 64, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF method.
Posted
Mean
Standard Deviation
Units on a scale
Baseline (Week 56) and Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
Secondary
Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
Safety analysis set included all participants randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 and received at least 1 dose of study drug as per actual treatment received during study irrespective of treatment assigned at randomization. Here N (number of subjects analyzed) signifies number of participants evaluable for this OM.
Posted
Number
Percentage of Participants
Up to Week 32
ID
Title
Description
OG000
Part I/IIa: Guselkumab (GUS)
In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Secondary
Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.
Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Here, n (number of participants analyzed) signifies number of participants analyzed for this OM for specified category.
Posted
Number
Percentage of Participants
Week 32 to Week 64
ID
Title
Description
OG000
Part IIb: Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (Weeks 36, 44 and 52). For participants, who discontinued study, a safety follow-up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
OG001
Part IIb: Fumaric Acid Esters (FAE)
Secondary
Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability
ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.
Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III.
Posted
Number
Percentage of Participants
Week 64 to Week 100
ID
Title
Description
OG000
Part III: Guselkumab (GUS)
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100 at the latest.
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Time Frame
Up to Week 100
Description
Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part I/IIa (Week 0 to Week 32): Guselkumab (GUS)
In Part I, participants received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Participants who completed treatment phase until Week 24 entered Part II of study. Participants who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
0
60
3
60
47
60
EG001
Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE)
In Part I, Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
0
58
2
58
57
58
EG002
Part IIb (Week 32 Through Week 56): Guselkumab (GUS)
At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52). Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.
0
55
3
55
43
55
EG003
Part IIb (Week 32 Through Week 56): Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of the FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.
0
14
1
14
13
14
EG004
Part IIb (Week 32 Through Week 56): FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to 100 mg guselkumab SC at Weeks 32 and continued at Week 36, 44 and Week 52. Safety follow up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all participants who continued study, safety was followed-up at every visit.
0
20
2
20
14
20
EG005
Part III (Week 64 Through Week 100): Guselkumab
Participants who received guselkumab in Study Part II (participants who started guselkumab treatment at Week 0), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
0
36
0
36
2
36
EG006
Part III (Week 64 Through Week 100): FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
0
12
0
12
0
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thymus Enlargement
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG0030 affected14 at risk
EG004
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG0030 affected14 at risk
EG0040 affected20 at risk
EG0050 affected36 at risk
EG0060 affected12 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0015 affected58 at risk
EG0020 affected55 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG00121 affected58 at risk
EG0020 affected55 at risk
EG003
Monocytosis
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Middle Ear Inflammation
Ear and labyrinth disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Tympanic Membrane Perforation
Ear and labyrinth disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Dry Eye
Eye disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Visual Impairment
Eye disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0013 affected58 at risk
EG0020 affected55 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0019 affected58 at risk
EG0020 affected55 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG00118 affected58 at risk
EG0020 affected55 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Defaecation Urgency
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0007 affected60 at risk
EG00134 affected58 at risk
EG0020 affected55 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0022 affected55 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Faeces Soft
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0016 affected58 at risk
EG0020 affected55 at risk
EG003
Tooth Disorder
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Chest Pain
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Chills
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Fatigue
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0015 affected58 at risk
EG0020 affected55 at risk
EG003
Feeling Hot
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Inflammation
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Injection Site Rash
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Malaise
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Pyrexia
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0021 affected55 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0025 affected55 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Ear Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Folliculitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0012 affected58 at risk
EG0021 affected55 at risk
EG003
Gastrointestinal Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0012 affected58 at risk
EG0021 affected55 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG00025 affected60 at risk
EG00119 affected58 at risk
EG00228 affected55 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Otitis Media
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0021 affected55 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0012 affected58 at risk
EG0021 affected55 at risk
EG003
Rhinitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0005 affected60 at risk
EG0010 affected58 at risk
EG0022 affected55 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0011 affected58 at risk
EG0021 affected55 at risk
EG003
Skin Candida
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Tinea Pedis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0021 affected55 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0003 affected60 at risk
EG0011 affected58 at risk
EG0022 affected55 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Bone Contusion
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Post Procedural Haematoma
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Post-Traumatic Neck Syndrome
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0004 affected60 at risk
EG0013 affected58 at risk
EG0023 affected55 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0021 affected55 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0013 affected58 at risk
EG0020 affected55 at risk
EG003
Hepatic Enzyme Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Human Chorionic Gonadotropin Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Lymph Node Palpable
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Transaminases Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Weight Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Food Intolerance
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0021 affected55 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0004 affected60 at risk
EG0013 affected58 at risk
EG0022 affected55 at risk
EG003
Articular Calcification
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0003 affected60 at risk
EG0012 affected58 at risk
EG0023 affected55 at risk
EG003
Muscle Tightness
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0003 affected60 at risk
EG0011 affected58 at risk
EG0021 affected55 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Giant Cell Tumour of Tendon Sheath
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0009 affected60 at risk
EG0018 affected58 at risk
EG0023 affected55 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Device Breakage
Product Issues
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Mood Altered
Psychiatric disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0012 affected58 at risk
EG0022 affected55 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0023 affected55 at risk
EG003
Pharyngeal Erythema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Pulmonary Arterial Hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Polymorphic Light Eruption
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0015 affected58 at risk
EG0022 affected55 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0002 affected60 at risk
EG0016 affected58 at risk
EG0020 affected55 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0013 affected58 at risk
EG0020 affected55 at risk
EG003
Seborrhoea
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Skin Burning Sensation
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Dental Operation
Surgical and medical procedures
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Skin Neoplasm Excision
Surgical and medical procedures
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Aortic Elongation
Vascular disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Flushing
Vascular disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG00119 affected58 at risk
EG0020 affected55 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0004 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0012 affected58 at risk
EG0020 affected55 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Eye Haemorrhage
Eye disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Hypothermia
General disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Bronchitis Viral
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Furuncle
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Gastroenteritis Norovirus
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Gastroenteritis Salmonella
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Impetigo
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Periodontitis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Root Canal Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Rotavirus Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Blood Glucose Decreased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Breath Sounds Abnormal
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Lymphocyte Count Increased
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0022 affected55 at risk
EG003
Lymphocyte Morphology Abnormal
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0022 affected55 at risk
EG003
Protein Urine Present
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
White Blood Cells Urine Positive
Investigations
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Femoroacetabular Impingement
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Dysplastic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0022 affected55 at risk
EG003
Cervicogenic Vertigo
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Ketonuria
Renal and urinary disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0011 affected58 at risk
EG0020 affected55 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0001 affected60 at risk
EG0010 affected58 at risk
EG0020 affected55 at risk
EG003
Peripheral Venous Disease
Vascular disorders
MedDRA Version 19.1
Non-systematic Assessment
EG0000 affected60 at risk
EG0010 affected58 at risk
EG0021 affected55 at risk
EG003
In Part III, small groups with less subjects generated through Part IIb, and further decline in subjects enrolled in Part III (ie, subjects started guselkumab (GUS) at Week 0/ switched from FAE to GUS in Week 32, and had PASI 90 response at Week 56).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00090.0
OG00127.1
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00061.7
OG00116.9
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00031.7
OG0013.4
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00158
Title
Denominators
Categories
Sign score
Title
Measurements
OG000-59.8± 18.3
OG001-39.7± 26.7
Symptom score
Title
Measurements
OG000-52.0± 22.0
OG001-34.0± 25.4
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00158
Title
Denominators
Categories
Itch score
Title
Measurements
OG000-5.85± 2.83
OG001-3.90± 2.86
Pain score
Title
Measurements
OG000-5.07± 2.86
OG001-2.93± 3.12
Scaling score
Title
Measurements
OG000-6.48± 2.25
OG001-4.43± 3.02
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00110.2
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00051.7
OG0016.8
Units
Counts
Participants
OG00059
OG00157
Title
Denominators
Categories
Title
Measurements
OG000-18.5± 10.4
OG001-9.2± 11.2
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00060
OG00158
Title
Denominators
Categories
Title
Measurements
OG000-15.2± 5.1
OG001-9.4± 7.2
Units
Counts
Participants
OG00054
OG00153
Title
Denominators
Categories
Title
Measurements
OG00048.1
OG00113.2
OG001
Part I: Fumaric Acid Esters (FAE)
Participants received FAE initial/FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study.
Units
Counts
Participants
OG00059
OG00157
Title
Denominators
Categories
SF-36 PCS scores
Title
Measurements
OG0008.0± 6.9
OG0012.3± 8.2
SF-36 MCS scores
Title
Measurements
OG0005.8± 10.6
OG0016.5± 9.3
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00098.1
OG00164.3
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00085.2
OG00135.7
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00064.8
OG00121.4
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00098.1
OG00164.3
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00090.7
OG00150.0
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00053.7
OG00121.4
OG001
Part IIb: Fumaric Acid Esters (FAE)
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00054
OG00114
Title
Denominators
Categories
Title
Measurements
OG00072.2
OG00128.6
OG001
Part I/IIa: FAE
In Part I, participants received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00090.0
OG00123.7
OG001
Part I/IIa: FAE
In Part I, participants received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00078.3
OG00111.9
OG001
Part I/IIa: FAE
In Part I, participants received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00043.3
OG0016.8
OG001
Part I/IIa: FAE
In Part I, participants received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
Title
Measurements
OG00063.3
OG00116.9
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG00047.2
OG00125.0
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG000315(301 to NA)The upper bound of the 95 percent confidence interval (CI) for median was not reached due to insufficient event rate.
OG001293(219 to 315)
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG000306(227 to 308)
OG001226(141 to 308)
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG000336(322 to NA)The upper bound of the 95 percent confidence interval (CI) for median was not reached due to insufficient event rate.
OG001321(251 to 350)
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG000334(252 to 337)
OG001254(173 to 329)
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG00013.9
OG0018.3
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG0005.6
OG0010.0
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
PASI Score <=1
Title
Measurements
OG0008.3
OG0010.0
PASI Score <=2
Title
Measurements
OG00019.4
OG0018.3
PASI Score <=3
Title
Measurements
OG00030.6
OG00116.7
PASI Score <=5
Title
Measurements
OG00047.2
OG00125.0
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Symptom Score at Baseline (Week 56)
Title
Measurements
OG0003.4± 5.4
OG00111.2± 13.2
Change in Symptom score at Week 100
Title
Measurements
OG00025.1± 24.7
OG00130.7± 21.7
Sign Score at Baseline (Week 56)
Title
Measurements
OG0005.4± 9.3
OG00113.5± 12.9
Change in Sign score at Week 100
Title
Measurements
OG00029.4± 24.8
OG00137.9± 28.7
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG0008.3
OG0010.0
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG00030.6
OG00116.7
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Baseline (Week 56)
Title
Measurements
OG0000.9± 1.2
OG0011.5± 2.1
Change at Week 100
Title
Measurements
OG0006.1± 6.3
OG0019.1± 5.8
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG00025
OG0018.3
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Baseline (Week 56)
Title
Measurements
OG0000.9± 1.3
OG0013.5± 4.0
Change at Week 100
Title
Measurements
OG0005.3± 6.0
OG0018.0± 5.4
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
Title
Measurements
OG00025
OG0018.3
Units
Counts
Participants
OG00034
OG00112
Title
Denominators
Categories
Title
Measurements
OG00014.7
OG0018.3
Units
Counts
Participants
OG00034
OG00112
Title
Denominators
Categories
Title
Measurements
OG00032.4
OG00125.0
OG001
Part III: FAE to Guselkumab
At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at Week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Participants who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Participants who switched from FAE to GUS treatment at Week 32, had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
Units
Counts
Participants
OG00036
OG00112
Title
Denominators
Categories
SF-36 PCS scores: Baseline (Week 56)
Title
Measurements
OG00057.8± 3.0
OG00154.9± 5.5
SF-36 PCS scores: Change at Week 100
Title
Measurements
OG000-4.3± 6.7
OG001-3.7± 7.0
SF-36 MCS scores: Baseline (Week 56)
Title
Measurements
OG00053.4± 6.2
OG00144.2± 11.3
SF-36 MCS scores: Change at Week 100
Title
Measurements
OG000-2.8± 5.9
OG001-3.1± 5.9
OG001
Part I/IIa: FAE
In Part I, participants received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Participants who completed the treatment phase until Week 24 entered the Part II of the study. Participants who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For participants who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.
Units
Counts
Participants
OG00060
OG00158
Title
Denominators
Categories
Title
Measurements
OG00078.3
OG00198.3
At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study (study Part IIb) up to Week 56. For participants, who discontinued study, a safety follow up was done at Week 64 (Part II)or 12 weeks after last treatment (whatever came first). For all participants who continued study, safety was followed-up at every visit.