Objectives

Vitiligo is a chronic autoimmune skin disease associated with quality-of-life (QoL) burden. 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 phase 3 vitiligo studies. Pooled interim subgroup analyses of QoL outcomes are reported in patients who achieved the primary endpoint of ≥75% improvement in facial Vitiligo Area Scoring Index (F-VASI75), since QoL improvements often require a high degree of repigmentation in vitiligo.

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. QoL measures included the Dermatology Life Quality Index (DLQI) and Vitiligo-specific QoL (VitiQoL), with higher scores indicating worse QoL.

Results

TRuE-V1/TRuE-V2 randomized 674 patients (ruxolitinib cream, n=450; vehicle, n=224). Mean (SD) age was 39.6 (15.1) years. Mean (SD) facial and total BSA at baseline was 1.02% (0.64) and 7.39% (2.03), respectively. At Week 24, F-VASI75 was achieved by 30.1% of patients who applied ruxolitinib cream vs 10.8% who applied vehicle (P<0.0001). Among patients who achieved F-VASI75, there were no significant differences in the change from baseline in total scores on the DLQI or VitiQoL at Weeks 12 or 24 for ruxolitinib cream vs vehicle (all P>0.05). However, QoL appeared to improve from Weeks 12 to 24 per the least squares mean change from baseline (SE) in DLQI (–1.3 [0.3] to –1.9 [0.4]) and VitiQoL (–6.3 [1.4] to –9.2 [1.5]) among patients who applied ruxolitinib cream.

Conclusions

Although application of ruxolitinib cream was not associated with improved QoL vs vehicle at Week 24, there were trends for improvement in both the DLQI and VitiQoL among patients who achieved the primary endpoint of F-VASI75.