NCT03334435: BREEZE-AD3

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Completed Phase 3 Results posted Last updated 3 September 2024

What this trial tests

Phase 3 trial testing Baricitinib in Atopic Dermatitis in 1,645 participants. Completed in 12 July 2023.

Timeline

28 March 2018

Primary endpoint
21 September 2020

12 July 2023

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,645
Start date	28 March 2018
Primary completion	21 September 2020
Estimated completion	12 July 2023
Sites	185 locations across Italy, Japan, Taiwan, Poland, South Korea, Denmark, Russia, Mexico

Drugs / interventions tested

• Baricitinib (baricitinib) — full drug profile →
• Placebo

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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 su

Week 16

Group	Value	95% CI
RPR-Placebo	36.5	24.8 – 50.1
RPR-Bari 1-mg	46.7	32.9 – 60.9
RPR-Bari 2-mg	59.3	46.0 – 71.3
RPR-Bari 4-mg	48.6	37.2 – 60.0

Week 36

Group	Value	95% CI
RPR-Placebo	23.1	13.7 – 36.1
RPR-Bari 1-mg	31.1	19.5 – 45.7
RPR-Bari 2-mg	63.0	49.6 – 74.6
RPR-Bari 4-mg	37.1	26.8 – 48.9

Week 52

Group	Value	95% CI
RPR-Placebo	28.8	18.3 – 42.3
RPR-Bari 1-mg	35.6	23.2 – 50.2
RPR-Bari 2-mg	50.0	37.1 – 62.9
RPR-Bari 4-mg	40.0	29.3 – 51.7

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 Primary · 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.

Week 16

Group	Value	95% CI
RPR-Placebo	47.1	31.5 – 63.3
RPR-Bari 2-mg	45.3	32.7 – 58.5
RPR-Bari 4-mg	31.7	21.6 – 44.0

Week 36

Group	Value	95% CI
RPR-Placebo	41.2	26.4 – 57.8
RPR-Bari 2-mg	24.5	14.9 – 37.6
RPR-Bari 4-mg	30.2	20.2 – 42.4

Week 52

Group	Value	95% CI
RPR-Placebo	29.4	16.8 – 46.2
RPR-Bari 2-mg	30.2	19.5 – 43.5
RPR-Bari 4-mg	31.7	21.6 – 44.0

RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 Secondary · 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.

Week 16

Group	Value	95% CI
RPR-Placebo	69.2	55.7 – 80.1
RPR-Bari 1-mg	77.8	63.7 – 87.5
RPR-Bari 2-mg	81.5	69.2 – 89.6
RPR-Bari 4-mg	72.9	61.5 – 81.9

Week 36

Group	Value	95% CI
RPR-Placebo	48.1	35.1 – 61.3
RPR-Bari 1-mg	60.0	45.5 – 73.0
RPR-Bari 2-mg	81.5	69.2 – 89.6
RPR-Bari 4-mg	58.6	46.9 – 69.4

Week 52

Group	Value	95% CI
RPR-Placebo	46.2	33.3 – 59.5
RPR-Bari 1-mg	53.3	39.1 – 67.1
RPR-Bari 2-mg	72.2	59.1 – 82.4
RPR-Bari 4-mg	58.6	46.9 – 69.4

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2 Secondary · 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.

Week 16

Group	Value	95% CI
RPR Placebo	70.6	53.8 – 83.2
RPR Bari 2 mg	73.6	60.4 – 83.6
RPR Bari 4 mg	63.5	51.1 – 74.3

Week 36

Group	Value	95% CI
RPR Placebo	55.9	39.5 – 71.1
RPR Bari 2 mg	49.1	36.1 – 62.1
RPR Bari 4 mg	52.4	40.3 – 64.2

Week 52

Group	Value	95% CI
RPR Placebo	50.0	34.1 – 65.9
RPR Bari 2 mg	54.7	41.5 – 67.3
RPR Bari 4 mg	52.4	40.3 – 64.2

Non Responders (NR): Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2 Secondary · 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.

Week 16

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	46.0	35.9 – 56.4
NR: Bari 1 mg to 4 mg	55.6	44.7 – 65.9
NR: Bari 2 mg to 2 mg	47.6	37.3 – 58.2
NR: Bari 2 mg to 4 mg	43.6	33.1 – 54.6
NR: Bari 4 mg to 4 mg	40.4	33.0 – 48.2

Week 36

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	40.2	30.6 – 50.7
NR: Bari 1 mg to 4 mg	43.2	33.0 – 54.1
NR: Bari 2 mg to 2 mg	44.0	33.9 – 54.7
NR: Bari 2 mg to 4 mg	48.7	37.9 – 59.6
NR: Bari 4 mg to 4 mg	39.1	31.8 – 46.9

Week 52

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	31.0	22.3 – 41.4
NR: Bari 1 mg to 4 mg	48.1	37.6 – 58.9
NR: Bari 2 mg to 2 mg	44.0	33.9 – 54.7
NR: Bari 2 mg to 4 mg	38.5	28.4 – 49.6
NR: Bari 4 mg to 4 mg	41.0	33.6 – 48.9

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2 Secondary · 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.

Week 16

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	35.0	18.1 – 56.7
NR: Bari 2 mg to 4 mg	57.1	36.5 – 75.5
NR: Bari 4 mg to 4 mg	30.8	18.6 – 46.4

Week 36

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	40.0	21.9 – 61.3
NR: Bari 2 mg to 4 mg	42.9	24.5 – 63.5
NR: Bari 4 mg to 4 mg	20.5	10.8 – 35.5

Week 52

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	45.0	25.8 – 65.8
NR: Bari 2 mg to 4 mg	42.9	24.5 – 63.5
NR: Bari 4 mg to 4 mg	28.2	16.5 – 43.8

NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1 Secondary · 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.

Week 16

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	13.8	8.1 – 22.6
NR: Bari 1 mg to 4 mg	23.5	15.6 – 33.8
NR: Bari 2 mg to 2 mg	15.5	9.3 – 24.7
NR: Bari 2 mg to 4 mg	17.9	11.0 – 27.9
NR: Bari 4 mg to 4 mg	10.3	6.4 – 16.0

Week 36

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	13.8	8.1 – 22.6
NR: Bari 1 mg to 4 mg	12.3	6.8 – 21.3
NR: Bari 2 mg to 2 mg	10.7	5.7 – 19.1
NR: Bari 2 mg to 4 mg	16.7	10.0 – 26.5
NR: Bari 4 mg to 4 mg	16.7	11.6 – 23.3

Week 52

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	12.6	7.2 – 21.2
NR: Bari 1 mg to 4 mg	12.3	6.8 – 21.3
NR: Bari 2 mg to 2 mg	19.0	12.1 – 28.7
NR: Bari 2 mg to 4 mg	15.4	9.0 – 25.0
NR: Bari 4 mg to 4 mg	20.5	14.9 – 27.5

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 Secondary · 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.

Week 16

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	10.0	2.8 – 30.1
NR: Bari 2 mg to 4 mg	28.6	13.8 – 50.0
NR: Bari 4 mg to 4 mg	5.1	1.4 – 16.9

Week 36

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	15.0	5.2 – 36.0
NR: Bari 2 mg to 4 mg	23.8	10.6 – 45.1
NR: Bari 4 mg to 4 mg	15.4	7.2 – 29.7

Week 52

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	15.0	5.2 – 36.0
NR: Bari 2 mg to 4 mg	19.0	7.7 – 40.0
NR: Bari 4 mg to 4 mg	5.1	1.4 – 16.9

RPR: Percentage of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75 Secondary · 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

Week 16

Group	Value	95% CI
RPR-Placebo	42.3	29.9 – 55.8
RPR-Bari 1-mg	62.2	47.6 – 74.9
RPR-Bari 2-mg	70.4	57.2 – 80.9
RPR-Bari 4-mg	64.3	52.6 – 74.5

Week 36

Group	Value	95% CI
RPR-Placebo	44.2	31.6 – 57.7
RPR-Bari 1-mg	46.7	32.9 – 60.9
RPR-Bari 2-mg	74.1	61.1 – 83.9
RPR-Bari 4-mg	51.4	40.0 – 62.8

Week 52

Group	Value	95% CI
RPR-Placebo	38.5	26.5 – 52.0
RPR-Bari 1-mg	51.1	37.0 – 65.0
RPR-Bari 2-mg	64.8	51.5 – 76.2
RPR-Bari 4-mg	51.4	40.0 – 62.8

RPR: Percentage of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 Secondary · 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

Week 16

Group	Value	95% CI
RPR-Placebo	55.9	39.5 – 71.1
RPR-Bari 2-mg	67.9	54.5 – 78.9
RPR-Bari 4-mg	55.6	43.3 – 67.2

Week 36

Group	Value	95% CI
RPR-Placebo	47.1	31.5 – 63.3
RPR-Bari 2-mg	47.2	34.4 – 60.3
RPR-Bari 4-mg	44.4	32.8 – 56.7

Week 52

Group	Value	95% CI
RPR-Placebo	38.2	23.9 – 55.0
RPR-Bari 2-mg	52.8	39.7 – 65.6
RPR-Bari 4-mg	42.9	31.4 – 55.1

NR: Percentage of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75 Secondary · 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

Week 16

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	33.3	24.3 – 43.8
NR: Bari 1 mg to 4 mg	43.2	33.0 – 54.1
NR: Bari 2 mg to 2 mg	38.1	28.4 – 48.8
NR: Bari 2 mg to 4 mg	38.5	28.4 – 49.6
NR: Bari 4 mg to 4 mg	26.9	20.6 – 34.4

Week 36

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	32.2	23.3 – 42.6
NR: Bari 1 mg to 4 mg	30.9	21.9 – 41.6
NR: Bari 2 mg to 2 mg	31.0	22.1 – 41.5
NR: Bari 2 mg to 4 mg	44.9	34.3 – 55.9
NR: Bari 4 mg to 4 mg	30.8	24.1 – 38.4

Week 52

Group	Value	95% CI
NR: Bari 1 mg to 2 mg	28.7	20.3 – 39.0
NR: Bari 1 mg to 4 mg	35.8	26.2 – 46.7
NR: Bari 2 mg to 2 mg	34.5	25.2 – 45.2
NR: Bari 2 mg to 4 mg	34.6	25.0 – 45.7
NR: Bari 4 mg to 4 mg	33.3	26.4 – 41.1

NR: Percentage of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75 Secondary · 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

Week 16

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	20.0	8.1 – 41.6
NR: Bari 2 mg to 4 mg	57.1	36.5 – 75.5
NR: Bari 4 mg to 4 mg	28.2	16.5 – 43.8

Week 36

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	25.0	11.2 – 46.9
NR: Bari 2 mg to 4 mg	28.6	13.8 – 50.0
NR: Bari 4 mg to 4 mg	23.1	12.6 – 38.3

Week 52

Group	Value	95% CI
NR: Bari 2 mg to 2 mg	20.0	8.1 – 41.6
NR: Bari 2 mg to 4 mg	28.6	13.8 – 50.0
NR: Bari 4 mg to 4 mg	28.2	16.5 – 43.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through Week 200. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 5/91 (5%)

Deaths: 0/91

Bari 1-mg

Serious: 1/45 (2%)

Deaths: 0/45

Bari 2-mg

Serious: 32/766 (4%)

Deaths: 0/766

Bari 4-mg

Serious: 40/743 (5%)

Deaths: 1/743

2 mg Bari to Placebo Substudy

Serious: 2/92 (2%)

Deaths: 1/92

2 mg Bari to 1 mg Bari Substudy

Serious: 1/91 (1%)

Deaths: 0/91

2 mg Bari to 2 mg Bari Substudy

Serious: 3/92 (3%)

Deaths: 0/92

4 mg Bari to Placebo Substudy

Serious: 3/84 (4%)

Deaths: 0/84

4 mg Bari to 2 mg Bari Substudy

Serious: 1/84 (1%)

Deaths: 0/84

4 mg Bari to 4 mg Bari Substudy

Serious: 11/84 (13%)

Deaths: 0/84

Placebo to Placebo Non-substudy

Serious: 1/70 (1%)

Deaths: 0/70

1 mg Bari to 1 mg Bari Non-substudy

Serious: 3/32 (9%)

Deaths: 0/32

2 mg Bari to 2 mg Bari Non-substudy

Serious: 16/249 (6%)

Deaths: 0/249

4 mg Bari to 4 mg Bari Non-substudy

Serious: 25/264 (9%)

Deaths: 1/264

Serious adverse events (122 terms)

Reaction	System	Placebo	Bari 1-mg	Bari 2-mg	Bari 4-mg	2 mg Bari to Placebo Subst…	2 mg Bari to 1 mg Bari Sub…	2 mg Bari to 2 mg Bari Sub…	4 mg Bari to Placebo Subst…	4 mg Bari to 2 mg Bari Sub…	4 mg Bari to 4 mg Bari Sub…	Placebo to Placebo Non-sub…	1 mg Bari to 1 mg Bari Non…	2 mg Bari to 2 mg Bari Non…	4 mg Bari to 4 mg Bari Non…
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Eczema herpeticum	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Retinal detachment	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Superinfection bacterial	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Device dislocation	Product Issues	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombophlebitis	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypochromic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiovascular disorder	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myocarditis	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thyroglossal cyst	Congenital, familial and genetic disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematotympanum	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Glaucoma	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Open angle glaucoma	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Retinopathy proliferative	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anal fistula	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (15 terms — click to expand)

Reaction	System	Placebo	Bari 1-mg	Bari 2-mg	Bari 4-mg	2 mg Bari to Placebo Subst…	2 mg Bari to 1 mg Bari Sub…	2 mg Bari to 2 mg Bari Sub…	4 mg Bari to Placebo Subst…	4 mg Bari to 2 mg Bari Sub…	4 mg Bari to 4 mg Bari Sub…	Placebo to Placebo Non-sub…	1 mg Bari to 1 mg Bari Non…	2 mg Bari to 2 mg Bari Non…	4 mg Bari to 4 mg Bari Non…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dermal cyst	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hepatic enzyme increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Dermatitis atopic, Eczema herpeticum, Cellulitis, Retinal detachment, Superinfection bacterial, Arthralgia, Device dislocation, Asthma.

Data from ClinicalTrials.gov NCT03334435 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. JAK inhibitors in the treatment of atopic dermatitis.
   Chovatiya R, Paller AS. · · 2021 · cited 258× · PMID 34437922 · DOI 10.1016/j.jaci.2021.08.009
2. JAK-STAT signaling pathway in the pathogenesis of atopic dermatitis: An updated review.
   Huang IH, Chung WH, Wu PC, Chen CB. · · 2022 · cited 195× · PMID 36569854 · DOI 10.3389/fimmu.2022.1068260
3. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
   Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
4. The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.
   Facheris P, Jeffery J, Del Duca E, Guttman-Yassky E. · · 2023 · cited 150× · PMID 36928371 · DOI 10.1038/s41423-023-00992-4
5. Tyrosine Kinases in Autoimmune and Inflammatory Skin Diseases.
   Szilveszter KP, Németh T, Mócsai A. · · 2019 · cited 102× · PMID 31447854 · DOI 10.3389/fimmu.2019.01862
6. Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches.
   Moyle M, Cevikbas F, Harden JL, Guttman-Yassky E. · · 2019 · cited 100× · PMID 30825336 · DOI 10.1111/exd.13911
7. New and Emerging Systemic Treatments for Atopic Dermatitis.
   Newsom M, Bashyam AM, Balogh EA, Feldman SR, et al · · 2020 · cited 76× · PMID 32519223 · DOI 10.1007/s40265-020-01335-7
8. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials.
   Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, et al · · 2021 · cited 75× · PMID 33978711 · DOI 10.1001/jamadermatol.2021.1273