AbbVie Announces Positive Topline Results from Phase 3 Pivotal Studies Evaluating Upadacitinib (RINVOQ®) in Adults and Adolescents with Vitiligo

Core Insights - AbbVie announced positive topline results from two Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ) for treating non-segmental vitiligo (NSV) [1][2] Efficacy Results - Upadacitinib achieved co-primary endpoints of a 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) and a 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) at week 48 compared to placebo [4][2] - In Study 1, 19.4% of patients on upadacitinib achieved T-VASI 50, while 5.9% in the placebo group did. For F-VASI 75, 25.2% achieved this endpoint compared to 5.9% in the placebo group [3] - In Study 2, 21.5% achieved T-VASI 50 and 23.4% achieved F-VASI 75 on upadacitinib, compared to 5.9% and 6.9% in the placebo group, respectively [3] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with no new safety signals identified [2] - The most common treatment-emergent adverse events (TEAEs) included upper respiratory tract infections, acne, and nasopharyngitis [3] - Serious adverse events (TESAEs) occurred in 3.9% and 4% of patients in the upadacitinib and placebo groups in Study 1, and 2% and 1% in Study 2, respectively [3] Background on Vitiligo - Vitiligo is a chronic autoimmune disease affecting approximately 0.5% to 2.3% of the global population, with non-segmental vitiligo (NSV) being the most common form [6] - NSV accounts for roughly 84% of vitiligo cases and can lead to significant psychosocial challenges, including depression and anxiety [6] Clinical Trial Design - The trials involved 614 participants across 90 sites worldwide, randomized in a 2:1 ratio to receive either upadacitinib 15 mg or placebo for 48 weeks [6] - Participants who completed the initial period were eligible for a 112-week open-label extension where all received upadacitinib [6]