Upadacitinib (Rinvoq, AbbVie) met its primary co-endpoints—The Total Vitiligo Area Scoring Index (T-VASI) 50- and Facial-VASI 75—in patients with non-segmental vitiligo, according to topline results from two replicate Phase 3 studies.
Approximately 70% of subjects had T-VASI > 10 at baseline across both studies. In both studies, patients taking upadacitinib 15mg once daily achieved the co-primary endpoints of T-VASI 50 50% reduction from baseline in T-VASI score) and F-VASI 75 75% reduction from baseline in F-VASI score) at Week 48 vs. placebo. Across both studies, statistically significant differences were observed with the selective Janus kinase (JAK) inhibitor vs. placebo in key ranked secondary endpoints, including F-VASI 50 at Week 48, AbbVie reports.
The safety profile of upadacitinib in both studies was generally consistent with that observed in approved indications. No new safety signals were observed. Across both studies, the most frequent treatment-emergent adverse events (TEAEs) in the 48 weeks upadacitinib treatment groups were upper respiratory tract infection, acne and nasopharyngitis. In study 1, treatment-emergent serious adverse events (TESAEs) occurred in 3.9% and 4% of patients in the upadacitinib 15mg and placebo groups, respectively. In study 2, TESAEs occurred in 2% and 1% of patients in the upadacitinib 15mg and placebo groups, respectively. There were no adjudicated cases of any major cardiovascular event (MACE) or venous thromboembolism (VTE) in the studies. Three malignancy events were reported: one was reported in both placebo groups (1% each) of studies 1 and 2, and one was reported in the upadacitinib 15mg group (0.5%) in study 1 (genital neoplasm). There were no deaths reported in the upadacitinib treated groups across both studies. There was one death reported in the placebo group in study 2.
“For many people living with vitiligo, the journey is marked by uncertainty, frustration and a lack of medicines that can treat the disease systemically,” says Thierry Passeron, MD, PhD, Professor and Chair of the Department of Dermatology at the Université Côte d’Azur in Nice, France, in a news release. “These positive results indicate that targeting the underlying inflammation may offer a systemic treatment option which could help patients achieve visible results.”
Use of upadacitinib in NSV is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
