Atopic Dermatitis
Conditions
Keywords
eczema, atopic eczema
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.
Interventions
DRUGBaricitinib
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Incyte Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Weeks 16, 36 and 52 | 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. |
| RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, and 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36 and 52 | 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. |
| NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36, and 52 | 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. |
| NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, 52 | 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. |
| NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 16, 36, and 52 | 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. |
| RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Weeks 16, 36, and 52 Weeks | 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. |
| RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Weeks 16, 36, and 52 | 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. |
| NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Weeks 16, 36, and 52 | 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. |
| NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Weeks 16, 36, and 52 | 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. |
| RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS) | Week 16 | 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. |
| RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | Week 16 | 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. |
| NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | Week 16 | 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. |
| NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | Week 16 | 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. |
| NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 4, 16, 24, 52 | 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. |
| NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 4, 16, 24, 52 | 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. |
| NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Weeks 4, 16, 24, 52 | 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. |
| NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Weeks 4, 16, 24, 52 | 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. |
| RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Weeks 16, 36, and 52 | 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. |
| NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Weeks 4, 16, 24, 52 | 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. |
| NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | Week 16 | 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. |
| NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | Week 16 | 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. |
| 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) | Weeks 68, 104 | 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). |
| 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) | Weeks 68, 104 | 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). |
| 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) | Weeks 68, 104 | 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. |
| 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) | Week 68 | 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). |
| Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | Week 52 Up to Week 200 | Participants who entered the Substudy, relapsed with an IGA ≥3 and were retreated |
| 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) | Weeks 68, 104 | 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). |
| 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) | Weeks 68, 104 | 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). |
| 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) | Weeks 68, 104 | 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. |
| 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) | Week 68 | 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). |
| 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) | Week 68 | 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. |
| Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy) | Week 104 | 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). |
| Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy) | Week 104 | 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). |
| Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy) | Week 104 | 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. |
| NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Weeks 4, 16, 24, 52 | 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. |
| RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Weeks 16, 36, and 52 | 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. |
Countries
Argentina, Australia, Austria, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Switzerland, Taiwan
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 91 |
| Bari 1-mg Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally. | 45 |
| 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. | 519 |
| 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. | 743 |
| Bari 2-mg Open-Label Addendum Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally. | 247 |
| Total | 1,645 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1: Week 0 to Week 52 | Adverse Event | 2 | 1 | 9 | 23 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Week 0 to Week 52 | Death | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Week 0 to Week 52 | Lack of Efficacy | 3 | 5 | 76 | 140 | 61 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Week 0 to Week 52 | Lost to Follow-up | 3 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Week 0 to Week 52 | Ongoing as of Week 52 (Later participants were moved to treatment period 2 [week 52 to 200]) | 70 | 32 | 379 | 519 | 146 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Week 0 to Week 52 | Other | 0 | 1 | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Week 0 to Week 52 | Withdrawal by Subject | 11 | 4 | 38 | 42 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 2: Week 52 to Week 200 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 6 | 1 | 2 | 2 | 3 | 9 | 3 | 2 | 11 | 13 |
| Treatment Period 2: Week 52 to Week 200 | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period 2: Week 52 to Week 200 | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 13 | 10 | 11 | 7 | 12 | 8 | 7 | 2 | 63 | 72 |
| Treatment Period 2: Week 52 to Week 200 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 1 | 1 | 1 | 0 | 4 | 4 |
| Treatment Period 2: Week 52 to Week 200 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Treatment Period 2: Week 52 to Week 200 | Physician is retiring | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 0 | 0 | 0 |
| Treatment Period 2: Week 52 to Week 200 | Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 |
| Treatment Period 2: Week 52 to Week 200 | Protocol deviation | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 2 |
| Treatment Period 2: Week 52 to Week 200 | Sponsor decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 3 | 1 | 0 | 0 |
| Treatment Period 2: Week 52 to Week 200 | Study Terminated by Sponsor | 0 | 0 | 0 | 0 | 0 | 17 | 21 | 17 | 19 | 15 | 17 | 16 | 3 | 66 | 70 |
| Treatment Period 2: Week 52 to Week 200 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 23 | 15 | 20 | 17 | 10 | 11 | 8 | 0 | 41 | 32 |
| Treatment Period 2: Week 52 to Week 200 | Withdrawal due to Caregiver Circumstances | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Bari 2-mg | Bari 4-mg | Bari 1-mg | Bari 2-mg Open-Label Addendum | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 14.06 | 34.2 years STANDARD_DEVIATION 12.69 | 35.6 years STANDARD_DEVIATION 12.85 | 33.5 years STANDARD_DEVIATION 8.49 | 34.9 years STANDARD_DEVIATION 12.98 | 34.9 years STANDARD_DEVIATION 12.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 70 Participants | 87 Participants | 10 Participants | 72 Participants | 254 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 332 Participants | 467 Participants | 32 Participants | 165 Participants | 1053 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants | 117 Participants | 189 Participants | 3 Participants | 10 Participants | 338 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 10 Participants | 6 Participants | 4 Participants | 16 Participants | 42 Participants |
| Race (NIH/OMB) Asian | 32 Participants | 174 Participants | 282 Participants | 7 Participants | 13 Participants | 508 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 18 Participants | 23 Participants | 2 Participants | 6 Participants | 54 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 48 Participants | 315 Participants | 429 Participants | 32 Participants | 211 Participants | 1035 Participants |
| Region of Enrollment Argentina | 6 Participants | 36 Participants | 46 Participants | 2 Participants | 24 Participants | 114 Participants |
| Region of Enrollment Australia | 4 Participants | 30 Participants | 42 Participants | 1 Participants | 32 Participants | 109 Participants |
| Region of Enrollment Austria | 2 Participants | 12 Participants | 23 Participants | 0 Participants | 12 Participants | 49 Participants |
| Region of Enrollment Czechia | 3 Participants | 22 Participants | 46 Participants | 3 Participants | 28 Participants | 102 Participants |
| Region of Enrollment Denmark | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 7 Participants |
| Region of Enrollment France | 0 Participants | 15 Participants | 19 Participants | 0 Participants | 0 Participants | 34 Participants |
| Region of Enrollment Germany | 7 Participants | 77 Participants | 100 Participants | 12 Participants | 0 Participants | 196 Participants |
| Region of Enrollment Hungary | 7 Participants | 15 Participants | 21 Participants | 2 Participants | 27 Participants | 72 Participants |
| Region of Enrollment India | 5 Participants | 7 Participants | 19 Participants | 0 Participants | 0 Participants | 31 Participants |
| Region of Enrollment Israel | 1 Participants | 16 Participants | 13 Participants | 0 Participants | 4 Participants | 34 Participants |
| Region of Enrollment Italy | 7 Participants | 16 Participants | 26 Participants | 4 Participants | 15 Participants | 68 Participants |
| Region of Enrollment Japan | 11 Participants | 89 Participants | 141 Participants | 3 Participants | 0 Participants | 244 Participants |
| Region of Enrollment Mexico | 9 Participants | 29 Participants | 21 Participants | 5 Participants | 43 Participants | 107 Participants |
| Region of Enrollment Poland | 10 Participants | 45 Participants | 70 Participants | 7 Participants | 0 Participants | 132 Participants |
| Region of Enrollment Russia | 0 Participants | 9 Participants | 13 Participants | 1 Participants | 28 Participants | 51 Participants |
| Region of Enrollment South Korea | 9 Participants | 39 Participants | 58 Participants | 1 Participants | 0 Participants | 107 Participants |
| Region of Enrollment Spain | 2 Participants | 27 Participants | 26 Participants | 1 Participants | 24 Participants | 80 Participants |
| Region of Enrollment Switzerland | 0 Participants | 5 Participants | 9 Participants | 1 Participants | 3 Participants | 18 Participants |
| Region of Enrollment Taiwan | 8 Participants | 30 Participants | 50 Participants | 2 Participants | 0 Participants | 90 Participants |
| Sex: Female, Male Female | 44 Participants | 206 Participants | 239 Participants | 16 Participants | 112 Participants | 617 Participants |
| Sex: Female, Male Male | 47 Participants | 313 Participants | 504 Participants | 29 Participants | 135 Participants | 1028 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 45 | 0 / 766 | 1 / 743 | 1 / 92 | 0 / 91 | 0 / 92 | 0 / 84 | 0 / 84 | 0 / 84 | 0 / 70 | 0 / 32 | 0 / 249 | 1 / 264 |
| other Total, other adverse events | 21 / 91 | 14 / 45 | 263 / 766 | 268 / 743 | 15 / 92 | 27 / 91 | 38 / 92 | 16 / 84 | 21 / 84 | 42 / 84 | 14 / 70 | 14 / 32 | 96 / 249 | 110 / 264 |
| serious Total, serious adverse events | 5 / 91 | 1 / 45 | 32 / 766 | 40 / 743 | 2 / 92 | 1 / 91 | 3 / 92 | 3 / 84 | 1 / 84 | 11 / 84 | 1 / 70 | 3 / 32 | 16 / 249 | 25 / 264 |
Outcome results
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.
Time frame: Weeks 16, 36 and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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 | Week 16 | 36.5 Percentage of participants |
| RPR-Placebo | 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 | Week 52 | 28.8 Percentage of participants |
| RPR-Placebo | 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 | Week 36 | 23.1 Percentage of participants |
| RPR-Bari 1-mg | 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 | Week 16 | 46.7 Percentage of participants |
| RPR-Bari 1-mg | 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 | Week 52 | 35.6 Percentage of participants |
| RPR-Bari 1-mg | 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 | Week 36 | 31.1 Percentage of participants |
| RPR-Bari 2-mg | 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 | Week 36 | 63.0 Percentage of participants |
| RPR-Bari 2-mg | 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 | Week 16 | 59.3 Percentage of participants |
| RPR-Bari 2-mg | 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 | Week 52 | 50.0 Percentage of participants |
| RPR-Bari 4-mg | 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 | Week 16 | 48.6 Percentage of participants |
| RPR-Bari 4-mg | 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 | Week 52 | 40.0 Percentage of participants |
| RPR-Bari 4-mg | 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 | Week 36 | 37.1 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 36 | 41.2 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 47.1 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 29.4 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 36 | 24.5 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 45.3 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 30.2 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 31.7 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 31.7 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 36 | 30.2 Percentage of participants |
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.
Time frame: Weeks 16, 36 and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 46.0 Percentage of participants |
| RPR-Placebo | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 31.0 Percentage of participants |
| RPR-Placebo | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 40.2 Percentage of participants |
| RPR-Bari 1-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 43.2 Percentage of participants |
| RPR-Bari 1-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 55.6 Percentage of participants |
| RPR-Bari 1-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 48.1 Percentage of participants |
| RPR-Bari 2-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 44.0 Percentage of participants |
| RPR-Bari 2-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 47.6 Percentage of participants |
| RPR-Bari 2-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 44.0 Percentage of participants |
| RPR-Bari 4-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 43.6 Percentage of participants |
| RPR-Bari 4-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 38.5 Percentage of participants |
| RPR-Bari 4-mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 48.7 Percentage of participants |
| NR: Bari 4 mg to 4 mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 39.1 Percentage of participants |
| NR: Bari 4 mg to 4 mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 40.4 Percentage of participants |
| NR: Bari 4 mg to 4 mg | Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 41.0 Percentage of participants |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 31.6 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 36.8 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 31.4 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 36 | 25.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 20.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 20.0 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 36 | 28.6 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 57.1 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 28.6 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 28.2 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 28.2 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 36 | 23.1 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 40.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 35.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 45.0 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 42.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 57.1 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 42.9 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 30.8 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 28.2 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 20.5 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 36 | 15.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 10.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 15.0 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 36 | 23.8 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 28.6 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 19.0 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 5.1 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 5.1 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 36 | 15.4 Percentage of participants |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 20.0 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 38.7 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 24.3 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 31.0 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 22.5 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 33.3 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 28.7 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 36 | 32.2 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 36 | 30.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 43.2 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 35.8 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 36 | 31.0 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 38.1 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 34.5 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 38.5 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 34.6 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 36 | 44.9 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 36 | 30.8 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 26.9 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 33.3 Percentage of participants |
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.
Time frame: Weeks 16, 36, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 13.8 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 12.6 Percentage of participants |
| RPR-Placebo | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 36 | 13.8 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 36 | 12.3 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 23.5 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 12.3 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 36 | 10.7 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 15.5 Percentage of participants |
| RPR-Bari 2-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 19.0 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 17.9 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 15.4 Percentage of participants |
| RPR-Bari 4-mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 36 | 16.7 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 36 | 16.7 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 10.3 Percentage of participants |
| NR: Bari 4 mg to 4 mg | NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 20.5 Percentage of participants |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 20.6 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 26.9 Percentage of participants |
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.
Time frame: Weeks 4, 16, 24, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 4 | 23.5 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 38.2 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 24 | 32.4 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 26.5 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 32.1 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 4 | 39.3 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 24 | 32.1 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 39.3 Percentage of participants |
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.
Time frame: Weeks 4, 16, 24, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 4 | 50.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 47.1 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 24 | 38.2 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 26.5 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 25.0 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 4 | 46.4 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 24 | 39.3 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 46.4 Percentage of participants |
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.
Time frame: Weeks 4, 16, 24, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 4 | 0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 5.9 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 24 | 11.8 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 5.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 52 | 10.7 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 4 | 14.3 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 24 | 17.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 | Week 16 | 25.0 Percentage of participants |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 33.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS | 35.7 Percentage of participants |
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.
Time frame: Weeks 4, 16, 24, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 4 | 38.9 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 43.9 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 24 | 45.0 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 41.1 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 52 | 38.7 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 4 | 46.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 24 | 45.4 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 | Week 16 | 53.6 Percentage of participants |
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.
Time frame: Weeks 4, 16, 24, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 4 | 57.8 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 56.7 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 24 | 55.6 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 50.6 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 46.9 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 4 | 67.0 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 24 | 57.2 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 62.9 Percentage of participants |
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.
Time frame: Weeks 4, 16, 24, 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 4 | 22.8 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 22.2 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 24 | 22.2 Percentage of participants |
| RPR-Placebo | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 20.6 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 52 | 23.7 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 4 | 25.8 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 24 | 27.8 Percentage of participants |
| RPR-Bari 1-mg | NR: Percentage of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 | Week 16 | 29.9 Percentage of participants |
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.
Time frame: Weeks 68, 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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) | Week 68 | 79.8 Percentage of participants |
| RPR-Placebo | 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) | Week 104 | 73.8 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 68 | 58.3 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 104 | 58.3 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 68 | 45.2 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 104 | 41.7 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 68 | 73.9 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 104 | 72.8 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 68 | 69.2 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 104 | 58.2 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 68 | 44.6 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 104 | 43.5 Percentage of participants |
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.
Time frame: Week 104
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy) | 39.8 Percentage of participants |
| RPR-Bari 1-mg | Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy) | 40.9 Percentage of participants |
| RPR-Bari 2-mg | Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy) | 65.6 Percentage of participants |
| RPR-Bari 4-mg | Percentage of Participants Achieving Response of EASI75 From Baseline of Originating Study Assessed at Week 104 (Participants Not Entered Into Substudy) | 54.3 Percentage of participants |
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.
Time frame: Week 68
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | 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) | 61.5 Percentage of participants |
| RPR-Bari 1-mg | 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) | 53.2 Percentage of participants |
| RPR-Bari 2-mg | 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) | 70.0 Percentage of participants |
| RPR-Bari 4-mg | 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) | 55.1 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | 44.4 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | 71.4 Percentage of participants |
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).
Time frame: Weeks 68, 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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) | Week 68 | 86.9 Percentage of participants |
| RPR-Placebo | 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) | Week 104 | 85.7 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 68 | 60.7 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 104 | 48.8 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 68 | 50.0 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 104 | 41.7 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 68 | 92.4 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 104 | 83.7 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 68 | 70.3 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 104 | 58.2 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 68 | 44.6 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 104 | 33.7 Percentage of participants |
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).
Time frame: Weeks 68, 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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) | Week 68 | 51.2 Percentage of participants |
| RPR-Placebo | 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) | Week 104 | 47.6 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 68 | 45.2 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 104 | 35.7 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 68 | 29.8 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 104 | 33.3 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 68 | 47.8 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 104 | 42.4 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 68 | 41.8 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 104 | 38.5 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 68 | 25.0 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 104 | 21.7 Percentage of participants |
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.
Time frame: Weeks 68, 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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) | Week 68 | 93 Percentage of participants |
| RPR-Placebo | 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) | Week 104 | 76.7 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 68 | 76.7 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 104 | 74.4 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 68 | 72.1 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 104 | 67.4 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 68 | 83.3 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 104 | 83.3 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 68 | 89.6 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 104 | 79.2 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 68 | 63.3 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 104 | 55.1 Percentage of participants |
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).
Time frame: Weeks 68, 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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) | Week 68 | 97.7 Percentage of participants |
| RPR-Placebo | 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) | Week 104 | 90.7 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 68 | 76.7 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 104 | 69.8 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 68 | 72.1 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 104 | 62.8 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 68 | 95.8 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 104 | 93.8 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 68 | 89.6 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 104 | 77.1 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 68 | 55.1 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 104 | 42.9 Percentage of participants |
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).
Time frame: Week 104
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy) | 41.3 Percentage of participants |
| RPR-Bari 1-mg | Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy) | 45.6 Percentage of participants |
| RPR-Bari 2-mg | Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy) | 71.9 Percentage of participants |
| RPR-Bari 4-mg | Percentage of Participants With a Response of IGA 0, 1, or 2 Assessed at Week 104 (Participants Not Entered Into Substudy) | 51.4 Percentage of participants |
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).
Time frame: Week 68
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | 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) | 69.2 Percentage of participants |
| RPR-Bari 1-mg | 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) | 74.5 Percentage of participants |
| RPR-Bari 2-mg | 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) | 80.0 Percentage of participants |
| RPR-Bari 4-mg | 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) | 57.1 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | 55.6 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | 76.2 Percentage of participants |
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).
Time frame: Weeks 68, 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | 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) | Week 68 | 74.4 Percentage of participants |
| RPR-Placebo | 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) | Week 104 | 62.8 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 68 | 69.8 Percentage of participants |
| RPR-Bari 1-mg | 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) | Week 104 | 55.8 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 68 | 55.8 Percentage of participants |
| RPR-Bari 2-mg | 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) | Week 104 | 58.1 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 68 | 70.8 Percentage of participants |
| RPR-Bari 4-mg | 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) | Week 104 | 60.4 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 68 | 66.7 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | Week 104 | 60.4 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 68 | 36.7 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | Week 104 | 32.7 Percentage of participants |
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).
Time frame: Week 104
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy) | 13.3 Percentage of participants |
| RPR-Bari 1-mg | Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy) | 13.5 Percentage of participants |
| RPR-Bari 2-mg | Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy) | 53.1 Percentage of participants |
| RPR-Bari 4-mg | Percentage of Participants With a Response of IGA 0 or 1 Assessed at Week 104 (Participants Not Entered Into Substudy) | 40.0 Percentage of participants |
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).
Time frame: Week 68
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | 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) | 23.1 Percentage of participants |
| RPR-Bari 1-mg | 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) | 25.5 Percentage of participants |
| RPR-Bari 2-mg | 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) | 44.0 Percentage of participants |
| RPR-Bari 4-mg | 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) | 10.2 Percentage of participants |
| NR: Bari 4 mg to 4 mg | 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) | 26.7 Percentage of participants |
| 2 mg Bari to Placebo Substudy | 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) | 39.7 Percentage of participants |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 37.5 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 45.8 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS | 46.4 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 36 | 47.1 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 55.9 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 38.2 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 36 | 47.2 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 67.9 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 52.8 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 16 | 55.6 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 52 | 42.9 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 | Week 36 | 44.4 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 36 | 55.9 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 16 | 70.6 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 52 | 50.0 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 36 | 49.1 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 16 | 73.6 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 52 | 54.7 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 16 | 63.5 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 52 | 52.4 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 | Week 36 | 52.4 Percentage of participants |
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.
Time frame: Week 16
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS) | 32.6 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS) | 25.8 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS) | 32.6 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch Numeric Rating Scale (NRS) | 41.0 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52 Weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 16 | 42.3 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 52 | 38.5 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 36 | 44.2 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 16 | 62.2 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 52 | 51.1 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 36 | 46.7 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 36 | 74.1 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 16 | 70.4 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 52 | 64.8 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 16 | 64.3 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 52 | 51.4 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 | Week 36 | 51.4 Percentage of participants |
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.
Time frame: Weeks 16, 36, and 52
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 69.2 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 46.2 Percentage of participants |
| RPR-Placebo | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 48.1 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 77.8 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 53.3 Percentage of participants |
| RPR-Bari 1-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 60.0 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 81.5 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 81.5 Percentage of participants |
| RPR-Bari 2-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 72.2 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 16 | 72.9 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 52 | 58.6 Percentage of participants |
| RPR-Bari 4-mg | RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 | Week 36 | 58.6 Percentage of participants |
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
Time frame: Week 52 Up to Week 200
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RPR-Placebo | Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 117.0 Days |
| RPR-Bari 1-mg | Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 56.0 Days |
| RPR-Bari 2-mg | Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 29.5 Days |
| RPR-Bari 4-mg | Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 61.0 Days |
| NR: Bari 4 mg to 4 mg | Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 169.0 Days |
| 2 mg Bari to Placebo Substudy | Time to Retreatment (Time to IGA ≥3) in Randomized Withdrawal and Down Titration (Participants Entering the Sub Study) | 30.0 Days |