722 - Efficacy of povorcitinib for the treatment of vitiligo by patient demographics and baseline clinical characteristics: week 52 subgroup analysis from a randomized, placebo-controlled, phase 2b clinical trial
Amit G Pandya, Thierry Passeron, Andrew Blauvelt, Nanja van Geel, Kurt Brown, Lois Erskine, Zhenyi Xue, Khaled EzzedineAbstract
Introduction/Background
Povorcitinib—an oral, small-molecule, selective Janus kinase 1 inhibitor—was statistically superior to placebo at Week 24 in patients with nonsegmental vitiligo in a phase 2b clinical trial (NCT04818346).
Objectives
To evaluate the efficacy of povorcitinib in subgroups of patients with nonsegmental vitiligo defined by demographics and baseline clinical characteristics.
Methods
Adults with nonsegmental vitiligo affecting ≥0.5%/≥8% facial/total body surface area (F-BSA/T-BSA) were randomized 1:1:1:1 to once-daily povorcitinib 15/45/75 mg or placebo for 24 weeks; subsequently, patients received povorcitinib 45/75 mg for an additional 28 weeks. The percentage of patients achieving ≥50% reduction from baseline in total Vitiligo Area Scoring Index (T-VASI50) and ≥50% and ≥75% reduction in facial-VASI (F-VASI50 and F-VASI75, respectively) were assessed by demographics and baseline characteristics. Data were analyzed using descriptive statistics; missing values were considered nonresponders.
Results
In total, 171 patients were randomized; at baseline, median (range) age was 50 (23–74) years, mean (SD) disease duration was 19.4 (14.0) years, and mean (SD) T-VASI was 25.5 (19.1). Subgroup analyses were conducted among the 103 patients who received any dose of povorcitinib from Day 1. At Week 52, 35/103 (34.0%) evaluable patients who received povorcitinib 15/45/75 mg achieved T-VASI50, 63/103 (61.2%) achieved F-VASI50, and 47/103 (45.6%) achieved F-VASI75. T-VASI50 responses were consistent within subgroups defined by age (≤40/>40 years, 42.9%/30.7%), sex (male/female, 23.8%/41.0%), race (White/Non-White, 31.6%/41.7%), Fitzpatrick skin type (I–III/IV–VI, 31.4%/39.4%), F-BSA (≤1.5%/>1.5%, 30.4%/41.2%), T-BSA (≤20%/>20%, 35.4%/32.7%), autoimmune comorbidities (Yes/No, 37.9%/32.4%), disease duration (≤10/10–20/>20 years, 41.7%/13.0%/38.6%), and previous therapy (Yes/No, 34.4%/30.0%). Similar findings were observed for F-VASI50 and F-VASI75.
Conclusions
Patients receiving povorcitinib achieved T-VASI50, F-VASI50, and F-VASI75 responses regardless of demographics or baseline clinical characteristics. Results should be confirmed in larger populations.