Eli Lilly, Incyte report results from BRAVE-AA-PEDS trial

New results from Eli Lilly (LLY) and Incyte (INCY) showed once-daily, oral baricitinib 4 mg helped the majority of adolescent patients with severe alopecia areata achieve successful hair regrowth on the scalp, eyebrows and eyelashes at one year. These 52-week results from the BRAVE-AA-PEDS trial – the largest Phase 3 study of its kind – will be presented at the 2025 Fall Clinical Dermatology Conference, taking place Oct. 23-26 in Las Vegas. These data build on 36-week results from the BRAVE-AA-PEDS trial previously presented at the 2025 American Academy of Dermatology annual meeting in March. At the start of the study, patients had an average of 89% scalp hair loss, with 63.8% of them having very severe AA at baseline. In addition, 65% had minimal or no eyebrow hair and 57% had minimal or no eyelash hair. At one year: 54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth; 41.2% of patients receiving baricitinib 4 mg and 26.2% of patients receiving baricitinib 2 mg achieved near-complete scalp hair regrowth; 64.8% of patients receiving baricitinib 4 mg and 27.8% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth and 63.3% of patients receiving baricitinib 4 mg and 34% receiving baricitinib 2 mg achieved eyelash regrowth. Among patients with severe disease, 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth. In a separate, post-hoc analysis of adolescent patients who had been diagnosed with severe AA less than two years before starting treatment, 80% of those receiving baricitinib 4 mg and 64.3% receiving baricitinib 2 mg achieved successful hair regrowth at one year. The safety profile of baricitinib in adolescents with AA was consistent with the safety profile seen in clinical trials for adult and adolescent patients, and no new safety signals were observed after one year of treatment. The most common treatment-emergent adverse events included acne, upper respiratory tract infection and influenza. No deaths, opportunistic infections, major adverse cardiovascular events or venous thromboembolic events were reported in the trial.