Press release
Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study
Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg Patients treated
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[{"type":"text","content":"Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg \nPatients treated with baricitinib 4 mg saw significant regrowth of eyebrows and eyelashes at Week 36 compared to placebo\nPositive data underscore Lilly's continued expansion across dermatologic conditions, with treatments that can improve outcomes for patients with the greatest need\nINDIANAPOLIS, March 8, 2025 /PRNewswire/ -- Late-breaking results from Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) 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. Findings from the Phase 3 BRAVE-AA-PEDS study were presented in a late-breaker presentation at the American Academy of Dermatology (AAD) Annual Meeting taking place March 7-11 in Orlando.1\nAA is an immune system condition that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress over time. Approximately 40% of patients with AA experience first onset by 20 years of age.2\n\"Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy,\" said Brittany Craiglow, M.D., Adjunct Associate Professor of Dermatology, Yale School of Medicine. \"These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib's potential as an effective treatment for adolescents with severe disease.\"\nIn the BRAVE-AA-PEDS study, 257 patients were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg or placebo. The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score ≤20 (i.e., 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).1\nAt Week 36:\n60.0% of patients receiving baricitinib 4 mg and 36.9% of patients...