A Study of Guselkumab in the Treatment of Participants Wi... | NCT02207231 | Trialant
NCT02207231
Sponsor
Janssen Research & Development, LLC
Status
Completed
Last Update Posted
Jul 23, 2021Actual
Enrollment
837Actual
Phase
Phase 3
Conditions
Psoriasis
Interventions
Guselkumab 100 mg
Placebo for guselkumab
Adalimumab
Placebo for adalimumab
Countries
United States
Australia
Canada
Germany
Hungary
Poland
Russia
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02207231
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR105047
Secondary IDs
ID
Type
Description
Link
CNTO1959PSO3001
Other Identifier
Janssen Research & Development, LLC
2014-000719-15
EudraCT Number
Brief Title
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Official Title
Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Acronym
VOYAGE 1
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jul 2021
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
Nov 26, 2014Actual
Primary Completion Date
Sep 29, 2015Actual
Completion Date
Jun 17, 2020Actual
First Submitted Date
Jul 31, 2014
First Submission Date that Met QC Criteria
Jul 31, 2014
First Posted Date
Aug 4, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 25, 2017
Results First Submitted that Met QC Criteria
Sep 15, 2017
Results First Posted Date
Oct 19, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 13, 2016
Certification/Extension First Submitted that Passed QC Review
Jun 13, 2016
Certification/Extension First Posted Date
Jun 15, 2016Estimated
Last Update Submitted Date
Jul 22, 2021
Last Update Posted Date
Jul 23, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
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 this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.
Detailed Description
This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab in participants with moderate to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8 weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study is defined as the time the last participant completes the Week 264 visit. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.
Conditions Module
Conditions
Psoriasis
Keywords
Psoriasis
Plaque-type psoriasis
Guselkumab
Adalimumab
CNTO 1959
Monoclonal antibody
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
837Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group I
Experimental
Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter [mL] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47.
Drug: Guselkumab 100 mg
Drug: Placebo for guselkumab
Drug: Placebo for adalimumab
Group II
Placebo Comparator
Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47.
Drug: Guselkumab 100 mg
Drug: Placebo for guselkumab
Drug: Placebo for adalimumab
Group III
Active Comparator
Participants received Adalimumab 80 mg at Week 0 (two 40 mg [0.8 mL] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252.
Drug: Guselkumab 100 mg
Drug: Placebo for guselkumab
Drug: Adalimumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Guselkumab 100 mg
Drug
100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Must be a candidate for either systemic therapy or phototherapy for psoriasis
Exclusion Criteria:
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)
Participants who have ever received guselkumab or adalimumab
History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
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 Research & Development, LLC Clinical Trial
Puig L, Costanzo A, de Jong EMGJ, Torres T, Warren RB, Wapenaar R, Wegner S, Gorecki P, Gramiccia T, Jazra M, Buyze J, Conrad C. Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial. Dermatol Ther (Heidelb). 2024 Sep;14(9):2539-2558. doi: 10.1007/s13555-024-01245-6. Epub 2024 Aug 17.
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.
80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.
Group III
HUMIRA®
Placebo for adalimumab
Drug
Subcutaneous injections to maintain the blind.
Group I
Group II
Week 24 and 48
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 24 and 48
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 24 and 48
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. 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 total score ranges 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. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Baseline, Week 16
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Week 16
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Week 16
Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Week 16
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
The PSSD (24-hour 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. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Baseline and Week 16
Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
The PSSD (24-hour 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.
Week 24
Percentage of Participants Who Achieved PASI 90 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved PASI 75 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. 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 total score ranges 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. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
The PSSD (24-hour version) is a 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 score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Week 252
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
The PSSD (24-hour version) is a 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 Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Blauvelt A, Langley RG, Branigan PJ, Liu X, Chen Y, DePrimo S, Ma K, Scott B, Campbell K, Munoz-Elias EJ, Papp KA. Guselkumab Reduces Disease- and Mechanism-Related Biomarkers More Than Adalimumab in Patients with Psoriasis: A VOYAGE 1 Substudy. JID Innov. 2024 Jun 5;4(5):100287. doi: 10.1016/j.xjidi.2024.100287. eCollection 2024 Sep.
Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15.
Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, ThaÒ«i D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
Puig L, Costanzo A, de Jong EMGJ, Torres T, Warren RB, Wapenaar R, Wegner S, Gorecki P, Gramiccia T, Jazra M, Buyze J, Conrad C. Guselkumab-Treated Patients with Plaque Psoriasis Who Achieved Complete Skin Clearance for >/= 156 Consecutive Weeks: A Post-Hoc Analysis From the VOYAGE 1 Clinical Trial. Am J Clin Dermatol. 2024 Mar;25(2):315-325. doi: 10.1007/s40257-023-00816-1. Epub 2023 Oct 7.
Kim BS, Jo SJ, Youn S, Reich K, Saadoun C, Chang CL, Yang YW, Huang YH, Tsai TF. Five-year Maintenance of Clinical Response and Consistent Safety Profile for Guselkumab in Asian patients with Psoriasis from VOYAGE 1 and VOYAGE 2. Dermatol Ther (Heidelb). 2023 Nov;13(11):2721-2737. doi: 10.1007/s13555-023-01026-7. Epub 2023 Sep 26.
Orbai AM, Chakravarty SD, You Y, Shawi M, Yang YW, Merola JF. Efficacy of Guselkumab in Treating Nails, Scalp, Hands, and Feet in Patients with Psoriasis and Self-reported Psoriatic Arthritis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2859-2868. doi: 10.1007/s13555-023-01012-z. Epub 2023 Sep 15.
Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, You Y, Han C, Yang YW, Foley P, Griffiths CEM. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.
Armstrong AW, Reich K, Foley P, Han C, Song M, Shen YK, You Y, Papp KA. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies. Am J Clin Dermatol. 2019 Feb;20(1):155-164. doi: 10.1007/s40257-018-0396-z.
Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, Li S, Shen YK, Blauvelt A. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018 Jun 1;154(6):676-683. doi: 10.1001/jamadermatol.2018.0793.
FG001
Guselkumab 100 mg
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.
FG002
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
FG003
Guselkumab Combined
All participants who received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
FG000174 subjects
FG001329 subjects
FG002334 subjects
FG0030 subjects
Treated
FG000174 subjects
FG001329 subjects
FG002333 subjects
FG0030 subjects
COMPLETED
FG000167 subjects
FG001322 subjects
FG002324 subjects
FG0030 subjects
NOT COMPLETED
FG0007 subjects
FG0017 subjects
FG00210 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
Lack of Efficacy
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Noncompliance
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
Active Controlled Period: Week 16 - 48
Type
Comment
Milestone Data
STARTED
FG000165 subjects2 participants did not cross-over.
FG001322 subjects
FG002324 subjects
FG0030 subjects
COMPLETED
FG000162 subjects
FG001301 subjects
FG002281 subjects
FG0030 subjects
NOT COMPLETED
FG0003 subjects
FG00121 subjects
FG00243 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0016 subjects
FG00210 subjects
FG003
Open-label Guselkumab: Week 48 - 264
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002280 subjectsOne participant did not crossover at Week 52 due to adverse event.
FG003463 subjects162 + 301= 463
COMPLETED
FG0000 subjects
FG0010 subjects
FG002242 subjects
FG003380 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00238 subjects
FG00383 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG00212 subjects
FG003
Randomized analysis set included all participants who were randomized at Week 0.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Then Guselkumab 100 mg
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.
BG001
Guselkumab 100 mg
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.
BG002
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000174
BG001329
BG002334
BG003837
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0023
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00044.9± 12.9
BG00143.9± 12.74
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00055
BG00189
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Australia
Title
Measurements
BG00013
BG00123
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
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
OG001
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Units
Counts
Participants
OG000174
OG001329
Title
Denominators
Categories
Title
Measurements
OG0006.9
OG00185.1
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
Cochran-Mantel-Haenszel chi-square test
<0.001
Superiority or Other (legacy)
Primary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
OG001
Guselkumab
Secondary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
OG001
Adalimumab
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Secondary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
OG001
Adalimumab
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.
Posted
Number
percentage of participants
Week 24 and 48
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. 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 total score ranges 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. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
OG001
Guselkumab
Secondary
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
OG001
Adalimumab
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
OG001
Adalimumab
Secondary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
OG001
Adalimumab
Secondary
Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group
The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (>=) 2 at baseline.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
OG001
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Secondary
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
The PSSD (24-hour 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. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).
Secondary
Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
The PSSD (24-hour 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.
PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
Secondary
Percentage of Participants Who Achieved PASI 90 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
OG001
Secondary
Percentage of Participants Who Achieved PASI 75 Response at Week 252
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
OG001
Secondary
Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
OG001
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Secondary
Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. 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 total score ranges 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. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score >1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
Secondary
Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
The PSSD (24-hour version) is a 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 score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score >0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
Secondary
Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
The PSSD (24-hour version) is a 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 Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score >0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.
Posted
Number
percentage of participants
Week 252
ID
Title
Description
OG000
Guselkumab Combined
All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.
Time Frame
Baseline (Week 0) up to Week 264
Description
Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.
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
Placebo (PCP)
Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.
3
174
51
174
EG001
Guselkumab 100 mg (PCP)
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.
8
329
101
329
EG002
Adalimumab (PCP)
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period.
6
333
98
333
EG003
Placebo Then Guselkumab 100 mg (ACP)
Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP).
5
165
67
165
EG004
Guselkumab 100 mg (ACP)
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.
8
324
134
324
EG005
Adalimumab (ACP)
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
10
326
137
326
EG006
Adalimumab Then Guselkumab 100 mg (After ACP)
Participants initially randomized to adalimumab entered a washout period after their final dose at Week 47 and crossed over to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252. This arm reports safety data for participants that crossed over to guselkumab from adalimumab.
34
280
193
280
EG007
Guselkumab Combined
All participants who crossed over to receive guselkumab (GUS) 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab. Participants that discontinued treatment prematurely were followed up for safety and hence were included in the safety data. Therefore, combined safety results are reported for this arm. This arm reports safety data for guselkumab.
79
494
307
494
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0021 affected333 at risk
EG0030 affected165 at risk
EG0040 affected324 at risk
EG0050 affected326 at risk
EG0060 affected280 at risk
EG0070 affected494 at risk
Angina Pectoris
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Aortic Valve Incompetence
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0021 affected333 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Sinus Node Dysfunction
Cardiac disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Dermoid Cyst
Congenital, familial and genetic disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Duodenal Ulcer
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Enterocutaneous Fistula
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Intestinal Strangulation
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Hernia
General disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Cholangitis Acute
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Ischaemic Hepatitis
Hepatobiliary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Abdominal Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0022 affected333 at risk
EG003
Chronic Tonsillitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Erysipelas
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Ovarian Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pneumonia Staphylococcal
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Scrotal Abscess
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Varicella
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Abdominal Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Avulsion Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Cervical Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0021 affected333 at risk
EG003
Chest Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Foreign Body
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Jaw Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Meniscus Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Post Procedural Fistula
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Procedural Hypotension
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0021 affected333 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Soft Tissue Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Tendon Injury
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Thoracic Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Human Chorionic Gonadotropin Increased
Investigations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Chondromalacia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Dupuytren's Contracture
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Intervertebral Disc Disorder
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Lateral Patellar Compression Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Meniscal Degeneration
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Trigger Finger
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Astrocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Bladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Epiglottic Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Gastric Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Invasive Papillary Breast Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Laryngeal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Malignant Melanoma in Situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Papillary Cystadenoma Lymphomatosum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Rectal Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Balance Disorder
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Idiopathic Partial Epilepsy
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Lacunar Infarction
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Abortion Missed
Pregnancy, puerperium and perinatal conditions
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Completed Suicide
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Substance Abuse
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Ovarian Cyst Ruptured
Reproductive system and breast disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Pulmonary Sarcoidosis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Erythema Nodosum
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Erythrodermic Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Lichen Planus
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Peripheral Artery Stenosis
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0021 affected333 at risk
EG003
Thrombophlebitis Superficial
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0020 affected333 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected174 at risk
EG0012 affected329 at risk
EG0024 affected333 at risk
EG0036 affected165 at risk
EG0048 affected324 at risk
EG0054 affected326 at risk
EG00613 affected280 at risk
EG00728 affected494 at risk
Injection Site Erythema
General disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected174 at risk
EG0016 affected329 at risk
EG00217 affected333 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected174 at risk
EG0012 affected329 at risk
EG0023 affected333 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected174 at risk
EG0015 affected329 at risk
EG0022 affected333 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0012 affected329 at risk
EG0022 affected333 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG00017 affected174 at risk
EG00130 affected329 at risk
EG00236 affected333 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0010 affected329 at risk
EG0022 affected333 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0013 affected329 at risk
EG0021 affected333 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 23.0
Non-systematic Assessment
EG0009 affected174 at risk
EG00125 affected329 at risk
EG00216 affected333 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0003 affected174 at risk
EG00111 affected329 at risk
EG0028 affected333 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0002 affected174 at risk
EG0016 affected329 at risk
EG0025 affected333 at risk
EG003
Psoriatic Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0000 affected174 at risk
EG0011 affected329 at risk
EG0020 affected333 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0007 affected174 at risk
EG00114 affected329 at risk
EG00213 affected333 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0001 affected174 at risk
EG0012 affected329 at risk
EG0024 affected333 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 23.0
Non-systematic Assessment
EG00010 affected174 at risk
EG0015 affected329 at risk
EG0027 affected333 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 23.0
Non-systematic Assessment
EG0004 affected174 at risk
EG00110 affected329 at risk
EG0027 affected333 at risk
EG003
All participants were on guselkumab after Week 48; therefore, there was no concurrent control group within the study after Week 48.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 in writing, such publication will be withheld for up to an additional 60 days.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000588857
guselkumab
D000068879
Adalimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Lack of Efficacy
FG0000 subjects
FG0013 subjects
FG00211 subjects
FG0030 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0025 subjects
FG0030 subjects
Withdrawal by Subject
FG0001 subjects
FG0014 subjects
FG00210 subjects
FG0030 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Noncompliance
FG0000 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
Other
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
19 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0037 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG00311 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG00210 subjects
FG00328 subjects
Other
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG00311 subjects
3
Between 18 and 65 years
BG000164
BG001311
BG002315
BG003790
>=65 years
BG00010
BG00118
BG00216
BG00344
42.9
± 12.58
BG00343.7± 12.72
85
BG003229
Male
BG000119
BG001240
BG002249
BG003608
21
BG00357
Taiwan, Province Of China
Title
Measurements
BG00015
BG00131
BG00227
BG00373
Hungary
Title
Measurements
BG0007
BG0019
BG00214
BG00330
Poland
Title
Measurements
BG00022
BG00142
BG00243
BG003107
Russia
Title
Measurements
BG00021
BG00148
BG00249
BG003118
Canada
Title
Measurements
BG00024
BG00150
BG00248
BG003122
United States
Title
Measurements
BG00038
BG00165
BG00267
BG003170
Germany
Title
Measurements
BG00023
BG00141
BG00243
BG003107
Spain
Title
Measurements
BG0004
BG0018
BG00213
BG00325
Korea, Democratic People'S Republic Of
Title
Measurements
BG0007
BG00112
BG0029
BG00328
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Units
Counts
Participants
OG000174
OG001329
Title
Denominators
Categories
Title
Measurements
OG0002.9
OG00173.3
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
Cochran-Mantel-Haenszel chi-square test
<0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000329
OG001334
Title
Denominators
Categories
Week 24
Title
Measurements
OG00052.6
OG00129.3
Week 48
Title
Measurements
OG00050.5
OG00125.7
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
Week 24
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG000
OG001
Week 48
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000329
OG001334
Title
Denominators
Categories
Week 24
Title
Measurements
OG00084.2
OG00161.7
Week 48
Title
Measurements
OG00080.5
OG00155.4
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
Week 24
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG000
OG001
Week 48
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG001
Adalimumab
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Units
Counts
Participants
OG000329
OG001334
Title
Denominators
Categories
Week 24
Title
Measurements
OG00080.2
OG00153.0
Week 48
Title
Measurements
OG00076.3
OG00147.9
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
Week 24
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG000
OG001
Week 48
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Units
Counts
Participants
OG000174
OG001329
Title
Denominators
Categories
Title
Measurements
OG000-0.6± 6.36
OG001-11.2± 7.24
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
p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).
ANOVA
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000329
OG001334
Title
Denominators
Categories
Title
Measurements
OG00085.1
OG00165.9
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
p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).
MH Z-test
< 0.001
Difference in Percentage
19.3
2-Sided
95
12.9
25.7
Non-Inferiority or Equivalence (legacy)
non-inferiority margin= 10.0%
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
Units
Counts
Participants
OG000329
OG001334
Title
Denominators
Categories
Title
Measurements
OG00073.3
OG00149.7
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
p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).
MH Z-test
< 0.001
Difference in Percentage
24.1
2-Sided
95
17.0
31.0
Non-Inferiority or Equivalence (legacy)
non-inferiority margin= 10.0%
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.
Units
Counts
Participants
OG000329
OG001334
Title
Denominators
Categories
Title
Measurements
OG00091.2
OG00173.1
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
p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).
MH Z-test
< 0.001
Difference in percentage
18.0
2-Sided
95
12.4
23.8
Non-Inferiority or Equivalence (legacy)
non-inferiority margin= 10%
OG000
OG001
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000145
OG001277
Title
Denominators
Categories
Title
Measurements
OG00014.5
OG00183.4
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
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
OG001
Guselkumab
Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.
Units
Counts
Participants
OG000129
OG001249
Title
Denominators
Categories
Title
Measurements
OG000-3.0± 19.56
OG001-41.9± 24.61
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
p value is based on ANOVA model stratified by investigator site (pooled).
ANOVA
< 0.001
Superiority or Other (legacy)
OG001
Adalimumab
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.
Units
Counts
Participants
OG000248
OG001273
Title
Denominators
Categories
Title
Measurements
OG00036.3
OG00121.6
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
p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).
Cochran-Mantel-Haenszel chi-square test
< 0.001
Superiority or Other (legacy)
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Units
Counts
Participants
OG000391
OG001246
Title
Denominators
Categories
Title
Measurements
OG00084.1
OG00182.5
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Units
Counts
Participants
OG000391
OG001246
Title
Denominators
Categories
Title
Measurements
OG00093.9
OG00193.1
Units
Counts
Participants
OG000391
OG001246
Title
Denominators
Categories
Title
Measurements
OG00082.4
OG00182.9
OG001
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Units
Counts
Participants
OG000374
OG001235
Title
Denominators
Categories
Title
Measurements
OG00072.7
OG00174.0
OG001
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.
Units
Counts
Participants
OG000297
OG001200
Title
Denominators
Categories
Title
Measurements
OG00042.4
OG00148.0
OG001
Adalimumab Then Guselkumab 100 mg
Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.