A Long-term Study of Baricitinib (LY3009104) With Topical... | NCT03428100 | Trialant
NCT03428100
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 14, 2024Actual
Enrollment
463Actual
Phase
Phase 3
Conditions
Atopic Dermatitis
Interventions
Baricitinib
Placebo
Topical corticosteroid
Countries
Austria
Belgium
Brazil
Finland
France
Germany
Italy
Japan
Netherlands
Poland
Russia
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03428100
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16841
Secondary IDs
ID
Type
Description
Link
I4V-MC-JAIN
Other Identifier
Eli Lilly and Company
2017-004574-34
EudraCT Number
Brief Title
A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable
Official Title
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate-to-Severe Atopic Dermatitis Who Have Experienced Failure to Cyclosporine or Are Intolerant to, or Have Contraindication to, Cyclosporine
Acronym
BREEZE-AD4
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 15, 2024
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
May 15, 2018Actual
Primary Completion Date
Nov 25, 2019Actual
Completion Date
Apr 20, 2023Actual
First Submitted Date
Feb 5, 2018
First Submission Date that Met QC Criteria
Feb 5, 2018
First Posted Date
Feb 9, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 26, 2020
Results First Submitted that Met QC Criteria
Jan 15, 2021
Results First Posted Date
Jan 19, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 18, 2024
Last Update Posted Date
May 14, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Incyte Corporation
INDUSTRY
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.
Detailed Description
Not provided
Conditions Module
Conditions
Atopic Dermatitis
Keywords
eczema
atopic eczema
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
463Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
4 mg Baricitinib
Experimental
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
2 mg Baricitinib
Experimental
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
1 mg Baricitinib
Experimental
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
Placebo
Placebo Comparator
Placebo administered orally once daily in combination with topical corticosteroids. Additional Placebo administered orally to maintain the blind.
Drug: Placebo
Drug: Topical corticosteroid
Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Baricitinib
Drug
Administered orally.
1 mg Baricitinib
2 mg Baricitinib
4 mg Baricitinib
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who permanently discontinue, are rescued, or are without at least 1 post-baseline observation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have been diagnosed with moderate to severe Atopic Eczema (Atopic Dermatitis) for at least 12 months.
Have had inadequate response to existing topical (applied to the skin) medications within 6 months preceding screening.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Agree to use emollients daily.
Have a medical contraindication to cyclosporine, or had intolerance and/or unacceptable toxicity or inadequate response to cyclosporine in the past.
Exclusion Criteria:
Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or are currently being treated, with topical or systemic antibiotics.
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
Have been treated with the following therapies:
Monoclonal antibody for less than 5 half-lives prior to randomization.
Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
Received oral corticosteroids within 4 weeks prior to randomization or parenteral corticosteroids administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
Have had an intra-articular corticosteroid injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
Have had major surgery within the past eight weeks or are planning major surgery during the study.
Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent and/or clinically serious viral, bacterial, fungal, or parasitic infection including but not limited to herpes zoster, tuberculosis.
Have specific laboratory abnormalities related to thyroid, renal and liver function, or blood cells.
Have received certain treatments that are contraindicated.
Pregnant or breastfeeding.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.
A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis (Eczema) Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Adv
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
FG001
1 mg Baricitinib
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment Week 0 to Week 52
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 6, 2019
Aug 4, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
Experimental
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
Experimental
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
Experimental
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo Comparator
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Drug: Placebo
Drug: Topical corticosteroid
LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Experimental
Placebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Drug: Placebo
Drug: Topical corticosteroid
LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
Placebo
Week 16
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Week 16
Percentage of Participants Achieving EASI90
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
Week 16
Percent Change From Baseline in EASI Score
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease).
Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline score and baseline score-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Week 16
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Week 16
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
The ADSS is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep due to itch, frequency of waking due to itch, and difficulty getting back to sleep last night due to itch. Item 2 frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.
LS Mean were calculated using an MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Change From Baseline in Skin Pain NRS
Skin Pain NRS is a participant-administered,11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.
LS Mean were calculated using MMRM model includes treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Percentage of Participants Achieving IGA of 0 or 1 With a >=2-point Improvement
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Week 24
Percentage of Participants Achieving EASI50
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI50 is defined as a ≥ 50% improvement from baseline in the EASI score.
Week 16
Percentage of Participants Achieving EASI75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 24
Percentage of Participants Achieving IGA of 0
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Week 16
Change From Baseline in SCORAD
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Percentage of Participants Achieving SCORAD90
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score.
Week 16
Change From Baseline in Body Surface Area (BSA) Affected
The BSA affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Percentage of participants developing skin infections requiring antibiotic treatment.
Week 16
Mean Number of Days Without Topical Corticosteroids (TCS) Use
The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors.
Week 16
Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)
Average weights of full tubes were used to determine the dispensed weights for each region. Returned tubes were weighed with cap without carton to determine the amount of TCS in grams (g) used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.
Week 16
Percent Change From Baseline in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Baseline, Week 16
Percent Change From Baseline in Itch NRS at Week 24
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Baseline, Week 24
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by visit-interactions as fixed continuous effects.
Baseline, Week 16
Change From Baseline in the Patient Global Impression of Severity - Atopic Dermatitis (PGI-S-AD) Score
The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe."
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Change From Baseline in the Dermatology Life Quality Index (DLQI)
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Baseline, Week 16
Percentage of Participants Achieving EASI75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 52
Percent Change From Baseline in Itch NRS at Week 52
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Baseline, Week 52
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Week 68
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Week 104
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Week 68
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Week 104
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 68
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 104
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Week 68
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 68
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 104
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 68 Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 68
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 68
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Week 104
Percentage of Participants With A Response of EASI75 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 68
Percentage of Participants With A Response of EASI75 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Week 104
Time to Retreatment (Time to IGA ≥3) Randomized Downtitration (All Patients Entering the Substudy)
Participants who entered the Substudy and relapsed with an IGA ≥3.
Week 52 Up to Week 200
Innsbruck
Tyrol
6020
Austria
KA Rudolfstiftung
Vienna
1030
Austria
AKH
Vienna
1090
Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna
1220
Austria
Universitair Ziekenhuis Brussel
Brussels
1090
Belgium
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
UZ Leuven - Campus Sint-Rafaël
Leuven
3000
Belgium
Cedoes Centro Diagnostico Pequisa Osteoporose E Santo Ltd
Vitória
Espírito Santo
29055 450
Brazil
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro
Rio de Janeiro
22271-100
Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil
Rio de Janeiro
Rio de Janeiro
22470-220
Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Rio Grande do Sul
90020-090
Brazil
Hospital Moinhos de Vento - Instituto de Educação e Pesquisa
Porto Alegre
Rio Grande do Sul
90560-030
Brazil
Faculdade de Ciências Médicas - UNICAMP
Campinas
São Paulo
13083-887
Brazil
Hospital das Clinicas da FMRP
Ribeirão Preto
São Paulo
14048-900
Brazil
Fundação Faculdade de Medicina do ABC
Santo André
São Paulo
09060-650
Brazil
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo
05403-000
Brazil
Terveystalo Tampere
Tampere
Irkanmaa
33100
Finland
Helsinki University Central Hospital
Helsinki
00250
Finland
Hospital Mehiläinen Neo
Turku
20520
Finland
Hôpital de Pontchaillou
Rennes
Cedex 9
35033
France
CHU de Besancon Hopital Jean Minjoz
Besançon
25030
France
CHU de Bordeaux Hopital Saint Andre
Bordeaux
33075
France
Hôpital C. HURIEZ
Lille
59037
France
Hôpital Emile Muller
Mulhouse
68100
France
Chru De Nantes Hotel-Dieu
Nantes
44093
France
CHU de Nice Hopital de L'Archet
Nice
06202
France
Hopital Sainte Anne (H.I.A)
Toulon
83800
France
Hopital Larrey
Toulouse
31059
France
Centre Hospitalier de Valence
Valence
26953
France
Universitätsklinikum Heidelberg
Heidelberg
Baden-Wurttemberg
69120
Germany
Hautarztpraxis Dr. Leitz und Kollegen
Stuttgart
Baden-Wurttemberg
70178
Germany
Universitätsklinikum Erlangen
Erlangen
Bavaria
91054
Germany
Klinikum Rechts der Isar der TU München
München
Bavaria
80802
Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
State scientific centre for dermatovenerology and cosmetolog
Moscow
107076
Russia
First Moscow State Medical University n.a. Sechenov
Moscow
119991
Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg
194021
Russia
LLC ArsVitae NorthWest
Saint Petersburg
194223
Russia
LLC Medical Center "Kurator"
Saint Petersburg
196240
Russia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Hospital Univ. Puerta de Hierro
Majadahonda
Madrid
28220
Spain
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón
Madrid
28223
Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz
Madrid
28850
Spain
Hospital de Manises
Manises
Valencia
46940
Spain
Hospital De Basurto
Bilbao
Vizcaya
48013
Spain
Hospital Universitario Dr Pesset
Valencia
46017
Spain
Kantonsspital St. Gallen
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
Inselspital Bern
Bern
3010
Switzerland
Universitätsspital Zürich
Zurich
8091
Switzerland
Salford Royal NHS Foundation Trust
Salford
Greater Manchester
M6 8HD
United Kingdom
West Glasgow Ambulatory Care Hospital
Glasgow
Lanarkshire
G3 8SJ
United Kingdom
Whipps Cross University Hospital
Leytonstone
London
E11 1NR
United Kingdom
Broadgreen Hospital
Liverpool
Merseyside
L14 3LB
United Kingdom
Guys/St. Thomas Hospital
London
Surrey
SE1 9RT
United Kingdom
The Dudley Group NHS Foundation Trust
Dudley
West Midlands
DY1 2HQ
United Kingdom
Derived
King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
FG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG003
4 mg Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG004
Long Term Extension(LTE) Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG008
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG009
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG010
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG011
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
FG012
LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG013
LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG014
LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG015
LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG016
LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG017
LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG018
LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Placebo rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
FG00093 subjects
FG00193 subjects
FG002185 subjects
FG00392 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Received at Least One Dose of Study Drug
FG00093 subjects
FG00193 subjects
FG002184 subjects
FG00392 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
COMPLETED
FG00072 subjects
FG00180 subjects
FG002173 subjects
FG00385 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
NOT COMPLETED
FG00021 subjects
FG00113 subjects
FG00212 subjects
FG0037 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Lack of Efficacy
FG00016 subjects
FG00110 subjects
FG0027 subjects
FG0036 subjects
FG004
Protocol Deviation
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Long-Term Extension Week 52 to Week 200
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants who completed the study through Week 52 progressed to the Long-term Extension Phase.
FG0010 subjectsParticipants who completed the study through Week 52 progressed to the Long-term Extension Phase.
FG0020 subjectsParticipants who completed the study through Week 52 progressed to the Long-term Extension Phase.
FG0030 subjectsParticipants who completed the study through Week 52 progressed to the Long-term Extension Phase.
FG00416 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization, were receiving investigational product, and had not used high- or ultra-high-potency TCS in the previous 14 days were enrolled into the downtitration substudy.
FG00516 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization, were receiving investigational product, and had not used high- or ultra-high-potency TCS in the previous 14 days were enrolled into the downtitration substudy.
FG00625 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization, were receiving investigational product, and had not used high- or ultra-high-potency TCS in the previous 14 days were enrolled into the downtitration substudy.
FG00724 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization, were receiving investigational product, and had not used high- or ultra-high-potency TCS in the previous 14 days were enrolled into the downtitration substudy.
FG0087 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who received Baricitinib 4 mg, 2 mg, 1 mg or placebo and were not eligible for the randomized downtitration substudy remained on their current dose of Baricitinib. If worsening of the symptoms occurred (IGA is ≥3), those receiving Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG00922 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who received Baricitinib 4 mg, 2 mg, 1 mg or placebo and were not eligible for the randomized downtitration substudy remained on their current dose of Baricitinib. If worsening of the symptoms occurred (IGA is ≥3), those receiving Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01034 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who received Baricitinib 4 mg, 2 mg, 1 mg or placebo and were not eligible for the randomized downtitration substudy remained on their current dose of Baricitinib. If worsening of the symptoms occurred (IGA is ≥3), those receiving Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01129 subjectsAt Week 52: Responders (IGA 0 or 1) and partial responders (IGA 2) who received Baricitinib 4 mg, 2 mg, 1 mg or placebo and were not eligible for the randomized downtitration substudy remained on their current dose of Baricitinib. If worsening of the symptoms occurred (IGA is ≥3), those receiving Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01224 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01327 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01426 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01513 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01614 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01711 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
FG01812 subjectsAt Week 52: Nonresponders (IGA ≥ 3) in the Placebo, Baricitinib 2 mg or 1 mg were rerandomized (1:1) to Baricitinib 4 mg or 2 mg.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
BG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
BG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
BG003
4 mg Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00093
BG00193
BG002185
BG00392
BG004463
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.7± 13.6
BG00138.9± 14.0
BG00237.3± 13.6
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00044
BG00135
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Austria
Title
Measurements
BG0001
BG0013
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 Achieving Eczema Area and Severity Index 75 (EASI75) (Placebo, 2 mg or 4 mg Baricitinib)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
All participants randomized to placebo, 2 mg or 4 mg of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
4 mg Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Units
Counts
Participants
OG00093
OG001185
OG00292
Title
Denominators
Categories
Title
Measurements
OG00017.2(10.9 to 26.1)
OG00127.6(21.6 to 34.4)
OG00231.5(22.9 to 41.6)
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
Regression, Logistic
0.071
Odds Ratio (OR)
1.78
2-Sided
95
0.95
3.32
Superiority
OG000
OG002
Regression, Logistic
0.031
Secondary
Percentage of Participants Achieving EASI75 (Placebo, 1 mg Baricitinib)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who permanently discontinue, are rescued, or are without at least 1 post-baseline observation.
All participants randomized to placebo or 1 mg of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids.
Placebo administered orally to maintain the blind
Secondary
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
4 mg Baricitinib
Secondary
Percentage of Participants Achieving EASI90
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
Secondary
Percent Change From Baseline in EASI Score
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease).
Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline score and baseline score-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 EASI data.
Posted
Geometric Least Squares Mean
Standard Error
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
All randomized participants with a baseline Itch NRS score >=4.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
The ADSS is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep due to itch, frequency of waking due to itch, and difficulty getting back to sleep last night due to itch. Item 2 frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.
LS Mean were calculated using an MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Change From Baseline in Skin Pain NRS
Skin Pain NRS is a participant-administered,11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.
LS Mean were calculated using MMRM model includes treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 Skin Pain NRS data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants Achieving IGA of 0 or 1 With a >=2-point Improvement
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
4 mg Baricitinib
Secondary
Percentage of Participants Achieving EASI50
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI50 is defined as a ≥ 50% improvement from baseline in the EASI score.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
Secondary
Percentage of Participants Achieving EASI75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
2 mg Baricitinib
Secondary
Percentage of Participants Achieving IGA of 0
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
4 mg Baricitinib
Secondary
Change From Baseline in SCORAD
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 SCORAD data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Percentage of Participants Achieving SCORAD90
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the SCORAD score.
All randomized participants.
Posted
Number
95% Confidence Interval
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Change From Baseline in Body Surface Area (BSA) Affected
The BSA affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 BSA data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
Percentage of participants developing skin infections requiring antibiotic treatment.
All randomized participants who received at least one dose of study drug and who did not discontinue from the study for the reason of "Lost to Follow-up" at the first post-baseline visit.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
4 mg Baricitinib
Secondary
Mean Number of Days Without Topical Corticosteroids (TCS) Use
The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors.
All randomized participants without use of TCS.
Posted
Least Squares Mean
Standard Error
days
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
4 mg Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Mean Gram Quantity of Low and Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)
Average weights of full tubes were used to determine the dispensed weights for each region. Returned tubes were weighed with cap without carton to determine the amount of TCS in grams (g) used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.
All randomized participants.
Posted
Least Squares Mean
Standard Error
grams
Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
Secondary
Percent Change From Baseline in Itch NRS
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
All randomized participants with Week 16 Itch NRS data.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally every day in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percent Change From Baseline in Itch NRS at Week 24
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
All randomized participants with Week 24 itch NRS data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally every day in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally every day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by visit-interactions as fixed continuous effects.
All randomized participants with Week 16 POEM data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered once daily day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
Secondary
Change From Baseline in the Patient Global Impression of Severity - Atopic Dermatitis (PGI-S-AD) Score
The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe."
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 PGI-S-AD data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
LS Mean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 HADS data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
Secondary
Change From Baseline in the Dermatology Life Quality Index (DLQI)
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered or "not relevant" responses scored as "0." Scores range from 0 to 30 ("no impact on participant's life" to "extremely large effect on participant's life"), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 DLQI data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 WPAI-AD data.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Change From Baseline in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with EQ-5D-5L US and UK Health scores.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
Secondary
Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)
EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
All randomized participants with Week 16 EQ-5D-5L VAS data.
Posted
Least Squares Mean
Standard Error
millimeters (mm)
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants Achieving EASI75
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered once daily day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
2 mg Baricitinib
Secondary
Percent Change From Baseline in Itch NRS at Week 52
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
All randomized participants with Week 52 Itch NRS data.
Posted
Least Squares Mean
Standard Error
Percent Change
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
OG001
1 mg Baricitinib
1 mg Baricitinib administered once daily day in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
OG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
LTE Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
LTE Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (All Participants Entering the Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
LTE Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of EASI75 From Baseline Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (All Participants Entering the Substudy)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
LTE Substudy 4mg Baricitinib to 4mg Baricitinib (Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using modified last observation carried forward (mLOCF).
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
LTE Substudy 4mg Baricitinib to 4mg Baricitinib(Responders/Partial Responders)
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1 Assessed at 16 Weeks After Rerandomization (Week 104) Randomized Downtitration (Participants Entering the Substudy With IGA 0 or 1)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN and entered the downtitration substudy with IGA 0 or 1 at Week 52. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 68 Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG001
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG001
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG001
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. All missing values were imputed using mLOCF.
Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG001
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With A Response of EASI75 Assessed at Week 68 - Participants Not Entered Into Substudy (All Participants)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 68
ID
Title
Description
OG000
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Percentage of Participants With A Response of EASI75 Assessed at Week 104 - Participants Not Entered Into Substudy (All Participants)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (no disease) to 72 (severe disease). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Participants who received at least one study medication Week 52 to Week 200 in Study JAIN, and were Responders (IGA 0 or 1) and Partial Responders (IGA 2) at Week 52 but were not eligible for downtitration substudy (i.e. had study drug interrupted at Week 52, or had received high or ultra-high potency TCS in the previous 14 days). Additionally, those participants who did not met study discontinuation criteria and continued will be considered in the analysis set.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Secondary
Time to Retreatment (Time to IGA ≥3) Randomized Downtitration (All Patients Entering the Substudy)
Participants who entered the Substudy and relapsed with an IGA ≥3.
Participants who received at least one study medication during Week 52 to Week 200 in Study JAIN, entered the downtitration substudy and experienced relapse from Week 52 up to Week 200. Additionally, those participants who did not meet study discontinuation criteria and continued will be considered in the analysis set.
Posted
Median
95% Confidence Interval
Days
Week 52 Up to Week 200
ID
Title
Description
OG000
4 mg Baricitinib to 4 mg Baricitinib to 4 mg Baricitinib
4 mg Baricitinib participants randomized to 4 mg Baricitinib in the downtitration substudy who experienced worsening symptoms (IGA increased to ≥3), were retreated with their presubstudy 4 mg Baricitinib dose.
OG001
4 mg Baricitinib to 2 mg Baricitinib to 4 mg Baricitinib
4 mg Baricitinb participants randomized to 2 mg Baricitinib in the downtitration substudy who experienced worsening symptoms (IGA increased to ≥3), were retreated with their presubstudy 4 mg Baricitinib dose.
OG002
2 mg Baricitinib to 2 mg Baricitinib to 2 mg Baricitinib
2 mg Baricitinb participants randomized to 2 mg Baricitinib in the downtitration substudy who experienced worsening symptoms (IGA increased to ≥3), were retreated with their presubstudy 2 mg Baricitinib dose.
Time Frame
Baseline up to Week 200
Description
All randomized participants who received at least 1 dose of investigational product and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first postbaseline visit. This definition excludes participants with no safety assessments postbaseline so that incidence rates are not underestimated. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
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
Placebo administered orally once daily in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
0
93
5
93
50
93
EG001
1 mg Baricitinib
1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
.
0
93
7
93
63
93
EG002
2 mg Baricitinib
2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
185
9
184
130
184
EG003
4 mg Baricitinib
4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
92
10
92
75
92
EG004
Long Term Extension(LTE) Substudy 2mg Baricitinib to 1mg Baricitinib (Responders/Partial Responders)
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
16
3
16
16
16
EG008
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
0
29
1
29
16
29
EG009
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
34
1
34
25
34
EG010
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
22
1
22
16
22
EG011
LTE 4 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
7
2
7
7
7
EG012
LTE Placebo to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Placebo rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
11
1
11
6
11
EG013
LTE Placebo to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
Placebo rerandomized to 4 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
12
2
12
10
12
EG014
LTE 1 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
1 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
13
2
13
11
13
EG015
LTE 1 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
1 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
14
3
14
13
14
EG016
LTE 2 mg Baricitinib to 2 mg Baricitinib (Non-responders) - Did Not Enter Substudy
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
27
3
27
18
27
EG017
LTE 2 mg Baricitinib to 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
2 mg Baricitinib rerandomized to 4 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
26
5
26
18
26
EG018
LTE 4 mg Baricitinib (Non-responders) - Did Not Enter Substudy
4 mg administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
0
24
4
24
16
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG0030 events0 affected92 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected16 at risk
EG0070 events0 affected16 at risk
EG0080 events0 affected29 at risk
EG0090 events0 affected34 at risk
EG0100 events0 affected22 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected11 at risk
EG0130 events0 affected12 at risk
EG0140 events0 affected13 at risk
EG0150 events0 affected14 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected26 at risk
EG0180 events0 affected24 at risk
Cardiac arrest
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Soft tissue inflammation
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Corneal abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Eczema herpeticum
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Fracture infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Furuncle
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ophthalmic herpes simplex
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Papilloma viral infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Perichondritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Pyelitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Injury corneal
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Mouth injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events2 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected132 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tremor
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Device dislocation
Product Issues
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0012 events2 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Hypertrophic scar
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG0030 events0 affected92 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected16 at risk
EG0070 events0 affected16 at risk
EG0080 events0 affected29 at risk
EG0090 events0 affected34 at risk
EG0101 events1 affected22 at risk
EG0110 events0 affected7 at risk
EG0121 events1 affected11 at risk
EG0130 events0 affected12 at risk
EG0140 events0 affected13 at risk
EG0150 events0 affected14 at risk
EG0160 events0 affected27 at risk
EG0170 events0 affected26 at risk
EG0180 events0 affected24 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events1 affected93 at risk
EG0022 events1 affected184 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Blepharitis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0024 events4 affected184 at risk
EG003
Conjunctival irritation
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected93 at risk
EG0010 events0 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Dry eye
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0004 events4 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Glaucoma
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Keratoconus
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Noninfective conjunctivitis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected93 at risk
EG0013 events2 affected93 at risk
EG0027 events7 affected184 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0024 events4 affected184 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected93 at risk
EG0012 events2 affected93 at risk
EG00210 events9 affected184 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0013 events2 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events2 affected93 at risk
EG00211 events8 affected184 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Asthenia
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0004 events3 affected93 at risk
EG0013 events3 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Implant site pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected93 at risk
EG0010 events0 affected93 at risk
EG0026 events6 affected184 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0014 events3 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Swelling face
General disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0013 events3 affected93 at risk
EG0029 events7 affected184 at risk
EG003
Candida infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0024 events1 affected184 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0003 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0023 events2 affected184 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0024 events3 affected184 at risk
EG003
Covid-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ear infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0029 events9 affected184 at risk
EG003
Ear infection bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Eczema herpeticum
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0023 events2 affected184 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0025 events4 affected184 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0003 events2 affected93 at risk
EG00111 events9 affected93 at risk
EG00210 events9 affected184 at risk
EG003
Furuncle
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events2 affected93 at risk
EG0025 events4 affected184 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Genital infection bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0025 events5 affected184 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0014 events4 affected93 at risk
EG0026 events6 affected184 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Impetigo
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0025 events5 affected184 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0014 events3 affected93 at risk
EG00218 events15 affected184 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG00025 events14 affected93 at risk
EG00120 events16 affected93 at risk
EG00248 events36 affected184 at risk
EG003
Ophthalmic herpes simplex
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0006 events6 affected93 at risk
EG0017 events5 affected93 at risk
EG0029 events6 affected184 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Paronychia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Perichondritis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0004 events4 affected93 at risk
EG0011 events1 affected93 at risk
EG0024 events4 affected184 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events2 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Post-acute covid-19 syndrome
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events2 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Pyoderma
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0026 events6 affected184 at risk
EG003
Skin infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0014 events3 affected93 at risk
EG0024 events4 affected184 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Suspected covid-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0012 events2 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0025 events5 affected184 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0015 events4 affected93 at risk
EG00210 events7 affected184 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0027 events4 affected184 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected52 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected52 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0013 events2 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Post vaccination syndrome
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0012 events2 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0011 events1 affected93 at risk
EG0025 events5 affected184 at risk
EG003
Arthroscopy
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0013 events3 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Colonoscopy
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected132 at risk
EG003
Sars-cov-2 antibody test positive
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Sars-cov-2 test positive
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Weight increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0011 events1 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0023 events3 affected184 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0014 events4 affected93 at risk
EG0028 events7 affected184 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0006 events5 affected93 at risk
EG0019 events6 affected93 at risk
EG0027 events6 affected184 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0014 events3 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0021 events1 affected184 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0014 events3 affected93 at risk
EG0024 events3 affected184 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected93 at risk
EG0010 events0 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected93 at risk
EG0012 events2 affected93 at risk
EG0026 events5 affected184 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0011 events1 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0022 events2 affected184 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Hepatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected93 at risk
EG0010 events0 affected93 at risk
EG0020 events0 affected184 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Units
Counts
Participants
OG00016
OG00116
OG00225
OG00324
Title
Denominators
Categories
Title
Measurements
OG00043.8(23.1 to 66.8)
OG00125.0(10.2 to 49.5)
OG00244.0(26.7 to 62.9)
OG0038.3(2.3 to 25.8)
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Units
Counts
Participants
OG00016
OG00116
OG00225
OG00324
Title
Denominators
Categories
Title
Measurements
OG00075.0(50.5 to 89.8)
OG00156.3(33.2 to 76.90)
OG00272.0(52.4 to 85.7)
OG00341.7(24.5 to 61.2)
4 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 2 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
2 mg Baricitinib rerandomized to 1 mg Baricitinib administered orally once daily in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
Units
Counts
Participants
OG00010
OG0019
OG00210
OG0039
Title
Denominators
Categories
Title
Measurements
OG00050.0(23.7 to 76.3)
OG00133.3(12.1 to 64.6)
OG00290.0(59.6 to 98.2)
OG00322.2(6.3 to 54.7)
OG002
LTE 1 mg Baricitinib (Responders/ Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Units
Counts
Participants
OG0007
OG00122
OG00234
OG00329
Title
Denominators
Categories
Title
Measurements
OG000100(64.6 to 100)
OG00186.4(66.7 to 95.3)
OG002100(89.8 to 100)
OG00393.1(78.0 to 98.1)
OG002
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Units
Counts
Participants
OG0007
OG00122
OG00234
OG00329
Title
Denominators
Categories
Title
Measurements
OG000100(64.6 to 100)
OG00186.4(66.7 to 95.3)
OG00297.1(85.1 to 99.5)
OG00393.1(78.0 to 98.1)
OG002
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Units
Counts
Participants
OG0007
OG00122
OG00234
OG00329
Title
Denominators
Categories
Title
Measurements
OG00014.3(2.6 to 51.3)
OG00150.0(30.7 to 69.3)
OG00247.1(31.5 to 63.3)
OG00351.7(34.4 to 68.6)
OG002
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Units
Counts
Participants
OG0007
OG00122
OG00234
OG00329
Title
Denominators
Categories
Title
Measurements
OG00042.9(15.8 to 75.0)
OG00150.0(30.7 to 69.3)
OG00247.1(31.5 to 63.3)
OG00348.3(31.4 to 65.6)
OG001
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Units
Counts
Participants
OG0007
OG00122
OG00234
OG00329
Title
Denominators
Categories
Title
Measurements
OG00057.1(25.0 to 84.2)
OG00163.6(43.0 to 80.3)
OG00276.5(60.0 to 87.6)
OG00362.1(44.0 to 77.3)
OG001
LTE 2 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
2 mg Baricitinib administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG002
LTE 1 mg Baricitinib (Responders/Partial Responders) - Did Not Enter Substudy
1 mg administered orally once daily (continued previous dose) in combination with topical corticosteroids. Placebo administered orally to maintain the blind.
OG003
LTE Placebo (Responders/Partial Responders) - Did Not Enter Substudy
Placebo administered orally once daily (continued previous dose) in combination with topical corticosteroids. Additional placebo administered orally to maintain the blind.
Units
Counts
Participants
OG0007
OG00122
OG00234
OG00329
Title
Denominators
Categories
Title
Measurements
OG00085.7(48.7 to 97.4)
OG00168.2(47.3 to 83.6)
OG00270.6(53.8 to 83.2)
OG00372.4(54.3 to 85.3)
OG003
2 mg Baricitinib to 1 mg Baricitinib to 2 mg Baricitinib
2 mg Baricitinib participants randomized to 1 mg Baricitinib in the downtitration substudy who experienced worsening symptoms (IGA increased to ≥3), were retreated with their presubstudy 2 mg Baricitinib dose.
Units
Counts
Participants
OG0005
OG00111
OG00215
OG00320
Title
Denominators
Categories
Title
Measurements
OG000218(29 to NA)Upper Confidence Level (CI) not estimable due to censoring.