Eli Lilly and Company has announced promising results from its Phase 3 BRAVE-AA-PEDS clinical trial, showing that baricitinib (Olumiant) delivered significant hair regrowth in adolescents with severe alopecia areata, potentially at a faster rate compared to adults.
The study, presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, demonstrated that adolescent patients aged 12 to 18 years treated with once-daily oral baricitinib achieved clinically meaningful improvements in scalp, eyebrow, and eyelash hair regrowth at 36 weeks.
Significant Clinical Outcomes
The primary endpoint of the study was a Severity of Alopecia Tool (SALT) score ≤20, representing 80% or more scalp hair coverage at week 36. At baseline, participants had an average of 89% scalp hair loss, with 65% having minimal or no eyebrow hair and 57% having minimal or no eyelash hair.
"This study is the largest study of a JAK inhibitor dedicated to adolescents with severe alopecia areata," said Dr. Anabela Cardoso, Senior Vice President of Immunology Medical Affairs at Eli Lilly and Company. "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families."
Notably, the results achieved by adolescents at 36 weeks were comparable to what adult patients achieved after 52 weeks of treatment in the previous BRAVE-AA1 and BRAVE-AA2 studies. In those adult trials, 40.9% of patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at week 52.
The accelerated response in adolescents suggests that hair regrowth may occur more rapidly in younger patients. Approximately 60% of adolescent patients achieved ≥50% hair regrowth at 36 weeks, a milestone that took one year to reach in adults.
Study Design and Patient Population
The BRAVE-AA-PEDS trial enrolled 250 adolescents with severe alopecia areata, defined as having a SALT score of ≥50 (indicating 50% or more scalp hair loss) and a current episode of severe alopecia areata lasting at least six months but no more than eight years.
Participants were randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib 4 mg, or baricitinib 2 mg. The first cohort included adolescents ages 12 to under 18 years weighing ≥30 kg. A planned second cohort of children ages 6 to under 12 will begin enrollment in the next year.
Alopecia areata affects approximately 40% of patients before age 20, making effective treatments for adolescents a significant unmet need. Early-onset disease can carry substantial psychosocial burdens, impacting self-esteem, social interactions, and mental health.
Safety Profile
The safety profile of baricitinib in adolescents with alopecia areata was consistent with the safety profile observed in clinical trials for adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis.
The most common treatment-emergent adverse events in the BRAVE-AA-PEDS study included acne, influenza, and upper respiratory tract infection. A higher frequency of serious adverse events was observed in the placebo group compared to the baricitinib groups.
No deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events, or malignancies were reported in the trial.
Regulatory Status and Future Plans
Baricitinib, a once-daily oral JAK inhibitor discovered by Incyte and licensed to Lilly, was approved by the U.S. Food and Drug Administration (FDA) for adult patients with severe alopecia areata in 2022, making it the first systemic treatment approved in the U.S. for severe disease.
Lilly plans to present additional data from the BRAVE-AA-PEDS study at scientific meetings later this year and submit the results for peer-reviewed publication. The company also intends to discuss findings with global regulators in the months ahead, potentially paving the way for expanded approval to include adolescent patients.
Broader Clinical Experience
Over 14,600 patients have received baricitinib in clinical trials across various indications; of these, 866 have been patients between the ages of >1 month to <18 years. The medication is currently approved in the U.S. and more than 75 countries for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries for patients as young as two years with moderate-to-severe atopic dermatitis, and in Europe and Japan for adult patients with severe alopecia areata.
Dr. Cardoso emphasized that the safety considerations were a key focus of the study, given baricitinib's status as a JAK inhibitor. The consistent safety profile across different age groups and indications reinforces its potential as a well-tolerated option for adolescents with severe alopecia areata.
Clinical Implications
These findings represent a significant advancement in the treatment of severe alopecia areata in adolescents, a population with limited therapeutic options. The faster response rate compared to adults suggests that early intervention with baricitinib may be particularly beneficial for younger patients.
As Lilly continues to analyze the data and engage with regulatory authorities, baricitinib could potentially become an important treatment option for adolescents suffering from this challenging autoimmune condition, addressing a critical gap in the current treatment landscape.
