Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study

Core Insights - Eli Lilly and Incyte presented late-breaking results showing that 42.4% of adolescents treated with baricitinib 4 mg achieved 80% or more scalp hair coverage at Week 36, indicating significant hair regrowth potential for severe alopecia areata [1][2][3] - The Phase 3 BRAVE-AA-PEDS study demonstrated that baricitinib can provide clinically meaningful improvements in hair regrowth for adolescents, with results comparable to those seen in adults after a longer treatment duration [2][3] - Baricitinib is positioned as a leading treatment option for severe alopecia areata, with ongoing studies expected to provide further data and regulatory discussions in the near future [2][5] Study Results - In the BRAVE-AA-PEDS study, 257 patients were randomized to receive either baricitinib 4 mg, 2 mg, or placebo, with the primary endpoint being a SALT score of ≤20 at Week 36 [1][7] - At Week 36, 60.0% of patients on baricitinib 4 mg and 36.9% on 2 mg saw at least a 50% improvement in their disease, compared to only 5.7% on placebo [3] - Significant eyebrow and eyelash regrowth was also observed, with 50.0% and 42.9% of patients on baricitinib 4 mg achieving notable improvements, respectively [3] Safety Profile - The most common treatment-emergent adverse events included acne, influenza, and upper respiratory tract infections, with a higher frequency of serious adverse events in the placebo group [4] - The safety profile of baricitinib in adolescents aligns with previous findings in trials for juvenile idiopathic arthritis and atopic dermatitis, indicating a consistent safety record [4][5] Regulatory and Market Position - Baricitinib, marketed as Olumiant, is already approved for adult patients with severe alopecia areata and has received regulatory approval for other conditions, including rheumatoid arthritis and atopic dermatitis [5][6] - The company plans to present additional data from the BRAVE-AA-PEDS study at scientific meetings and submit results for peer-reviewed publication, reinforcing its commitment to advancing treatment options for alopecia areata [5][6]