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Olumiant® (baricitinib) tablets1mg, 2mg, 4mg
baricitinib1mg, 2mg, 4mg
This 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.
Are there any data about the use of Olumiant® (baricitinib) in pediatric patients with alopecia areata?
BRAVE-AA-PEDS is an ongoing clinical trial evaluating baricitinib in pediatric patients with severe alopecia areata. No results from this trial are available at this time.
See important safety information, including boxed warning, in the attached prescribing information.
Baricitinib Prescribing Information
Baricitinib is not approved for use in pediatric patients with alopecia areata. Please see prescribing information for approved indication(s).
Ongoing Alopecia Areata Pediatric Trial
BRAVE-AA-PEDS (NCT05723198) is a 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).1
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 post-treatment follow-up period.1
Approximately 595 patients will be randomized to
- baricitinib high dose
- baricitinib low dose, or
Enrollment will be sequential by age group, with adolescents (12 to <18 years old) enrolling prior to children (6 to <12 years old).2
Inclusion and Exclusion Criteria
Patients 6 years to <18 years of age enrolled in the study must have
- severe AA for at least 1 year
- Severity of Alopecia Tool (SALT) score of ≥50% at screening and baseline (hair loss encompassing at least 50% of the scalp)
- current AA episode of at least 6 months durations with hair loss of ≥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 trial and failure with ≥1 available treatment (topical or other) for AA
- history of psychological counseling related to AA.1
Key Exclusion Criteria
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:
- 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.1
The primary efficacy outcome is the proportion of patients achieving SALT ≤20 (≤20% scalp hair loss or ≥80% of scalp coverage with hair) at week 36.1
Key Secondary Outcomes
In addition to safety and pharmacokinetics, major secondary efficacy outcomes include changes, compared to placebo, in
- other SALT endpoints
- Clinician-Reported Outcome (ClinRO) Measures for eyebrow and eyelash hair loss, and
- Patient-Reported Outcome (PRO) for scalp hair assessment, eyebrow and eyelash hair loss.1
BRAVE-AA-PEDS will also assess changes in anxiety and depression, and social and family related quality of life. 1
Available Data From the Baricitinib Alopecia Areata Phase 3 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.3
To be included in BRAVE-AA1 or BRAVE-AA2, patients were required to be at least 18 years old. Pediatric patients were not eligible for enrollment.3
Therefore, no efficacy or safety data are available for pediatric patients from the BRAVE-AA1 and BRAVE-AA2 trials.
Enclosed Prescribing Information
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1A study of baricitinib (LY3001904) in children from 6 years to less than 18 years of age with alopecia areata (BRAVE-AA-PEDS). ClinicalTrials.gov identifier: NCT05723198. Updated March 6, 2023. Accessed March 6, 2023. https://clinicaltrials.gov/ct2/show/NCT05723198
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3King 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
Date of Last Review: February 10, 2023