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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?
The phase 3 BRAVE-AA1 and BRAVE-AA2 clinical trials excluded patients less than 18 years old. There is no ongoing trial evaluating baricitinib in pediatric patients with alopecia areata.
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 Pediatric Trials
There is currently no ongoing trial evaluating baricitinib in pediatric patients with alopecia areata (AA).
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 AA
- BRAVE-AA1 (N=654) compared baricitinib 2-mg or 4-mg monotherapy to placebo in adult patients with ≥50% scalp hair loss, and
- BRAVE-AA2 (N=546) compared baricitinib 2-mg or 4-mg monotherapy to placebo in adult patients with ≥50% scalp hair loss.1
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.1
Therefore, no efficacy or safety data are available for pediatric patients in the BRAVE-AA trials.
Enclosed Prescribing Information
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1King 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: June 15, 2022