A Study of Long-term Baricitinib (LY3009104) Therapy in A... | NCT03334435 | Trialant
NCT03334435
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 3, 2024Actual
Enrollment
1,645Actual
Phase
Phase 3
Conditions
Atopic Dermatitis
Interventions
Baricitinib
Placebo
Countries
Argentina
Australia
Austria
Czechia
Denmark
France
Germany
Hungary
India
Israel
Italy
Japan
Mexico
Poland
Russia
South Korea
Spain
Switzerland
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03334435
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16587
Secondary IDs
ID
Type
Description
Link
I4V-MC-JAHN
Other Identifier
Eli Lilly and Company
2017-000873-35
EudraCT Number
Brief Title
A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
Official Title
A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis
Acronym
BREEZE-AD3
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 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
Mar 28, 2018Actual
Primary Completion Date
Sep 21, 2020Actual
Completion Date
Jul 12, 2023Actual
First Submitted Date
Nov 3, 2017
First Submission Date that Met QC Criteria
Nov 3, 2017
First Posted Date
Nov 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Apr 14, 2022
Results First Submitted that Met QC Criteria
Jun 7, 2022
Results First Posted Date
Jul 1, 2022Actual
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
Aug 30, 2024
Last Update Posted Date
Sep 3, 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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.
Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.
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
1,645Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Responders and Partial Responders (RPR)-Placebo
Placebo Comparator
Responders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
Drug: Baricitinib
Drug: Placebo
RPR-Bari 1-milligram (mg)
Experimental
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
Drug: Baricitinib
RPR-Bari 2-mg
Experimental
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
RPR-Bari 4-mg
Experimental
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
Non-responders (NR): Bari 1 mg to 2 mg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Baricitinib
Drug
Administered orally
Bari 1 mg
Bari 2 mg
Bari 2-mg Open-Label Addendum
Bari 4 mg
NR: Bari 1 mg to 4 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 16, 36 and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 16, 36, and 52
Secondary Outcomes
Measure
Description
Time Frame
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Have participated in previous studies (JAHL, JAHM and JAIY) and met specific completion requirements for those studies, and do not meet any of the following Exclusions:
Exclusion Criteria:
Had investigational product permanently discontinued at any time during a previous Baricitinib study.
Had temporary investigational product interruption continue at the final study visit of a previous Baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study
OR
Have not participated in previous studies (JAHL, JAHM and JAIY) and satisfy the following criteria:
Inclusion Criteria:
Have been diagnosed with moderate to severe Atopic Dermatitis for at least 12 months.
Have had inadequate response or intolerance 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.
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 episode of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or is 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.
Received any 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, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
Have specific laboratory abnormalities.
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)
Thyssen JP, Werfel T, Barbarot S, Hunter HJA, Pierce E, Sun L, Cirri L, Buchanan AS, Lu N, Wollenberg A. Maintained improvement in physician- and patient-reported outcomes with baricitinib in adults with moderate-to-severe atopic dermatitis who were treated for up to 104 weeks in a randomized trial. J Dermatolog Treat. 2023 Dec;34(1):2190430. doi: 10.1080/09546634.2023.2190430.
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Participants who entered Study JAHN were classified as "Responders and Partial Responders (RPR): Investigator's Global Assessment (IGA) of (0, 1, or 2) at entry to study JAHN and never rescued in originating study" or "Non-responders (NR): those not meeting definition of RPR". The study has two treatment periods: Treatment period 1, from Week 0 up to Week 52, and Treatment period 2, from Week 52 through Week 200 which included randomized withdrawal and downtitration substudy (RWDT).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
FG001
Baricitinib (Bari) 1- Milligram (mg)
Periods
Title
Milestones
Reasons Not Completed
Treatment Period 1: 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: Original Protocol
Nov 27, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Eswatini
Ireland
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
Non-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
NR: Bari 1 mg to 4 mg
Experimental
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
NR: Bari 2 mg to 2 mg
Experimental
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
NR: Bari 2 mg to 4 mg
Experimental
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
NR: Bari 4 mg to 4 mg
Experimental
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
NR: Placebo to Bari 2 mg
Experimental
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
Drug: Placebo
NR: Placebo to Bari 4 mg
Experimental
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
Drug: Placebo
Placebo
Placebo Comparator
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
Drug: Placebo
Bari 1 mg
Experimental
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
Drug: Baricitinib
Bari 2 mg
Experimental
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
Drug: Baricitinib
Bari 4 mg
Experimental
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
Drug: Baricitinib
Bari 2-mg Open-Label Addendum
Experimental
Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
Drug: Baricitinib
NR: Bari 2 mg to 2 mg
NR: Bari 2 mg to 4 mg
NR: Bari 4 mg to 4 mg
NR: Placebo to Bari 2 mg
NR: Placebo to Bari 4 mg
Non-responders (NR): Bari 1 mg to 2 mg
RPR-Bari 1-milligram (mg)
RPR-Bari 2-mg
RPR-Bari 4-mg
Responders and Partial Responders (RPR)-Placebo
LY3009104
Placebo
Drug
Administered orally
NR: Placebo to Bari 2 mg
NR: Placebo to Bari 4 mg
Placebo
Responders and Partial Responders (RPR)-Placebo
Weeks 16, 36, and 52
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Weeks 16, 36, and 52
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Weeks 16, 36 and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 16, 36, 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 16, 36, and 52 Weeks
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 16, 36, and 52
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 16, 36, and 52
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Week 16
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Week 16
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Week 16
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Week 16
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 4, 16, 24, 52
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Week 16
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Week 16
Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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).
Weeks 68, 104
Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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).
Weeks 68, 104
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Weeks 68, 104
Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated
Week 52 Up to Week 200
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (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 atopic dermatitis (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).
Weeks 68, 104
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (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 atopic dermatitis (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).
Weeks 68, 104
Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
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.
Weeks 68, 104
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During 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 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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 Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During 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 IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. 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 Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into 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
Buenos Aires
C1027AAP
Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires
C1055AA0
Argentina
Fundacion CIDEA
Ciudad Autonoma Buenos Aires
C1121ABE
Argentina
Instituto de Neumonología y Dermatología
Ciudad Autonoma Buenos Aires
C1425BEA
Argentina
Psoriahue Medicina Interdisciplinaria
Ciudad Autonoma Buenos Aires
C1425DKG
Argentina
Parra Dermatología
Mendoza
5500
Argentina
Woden Dermatology
Phillip
Australian Capital Territory
2606
Australia
Skin & Cancer Foundation Australia
Westmead
New South Wales
2145
Australia
The Skin Centre
Benowa
Queensland
4217
Australia
Veracity Clinical Research Pty Ltd
Woolloongabba
Queensland
4102
Australia
Clinical Trials SA Pty Ltd
Adelaide
South Australia
5073
Australia
Skin and Cancer Foundation Inc.
Carlton
Victoria
3053
Australia
Fremantle Dermatology
Perth
Western Australia
6160
Australia
Universitätsklinikum Graz
Graz
Styria
8036
Austria
Ordensklinikum Linz GmbH - Elisabethinen
Linz
Upper Austria
4020
Austria
KA Rudolfstiftung
Vienna
1030
Austria
AKH
Vienna
1090
Austria
KH Hietzing mit neurologischem Zentrum Rosenhügel
Vienna
1130
Austria
Sozialmed. Zentrum Ost - Donauspital
Vienna
1220
Austria
Kozni ambulance Kutna Hora, s.r.o.
Kutná Hora
Central Bohemia
28401
Czechia
Clintrial, s.r.o.
Prague
Hl. M. Praha
100 00
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague
Hl. M. Praha
100 34
Czechia
Fakultni Nemocnice v Motole
Prague
Hl. M. Praha
150 06
Czechia
Nemocnice Na Bulovce
Prague
Hl. M. Praha
180 81
Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín
Moravian-Silesian Region
741 01
Czechia
Fakultni Nemocnice Plzen
Plzen-Bory
Plzeň Region
305 99
Czechia
Fakultni Nemocnice U svate Anny
Brno
South Moravian
656 91
Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem
Ustecký Kraj
40113
Czechia
Gentofte Hospital
Hellerup
Capital Region
2900
Denmark
Aarhus Universitehospital Marselisborg Centret
Aarhus
Region Midtjyland
8200
Denmark
Hopital Saint-Louis
Paris
Cedex 10
75475
France
CHU de Bordeaux Hopital Saint Andre
Bordeaux
33075
France
CHU Grenoble Alpes
Grenoble Cédex 9
38043
France
Chru De Nantes Hotel-Dieu
Nantes
44093
France
CHU de Nice Hopital de L'Archet
Nice
06202
France
Centre Hospitalier Lyon Sud
Pierre-Bénite
69495
France
Hopital Larrey
Toulouse
31059
France
Universitätsklinikum Freiburg
Freiburg im Breisgau
Baden-Wurttemberg
79104
Germany
Universitätsklinikum Heidelberg
Heidelberg
Baden-Wurttemberg
69120
Germany
Klinikum der Universität München
München
Bavaria
80337
Germany
Gemeinschaftspraxis Mahlow
Blankenfelde-Mahlow
Brandenburg
15831
Germany
Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH
Darmstadt
Hesse
64283
Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii
Olsztyn
Warmian-Masurian Voivodeship
10-229
Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin
West Pomeranian Voivodeship
70-332
Poland
Dermed Centrum Medyczne Sp. z o.o.
Lodz
Łódź Voivodeship
90-265
Poland
GBUZ Clinical dermatology and venereological dispensary
Krasnodar
Krasnodarskiy Kray
350020
Russia
State scientific centre for dermatovenerology and cosmetolog
Moscow
107076
Russia
Russian state medical-stomatological university n.a. Evdokimov
Moscow
111398
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
Korea University Ansan Hospital
Ansan-si
Gyeonggi-do
15355
South Korea
Dongguk University Ilsan Hospital
Goyang-si
Gyeonggi-do
10326
South Korea
Ajou University Hospital
Suwon
Gyeonggi-do
16499
South Korea
Gachon University Gil Medical Center
Incheon
Korea
21565
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Konkuk University Medical Center
Seoul
05030
South Korea
Seoul St. Mary's Hospital
Seoul
06591
South Korea
Chungang University Hospital
Seoul
06973
South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul
07441
South Korea
Hospital Germans Trias i Pujol
Barcelona
Badalona
08916
Spain
Hospital Universitario Rey Juan Carlos
Móstoles
Madrid
28933
Spain
Clinica Universitaria De Navarra
Pamplona
Navarre
31008
Spain
Hospital General Universitario Alicante
Alicante
03010
Spain
Hospital del Mar
Barcelona
08003
Spain
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria
35010
Spain
Hospital Infanta Leonor
Madrid
28031
Spain
Hospital Universitario Ramon y Cajal
Madrid
28034
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Centro de Especialidades Mollabao
Pontevedra
36001
Spain
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne
Canton of Vaud
1011
Switzerland
Inselspital Bern
Bern
3010
Switzerland
HUG-Hôpitaux Universitaires de Genève
Geneva
1205
Switzerland
Universitätsspital Zürich
Zurich
8091
Switzerland
Chang Gung Memorial Hospital - Linkou
Taoyuan, (r.o.c.)
Taiwan
33342
Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
83301
Taiwan
Taipei Medical University- Shuang Ho Hospital
New Taipei City
23561
Taiwan
Chung Shan Medical University Hospital
Taichung
40201
Taiwan
National Cheng Kung University Hospital
Tainan
70403
Taiwan
National Taiwan University Hospital
Taipei
10048
Taiwan
Chang Gung Memorial Hospital - Taipei
Taipei
10508
Taiwan
Derived
Reich K, Simpson E, Wollenberg A, Bissonnette R, Abe M, Cardillo T, Janes J, Sun L, Chen S, Silverberg JI. Efficacy of downtitration or treatment withdrawal compared with continuous dosing after successful treatment with baricitinib in patients with moderate-to-severe atopic dermatitis in a randomized substudy from the long-term extension study BREEZE-AD3. Br J Dermatol. 2023 Feb 10;188(2):208-217. doi: 10.1093/bjd/ljac057.
Wollenberg A, Kircik L, Simpson E, Brinker D, Katoh N, Rueda MJ, Issa M, Yang F, Feely M, Alexis A. Pooled Analysis of Baricitinib Tolerability in Patients With Atopic Dermatitis in Relation to Acne, Headache, and Gastrointestinal Events From 8 Clinical Trials. Dermatitis. 2023 Jul-Aug;34(4):308-314. doi: 10.1089/derm.2022.0027. Epub 2023 Feb 6.
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.
Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.
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.
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
FG002
Bari 2-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
FG003
Bari 4-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
FG004
Bari 2-mg Open-Label Addendum
Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
FG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
FG006
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
FG007
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
FG008
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
FG009
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
FG010
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
FG011
Placebo to Placebo Non-substudy
Participants who received placebo at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive placebo orally.
FG012
1 mg Bari to 1 mg Bari Non-substudy
Participants who received Baricitinib 1 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 1 mg orally.
FG013
2 mg Bari to 2 mg Bari Non-substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 2 mg orally.
FG014
4 mg Bari to 4 mg Bari Non-substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 4 mg orally.
FG00091 subjects
FG00145 subjects
FG002519 subjects
FG003743 subjects
FG004247 subjectsParticipants from the Bari 2-mg Open-Label Addendum were randomized into Treatment Period 2.
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Received at Least 1 Dose of Investigational Product (IP)
FG00091 subjects
FG00145 subjects
FG002519 subjects
FG003743 subjects
FG004247 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
RPR
FG00091 subjects
FG00145 subjects
FG002108 subjects
FG003134 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NR
FG0000 subjects
FG0010 subjects
FG002411 subjects
FG003609 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG00212 subjects
FG00315 subjects
FG0045 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG00089 subjects
FG00143 subjects
FG002507 subjects
FG003728 subjects
FG004242 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Ongoing as of Week 52 (Later participants were moved to treatment period 2 [week 52 to 200])
FG00070 subjects
FG00132 subjects
FG002379 subjects
FG003519 subjects
FG004146 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Lack of Efficacy
FG0003 subjects
FG0015 subjects
FG00276 subjects
FG003140 subjects
FG004
Adverse Event
FG0002 subjects
FG0011 subjects
FG0029 subjects
FG00323 subjects
FG004
Withdrawal by Subject
FG00011 subjects
FG0014 subjects
FG00238 subjects
FG00342 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG004
Treatment Period 2: Week 52 to Week 200
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants were assigned to this arm only during treatment period 1,
FG0010 subjectsParticipants were assigned to this arm only during treatment period 1,
FG0020 subjectsParticipants were assigned to this arm only during treatment period 1,
FG0030 subjectsParticipants were assigned to this arm only during treatment period 1,
FG0040 subjectsParticipants were assigned to this arm only during treatment period 1,
FG00592 subjectsAt Week 52: participants (with IGA 0, 1, or 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization were receiving IP and had not used high-potency TCS in the previous 14 days were enrolled in the RWDT substudy.
FG00691 subjectsAt Week 52: participants (with IGA 0, 1, or 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization were receiving IP and had not used high-potency TCS in the previous 14 days were enrolled in the RWDT substudy.
FG00792 subjectsAt Week 52: participants (with IGA 0, 1, or 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization were receiving IP and had not used high-potency TCS in the previous 14 days were enrolled in the RWDT substudy.
FG00884 subjectsAt Week 52: participants (with IGA 0, 1, or 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization were receiving IP and had not used high-potency TCS in the previous 14 days were enrolled in the RWDT substudy.
FG00984 subjectsAt Week 52: participants (with IGA 0, 1, or 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization were receiving IP and had not used high-potency TCS in the previous 14 days were enrolled in the RWDT substudy.
FG01084 subjectsAt Week 52: participants (with IGA 0, 1, or 2) who were assigned to Baricitinib 4 mg or 2 mg, at randomization were receiving IP and had not used high-potency TCS in the previous 14 days were enrolled in the RWDT substudy.
FG01170 subjectsAt Week 52: Participants who received Baricitinib 4 mg, 2 mg, 1 mg or placebo in treatment period 1 and were not eligible for the RWDT substudy remained on their current dose of Baricitinib.
FG01232 subjectsAt Week 52: Participants who received Baricitinib 4 mg, 2 mg, 1 mg or placebo in treatment period 1 and were not eligible for the RWDT substudy remained on their current dose of Baricitinib.
FG013249 subjectsAt Week 52: Participants who received Baricitinib 4 mg, 2 mg, 1 mg or placebo in treatment period 1 and were not eligible for the RWDT substudy remained on their current dose of Baricitinib.
FG014264 subjectsAt Week 52: Participants who received Baricitinib 4 mg, 2 mg, 1 mg or placebo in treatment period 1 and were not eligible for the RWDT substudy remained on their current dose of Baricitinib.
Received at Least 1 Dose of IP
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
Regarding the participants who did not complete the study due to the reason "study termination by sponsor". As pre-planned in the protocol, study termination may have occurred in a specific country or region when baricitinib was approved for the treatment of AD and became reimbursed or commercially available in that country or region, or a negative regulatory opinion was received in that country or region.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Modified Intent-to-treat Population: All participants who received at least one dose of investigational product (IP) in JAHN.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
BG001
Bari 1-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
BG002
Bari 2-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
BG003
Bari 4-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
BG004
Bari 2-mg Open-Label Addendum
Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00091
BG00145
BG002519
BG003743
BG004247
BG0051645
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
BG00035.2± 14.06
BG00133.5± 8.49
BG00234.2± 12.69
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00044
BG00116
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00015
BG00110
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0006
BG0014
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
Title
Measurements
BG0006
BG0012
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
Responder and Partial Responders (RPR): Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36 and 52
ID
Title
Description
OG000
RPR-Placebo
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive placebo orally.
OG001
RPR-Bari 1-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
OG002
RPR-Bari 2-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 2 mg orally.
OG003
RPR-Bari 4-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00052
OG00145
OG00254
OG003
Title
Denominators
Categories
Week 16
Title
Measurements
OG00036.5(24.8 to 50.1)
OG00146.7(32.9 to 60.9)
OG00259.3(46.0 to 71.3)
OG003
Primary
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
RPR-Placebo
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
OG001
RPR-Bari 2-mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
Secondary
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
RPR-Placebo
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive placebo orally.
OG001
RPR-Bari 1-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
Secondary
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
RPR Placebo
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
OG001
RPR Bari 2 mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
Secondary
Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36 and 52
ID
Title
Description
OG000
NR: Bari 1 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Bari 1 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, 52
ID
Title
Description
OG000
NR: Bari 1 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Bari 1 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52 Weeks
ID
Title
Description
OG000
RPR-Placebo
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were randomized were assigned to remain in this arm to receive placebo orally.
Secondary
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
RPR-Placebo
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
OG001
Secondary
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
NR: Bari 1 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Secondary
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 16, 36, and 52
ID
Title
Description
OG000
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Secondary
RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
RPR-Placebo
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive placebo orally.
OG001
RPR-Bari 1-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
Secondary
RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
RPR Placebo
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.
OG001
RPR Bari 2 mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
Secondary
NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
NR: Bari 1 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Bari 1 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 16, 24, 52
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 16, 24, 52
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 16, 24, 52
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 16, 24, 52
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 16, 24, 52
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75
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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 16, 24, 52
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch 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 participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS.
Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 16
ID
Title
Description
OG000
NR: Placebo to Bari 2 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Secondary
Percentage of Participants Who Achieved a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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).
Randomized Downtitration Withdrawal Substudy Population: All participants (including open-label participants) who are rerandomized at Week 52, entered the substudy, and received at least 1 dose of the IP in Period 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 68, 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
Secondary
Percentage of Participants Who Achieved a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering the Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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).
Randomized Downtitration Withdrawal Substudy Population: All participants (including open-label participants) who are rerandomized at Week 52, entered the substudy, and received at least 1 dose of the IP in Period 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 68, 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
Secondary
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (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.
The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI 75.
Randomized Downtitration Withdrawal Substudy Population: All participants (including open-label participants) who are rerandomized at Week 52, entered the substudy, and received at least 1 dose of the IP in Period 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 68, 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
Secondary
Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study)
Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated
Participants who received at least one dose of study medication during Week 52 to Week 200 in Study JAHN, entered the randomized down titration withdrawal sub study, relapsed with an IGA ≥3 and were retreated from Week 52 up to Week 200.
Posted
Median
Inter-Quartile Range
Days
Week 52 Up to Week 200
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (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 atopic dermatitis (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).
Randomized Downtitration Withdrawal Substudy Population with Week 52 IGA of 0 or 1: All participants (including open-label participants) who are rerandomized at Week 52, entered the substudy with IGA 0 or 1, and received atleast 1 dose of the IP in Period 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 68, 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
Secondary
Percentage of Participants With a Response of IGA 0 or 1 Assessed at 16 Weeks After Rerandomization (Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (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 atopic dermatitis (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).
Randomized Downtitration Withdrawal Substudy Population with Week 52 IGA of 0 or 1: All participants (including open-label participants) who are rerandomized at Week 52, entered the substudy with IGA 0 or 1, and received atleast 1 dose of the IP in Period 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 68, 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
Secondary
Percentage of Participants With a Response of EASI75 From Baseline of Originating Study Assessed at 16 Weeks After Rerandomization(Week 68) and Week 104 in Randomized Withdrawal and Downtitration Substudy (Participants Entering Substudy With IGA 0 or 1)
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.
Randomized Downtitration Withdrawal Substudy Population with Week 52 IGA of 0 or 1: All participants (including open-label participants) who are rerandomized at Week 52, entered the substudy with IGA 0 or 1, and received atleast 1 dose of the IP in Period 2.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 68, 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally
OG001
4 mg Bari to 2 mg Bari Substudy
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During 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).
Re-Treatment Substudy Population: A subset of Randomized Downtitration Withdrawal Substudy Population who experienced IGA ≥3 at any time in Period 2 and received at least 1 dose of retreatment of the original dose.
Posted
Number
Percentage of participants
Week 68
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN are rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN are rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG002
4 mg Bari to Placebo Substudy
Secondary
Percentage of Participants With a Response of IGA 0 or 1 Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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).
Re-Treatment Substudy Population: A subset of Randomized Downtitration Withdrawal Substudy Population who experienced IGA ≥3 at any time in Period 2 and received at least 1 dose of retreatment of the original dose.
Posted
Number
Percentage of participants
Week 68
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG002
Secondary
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed Within 16 Weeks of Retreatment (Week 68) Randomized Withdrawal and Downtitration (Participants Retreated During 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.
Re-Treatment Substudy Population: A subset of Randomized Downtitration Withdrawal Substudy Population who experienced IGA ≥3 at any time in Period 2 and received at least 1 dose of retreatment of the original dose.
Posted
Number
Percentage of participants
Week 68
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
OG001
4 mg Bari to 2 mg Bari Substudy
Secondary
Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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).
Period 2 Nonsubstudy Population: All participants randomized at Week 0 of main Study JAHN (excluding open-label participants) who were not eligible to enter the substudy at Week 52 and received at least 1 dose of the IP in Period 2
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Non-substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 4 mg orally.
OG001
2 mg Bari to 2 mg Bari Non-substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 2 mg orally.
OG002
Secondary
Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy)
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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. 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).
Period 2 Nonsubstudy Population: All participants randomized at Week 0 of main Study JAHN (excluding open-label participants) who were not eligible to enter the substudy at Week 52 and received at least 1 dose of the IP in Period 2
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Non-substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 4 mg orally.
OG001
2 mg Bari to 2 mg Bari Non-substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 2 mg orally.
Secondary
Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into 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.
Period 2 Nonsubstudy Population: All participants randomized at Week 0 of main Study JAHN (excluding open-label participants) who were not eligible to enter the substudy at Week 52 and received at least 1 dose of the IP in Period 2
Posted
Number
95% Confidence Interval
Percentage of participants
Week 104
ID
Title
Description
OG000
4 mg Bari to 4 mg Bari Non-substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 4 mg orally.
OG001
2 mg Bari to 2 mg Bari Non-substudy
Time Frame
Baseline through Week 200
Description
All participants who received at least one dose of IP. The participants from open label arm were included in the Baricitinib 2-mg arm while reporting the safety data. Gender specific events only occurring 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
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.
0
91
5
91
21
91
EG001
Bari 1-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.
0
45
1
45
14
45
EG002
Bari 2-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.
0
766
32
766
263
766
EG003
Bari 4-mg
Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.
1
743
40
743
268
743
EG004
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
1
92
2
92
15
92
EG005
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
0
91
1
91
27
91
EG006
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
0
92
3
92
38
92
EG007
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
0
84
3
84
16
84
EG008
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
0
84
1
84
21
84
EG009
4 mg Bari to 4 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 4 mg orally.
0
84
11
84
42
84
EG010
Placebo to Placebo Non-substudy
Participants who received placebo at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive placebo orally.
0
70
1
70
14
70
EG011
1 mg Bari to 1 mg Bari Non-substudy
Participants who received Baricitinib 1 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 1 mg orally.
0
32
3
32
14
32
EG012
2 mg Bari to 2 mg Bari Non-substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 2 mg orally.
0
249
16
249
96
249
EG013
4 mg Bari to 4 mg Bari Non-substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 4 mg orally.
1
264
25
264
110
264
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG0030 events0 affected743 at risk
EG004
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Thyroglossal cyst
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Haematotympanum
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Glaucoma
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Open angle glaucoma
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Retinopathy proliferative
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Dental cyst
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Pancreatic failure
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Abscess jaw
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0011 events1 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Eczema herpeticum
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0022 events2 affected766 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Erysipeloid
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Hepatitis syphilitic
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Syphilis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Varicella
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Pneumocephalus
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Skull fractured base
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Dairy intolerance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Anaplastic large cell lymphoma t- and null-cell types
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Angiocentric lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Breast cancer stage ii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Diffuse large b-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Follicular lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Peripheral t-cell lymphoma unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected448 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected766 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected91 at risk
EG0010 events0 affected45 at risk
EG0020 events0 affected766 at risk
EG003
Testis cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected47 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected448 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected318 at risk
EG003
Xanthogranuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872
Dermatitis
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D017443
Skin Diseases, Eczematous
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000596027
baricitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
61 subjects
FG0050 subjects
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13 subjects
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20 subjects
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1 subjects
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0 subjects
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1 subjects
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Lack of Efficacy
FG0000 subjects
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FG0030 subjects
FG0040 subjects
FG00513 subjects
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FG0087 subjects
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Withdrawal by Subject
FG0000 subjects
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Adverse Event
FG0000 subjects
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FG0030 subjects
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FG0056 subjects
FG0061 subjects
FG0072 subjects
FG0082 subjects
FG0093 subjects
FG0109 subjects
FG0113 subjects
FG0122 subjects
FG01311 subjects
FG01413 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
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FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0091 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0134 subjects
FG0144 subjects
Withdrawal due to Caregiver Circumstances
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
Physician is retiring
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0093 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0132 subjects
FG0142 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0113 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
FG0141 subjects
35.6
± 12.85
BG00434.9± 12.98
BG00534.9± 12.83
206
BG003239
BG004112
BG005617
Male
BG00047
BG00129
BG002313
BG003504
BG004135
BG0051028
70
BG00387
BG00472
BG005254
Not Hispanic or Latino
BG00057
BG00132
BG002332
BG003467
BG004165
BG0051053
Unknown or Not Reported
BG00019
BG0013
BG002117
BG003189
BG00410
BG005338
10
BG0036
BG00416
BG00542
Asian
BG00032
BG0017
BG002174
BG003282
BG00413
BG005508
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
Black or African American
BG0000
BG0010
BG0021
BG0031
BG0041
BG0053
White
BG00048
BG00132
BG002315
BG003429
BG004211
BG0051035
More than one race
BG0005
BG0012
BG00218
BG00323
BG0046
BG00554
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0032
BG0040
BG0052
36
BG00346
BG00424
BG005114
Hungary
Title
Measurements
BG0007
BG0012
BG00215
BG00321
BG00427
BG00572
Czechia
Title
Measurements
BG0003
BG0013
BG00222
BG00346
BG00428
BG005102
Japan
Title
Measurements
BG00011
BG0013
BG00289
BG003141
BG0040
BG005244
Switzerland
Title
Measurements
BG0000
BG0011
BG0025
BG0039
BG0043
BG00518
India
Title
Measurements
BG0005
BG0010
BG0027
BG00319
BG0040
BG00531
Spain
Title
Measurements
BG0002
BG0011
BG00227
BG00326
BG00424
BG00580
Russia
Title
Measurements
BG0000
BG0011
BG0029
BG00313
BG00428
BG00551
Austria
Title
Measurements
BG0002
BG0010
BG00212
BG00323
BG00412
BG00549
South Korea
Title
Measurements
BG0009
BG0011
BG00239
BG00358
BG0040
BG005107
Taiwan
Title
Measurements
BG0008
BG0012
BG00230
BG00350
BG0040
BG00590
Denmark
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0047
BG0057
Poland
Title
Measurements
BG00010
BG0017
BG00245
BG00370
BG0040
BG005132
Italy
Title
Measurements
BG0007
BG0014
BG00216
BG00326
BG00415
BG00568
Mexico
Title
Measurements
BG0009
BG0015
BG00229
BG00321
BG00443
BG005107
Israel
Title
Measurements
BG0001
BG0010
BG00216
BG00313
BG0044
BG00534
France
Title
Measurements
BG0000
BG0010
BG00215
BG00319
BG0040
BG00534
Australia
Title
Measurements
BG0004
BG0011
BG00230
BG00342
BG00432
BG005109
Germany
Title
Measurements
BG0007
BG00112
BG00277
BG003100
BG0040
BG005196
70
48.6
(37.2 to 60.0)
Week 36
Title
Measurements
OG00023.1(13.7 to 36.1)
OG00131.1(19.5 to 45.7)
OG00263.0(49.6 to 74.6)
OG00337.1(26.8 to 48.9)
Week 52
Title
Measurements
OG00028.8(18.3 to 42.3)
OG00135.6(23.2 to 50.2)
OG00250.0(37.1 to 62.9)
OG00340.0(29.3 to 51.7)
OG002
RPR-Bari 4-mg
RPR participants from previous Baricitinib combination therapy study JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00034
OG00153
OG00263
Title
Denominators
Categories
Week 16
Title
Measurements
OG00047.1(31.5 to 63.3)
OG00145.3(32.7 to 58.5)
OG00231.7(21.6 to 44.0)
Week 36
Title
Measurements
OG00041.2(26.4 to 57.8)
OG00124.5(14.9 to 37.6)
OG00230.2(20.2 to 42.4)
Week 52
Title
Measurements
OG00029.4(16.8 to 46.2)
OG00130.2(19.5 to 43.5)
OG00231.7(21.6 to 44.0)
OG002
RPR-Bari 2-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 2 mg orally.
OG003
RPR-Bari 4-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00052
OG00145
OG00254
OG00370
Title
Denominators
Categories
Week 16
Title
Measurements
OG00069.2(55.7 to 80.1)
OG00177.8(63.7 to 87.5)
OG00281.5(69.2 to 89.6)
OG00372.9(61.5 to 81.9)
Week 36
Title
Measurements
OG00048.1(35.1 to 61.3)
OG00160.0(45.5 to 73.0)
OG00281.5(69.2 to 89.6)
OG003
Week 52
Title
Measurements
OG00046.2(33.3 to 59.5)
OG00153.3(39.1 to 67.1)
OG00272.2(59.1 to 82.4)
OG003
OG002
RPR Bari 4 mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00034
OG00153
OG00263
Title
Denominators
Categories
Week 16
Title
Measurements
OG00070.6(53.8 to 83.2)
OG00173.6(60.4 to 83.6)
OG00263.5(51.1 to 74.3)
Week 36
Title
Measurements
OG00055.9(39.5 to 71.1)
OG00149.1(36.1 to 62.1)
OG00252.4(40.3 to 64.2)
Week 52
Title
Measurements
OG00050.0(34.1 to 65.9)
OG00154.7(41.5 to 67.3)
OG00252.4(40.3 to 64.2)
OG002
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG003
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
OG004
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00087
OG00181
OG00284
OG00378
OG004156
Title
Denominators
Categories
Week 16
Title
Measurements
OG00046.0(35.9 to 56.4)
OG00155.6(44.7 to 65.9)
OG00247.6(37.3 to 58.2)
OG00343.6(33.1 to 54.6)
OG00440.4(33.0 to 48.2)
Week 36
Title
Measurements
OG00040.2(30.6 to 50.7)
OG00143.2(33.0 to 54.1)
OG00244.0(33.9 to 54.7)
OG003
Week 52
Title
Measurements
OG00031.0(22.3 to 41.4)
OG00148.1(37.6 to 58.9)
OG00244.0(33.9 to 54.7)
OG003
OG002
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00020
OG00121
OG00239
Title
Denominators
Categories
Week 16
Title
Measurements
OG00035.0(18.1 to 56.7)
OG00157.1(36.5 to 75.5)
OG00230.8(18.6 to 46.4)
Week 36
Title
Measurements
OG00040.0(21.9 to 61.3)
OG00142.9(24.5 to 63.5)
OG00220.5(10.8 to 35.5)
Week 52
Title
Measurements
OG00045.0(25.8 to 65.8)
OG00142.9(24.5 to 63.5)
OG00228.2(16.5 to 43.8)
OG002
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG003
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
OG004
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00087
OG00181
OG00284
OG00378
OG004156
Title
Denominators
Categories
Week 16
Title
Measurements
OG00013.8(8.1 to 22.6)
OG00123.5(15.6 to 33.8)
OG00215.5(9.3 to 24.7)
OG00317.9(11.0 to 27.9)
OG00410.3(6.4 to 16.0)
Week 36
Title
Measurements
OG00013.8(8.1 to 22.6)
OG00112.3(6.8 to 21.3)
OG00210.7(5.7 to 19.1)
OG003
Week 52
Title
Measurements
OG00012.6(7.2 to 21.2)
OG00112.3(6.8 to 21.3)
OG00219.0(12.1 to 28.7)
OG003
OG002
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00020
OG00121
OG00239
Title
Denominators
Categories
Week 16
Title
Measurements
OG00010.0(2.8 to 30.1)
OG00128.6(13.8 to 50.0)
OG0025.1(1.4 to 16.9)
Week 36
Title
Measurements
OG00015.0(5.2 to 36.0)
OG00123.8(10.6 to 45.1)
OG00215.4(7.2 to 29.7)
Week 52
Title
Measurements
OG00015.0(5.2 to 36.0)
OG00119.0(7.7 to 40.0)
OG0025.1(1.4 to 16.9)
OG001
RPR-Bari 1-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.
OG002
RPR-Bari 2-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 2 mg orally.
OG003
RPR-Bari 4-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00052
OG00145
OG00254
OG00370
Title
Denominators
Categories
Week 16
Title
Measurements
OG00042.3(29.9 to 55.8)
OG00162.2(47.6 to 74.9)
OG00270.4(57.2 to 80.9)
OG00364.3(52.6 to 74.5)
Week 36
Title
Measurements
OG00044.2(31.6 to 57.7)
OG00146.7(32.9 to 60.9)
OG00274.1(61.1 to 83.9)
OG003
Week 52
Title
Measurements
OG00038.5(26.5 to 52.0)
OG00151.1(37.0 to 65.0)
OG00264.8(51.5 to 76.2)
OG003
RPR-Bari 2-mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.
OG002
RPR-Bari 4-mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00034
OG00153
OG00263
Title
Denominators
Categories
Week 16
Title
Measurements
OG00055.9(39.5 to 71.1)
OG00167.9(54.5 to 78.9)
OG00255.6(43.3 to 67.2)
Week 36
Title
Measurements
OG00047.1(31.5 to 63.3)
OG00147.2(34.4 to 60.3)
OG00244.4(32.8 to 56.7)
Week 52
Title
Measurements
OG00038.2(23.9 to 55.0)
OG00152.8(39.7 to 65.6)
OG00242.9(31.4 to 55.1)
OG001
NR: Bari 1 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
OG002
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG003
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
OG004
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00087
OG00181
OG00284
OG00378
OG004156
Title
Denominators
Categories
Week 16
Title
Measurements
OG00033.3(24.3 to 43.8)
OG00143.2(33.0 to 54.1)
OG00238.1(28.4 to 48.8)
OG00338.5(28.4 to 49.6)
OG00426.9(20.6 to 34.4)
Week 36
Title
Measurements
OG00032.2(23.3 to 42.6)
OG00130.9(21.9 to 41.6)
OG00231.0(22.1 to 41.5)
OG003
Week 52
Title
Measurements
OG00028.7(20.3 to 39.0)
OG00135.8(26.2 to 46.7)
OG00234.5(25.2 to 45.2)
OG003
OG001
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
OG002
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00020
OG00121
OG00239
Title
Denominators
Categories
Week 16
Title
Measurements
OG00020.0(8.1 to 41.6)
OG00157.1(36.5 to 75.5)
OG00228.2(16.5 to 43.8)
Week 36
Title
Measurements
OG00025.0(11.2 to 46.9)
OG00128.6(13.8 to 50.0)
OG00223.1(12.6 to 38.3)
Week 52
Title
Measurements
OG00020.0(8.1 to 41.6)
OG00128.6(13.8 to 50.0)
OG00228.2(16.5 to 43.8)
OG002
RPR-Bari 2-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 2 mg orally.
OG003
RPR-Bari 4-mg
RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00043
OG00131
OG00243
OG00361
Title
Denominators
Categories
Title
Measurements
OG00032.6(20.5 to 47.5)
OG00125.8(13.7 to 43.2)
OG00232.6(20.5 to 47.5)
OG00341.0(29.5 to 53.5)
OG002
RPR Bari 4 mg
RPR participants from previous Baricitinib combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00032
OG00148
OG00256
Title
Denominators
Categories
Title
Measurements
OG00037.5(22.9 to 54.7)
OG00145.8(32.6 to 59.7)
OG00246.4(34.0 to 59.3)
OG002
NR: Bari 2 mg to 2 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.
OG003
NR: Bari 2 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
OG004
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00080
OG00162
OG00270
OG00371
OG004138
Title
Denominators
Categories
Title
Measurements
OG00020.0(12.7 to 30.0)
OG00138.7(27.6 to 51.2)
OG00224.3(15.8 to 35.5)
OG00331.0(21.4 to 42.5)
OG00422.5(16.3 to 30.1)
OG002
NR: Bari 4 mg to 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00019
OG00119
OG00235
Title
Denominators
Categories
Title
Measurements
OG00031.6(15.4 to 54.0)
OG00136.8(19.1 to 59.0)
OG00231.4(18.6 to 48.0)
Units
Counts
Participants
OG000180
OG001194
Title
Denominators
Categories
Week 4
Title
Measurements
OG00057.8(50.5 to 64.8)
OG00167.0(60.1 to 73.2)
Week 16
Title
Measurements
OG00056.7(49.4 to 63.7)
OG00162.9(55.9 to 69.4)
Week 24
Title
Measurements
OG00055.6(48.3 to 62.6)
OG00157.2(50.2 to 64.0)
Week 52
Title
Measurements
OG00050.6(43.3 to 57.8)
OG00146.9(40.0 to 53.9)
Units
Counts
Participants
OG00034
OG00128
Title
Denominators
Categories
Week 4
Title
Measurements
OG00050.0(34.1 to 65.9)
OG00146.4(29.5 to 64.2)
Week 16
Title
Measurements
OG00047.1(31.5 to 63.3)
OG00146.4(29.5 to 64.2)
Week 24
Title
Measurements
OG00038.2(23.9 to 55.0)
OG00139.3(23.6 to 57.6)
Week 52
Title
Measurements
OG00026.5(14.6 to 43.1)
OG00125.0(12.7 to 43.4)
Units
Counts
Participants
OG000180
OG001194
Title
Denominators
Categories
Week 4
Title
Measurements
OG00022.8(17.3 to 29.4)
OG00125.8(20.1 to 32.4)
Week 16
Title
Measurements
OG00022.2(16.8 to 28.8)
OG00129.9(23.9 to 36.7)
Week 24
Title
Measurements
OG00022.2(16.8 to 28.8)
OG00127.8(22.0 to 34.5)
Week 52
Title
Measurements
OG00020.6(15.3 to 27.0)
OG00123.7(18.3 to 30.2)
Units
Counts
Participants
OG00034
OG00128
Title
Denominators
Categories
Week 4
Title
Measurements
OG0000(0.0 to 10.2)
OG00114.3(5.7 to 31.5)
Week 16
Title
Measurements
OG0005.9(1.6 to 19.1)
OG00125.0(12.7 to 43.4)
Week 24
Title
Measurements
OG00011.8(4.7 to 26.6)
OG00117.9(7.9 to 35.6)
Week 52
Title
Measurements
OG0005.9(1.6 to 19.1)
OG00110.7(3.7 to 27.2)
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG000180
OG001194
Title
Denominators
Categories
Week 4
Title
Measurements
OG00038.9(32.1 to 46.2)
OG00146.9(40.0 to 53.9)
Week 16
Title
Measurements
OG00043.9(36.8 to 51.2)
OG00153.6(46.6 to 60.5)
Week 24
Title
Measurements
OG00045.0(37.9 to 52.3)
OG00145.4(38.5 to 52.4)
Week 52
Title
Measurements
OG00041.1(34.2 to 48.4)
OG00138.7(32.1 to 45.7)
OG001
NR: Placebo to Bari 4 mg
NR participants from previous Baricitinib combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 4 mg orally.
Units
Counts
Participants
OG00034
OG00128
Title
Denominators
Categories
Week 4
Title
Measurements
OG00023.5(12.4 to 40.0)
OG00139.3(23.6 to 57.6)
Week 16
Title
Measurements
OG00038.2(23.9 to 55.0)
OG00139.3(23.6 to 57.6)
Week 24
Title
Measurements
OG00032.4(19.1 to 49.2)
OG00132.1(17.9 to 50.7)
Week 52
Title
Measurements
OG00026.5(14.6 to 43.1)
OG00132.1(17.9 to 50.7)
Units
Counts
Participants
OG000165
OG001171
Title
Denominators
Categories
Title
Measurements
OG00033.9(27.2 to 41.5)
OG00135.7(28.9 to 43.1)
Units
Counts
Participants
OG00034
OG00126
Title
Denominators
Categories
Title
Measurements
OG00020.6(10.3 to 36.8)
OG00126.9(13.7 to 46.1)
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00084
OG00184
OG00284
OG00392
OG00491
OG00592
Title
Denominators
Categories
Week 68
Title
Measurements
OG00086.9(78.1 to 92.5)
OG00160.7(50.0 to 70.5)
OG00250.0(39.5 to 60.5)
OG00392.4(85.1 to 96.3)
OG00470.3(60.3 to 78.7)
OG00544.6(34.8 to 54.7)
Week 104
Title
Measurements
OG00085.7(76.7 to 91.6)
OG00148.8(38.4 to 59.3)
OG00241.7(31.7 to 52.3)
OG003
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00084
OG00184
OG00284
OG00392
OG00491
OG00592
Title
Denominators
Categories
Week 68
Title
Measurements
OG00051.2(40.7 to 61.6)
OG00145.2(35.0 to 55.9)
OG00229.8(21.0 to 40.2)
OG00347.8(37.9 to 57.9)
OG00441.8(32.2 to 52.0)
OG00525.0(17.3 to 34.7)
Week 104
Title
Measurements
OG00047.6(37.3 to 58.2)
OG00135.7(26.3 to 46.4)
OG00233.3(24.2 to 43.9)
OG003
OG001
4 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00084
OG00184
OG00284
OG00392
OG00491
OG00592
Title
Denominators
Categories
Week 68
Title
Measurements
OG00079.8(70.0 to 87.0)
OG00158.3(47.7 to 68.3)
OG00245.2(35.0 to 55.9)
OG00373.9(64.1 to 81.8)
OG00469.2(59.1 to 77.8)
OG00544.6(34.8 to 54.7)
Week 104
Title
Measurements
OG00073.8(63.5 to 82.0)
OG00158.3(47.7 to 68.3)
OG00241.7(31.7 to 52.3)
OG003
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00039
OG00147
OG00250
OG00349
OG00445
OG00563
Title
Denominators
Categories
Title
Measurements
OG000117.0(57.0 to 289.0)
OG00156.0(29.0 to 170.0)
OG00229.5(26.0 to 113.0)
OG00361.0(29.0 to 269.0)
OG004169.0(56.0 to 368.0)
OG00530.0(28.0 to 87.0)
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00043
OG00143
OG00243
OG00348
OG00448
OG00549
Title
Denominators
Categories
Week 68
Title
Measurements
OG00097.7(87.9 to 99.6)
OG00176.7(62.3 to 86.8)
OG00272.1(57.3 to 83.3)
OG00395.8(86.0 to 98.8)
OG00489.6(77.8 to 95.5)
OG00555.1(41.3 to 68.1)
Week 104
Title
Measurements
OG00090.7(78.4 to 96.3)
OG00169.8(54.9 to 81.4)
OG00262.8(47.9 to 75.6)
OG003
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00043
OG00143
OG00243
OG00348
OG00448
OG00549
Title
Denominators
Categories
Week 68
Title
Measurements
OG00074.4(59.8 to 85.1)
OG00169.8(54.9 to 81.4)
OG00255.8(41.1 to 69.6)
OG00370.8(56.8 to 81.8)
OG00466.7(52.5 to 78.3)
OG00536.7(24.7 to 50.7)
Week 104
Title
Measurements
OG00062.8(47.9 to 75.6)
OG00155.8(41.1 to 69.6)
OG00258.1(43.3 to 71.6)
OG003
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00043
OG00143
OG00243
OG00348
OG00448
OG00549
Title
Denominators
Categories
Week 68
Title
Measurements
OG00093(81.4 to 97.6)
OG00176.7(62.3 to 86.8)
OG00272.1(57.3 to 83.3)
OG00383.3(70.4 to 91.3)
OG00489.6(77.8 to 95.5)
OG00563.3(49.3 to 75.3)
Week 104
Title
Measurements
OG00076.7(62.3 to 86.8)
OG00174.4(59.8 to 85.1)
OG00267.4(52.5 to 79.5)
OG003
Participants who received Baricitinib 4 mg at the start of Study JAHN are rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN are rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN are rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN are rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00039
OG00147
OG00250
OG00349
OG00445
OG00563
Title
Denominators
Categories
Title
Measurements
OG00069.2
OG00174.5
OG00280.0
OG00357.1
OG00455.6
OG00576.2
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00039
OG00147
OG00250
OG00349
OG00445
OG00563
Title
Denominators
Categories
Title
Measurements
OG00023.1
OG00125.5
OG00244.0
OG00310.2
OG00426.7
OG00539.7
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG002
4 mg Bari to Placebo Substudy
Participants who received Baricitinib 4 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
OG003
2 mg Bari to 2 mg Bari Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 2 mg orally.
OG004
2 mg Bari to 1 mg Bari SubstudY
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive Baricitinib 1 mg orally.
OG005
2 mg Bari to Placebo Substudy
Participants who received Baricitinib 2 mg at the start of Study JAHN were rerandomized at week 52 or assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG00039
OG00147
OG00250
OG00349
OG00445
OG00563
Title
Denominators
Categories
Title
Measurements
OG00061.5
OG00153.2
OG00270.0
OG00355.1
OG00444.4
OG00571.4
1 mg Bari to 1 mg Bari Non-substudy
Participants who received Baricitinib 1 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 1 mg orally.
OG003
Placebo to Placebo Non-substudy
Participants who received placebo at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG000264
OG001193
OG00232
OG00370
Title
Denominators
Categories
Title
Measurements
OG00041.3(35.5 to 47.3)
OG00145.6(38.7 to 52.6)
OG00271.9(54.6 to 84.4)
OG00351.4(40.0 to 62.8)
OG002
1 mg Bari to 1 mg Bari Non-substudy
Participants who received Baricitinib 1 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 1 mg orally.
OG003
Placebo to Placebo Non-substudy
Participants who received placebo at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive placebo orally.
Units
Counts
Participants
OG000264
OG001193
OG00232
OG00370
Title
Denominators
Categories
Title
Measurements
OG00013.3(9.7 to 17.9)
OG00113.5(9.4 to 19.0)
OG00253.1(36.4 to 69.1)
OG00340.0(29.3 to 51.7)
Participants who received Baricitinib 2 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 2 mg orally.
OG002
1 mg Bari to 1 mg Bari Non-substudy
Participants who received Baricitinib 1 mg at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive Baricitinib 1 mg orally.
OG003
Placebo to Placebo Non-substudy
Participants who received placebo at the start of Study JAHN who were not eligible to enter the substudy at week 52 assigned to this arm to receive placebo orally.