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Jump to Key Points The FDA has approved baricitinib for the treatment of severe alopecia areata (AA) in patients aged 12 years and older, according to a press release from the manufacturer.
The approval extends the use of baricitinib (Olumiant, Eli Lilly), a JAK inhibitor, to younger patients. The once-daily pill was initially approved for adults with moderate-to-severe rheumatoid arthritis in 2018 and subsequently approved for adults with severe AA in 2022. It also was approved in 2022 to treat COVID in certain hospitalized adults.
The new approval is based on 36-week data from patients with severe AA aged 12-17 years in the BRAVE-AA-PEDS phase 3 study, according to Lilly. In the ongoing study, individuals were randomized to 2 mg or 4 mg of oral baricitinib daily or a placebo.
The primary outcome was a Severity of Alopecia Tool (SALT) score of 20 or less on a scale of 100, representing scalp hair coverage of at least 80%, after 36 weeks of treatment. At baseline, median SALT score was 100 (complete hair loss), and patients had had AA for a mean of 6.4 years.
- FDA approved baricitinib for severe AA age ≥12 years.
- Indication expansion follows prior adult AA approval in 2022.
- BRAVE-AA-PEDS: 36-week RCT in ages 12–17; baseline median SALT 100.
- Week 36 SALT ≤20: 42% with 4 mg, 27% with 2 mg, 5% with placebo.
- Boxed warning persists: serious infection, malignancy, MACE, thrombosis.
At week 36, 42% of patients who received 4 mg and 27% of those who received 2 mg met the primary endpoint, compared with 5% of those on placebo. In addition, 37% and 21% of patients in the 4-mg and 2-mg groups, respectively, achieved SALT scores of 10 or less, representing at least 90% of scalp hair coverage, compared to 2% of those on placebo.
Patients with significant eyebrow and eyelash hair loss at baseline who received 4 mg of baricitinib showed improvement in hair coverage in these areas after 36 weeks.
Safety data for adolescent patients were similar to the data reported in adults, according to the press release. The FDA's labeling for baricitinib continues to include a boxed warning for increased risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
The BRAVE-AA-PEDS study is currently recruiting patients aged 6-18 years with severe AA. Baricitinib is approved for treating severe AA in patients 12 years and older in the European Union and Japan
Full prescribing information is available here.
