Objectives

Vitiligo is a chronic autoimmune skin disease that impacts patient quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated clinically meaningful repigmentation and was generally well tolerated in the 52-week TRuE-V1/TRuE-V2 randomized phase 3 vitiligo studies. Pooled interim subgroup analyses of patient-reported outcomes are reported based on disease duration and use of prior treatment.

Methods

Patients ≥12 years old with nonsegmental vitiligo and depigmentation covering ≤10% total body surface area (BSA) were randomized 2:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 24 weeks. Treatment satisfaction was evaluated using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9); higher scores indicate greater satisfaction. QoL measures included the Dermatology Life Quality Index (DLQI), Vitiligo-specific QoL (VitiQoL), World Health Organization-Five Well-Being Index (WHO-5), and Hospital Anxiety and Depression Scale (HADS).

Results

TRuE-V1/TRuE-V2 randomized 674 patients (ruxolitinib cream, n=450; vehicle, n=224). Mean (SD) age was 39.6 (15.1) years, and disease duration was 14.8 (11.6) years; 61.0% of patients had used prior therapy. Mean (SD) facial and total BSA at baseline was 1.02% (0.64) and 7.39% (2.03), respectively. At Week 24, patients had significantly higher (P<0.01) treatment satisfaction with application of ruxolitinib cream vs vehicle per least squares mean TSQM-9 scores regardless of disease duration (≤10 years, 63.6 vs 48.1; >10 years, 63.2 vs 51.8) or use of prior treatment (yes, 64.8 vs 49.7; no, 61.0 vs 51.4). There were no significant differences between ruxolitinib cream and vehicle at Week 24 in subgroup analyses of the DLQI, VitiQoL, WHO-5, or HADS.

Conclusions

Ruxolitinib cream was associated with significantly improved treatment satisfaction vs vehicle, although effects on QoL as assessed by the DLQI, VitiQoL, WHO-5, and HADS were not apparent at Week 24 among patients in this phase 3 clinical study population based on disease duration and use of prior treatment.