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 hair regrowth in patients [1][4][34] Study Results - In Study 1, 45.2% of patients on 15 mg and 55.0% on 30 mg of upadacitinib achieved 80% or more scalp hair coverage at week 24, compared to only 1.5% in the placebo group (p<0.001) [1][4] - Additionally, 35.2% and 45.8% of patients on 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage at week 24, compared to 0.7% in the placebo group (p<0.001) [2][4] - Key secondary endpoints were also met, including improvements in eyebrows and eyelashes, and complete scalp hair coverage (SALT=0) [2][4] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with treatment-emergent serious adverse events occurring in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups, respectively, compared to 0.7% in the placebo group [2][4] - Common treatment-emergent adverse events included upper respiratory tract infections, acne, and increased blood creatine phosphokinase levels [2][4] Clinical Trial Design - The UP-AA clinical trial included two pivotal studies (Study 1 and Study 2) with a total of 1,399 participants aged 12 to 64 across 248 sites globally [5][34] - The studies were randomized, placebo-controlled, and double-blind, evaluating the efficacy and safety of upadacitinib over a total duration of 52 weeks [5][34]

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]

Core Viewpoint - AbbVie announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (RINVOQ®) for treating adult patients with giant cell arteritis (GCA), with a final decision expected in the first half of 2025 [1][2]. Group 1: Product Information - Upadacitinib (RINVOQ) is a selective and reversible JAK inhibitor being studied for various immune-mediated inflammatory diseases, including GCA [7]. - If approved, upadacitinib would be the first and only oral advanced therapy for adults with GCA [1]. - RINVOQ is already approved in the EU for several conditions, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis [2][8][12]. Group 2: Clinical Trial Data - The positive opinion is based on the pivotal Phase 3 SELECT-GCA clinical trial, which evaluated the efficacy and safety of upadacitinib in adults aged 50 and older with GCA [2][5]. - The trial involved 428 patients and demonstrated that the primary endpoint of sustained remission and key secondary endpoints were met [5][6]. - The safety profile of upadacitinib during the trial was consistent with that observed in other approved indications [2][5]. Group 3: Disease Background - GCA is an inflammatory disease that can lead to severe outcomes such as blindness and stroke if untreated [2][4]. - It is the most common vasculitis affecting adults in Western countries, with the highest risk among white women over 50 years old [4].