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 long-term efficacy of Olumiant® (baricitinib) in patients with severe alopecia areata?
In the pediatric alopecia areata trial, treatment with baricitinib 4 mg and 2 mg resulted in further increase in the proportion of patients achieving scalp, eyebrow, and eyelash hair regrowth from week 36 to week 52.
See important safety information, including boxed warning, in the attached prescribing information.
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 was the scalp hair regrowth with baricitinib through week 52?
- What was the eyebrow and eyelash regrowth with baricitinib through week 52?
- What is the design of the BRAVE-AA-PEDS study?
- What further details are available about the BRAVE-AA-PEDS study?
- References
What was the scalp hair regrowth with baricitinib through week 52?
Patients Achieving SALT Scores by Week 52
As presented in Figure 1, the proportion of patients with severe alopecia areata (AA) achieving a severity of alopecia tool (SALT) score of ≤20 and a SALT score of ≤10 continued to increase from week 36 to week 52 with both baricitinib 4 mg and 2 mg. By week 52, >50% of patients achieved SALT score ≤20 (at least 80% scalp hair) with baricitinib 4 mg, and the majority of these also had a deep response (>90% scalp hair coverage).2
Figure 1. SALT Scores ≤20 and ≤10 After 52 Weeks of Treatment With Baricitinib 2 mg or 4 mg vs Placebo in Adolescent Patients, NRI3
Figure 1 description: The figures represent the proportions of adolescent patients who achieved SALT scores ≤20 and ≤10 through 52 weeks of treatment with baricitinib 2 mg or 4 mg. At week 36, 42.4% of patients treated with baricitinib 4 mg and 27.4% of patients treated with 2 mg achieved a SALT score ≤20, while 36.5% (4 mg) and 21.4% (2 mg) achieved a SALT score ≤10. By week 52, the response rates increased, with 54.1% (4 mg) and 31.0% (2 mg) achieving SALT ≤20, and 41.2% (4 mg) and 26.2% (2 mg) achieving SALT ≤10. These results show that by week 52, higher proportions of patients treated with baricitinib 2 mg or 4 mg achieved SALT score ≤20 and SALT score ≤10 in week 52 vs week 36.
Abbreviations: BARI = baricitinib; NRI = nonresponder imputation; PBO = placebo.
† 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 or SALT score ≤10 indicates ≤20% or ≤10% scalp hair loss.
What was the eyebrow and eyelash regrowth with baricitinib through week 52?
Patients Achieving ClinRO Measure at Week 52
Figure 2 represents the proportions of patients who achieved clinician-reported outcome (ClinRO) measures for Eyebrow (EB) and Eyelash (EL) Hair Loss 0 or 1 with ≥2-point improvement from baseline in both the baricitinib 4-mg and 2-mg groups. The improvement from baseline continued to increase from week 36 to week 52 and was observed in both the baricitinib 4-mg and 2-mg treatment groups. By week 52, almost 2/3 of patients who had significant gaps or no notable eyebrow or eyelash hair at baseline achieved complete or near-complete coverage at these sites.2
Figure 2. Regrowth of Eyebrows and Eyelashes in Adolescent Patients Measured by ClinRO (0,1) With ≥2-Point Improvement at Week 52 (Adolescent ITT Population NRI)3
Figure 2 description: The graphs show regrowth of eyebrows and eyelashes in adolescent patients with alopecia areata and significant eyebrow or eyelash loss at baseline (ClinRO EB or EL ≥2) treated with baricitinib through week 52. By week 52, 64.8% of patients treated with baricitinib 4 mg and 27.8% of those receiving baricitinib 2 mg experienced at least a 2-point improvement in eyebrow regrowth. For eyelash regrowth, 63.3% of patients on baricitinib 4 mg and 34.0% on baricitinib 2 mg achieved similar improvement. Regrowth began early in treatment and continued to increase throughout the 52-week period.
Abbreviations: BARI = baricitinib; ClinRO = clinicianreported outcome; EB = eyebrow; EL = eyelash; ITT = intent to treat; NRI = nonresponder imputation; PBO = placebo.
*p≤.05, **p≤.01, ***p≤.001 vs PBO without adjustment for multiple comparisons (Fisher’s exact test).
Note: Analysis population includes participants with ClinRO EB/EL ≥2 at baseline.
What is the design of the BRAVE-AA-PEDS study?
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 AA. To be eligible for the study, patients must have severe AA for at least 1 year with a SALT score of ≥50% at screening and baseline.4
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.4
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 this document describes a subgroup analysis of the 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 3.
Figure 3. BRAVE-AA-PEDS Study Design2
Figure 3 description: The phase 3 BRAVE-AA-PEDS study includes a 36-week double-blinded placebo-controlled period with SALT score ≤20 as the primary study endpoint. 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. An extension period from week 36 onwards continues treatment and observation of participants beyond the initial study phase.
Abbreviations: BARI = baricitinib; N = total population size; PBO = placebo; QD = once daily; R = randomized; SALT = severity of alopecia tool; W = week.
a Figure is not the full study design, pediatric population: 6 to <12 years (at least n=180) was also randomized 1:1:1 but not included in this analysis.
b At week 36, nonresponders (absolute SALT score >20) who were initially randomized to placebo were re-randomized in a double-blind manner to baricitinib 4 mg or baricitinib 2 mg.
c Adolescents should weigh ≥30 kg. For participants weighing ≥30 kg: 4 mg QD = high dose, 2-mg QD = low dose; for participants weighing <30 kg: 2 mg QD = high dose, 1 mg QD = low dose.
What further details are available about the BRAVE-AA-PEDS study?
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 ClinRO Measures for Eyebrow Hair Loss and Eyelash Hair Loss scale, which ranges from 0 to 3: 0 (full eyebrow or eyelash coverage), 1 (minimal gaps in hair and even distribution), 2 (significant gaps in hair or uneven distribution), and 3 (no notable hair).3,5,6
Statistical Analysis
The adolescent (12 to <18 years of age) intent-to-treat population was continuously treated with baricitinib 4 mg or 2 mg for at least 52 weeks. Missing data were handled by nonresponder imputation, and data collected after permanent study drug discontinuation were excluded.2
The pediatric population aged 6 to <12 years was not included in this analysis.2
Primary and Key Secondary Endpoints
The primary efficacy outcome is the proportion of patients achieving a SALT score of ≤20 (≤20% scalp hair loss or ≥80% of scalp coverage with hair) at week 36.3
In addition to safety and pharmacokinetics, major secondary efficacy outcomes include changes, compared with placebo, in
- other SALT endpoints
- ClinRO measures for eyebrow and eyelash hair loss, and
- patient-reported outcome 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
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.3,7
Patients are excluded if they
- have primarily "diffuse" type of AA (characterized by diffuse hair shedding), and
- 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
- 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, or
- HMG CoA reductase inhibitors or statins for treatment of AA.3,7
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.
- Craiglow B, Arkin L, Saceda-Corralo D, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 52-week efficacy and safety results from a phase 3 randomized, controlled trial. Poster presented at: Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, NV.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
- 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
- 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
- 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.
Date of Last Review: October 07, 2026