Efficacy and safety of ruxolitinib cream for the treatment of vitiligo by patient demographics and baseline clinical characteristics: Week 52 pooled subgroup analysis from two randomized phase 3 studies

Autor: Julien Seneschal, Albert Wolkerstorfer, Seemal R Desai, Pearl Grimes, Khaled Ezzedine, Deanna Kornacki, Shaoceng Wei, Kathleen Butler, David Rosmarin
Rok vydání: 2023
Předmět:
Zdroj: British Journal of Dermatology. 188
ISSN: 1365-2133
0007-0963
Popis: Vitiligo is a chronic autoimmune disease that targets melanocytes, causing skin depigmentation. Disease pathogenesis is largely regulated by interferon-γ activation of the Janus kinase (JAK) signalling pathway. A cream formulation of the JAK1/JAK2 inhibitor ruxolitinib demonstrated substantial re-pigmentation in two randomized, double-blind, vehicle-controlled phase 3 studies of adults and adolescents with vitiligo (TruE-V1 and TruE-V2). Pooled 52-week efficacy and safety data based on baseline demographics and clinical characteristics from the TruE-V studies are analysed and reported here. TruE-V1 (NCT04052425) and TruE-V2 (NCT04057573) were conducted in North America and Europe. Patients ≥ 12 years old diagnosed with nonsegmental vitiligo (NSV) with depigmentation covering ≤ 10% total body surface area (BSA), including facial and total Vitiligo Area Scoring Index (F-VASI/T-VASI) scores ≥ 0·5/≥ 3, were eligible for enrolment. Patients were randomized 2 : 1 to twice-daily 1·5% ruxolitinib cream or vehicle for 24 weeks, after which all patients could apply 1·5% ruxolitinib cream through Week 52 (open-label extension). At Week 52, patients who achieved ≥ 75% improvement from baseline in F-VASI (F-VASI75) were evaluated by sex, age group, Fitzpatrick skin type, facial BSA (F-BSA), investigator-assessed disease stability and previous therapy. Safety and tolerability were also assessed. Week 52 data are reported as observed. In total, 674 patients were randomized in the TRuE-V studies (ruxolitinib cream, n = 450; vehicle, n = 224); 673 and 661 patients were included in the safety and efficacy analyses, respectively, and 569 patients continued in the open-label extension (ruxolitinib cream from Day 1, n = 385; crossover from vehicle, n = 184). Mean (SD) age at baseline was 39·5 (15·1) years, and 27·9% of patients had Fitzpatrick skin types IV–VI. Baseline mean F-VASI and T-VASI values were 0·92 and 6·69, respectively. At Week 52, 50·3% of patients who applied ruxolitinib cream from Day 1 achieved F-VASI75. Efficacy by F-VASI75 response was identified in all demographic and clinical characteristic subgroups. Substantive F-VASI75 responses were seen for men [(n = 149), 43·6%] and women [(n = 201), 55·2%], and all age groups [12–17 years (n = 50), 48·0%; 18–64 years (n = 275), 52·0%; ≥ 65 years (n = 25), 36·0%]. F-VASI75 responses were also generally consistent based on skin type [I–III (n = 249), 47·4%; IV–VI (n = 101), 57·4%], F-BSA [
Databáze: OpenAIRE
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