Efficacy and Safety of Oral Ritlecitinib for the Treatment of Active Nonsegmental Vitiligo: A Randomized Phase 2b Clinical Trial - Supplementary Material

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Background Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin. Objective To evaluate the efficacy and safety of ritlecitinib, an oral JAK3/TEC inhibitor, in patients with active nonsegmental vitiligo (NSV) in a phase 2b trial (NCT03715829). Methods Patients were randomized to once-daily oral ritlecitinib ± 4-week loading dose (200/50 mg, 100/50 mg, 30 mg, or 10 mg) or placebo for 24 weeks (dose-ranging period). Patients subsequently received ritlecitinib 200/50 mg daily in a 24-week extension period. The primary efficacy endpoint was percent change from baseline (%CFB) in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24. Results 364 patients were treated in the dose-ranging period. Significant differences from placebo in %CFB in F-VASI were observed for the ritlecitinib 50 mg groups with (-21.2 vs 2.1, P<0.001) or without (-18.5 vs 2.1, P<0.001) a loading dose and ritlecitinib 30 mg group (-14.6 vs 2.1, P=0.01). Accelerated improvement was observed after treatment with ritlecitinib 200/50 mg in the extension period (n=187). No dose-dependent trends in treatment-emergent or serious adverse events were observed across the 48-week treatment. Limitations Patients with stable vitiligo only were excluded. Conclusions Oral ritlecitinib was effective and well-tolerated over 48 weeks in patients with active NSV.

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