Almost Half of Severe Alopecia Areata Pediatric Patients Saw Hair Regrowth on Olumiant, Study Shows | 2025 Fall Clinical Derm

The Eli Lilly drug, Olumiant (oral baricitinib), led to significant hair regrowth in adolescents with severe alopecia, according to 52-week data from the phase 3 BRAVE-AA-PEDS study (NCT05723198), presented at the 2025 Fall Clinical Dermatology conference, held from Oct. 23 to Oct. 26 in Las Vegas, Nevada.

Specifically, 54% of patients treated with 4-mg of Olumiant and 31% of patients given Olumiant 2-mg showed successful scalp regrowth after one year and The study also showed eyelash and eyebrow growth in 65% and 63% of patients, respectively. Significant hair regrowth was defined as 80% or greater scalp hair coverage. Alopecia severity was defined as a Severity of Alopecia Tool (SALT) score of 50 or greater, which would indicate 50% hair loss.

"These promising results for adolescents reinforce what we see in clinical practice with adults, which is that starting treatment with baricitinib early can lead to higher rates of scalp hair regrowth, including near-complete regrowth for many patients," Brittany Craiglow, M.D., adjunct associate professor of dermatology at Yale School of Medicine, said in a news release. "Systemic treatments for adolescents shouldn't be the last resort but part of the treatment conversation among doctors, caregivers and patients from the beginning."

The study enrolled more than 1,300 adults and 423 adolescents in two cohorts. At the start of the study, patients had a scalp hair loss average of 89%. Next year, a third cohort will be enrolled, this time with children ages 6 to 12 randomized in a 1:1:1 ratio to receive once-daily placebo, high dose Olumiant or low dose Olumiant.

"For nearly half of the people with severe alopecia areata, the disease starts before adulthood and can progress quickly, significantly impacting

patients' lives," Nicole Friedland, president and CEO, National Alopecia Areata Foundation (NAAF), said in a news release. "Given the profound burden of this disease, new treatment options are needed for children and adolescents, populations that have been underrepresented for far too long."

Olumiant is a once-daily oral Janus kinase (JAK) inhibitor, originally approved as a severe alopecia treatment for adults in 2022. It works by targeting inflammation systematically and was previously approved to treat rheumatoid arthritis.

The safety of Olumiant in adolescents was consistent with the safety profile in adults. Side effects reported in at least 1% of patients include upper respiratory tract infection, headache and acne.

Severe alopecia areata is an autoimmune condition that attacks the body’s hair follicles. Approximately seven million people in the United States have alopecia areata and of those, approximately 300,000 have moderate to severe alopecia areata.

"We look forward to submitting these data to global regulators in the coming months,” Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs, said in the news release. “If approved, baricitinib could offer an important new option that raises treatment expectations for adolescents living with the profound burden of this disease."