Prnewswireยท2025-10-24 10:45Core Insights - The BRAVE-AA-PEDS trial is the first and largest study focused on children and adolescents with severe alopecia areata, showing that 71% of adolescents treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year [1][2][4] - Eli Lilly plans to submit the trial data to global regulators for a potential label update for baricitinib, commercially known as Olumiant [1][9][10] Group 1: Trial Results - At one year, 54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth, defined as 80% or more scalp hair coverage [7] - Among patients with severe disease, 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth [7] - In a post-hoc analysis, 80% of adolescents diagnosed with severe AA less than two years before treatment achieved successful hair regrowth with baricitinib 4 mg [4] Group 2: Safety Profile - The safety profile of baricitinib in adolescents was consistent with that seen in adult trials, with no new safety signals observed after one year [5][8] - Common treatment-emergent adverse events included acne, upper respiratory tract infection, and influenza, with no deaths or major adverse cardiovascular events reported [5][8] Group 3: Future Plans and Context - Lilly intends to enroll a new cohort of children ages 6 to under 12 in the BRAVE-AA-PEDS trial in the next year [9][12] - Baricitinib is the most-researched JAK inhibitor in alopecia areata, with over 1,300 adults and 423 adolescents enrolled in clinical trials [10]