Late-Breaking Data: Baricitinib Shows Rapid Hair Regrowth in Adolescents With Severe Alopecia Areata

“This study we presented here for the first time is just dedicated to adolescents. It is the largest study of a JAK inhibitor dedicated to adolescents with severe alopecia areata,” said Anabela Cardoso, MD, in an interview at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Cardoso, the senior vice president of immunology medical affairs at Eli Lilly and Company, discussed pivotal findings on baricitinib (Olumiant; Lilly/Incyte) for adolescents with severe alopecia areata during an AAD late-breaker session. The data demonstrated that adolescent patients (aged 12 to 18 years) with severe alopecia areata treated with once-daily, oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows, and eyelashes at week 36.^1,2

The primary end point of the study was a Severity of Alopecia Tool score ≤20 (80% or more scalp hair coverage) at week 36. At the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3), and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).²

Alopecia areata affects both adults and adolescents, with approximately 40% of cases beginning before age 20. Early-onset disease carries a significant psychosocial burden, impacting self-esteem, social interactions, and mental health, making effective treatment crucial for this high unmet need population.

The phase 3 BRAVE-AA-PEDS trial was a dedicated adolescent study on baricitinib, the largest JAK inhibitor study for this population, and enrolled 250 patients with severe alopecia areata, many of whom had complete or near-complete scalp hair loss. Compared to adults, adolescents presented with more severe disease, yet baricitinib demonstrated faster efficacy in this group. At 36 weeks, approximately 60% of patients achieved ≥50% hair regrowth, a milestone that took one year in adults, highlighting potentially accelerated responsiveness in younger patients.

According to Cardoso, safety considerations were a key focus, given baricitinib’s status as a JAK inhibitor. The study’s safety profile was consistent with adult trials, reinforcing its potential as a well-tolerated option for adolescents. Cardoso noted baricitinib has been studied in over 800 patients aged 18 years, including those as young as 2 years old, and in more than 14,000 adults across various immune-mediated diseases.

The latest data shows baricitinib’s potential to fill a critical treatment gap for adolescents with severe alopecia areata, offering faster and effective hair regrowth with a well-established safety profile.

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References

1. Passerson T. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a phase 3 randomized, controlled trial. Presented at: 2025 American Academy of Dermatology Annual Meeting. March 7-11, 2025; Orlando, FL.
2. Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study. News release. Eli Lilly and Company. March 8, 2025. Accessed March 8, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-high-rates-hair-regrowth