Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial

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 (Janus kinase)/TEC (tyrosine kinase expressed in hepatocelluar carcinoma) inhibitor, in patients with active nonsegmental vitiligo in a phase 2b trial (NCT03715829).Methods: Patients were randomized to once-daily oral ritlecitinib 6 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 in Facial-Vitiligo Area Scoring Index at week 24.Results: A total of 364 patients were treated in the dose-ranging period. Significant differences from placebo in percent change from baseline in Facial-Vitiligo Area Scoring Index were observed for the ritlecitinib 50 mg groups with (-21.2 vs 2.1; P < .001) or without (-18.5 vs 2.1; P < .001) a loading dose and ritlecitinib 30 mg group (-14.6 vs 2.1; P = .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 nonsegmental vitiligo. ( J Am Acad Dermatol 2023;88:395-403.)

Automated summary

This study evaluated the efficacy and safety of oral JAK3/TEC inhibitor ritlecitinib in patients with active nonsegmental vitiligo. The results showed that ritlecitinib demonstrated significant efficacy and good tolerability in treating vitiligo.