Core Insights - AbbVie announced positive topline results from the Phase 3 UP-AA clinical program for upadacitinib (RINVOQ®) in treating severe alopecia areata, showing significant efficacy in hair regrowth [1][3][4] Efficacy Results - In Study 2, 44.6% of patients on 15 mg and 54.3% on 30 mg of upadacitinib achieved 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 3.4% in the placebo group (p<0.001) [1][3] - Additionally, 36.0% and 47.1% of patients reached 90% or more scalp hair coverage (SALT ≤ 10) with the respective doses, against 1.4% in the placebo group (p<0.001) [1][3] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with serious adverse events occurring in 1.4% and 2.8% of patients in the 15 mg and 30 mg groups, respectively, and none in the placebo group [1][3] - Common treatment-emergent adverse events included acne, nasopharyngitis, and upper respiratory tract infections, with serious infections reported infrequently [1][3] Study Design - The UP-AA clinical program consists of two pivotal studies (Study 1 and Study 2) with a total of 1,399 participants aged 12 to 64 across 248 sites globally [4][3] - Participants were randomized to receive either upadacitinib or placebo for 24 weeks, followed by an additional 28 weeks for those originally on upadacitinib [4] Future Outlook - Results from the parallel Study 1 are expected in the third quarter of 2025, which will further inform the efficacy and safety of upadacitinib in alopecia areata [3][4]