Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis (NCT NCT03733301)
NCT ID: NCT03733301
Last Updated: 2020-08-11
Results Overview
The IGA measures investigators 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) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
COMPLETED
PHASE3
329 participants
Week 16
2020-08-11
Participant Flow
Participants who completed the 16-week treatment period had an option to enter extension study JAHN (NCT03334435).
Participant milestones
| Measure |
Placebo
Placebo administered orally once daily.
|
2 mg Baricitinib
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
109
|
111
|
|
Overall Study
Received One Dose of Study Drug
|
108
|
109
|
111
|
|
Overall Study
COMPLETED
|
102
|
100
|
107
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered orally once daily.
|
2 mg Baricitinib
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Overall Study
Screen Fail
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
1
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
322 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants.
The IGA measures investigators 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) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement
|
14.7 percentage of participants
|
23.9 percentage of participants
|
30.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
|
22.9 percentage of participants
|
43.1 percentage of participants
|
47.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving EASI90
|
13.8 percentage of participants
|
16.5 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who had Week 16 EASI data.
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 to 72 (severe). Least Squares Mean (LSM) were calculated using mixed model repeated measures (MMRM) with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit interaction as fixed categorical effects and baseline score and baseline score-by-visit interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=90 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=100 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=100 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percent Change From Baseline on EASI Score
|
-45.08 percent change
Standard Error 3.828
|
-58.16 percent change
Standard Error 3.689
|
-67.21 percent change
Standard Error 3.679
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with a visual analogue scales (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
|
7.3 percentage of participants
|
11.0 percentage of participants
|
18.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants with Baseline Itch Score \>= 4.
The Itch NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Outcome measures
| Measure |
Placebo
n=104 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=97 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=100 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)
|
20.2 percentage of participants
|
38.1 percentage of participants
|
44.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data.
The ADSS is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep due to itch, frequency of waking due to itch, and difficulty getting back to sleep last night due to itch. Item 2 frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Mean were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit interaction as fixed categorical effects and baseline score and baseline score-by-visit interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=98 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=94 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)
|
-0.51 units on a scale
Standard Error 0.151
|
-1.33 units on a scale
Standard Error 0.147
|
-1.42 units on a scale
Standard Error 0.147
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 Skin Pain NRS data.
Skin Pain NRS is a patient-administered,11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=98 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=94 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Skin Pain NRS
|
-2.06 units on a scale
Standard Error 0.231
|
-3.22 units on a scale
Standard Error 0.224
|
-3.73 units on a scale
Standard Error 0.226
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in the EASI score.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving EASI50
|
41.3 percentage of participants
|
64.2 percentage of participants
|
70.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving IGA of 0
|
2.8 percentage of participants
|
3.7 percentage of participants
|
8.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 SCORAD data.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=90 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=100 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=99 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline in SCORAD
|
-21.40 units on a scale
Standard Error 1.941
|
-29.88 units on a scale
Standard Error 1.867
|
-35.78 units on a scale
Standard Error 1.862
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants.
The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3)oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease: (A: 0-1-2), disease severity (B: 0-18), \& subjective symptoms (C: 0-20) combine using A/5 + 7\*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving SCORAD90
|
0.9 percentage of participants
|
3.7 percentage of participants
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 BSA data.
The BSA affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1\*BSAhead and neck + 0.3\*BSAtrunk + 0.2\* BSAupper limbs + 0.4\*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=90 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=100 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=100 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline in Body Surface Area (BSA) Affected
|
-18.03 units on a scale
Standard Error 1.888
|
-27.00 units on a scale
Standard Error 1.825
|
-29.73 units on a scale
Standard Error 1.814
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who receive at least 1 dose of study drug.
Percentage of participants developing skin infections requiring antibiotic treatment.
Outcome measures
| Measure |
Placebo
n=108 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
|
2.8 percentage of participants
|
4.6 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: All randomized participants.
Average weights of full tubes were used to determine the dispensed weights for each region. Returned tubes were weighed with cap without carton to determine the amount of TCS in grams (g) used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity (IGA) and treatment as factors in the model.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Mean Gram Quantity of Moderate Potency Background Topical Corticosteroid (TCS) Used (Tube Weights)
|
252.75 grams
Standard Error 17.536
|
187.59 grams
Standard Error 17.508
|
161.61 grams
Standard Error 17.280
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 Itch NRS data.
The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM model with treatment, region, baseline disease severity, visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=98 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=94 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percent Change From Baseline in Itch NRS
|
-27.00 percent change
Standard Error 3.370
|
-43.44 percent change
Standard Error 3.263
|
-51.22 percent change
Standard Error 3.280
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 POEM data.
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=99 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=99 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)
|
-5.60 units on a scale
Standard Error 0.764
|
-8.50 units on a scale
Standard Error 0.736
|
-10.83 units on a scale
Standard Error 0.730
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 PGI-S-AD.
The PGI-S-AD is a single-item question asking the participant how they would rate their overall AD symptoms over the past 24 hours, using a daily diary. The 5 categories of responses are "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=98 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=94 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score
|
-0.69 units on a scale
Standard Error 0.094
|
-1.06 units on a scale
Standard Error 0.091
|
-1.18 units on a scale
Standard Error 0.091
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants Week 16 HADS data.
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=88 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=99 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=99 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
Anxiety
|
-1.89 units on a scale
Standard Error 0.304
|
-2.70 units on a scale
Standard Error 0.292
|
-2.80 units on a scale
Standard Error 0.289
|
|
Change From Baseline on the Hospital Anxiety Depression Scale (HADS)
Depression
|
-1.31 units on a scale
Standard Error 0.311
|
-2.05 units on a scale
Standard Error 0.298
|
-2.33 units on a scale
Standard Error 0.296
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 DLQI data.
The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=89 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=99 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=99 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline on the Dermatology Life Quality Index (DLQI)
|
-5.58 units on a scale
Standard Error 0.608
|
-7.50 units on a scale
Standard Error 0.584
|
-8.89 units on a scale
Standard Error 0.851
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 WPAI-AD data.
The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=99 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=98 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Absenteeism
|
-6.27 units on a scale
Standard Error 1.897
|
-4.25 units on a scale
Standard Error 1.741
|
-5.29 units on a scale
Standard Error 1.737
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Presenteeism
|
-13.15 units on a scale
Standard Error 3.203
|
-21.28 units on a scale
Standard Error 2.978
|
-23.89 units on a scale
Standard Error 2.955
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Work Productivity Loss
|
-14.25 units on a scale
Standard Error 3.300
|
-22.17 units on a scale
Standard Error 3.070
|
-24.96 units on a scale
Standard Error 3.051
|
|
Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire
Activity Impairment
|
-16.75 units on a scale
Standard Error 2.570
|
-26.55 units on a scale
Standard Error 2.458
|
-27.25 units on a scale
Standard Error 2.447
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 EQ-5D-5L Health State Index US and UK data.
The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=99 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=98 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline on the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
Health State Index Score (US Algorithm)
|
0.09 units on a scale
Standard Error 0.013
|
0.12 units on a scale
Standard Error 0.012
|
0.14 units on a scale
Standard Error 0.012
|
|
Change From Baseline on the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm
Health State Index Score (UK Algorithm)
|
0.13 units on a scale
Standard Error 0.018
|
0.17 units on a scale
Standard Error 0.017
|
0.21 units on a scale
Standard Error 0.017
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with Week 16 EQ-5D-5L VAS data.
The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=99 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=98 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Change From Baseline on the EQ-5D-5L Visual Analog Scale (VAS)
|
11.00 millimeters
Standard Error 1.903
|
15.12 millimeters
Standard Error 1.806
|
17.06 millimeters
Standard Error 1.805
|
SECONDARY outcome
Timeframe: Week 0 through Week 16Population: All randomized participants.
The ANCOVA model includes treatment, region, and baseline disease severity (IGA) as factors.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Mean Number of Days Without Use of Background TCS
|
12.45 days
Standard Error 3.17
|
22.49 days
Standard Error 3.16
|
29.78 days
Standard Error 3.12
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Outcome measures
| Measure |
Placebo
n=109 Participants
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 Participants
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 Participants
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement
|
5.5 percentage of participants
|
17.4 percentage of participants
|
19.8 percentage of participants
|
Adverse Events
Placebo
2 mg Baricitinib
4 mg Baricitinib
Serious adverse events
| Measure |
Placebo
n=108 participants at risk
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 participants at risk
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 participants at risk
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.90%
1/111 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.93%
1/108 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/111 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Eye infection toxoplasmal
|
0.93%
1/108 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/111 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Postoperative abscess
|
0.93%
1/108 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/111 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.92%
1/109 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/111 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.90%
1/111 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.93%
1/108 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/111 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.90%
1/111 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/109 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.90%
1/111 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.92%
1/109 • Number of events 1 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/111 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=108 participants at risk
Placebo administered orally once daily.
|
2 mg Baricitinib
n=109 participants at risk
2 mg Baricitinib administered orally once daily.
|
4 mg Baricitinib
n=111 participants at risk
4 mg Baricitinib administered orally once daily.
|
|---|---|---|---|
|
Infections and infestations
Folliculitis
|
0.00%
0/108 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
3.7%
4/109 • Number of events 4 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
5.4%
6/111 • Number of events 6 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
12.0%
13/108 • Number of events 14 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
11.0%
12/109 • Number of events 16 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
15.3%
17/111 • Number of events 18 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
2/108 • Number of events 2 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
7.3%
8/109 • Number of events 12 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
3/111 • Number of events 4 • Baseline up to 20 weeks
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60