33304 Ritlecitinib (PF-06651600), an oral JAK3/TEC inhibitor, shows efficacy in patients with active nonsegmental vitiligo and either a lighter or darker Fitzpatrick skin type: Results from a phase 2b, randomized, dose-ranging study with an extension period

Abstract

Introduction: We evaluated the efficacy of ritlecitinib, an oral JAK3/TEC inhibitor, in patients with active nonsegmental vitiligo who participated in a phase 2b study (NCT03715829) and who were grouped according to lighter skin type (Fitzpatrick skin types [FST] I–III) or darker skin type (FST IV–VI). Methods: Patients were randomized to placebo or ritlecitinib with or without a 4-week loading dose (200/50 mg, 100/50 mg, 50 mg, 30 mg, or 10 mg) in a 24-week, dose-ranging period (DR), followed by a 24-week extension wherein patients were allocated to ritlecitinib 200/50 mg. Percent change from baseline (%CFB) in Facial-Vitiligo Area Scoring Index (F-VASI) was evaluated at Weeks 24 and 48. Results: 364 patients initiated treatment and 253 (170 and 83 with lighter or darker FST, respectively) completed the DR. For patients with lighter FST, placebo-adjusted mean %CFB in F-VASI at Week 24 among the 200/50 mg, 100/50 mg, 50 mg, and 30 mg groups were −14.3, −16.8, −14.6, and −10.4, respectively (P < .05 for each group except 30 mg). For patients with darker FST, placebo-adjusted mean %CFB in F-VASI at Week 24 were −37.5, −37.3, −37.9, and −26.7, respectively (P < .05 for each group). In the extension, 187 patients were allocated to ritlecitinib 200/50 mg and 136 (96 and 40 with lighter or darker FST, respectively) completed Week 48. Continuous repigmentation without plateau of effect was observed in all FST through Week 48. Conclusion: Ritlecitinib 50 mg for up to 48 weeks, with or without a loading dose during the DR, showed efficacy in patients with active nonsegmental vitiligo and either lighter or darker FST.