Lilly and Incyte Report Positive One-Year Results for Baricitinib in Adolescents with Severe Alopecia Areata

Eli Lilly and Company and Incyte have reported new one-year data from the Phase 3 BRAVE-AA-PEDS study showing that once-daily, oral baricitinib 4 mg led to significant hair regrowth in adolescents (ages 12–<18) with severe alopecia areata (AA). The results were presented at the 2025 Fall Clinical Dermatology Conference.

According to the data, the majority of adolescent patients achieved substantial regrowth of scalp, eyebrow, and eyelash hair after 52 weeks of treatment.

At baseline, participants had an average of 89% scalp hair loss, with nearly two-thirds showing very severe disease (SALT score 95–100). After one year:

• 54.1% of patients on baricitinib 4 mg and 31% on 2 mg achieved at least 80% scalp hair coverage (SALT ≤20).
• 41.2% on 4 mg and 26.2% on 2 mg achieved near-complete regrowth (SALT ≤10).
• 64.8% on 4 mg and 27.8% on 2 mg achieved significant eyebrow regrowth.
• 63.3% on 4 mg and 34% on 2 mg achieved eyelash regrowth.

Among patients with severe disease (SALT 50–94), 71% and 58.6% achieved successful regrowth on the 4 mg and 2 mg doses, respectively. In those diagnosed less than two years before starting therapy, the response rate reached 80% with 4 mg.

The safety profile in adolescents was consistent with previous adult studies, with no new safety signals observed after one year. The most common side effects included acne, upper respiratory tract infection, and influenza. No deaths or major cardiovascular or thromboembolic events occurred.

“These promising results reinforce what we’ve observed in adults — that early initiation of baricitinib can result in meaningful and, in many cases, near-complete regrowth,” said Dr. Brittany Craiglow, Yale School of Medicine.

The BRAVE-AA-PEDS study is the largest Phase 3 trial of its kind in pediatric AA. Lilly plans to submit the adolescent data to regulators worldwide for a potential label update for Olumiant (baricitinib), already approved in the U.S. for adults with severe AA. Enrollment of a younger cohort (ages 6–<12) is expected to begin in the U.S. next year.

At the same conference, Lilly also presented long-term data from the BRAVE-AA1/AA2 trials in adults, showing that more than 85% of responders maintained scalp hair regrowth through approximately four years of continuous treatment, with a consistent safety profile up to five years.

Baricitinib, a JAK inhibitor discovered by Incyte and licensed to Lilly, was first approved in 2022 as the first systemic therapy for severe AA in the U.S. It is now approved for this indication in over 75 countries, alongside other indications such as rheumatoid arthritis, atopic dermatitis, and, in some markets, COVID-19.

“Adolescents have long faced limited treatment options for severe alopecia areata,” said Anabela Cardoso, Senior Vice President, Lilly Immunology Medical Affairs. “If approved, these data could expand access to a proven therapy for a group that has been underserved for far too long.”

Lilly’s immunology pipeline includes additional small molecule and biologic candidates, such as DICE Therapeutics’ DC-853 for psoriasis and eltrekibart, a monoclonal antibody targeting neutrophil-driven inflammation.

Lilly is a global pharmaceutical company focused on advancing treatments across immunology, oncology, neuroscience, and diabetes. Incyte, based in Wilmington, Delaware, specializes in discovering and commercializing therapies for serious unmet medical needs.

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