The U.S. Food and Drug Administration approved the once-daily pill baricitinib, marketed as Olumiant by Eli Lilly and Company, for pediatric patients aged 12 and older suffering from severe alopecia areata.
Clinical Trial Data and Efficacy Results
The FDA approval stems from 36-week data gathered during the adolescent cohort of the Phase 3 BRAVE-AA-PEDS study. At the start of the trial, participants presented with a median Severity of Alopecia Tool score of 100, which indicates complete scalp hair loss, and had lived with the condition for a mean of 6.4 years.
By Week 36, treatment with the medication demonstrated measurable hair regrowth compared to a placebo group:
- 42% of patients receiving the 4 mg dose and 27% of those receiving the 2 mg dose achieved 80% or more scalp hair coverage, defined as a SALT score of 20 or less, compared to 5% of patients taking a placebo.
- 37% of patients on the 4 mg dose and 21% on the 2 mg dose reached 90% or more scalp hair coverage, measured as a SALT score of 10 or less, versus 2% in the placebo group.
- Patients with substantial eyebrow and eyelash hair loss at baseline experienced improved eyebrow and eyelash coverage when treated with the 4 mg dose.
Safety Profile and Regulatory Warnings
The safety profile recorded in pediatric patients aged 12 and older matches the established safety profile seen in adults with severe alopecia areata. However, the FDA-approved labeling for baricitinib carries a boxed warning.
The warning highlights risks for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Expert Perspectives on Pediatric Treatment
Medical professionals note that early-onset severe alopecia areata often proves more extensive and harder to manage over time. Brittany Craiglow, MD, Adjunct Associate Professor of Dermatology at Yale School of Medicine, emphasized the value of the new data in a news release.
George Gondo, Chief Mission Officer of the National Alopecia Areata Foundation, highlighted the psychosocial impact of the condition during adolescence.
Dosage Guidelines and Industry Context
Baricitinib is manufactured in 4 mg, 2 mg, and 1 mg tablets. Regulatory labeling establishes a recommended starting dose of 2 mg per day, with provisions to increase the dosage to 4 mg per day if the initial treatment response remains inadequate.
For patients presenting with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow loss, clinicians may initiate treatment at 4 mg per day. Once an adequate response occurs at the 4 mg daily level, the dosage is reduced back to 2 mg per day. To support access, Eli Lilly and Company offers a patient support program via Lilly Support Services, which includes co-pay assistance for eligible commercially insured patients.
Baricitinib joins two other Janus kinase inhibitors approved for treating the condition. Pfizer’s ritlecitinib, sold as Litfulo, is approved for adolescents aged 12 and older, while Sun Pharma’s deuruxolitinib, marketed as Leqselvi, holds approval for adults aged 18 and older.