AbbVie reports results from Phase 3 studies evaluating upadacitinib

AbbVie (ABBV) announced positive topline results from two replicate Phase 3 studies evaluating the safety and efficacy of upadacitinib, or RINVOQ, once daily in adult and adolescent patients living with non-segmental vitiligo, or NSV. NSV, the most common form of vitiligo, is characterized by symmetrical and bilateral white patches on both sides of the body. The Total Vitiligo Area Scoring Index, or T-VASI, is a tool that measures the extent of de-pigmentation over the entire body while F-VASI measures de-pigmentation of the face, an area among the most visible and psychosocially impactful for people living with NSV. Across both studies approximately 70% of subjects had T-VASI greater than 10 at baseline. In both studies, upadacitinib achieved the co-primary endpoints of T-VASI 50 and F-VASI 75 at week 48 versus placebo. Across both studies, statistically significant differences were observed with upadacitinib versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48. The safety profile of upadacitinib in both studies was generally consistent with that observed in approved indications. No new safety signals were observed.