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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 pediatric patients with alopecia areata?
Baricitinib was superior to placebo in achieving SALT ≤20 at week 36 in adolescent alopecia areata patients. Safety results were consistent with the adult safety profile.
See important safety information, including boxed warning, in the attached prescribing information.
What is the approved indication for baricitinib?
Baricitinib is indicated for the treatment of severe alopecia areata in adults and pediatric patients 12 years of age and older.1
Content Overview
- What is the study design of BRAVE-AA-PEDS?
- What were the baseline demographics and clinical characteristics in BRAVE-AA-PEDS?
- What were the efficacy results in adolescents in BRAVE-AA-PEDS?
- What were the eyebrow and eyelash regrowth results in BRAVE-AA-PEDS?
- What were the safety results in adolescents in BRAVE-AA-PEDS?
- References
What is the study design of BRAVE-AA-PEDS?
BRAVE-AA-PEDS (NCT05723198) is an ongoing phase 3, double-blind, placebo-controlled, randomized study evaluating the efficacy, safety, and pharmacokinetics of baricitinib in children from 6 years to less than 18 years of age with severe or very severe alopecia areata (AA). To be eligible for the study, patients must have severe AA for at least 1 year with a Severity of Alopecia Tool (SALT) score of ≥50% at screening and baseline.2
The study is divided into 4 periods
- a 5-week screening period
- a 36-week double-blind treatment period
- an approximately 2-year long-term extension period, and
- a 4-week posttreatment follow-up period.2
An estimate of 595 patients will be enrolled in the study. Enrollment will be sequential by age group, with adolescents (12 to <18 years old) enrolling prior to children (6 to <12 years old).3
Most adolescent participants (12 to <18 years) will be randomized to baricitinib high dose, low dose, or placebo in a 1:1:1 ratio. A portion of adolescents will be randomly assigned 1:1 to double-blind treatment with baricitinib low dose or high dose to accumulate additional safety exposures.3
Please note that these data describe a subgroup analysis of adolescent patients only. This ongoing study will also include a separate cohort of younger patients (6 to <12 years). This pediatric population is not part of this analysis.
The study design for the double-blind period in adolescent patients is shown in Figure 1.
Figure 1. BRAVE-AA-PEDS Study Design4
Figure 1 description: The phase 3 BRAVE-AA-PEDS study includes a 36-week double-blinded, placebo-controlled period where adolescents from 12 years to less than 18 years of age with severe or very severe alopecia areata are randomized to receive once-daily oral placebo, baricitinib 2 mg, or baricitinib 4 mg. The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata in children.
Abbreviations: BARI = baricitinib; N = total population size; PBO = placebo; QD = once daily; SALT = Severity of Alopecia Tool; W = week.
a Children aged 6 to <12 years (at least N=180) will also be randomized 1:1:1 double-blind treatment with PBO, BARI low dose, or BARI high dose and contribute to efficacy analyses, pediatric population are not included in this analysis.
b Patients who complete the double-blind period to week 36 will be eligible to continue treatment in the long-term extension period to week 136.
Clinical Assessments
Clinical assessment of AA used in BRAVE-AA-PEDS included
- the SALT score, representing the extent in percentage of scalp hair loss and ranging from 0 (no hair loss) to 100 (complete hair loss), and
- the Clinician-Reported Outcome (ClinRO) Measures for Eyebrow Hair Loss™ and Eyelash Hair Loss™, ranging from a scale of 0 (full eyebrow or eyelash coverage) to scale of 3 (no notable eyebrow or eyelash hair).3,5,6
Key Inclusion and Exclusion Criteria
To be enrolled in the study, patients must have a
- weight of ≥30 kg at the age of 12 to <18 years
- diagnosis of AA for ≥1 year
- current AA episode of at least 6 months duration with hair loss of ≥50% of the scalp
- SALT score of ≥50% at screening and baseline (hair loss encompassing at least 50% of the scalp)
- current episode of severe AA <8 years (patients who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed over the past 8 years)
- history of psychological counseling related to AA
- history of psychological impact from refractory AA as reported by the investigator, parent, or participant, and
- no spontaneous improvement of AA in the investigator’s opinion.3,4
Patients are excluded if they
- have primarily "diffuse" type of AA (characterized by diffuse hair shedding)
- are currently experiencing other forms of alopecia including, but not limited to
- trichotillomania
- telogen effluvium
- chemotherapy-induced hair loss, or
- any other concomitant conditions that would interfere with the evaluations of the effect of study medication on AA, and
- have been treated with the following therapies at defined time points when starting the study
- corticosteroids (topical applied to the scalp or eyebrows; systemic; intralesional; or intra-articular)
- Janus kinase inhibitors (topical applied to the scalp; oral)
- minoxidil (oral) and finasteride (or other 5-alpha reductase inhibitors)
- platelet-rich plasma
- other immunosuppressants, like monoclonal antibodies
- methotrexate, cyclosporine, dimethyl fumarate derivatives, mycophenolate mofetil, IFN-γ, azathioprine, apremilast, or hydroxychloroquine
- other topical (immuno)therapies for the treatment of AA
- phototherapy (ultraviolet therapy and laser on scalp lesions)
- cryotherapy for treatment of AA
- probenecid
- HMG CoA reductase inhibitors or statins for treatment of AA.3,4
Primary and Key Secondary Endpoints
The primary outcome of the trial was the proportion of subjects who achieved a SALT score of ≤20 (80% or more scalp coverage with hair) at week 36.1
In addition to safety and pharmacokinetics, major secondary efficacy outcomes include changes, compared to placebo, in
- other SALT endpoints
- ClinRO measures for eyebrow and eyelash hair loss, and
- Patient-Reported Outcome (PRO) for scalp hair assessment, eyebrow and eyelash hair loss.3
BRAVE-AA-PEDS will also assess changes in anxiety and depression, and social and family-related quality of life.3
What were the baseline demographics and clinical characteristics in BRAVE-AA-PEDS?
Patient baseline demographics and clinical characteristics in BRAVE-AA-PEDS are presented in Table 1.
|
PBO (N=88) |
BARI 2 mg (N=84) |
BARI 4 mg (N=85) |
|---|---|---|---|
Age, years, mean (SD) |
14.7 (1.7) |
14.9 (1.6) |
14.6 (1.8) |
Female |
47 (53.4) |
39 (46.4) |
41 (48.2) |
Male |
41 (46.6) |
45 (53.6) |
44 (51.8) |
Race |
|||
White |
51 (58.0) |
52 (61.9) |
52 (61.2) |
Asian |
26 (29.5) |
23 (27.4) |
23 (27.1) |
Black or African American |
6 (6.8) |
5 (6.0) |
8 (9.4) |
Other, multiple, or not reported |
5 (5.7) |
4 (4.8) |
2 (2.4) |
Region |
|||
United States and Canada |
24 (27.3) |
26 (31.0) |
26 (30.6) |
Europeb |
38 (43.2) |
35 (41.7) |
36 (42.4) |
Japan |
7 (8.0) |
5 (6.0) |
4 (4.7) |
Rest of Worldc |
19 (21.6) |
18 (21.4) |
19 (22.4) |
AA, years, mean (SD) |
|||
Duration since onset |
6.6 (3.9) |
6.4 (3.9) |
6.1 (4.0) |
Duration of current episode |
3.1 (1.8) (n=87) |
3.2 (1.9) (n=83) |
3.3 (2.2) |
Duration of the current AA episode |
|||
<4 years |
61 (69.3) |
54 (64.3) |
54 (63.5) |
≥4 years |
26 (29.5) |
29 (34.5) |
31 (36.5) |
SALT |
|||
Score, mean (SD) |
88.0 (17.1) |
90.4 (15.1) |
88.8 (16.6) |
Severe category (SALT score 50%-94%) |
32 (36.4) |
29 (34.5) |
31 (36.5) |
Very severe category (SALT score 95%-100%) |
55 (62.5) |
55 (65.5) |
54 (63.5) |
ClinRO eyebrow (2,3) |
60 (68.2) |
54 (64.3) |
54 (63.5) |
ClinRO eyelash (2,3) |
50 (56.8) |
47 (56.0) |
49 (57.6) |
Abbreviations: AA = alopecia areata; BARI = baricitinib; ClinRO = clinician-reported outcome; PBO = placebo; SALT = severity of alopecia tool.
a Data are n (%) unless stated otherwise.
b Includes France, Hungary, Poland, and Spain.
c Includes Australia, South Korea, and Taiwan.
What were the efficacy results in adolescents in BRAVE-AA-PEDS?
For the primary efficacy endpoint, once-daily, oral baricitinib 4 mg resulted in 42.4% of adolescents with AA in clinically meaningful hair regrowth (80% or more scalp hair coverage) compared with placebo after 36 weeks of treatment.3
Adolescent intent-to-treat population
- analysis of categorical outcomes by logistic regression
- factors for multiplicity adjustment: treatment group, geographic region, duration of current episode at baseline (<4 years vs ≥4 years), disease severity (SALT score 50-94 vs SALT score 95-100), and baseline SALT score, and
- missing data was handled by nonresponder imputation (NRI) and data collected after permanent study drug discontinuation was excluded.4
The pediatric population aged 6 to <12 years was not included in this analysis.
Patients Achieving SALT Scores at Week 36
For the SALT score ≤20 as the primary efficacy endpoint at week 36
- 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared with 4.5% on placebo (p=.001, Figure 2).3,4
Also, for the SALT score ≤10 at week 36
- 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage, compared with 2.3% on placebo (p=.001, Figure 2).3,4
Figure 2. SALT Scores ≤20 and ≤10 Achieved by Adolescent Patients Treated With Baricitinib 2 mg or 4 mg vs Placebo at Week 36, NRI4
Figure 2 description: At week 36, significantly higher proportions of patients treated with baricitinib 2 mg or 4 mg vs placebo achieved SALT score ≤20 and SALT score ≤10.
Abbreviations: BARI = baricitinib; NRI = nonresponder imputation; PBO = placebo; SALT = severity of alopecia tool.
† Statistically significant vs PBO after multiplicity adjustment.
*p≤.05, **p≤.01, ***p≤.001 vs PBO without adjustment for multiple comparisons (Fisher’s exact test).
Note: SALT score ≤20/≤10 indicates ≤20%/≤10% scalp hair loss.
For the SALT50 score at week 36
- 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg achieved at least 50% improvement from baseline in SALT score, compared with 5.7% on placebo (p=.001, Figure 3).3,4
Furthermore, for the SALT90 score at week 36
- 32.9% of patients receiving baricitinib 4 mg and 20.2% of patients receiving baricitinib 2 mg had at least 90% improvement from baseline in SALT score, compared with 1.1% on placebo (p=.001, Figure 3).3,4
Figure 3. SALT50 and SALT90 Scores Achieved by Adolescent Patients Treated With Baricitinib 2 mg or 4 mg vs Placebo at Week 36, NRI4
Figure 3 description: At week 36, significantly higher proportions of patients treated with baricitinib 2 mg or 4 mg vs placebo achieved SALT50 and SALT90 scores.
Abbreviations: BARI = baricitinib; NRI = nonresponder imputation; PBO = placebo; SALT = severity of alopecia tool.
† Statistically significant vs PBO after multiplicity adjustment.
*p≤.05, **p≤.01, ***p≤.001 vs PBO without adjustment for multiple comparisons (Fisher’s exact test).
Note: SALT50/SALT90 indicates ≥50%/≥90% improvement from baseline in SALT score.
What were the eyebrow and eyelash regrowth results in BRAVE-AA-PEDS?
Patients Achieving ClinRO Measure at Week 36
For the eyebrow and eyelash regrowth as the key secondary efficacy endpoints at week 36
- 50.0% of patients receiving baricitinib 4 mg and
- 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2-point improvement from baseline) compared with
- 0% on placebo (p<.01; NRI) (Figure 4).3,4
- 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth (p=.002; NRI), and
- 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared with
- 14.0% on placebo (p=.097) (Figure 4).3,4
Figure 4. Regrowth of Eyebrows and Eyelashes in Adolescent Patients Measured by ClinRO (0,1) With ≥2-Point Improvement at Week 36, NRI4
Figure 4 description: At week 36, regrowth of eyebrows and eyelashes was significantly higher for baricitinib 4 mg vs placebo.
Abbreviations: BARI = baricitinib; ClinRO = clinician-reported outcome; NRI = nonresponder imputation; PBO = placebo.
*p≤.05, **p≤.01, ***p≤.001 vs PBO without adjustment for multiple comparisons (Fisher’s exact test).
Note: Among participants with ClinRO eyebrow/eyelash ≥2 at baseline.
What were the safety results in adolescents in BRAVE-AA-PEDS?
No new safety signals have been identified in the BRAVE-AA-PEDS study.3,4
Overall, the safety profile observed in pediatric subjects 12 years of age and older with severe AA treated with baricitinib is consistent with the safety profile in adults with severe AA.1 Details are presented in Table 2 and Table 3.
The adolescent safety population included all randomized patients who received ≥1 dose of study drug and who did not discontinue for the reason “lost to follow-up” at the first postbaseline visit.3
The pediatric population aged 6 to <12 years was not included in this analysis.
|
PBO |
BARI 2 mg |
BARI 4 mg |
Pooled BARI |
|---|---|---|---|---|
At least one TEAE |
47 (53.4) |
50 (60.2) |
60 (70.6) |
110 (65.5) |
TEAEs severityb |
||||
Mild |
27 (30.7) |
37 (44.6) |
43 (50.6) |
80 (47.6) |
Moderate |
18 (20.5) |
12 (14.5) |
15 (17.6) |
27 (16.1) |
Severe |
2 (2.3) |
1 (1.2) |
2 (2.4) |
3 (1.8) |
At least one serious AEc |
3 (3.4) |
ND |
ND |
2 (1.2) |
Permanent discontinuation of study drug due to AE |
2 (2.3) |
ND |
ND |
1 (0.6) |
Abbreviations: AE = adverse event; BARI = baricitinib; MedDRA = Medical Dictionary for Regulatory Activities; ND = not disclosed; PBO = placebo; TEAE = treatment-emergent adverse event.
Note: This is an ongoing study and remains double-blinded post the week 36 PBO period. Due to the low number of serious AEs and TEAEs reported, it is not possible to provide certain details to maintain the blind.
a Data are presented as n (%).
b Patients with multiple occurrences of the same event are counted under the highest severity. Classifications of AE are based on the MedDRA (version 27.0). TEAE is defined as any event that occurred on or after the first dose of study drug administration or any preexisting event which worsened in severity after dosing.
c Appendicitis, depression, epilepsy, ligament sprain and spontaneous pneumothorax. The event of a non-complicated appendicitis qualified as serious infection. This event resolved in 5 days.
|
PBO |
BARI 2 mg |
BARI 4 mg |
Pooled BARI |
|---|---|---|---|---|
TEAEsb reported in ≥5% of patients in any group |
||||
Acne |
4 (4.5) [7.0] |
7 (8.4) [13.0] |
8 (9.4) [14.8] |
15 (8.9) [13.9] |
Headache |
5 (5.7) [8.9] |
4 (4.8) [7.2] |
7 (8.2) [13.1] |
11 (6.5) [10.1] |
Upper respiratory tract infection |
6 (6.8) [10.8] |
7 (8.4) [13.1] |
7 (8.2) [13.0] |
14 (8.3) [13.0] |
Rhinitis |
3 (3.4) [5.3] |
1 (1.2) [1.8] |
6 (7.1) [11.1] |
7 (4.2) [6.3] |
Nasopharyngitis |
9 (10.2) [16.3] |
7 (8.4) [12.9] |
6 (7.1) [10.8] |
13 (7.7) [11.9] |
Influenza |
3 (3.4) [5.2] |
10 (12.0) [19.2] |
5 (5.9) [9.0] |
15 (8.9) [13.9] |
Blood creatine phosphokinase increase |
2 (2.3) [3.4] |
ND |
ND |
5 (3.0) [4.5] |
Abbreviations: AE = adverse event; BARI = baricitinib; IR = incidence rate; MedDRA = Medical Dictionary for Regulatory Activities; ND = not disclosed; PBO = placebo; PYE = patient-years of exposure; TEAE = treatment-emergent adverse event.
Note: This is an ongoing study and remains double-blinded post the week 36 PBO period. Due to the low number of serious AEs and TEAEs reported, it is not possible to provide certain details to maintain the blind.
a Data are presented as n (%) [IR]. IR represents 100× the number of patients experiencing the AE divided by the event-specific exposure to treatment (exposure time up to the event for patients with the event and exposure time to the end of the period for patients without the event, in years). Classifications of AE are based on the MedDRA (version 27.0).
b TEAE is defined as any event that occurred on or after the first dose of study drug administration or any preexisting event which worsened in severity after dosing.
Enclosed Prescribing Information
OLUMIANT® (baricitinib) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- A study of baricitinib (LY3009104) in children from 6 years to less than 18 years of age with alopecia areata (BRAVE-AA-PEDS). ClinicalTrials.gov identifier: NCT05723198. Updated April 17, 2026. Accessed April 27, 2026. https://clinicaltrials.gov/study/NCT05723198
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- Passeron T, Soung J, Kwon O, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a phase 3 randomized, controlled trial. Poster presented at: Annual Meeting of the American Academy of Dermatology; March 7-11, 2025; Orlando, FL.
- Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines–part II. J Am Acad Dermatol. 2004;51(3):440-447. https://doi.org/10.1016/j.jaad.2003.09.032
- Wyrwich KW, Kitchen H, Knight S, et al. Development of clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures for eyebrow, eyelash and nail assessment in alopecia areata. Am J Clin Dermatol. 2020;21(5):725-732. https://doi.org/10.1007/s40257-020-00545-9
Date of Last Review: September 28, 2026