Efficacy of Ritlecitinib for Vitiligo Treatment Stratified by Baseline Demographic and Clinical Characteristics: Post Hoc Analysis of a Phase 2b Study

ABSTRACT Background Ritlecitinib demonstrated efficacy and safety in a phase 2b trial in patients with non‐segmental vitiligo (NSV). Objectives To explore the efficacy of ritlecitinib for the treatment of NSV in patient subgroups stratified by baseline demographic and clinical characteristics. Methods This post hoc analysis of the phase 2b study (NCT03715829) of ritlecitinib included patients with active NSV who completed the 24‐week dose‐ranging period (ritlecitinib 50 mg once daily [QD] with or without a 4‐week 200‐mg or 100‐mg QD loading dose) and 24‐week extension period (ritlecitinib 50 mg QD with a 4‐week 200‐mg QD loading dose). Efficacy was assessed by measuring the proportion of patients achieving ≥ 75% improvement from baseline on the centrally read Facial Vitiligo Area Scoring Index (F‐VASI75) at Weeks 24 and 48. Patients were stratified by baseline demographic and clinical characteristics. Results A total of 184 and 90 patients were included from the dose‐ranging and extension periods, respectively. The F‐VASI75 response rates were 8.7% at Week 24 (dose‐ranging period) and 26.7% at Week 48 (extension period). Ritlecitinib was effective in achieving meaningful repigmentation in all analyzed subgroups of patients with NSV. Nonsignificant differences in repigmentation were observed between certain subgroups at Week 24 (higher response rates in male vs. female, Fitzpatrick skin type III‐VI vs. I/II, absence vs. presence of leukotrichia, facial body surface area ≥ 0.5% vs. < 0.5%, and treatment‐naïve vs. previously treated subgroups); however, these differences diminished by Week 48. At the end of the extension period, notable but not significant differences were observed only in body mass index (BMI), leukotrichia, and comorbidity subgroups (higher response rates in BMI ≤ 30 vs. > 30 kg/m 2 , absent vs. present leukotrichia, and without vs. with comorbidities subgroups), with no notable differences among the other analyzed subgroups. Conclusions Ritlecitinib was efficacious across various subgroups of patients with NSV up to 48 weeks. Trial Registration: NCT03715829.