If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Olumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgOlumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the efficacy and safety of Olumiant® (baricitinib) in patients with severe alopecia areata and comorbid autoimmune disorders?
A statistically significant proportion of patients treated with baricitinib achieved SALT ≤20 regardless of preexisting autoimmune disorders versus placebo. An analysis of safety has not been conducted in patients with comorbid autoimmune disorders.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- What is the overview of the BRAVE-AA phase 3 placebo-controlled clinical trials?
- What were the BRAVE-AA clinical trial criteria?
- How many patients with alopecia areata had historical or preexisting autoimmune disorders in the BRAVE-AA trials?
- Subgroup Analysis of Efficacy in Patients With Comorbid Autoimmune Disorders
- What are the clinical use considerations for baricitinib in patients with severe alopecia areata and comorbid autoimmune disorders?
- References
What is the overview of the BRAVE-AA phase 3 placebo-controlled clinical trials?
The efficacy and safety of baricitinib have been evaluated in the following pivotal, phase 3, placebo-controlled trials in adult patients with severe alopecia areata (AA)
- BRAVE-AA1 (N=654) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss, and
- BRAVE-AA2 (N=546) compared baricitinib 2 mg or 4 mg to placebo in adult patients with ≥50% scalp hair loss.1
What were the BRAVE-AA clinical trial criteria?
Patients were excluded from enrollment in the BRAVE-AA1 and BRAVE-AA2 studies if they
- were immunocompromised and, in the opinion of the investigator, at an unacceptable risk for participating in the study
- had a history or presence of any serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data, or
- had any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring.1
Any systemic treatment with an immunosuppressive/immunomodulating substance was prohibited during the studies, including but not limited to
- biologics (eg, monoclonal antibodies)
- cyclosporine
- mycophenolate mofetil
- interferon γ
- azathioprine
- methotrexate
- hydroxychloroquine, or
- dimethyl fumarate derivatives.1
How many patients with alopecia areata had historical or preexisting autoimmune disorders in the BRAVE-AA trials?
The number of patients in the combined analysis of the pivotal phase 3 BRAVE-AA1 and BRAVE-AA2 clinical trials with severe AA and historical or preexisting autoimmune disorders is presented in Table 1 and Table 2.
Autoimmune disorders included in the analysis were ankylosing spondylitis, autoimmune thyroiditis, chronic urticaria, chronic spontaneous urticaria, Crohn's disease, fibromyalgia, microscopic colitis, pernicious anemia, psoriasis, psoriatic arthritis, psoriatic arthropathy, rheumatoid arthritis, spondylitis, systemic lupus erythematosus, thrombocytopenia, vitiligo, and ulcerative colitis.2
Historical Illnessa |
Placebo (N=371) |
BARI 2 mg (N=365) |
BARI 4 mg (N=540) |
|---|---|---|---|
Autoimmune thyroiditis |
1 (0.3) |
2 (0.5) |
3 (0.6) |
Psoriasis |
1 (0.3) |
0 |
7 (1.3) |
Thrombocytopenia |
0 |
0 |
1 (0.2) |
Vitiligo |
0 |
0 |
1 (0.2) |
Ulcerative colitis |
0 |
1 (0.3) |
1 (0.2) |
Abbreviations: AA = alopecia areata; BARI = baricitinib; N = number of subjects in population; n = number of subjects with a condition; SAS = safety analysis set.
a Historical illness are medical conditions that occurred prior to the entry into the study.
Preexisting Conditiona |
Placebo (N=371) |
BARI 2 mg (N=365) |
BARI 4 mg (N=540) |
|---|---|---|---|
Ankylosing spondylitis |
0 |
1 (0.3) |
0 |
Autoimmune thyroiditis |
34 (9.2) |
21 (5.8) |
33 (6.1) |
Chronic urticaria |
2 (0.5) |
2 (0.5) |
2 (0.4) |
Chronic spontaneous urticaria |
0 |
1 (0.3) |
0 |
Crohn's disease |
1 (0.3) |
1 (0.3) |
1 (0.2) |
Fibromyalgia |
1 (0.3) |
2 (0.5) |
4 (0.7) |
Microscopic colitis |
0 |
1 (0.3) |
1 (0.2) |
Pernicious anemia |
3 (0.8) |
0 |
1 (0.2) |
Psoriasis |
3 (0.8) |
7 (1.9) |
2 (0.4) |
Psoriatic arthropathy |
0 |
0 |
1 (0.2) |
Rheumatoid arthritis |
3 (0.8) |
2 (0.5) |
2 (0.4) |
Spondylitis |
0 |
0 |
2 (0.4) |
Systemic lupus erythematosus |
0 |
1 (0.3) |
0 |
Thrombocytopenia |
0 |
0 |
1 (0.2) |
Vitiligo |
12 (3.2) |
7 (1.9) |
10 (1.9) |
Ulcerative colitis |
2 (0.5) |
3 (0.8) |
4 (0.7) |
Abbreviations: AA = alopecia areata; BARI = baricitinib; N = number of subjects in population; n = number of subjects with a condition; SAS = safety analysis set.
a Preexisting conditions include medical conditions that were ongoing at the entry into the study.
Subgroup Analysis of Efficacy in Patients With Comorbid Autoimmune Disorders
A subgroup analysis of efficacy was conducted in patients with severe AA and comorbid autoimmune disorders.2
Table 3 shows the baseline characteristics of patients analyzed with preexisting autoimmune disorders.
Characteristics |
Autoimmune Disordersa |
||
|---|---|---|---|
Placebo |
BARI 2 mg |
BARI 4 mg |
|
Age, years |
40.2 (12.3) |
45.2 (13.6) |
44.4 (12.9) |
Female, n (%) |
38 (76.0) |
33 (75.0) |
40 (75.5) |
Race, n (%) |
|||
White |
37 (74.0) |
29 (65.9) |
40 (75.5) |
Asian |
6 (12.0) |
10 (22.7) |
7 (13.2) |
Black |
6 (12.0) |
4 (9.1) |
3 (5.7) |
BMI, kg/m2 |
28.5 (7.4) |
26.5 (5.5) |
27.4 (5.8) |
Duration of AA since onset, years |
12.5 (9.6) |
13.7 (11.2) |
15.2 (12.7) |
Duration of current AA episode, years |
4.5 (4.3) |
3.6 (4.9) |
3.7 (3.0) |
SALT score |
89.7 (15.1) |
91.1 (15.7) |
81.7 (20.6) |
Severity, n (%) |
|||
Severe (SALT 50-94) |
17 (34.0) |
14 (31.8) |
27 (50.9) |
Very severe (SALT 95-100) |
33 (66.0) |
30 (68.2) |
26 (49.1) |
Abbreviations: AA = alopecia areata; BARI = baricitinib; BMI = body mass index; N = total number of participants in the population; n = number of participants in a group; SALT = Severity of Alopecia Tool.
Note: Data are presented as mean (SD) unless stated otherwise.
a Includes ankylosing spondylitis, autoimmune thyroiditis, chronic urticaria, chronic spontaneous urticaria, Crohn's disease, fibromyalgia, microscopic colitis, pernicious anemia, psoriasis, psoriatic arthritis, psoriatic arthropathy, rheumatoid arthritis, spondylitis, systemic lupus erythematosus, thrombocytopenia, vitiligo, and ulcerative colitis.
At week 36, baricitinib demonstrated efficacy for scalp hair regrowth regardless of underlying autoimmune disorder; see Figure 1.
Figure 1. SALT ≤20 Response in Patients With Versus Without Preexisting Comorbid Autoimmune Disorders2
Figure 1 description: A significantly greater proportion of patients achieved SALT ≤20 on baricitinib 4 mg and 2 mg versus placebo by week 36 regardless of whether or not they had preexisting comorbid autoimmune disorders. Baseline comorbid autoimmune disorders had no statistically significant effect on the SALT ≤20 response rate at any time point through week 36.
Abbreviations: BARI = baricitinib; NRI = nonresponder imputation; PBO = placebo; SALT = Severity of Alopecia Tool.
* p≤.05; ** p≤.01; *** p≤.001 vs placebo from the Fisher exact test.
An analysis of safety has not been conducted in patients with comorbid autoimmune disorders.
What are the clinical use considerations for baricitinib in patients with severe alopecia areata and comorbid autoimmune disorders?
Baricitinib is not recommended for use in combination with other Janus kinase inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.4
Eli Lilly and Company cannot provide a recommendation on whether to use baricitinib in a patient with severe AA and historical or preexisting condition of an autoimmune disorder. The treating physician may use the information provided, the patient’s prior medical history and concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options, and monitor appropriately.
Enclosed Prescribing Information
OLUMIANT® (baricitinib) tablets, for oral use, Lilly
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
- King B, Ohyama M, Kwon O, et al; BRAVE-AA Investigators. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699. https://doi.org/10.1056/NEJMoa2110343
- Vano-Galvan S, Papp K, Mayo T, et al. Efficacy of baricitinib in adult patients with severe alopecia areata and comorbid immune disorders. Poster presented at: European Academy of Dermatology and Venereology (EADV) Congress; October 11-14, 2023; Berlin, Germany.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: August 28, 2026