Submissions are supported by data demonstrating upadacitinib achieved the co-primary endpoints of at least a 50% improvement in total body re-pigmentation and at least a 75% in facial re-pigmentation.
AbbVie has submitted applications for a new indication to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ; 15 mg, once daily) for the treatment of adult and adolescent patients living with non-segmental vitiligo (NSV).
The regulatory submissions to the FDA and EMA are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV.
NSV, the most common form of vitiligo (afflicting approximately 84% of patients), is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability. Vitiligo management is anchored in three primary treatment goals: disease stabilization, re-pigmentation, and maintaining re-pigmentation. There are currently no approved systemic medicines for achieving these treatment goals in vitiligo.
“Many patients experience ongoing frustration due to the unpredictability of non-segmental vitiligo spread and the lack of systemic treatment options that can stabilize disease progression and achieve skin re-pigmentation,” says Kori Wallace, MD, PhD, vice president, global head of immunology clinical development at AbbVi, in a release. “The Viti-Up clinical studies explored these treatment gaps in vitiligo care and reinforced AbbVie’s dedication to providing the first systemic treatment for patients, aiming to evolve the vitiligo treatment landscape.”
Viti-Up Clinical Studies
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate phase 3 studies (study 1 and study 2) with independent randomization, investigative sites, data collection, analysis, and reporting for each study. The studies were designed to evaluate the efficacy, safety, and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with NSV who were eligible for systemic therapy.
In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks.
The two studies randomized 614 participants with NSV across 90 sites worldwide.
The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.
The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV.
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