Repigmentation Response Trajectories With Ruxolitinib Cream in Patients With Nonsegmental Vitiligo: Pooled Analysis From 104-Week TRuE-V Phase 3 Studies

Introduction: Long-term results from the phase 3 TRuE-V program showed continued repigmentation with ruxolitinib cream through 2 years. This analysis characterized 2-year repigmentation trajectories according to Week 24 response among patients randomized to 1.5% ruxolitinib cream in TRuE-V1/TRuE-V2. Methods: Patients completing the 52-week TRuE-V1/TRuE-V2 phase 3, randomized, vehicle-controlled studies could enroll in the 52-week TRuE-V long-term extension rollover study. This post hoc analysis included patients who applied 1.5% ruxolitinib cream twice daily from Day 1 through Week 104. Patients were stratified by Week 24 response: ≥25%/≥50%/≥75%/≥90% improvement in facial and total Vitiligo Area Scoring Index (F‑VASI25/50/75/90 and T‑VASI25/50/75/90). Within each Week 24 response cohort, percentages of patients achieving higher F‑VASI and T‑VASI threshold responses were assessed through Week 104. Results: At Week 24, 169/126/66/27 patients achieved F‑VASI25/50/75/90, and 117/51/10/2 achieved T‑VASI25/50/75/90. Baseline characteristics were generally comparable between Week 24 F‑VASI and T‑VASI response cohorts, although the T‑VASI75 and T‑VASI90 groups were small, limiting interpretation of potential differences. Among Week 24 F‑VASI25 responders, 89.3%, 60.7%, and 26.8% achieved F‑VASI50, F‑VASI75, and F‑VASI90 at Week 52; respective response rates increased to 95.6%, 78.8%, and 49.6% at Week 104. Among Week 24 F‑VASI50 responders, 69.6% and 32.8% achieved F‑VASI75 and F‑VASI90 at Week 52; these rates increased to 85.7% and 56.1%, respectively, at Week 104. Among Week 24 F‑VASI75 responders, 45.5% and 67.3% achieved F‑VASI90 at Weeks 52 and 104, respectively. Among Week 24 F‑VASI90 responders, 70.4% and 88.9% maintained F‑VASI90 at Weeks 52 and 104, respectively. Comparable trends were observed for T‑VASI. Among Week 24 T‑VASI25 responders, 76.7%, 33.6%, and 7.8% achieved T‑VASI50, T‑VASI75, and T‑VASI90 at Week 52; respective response rates increased to 84.9%, 44.1%, and 14.0% at Week 104. Among Week 24 T‑VASI50 responders, 58.8% and 17.6% achieved T‑VASI75 and T‑VASI90 at Week 52; these rates increased to 65.0% and 20.0%, respectively, at Week 104. Among Week 24 T‑VASI75 responders, 50.0% and 33.3% achieved T‑VASI90 at Weeks 52 and 104, respectively. All Week 24 T‑VASI90 responders maintained T‑VASI90 at Week 52; Week 104 outcomes were unavailable. Conclusions: Ruxolitinib cream treatment resulted in continued improvements in facial and total body repigmentation through 2 years, regardless of the repigmentation response achieved at Week 24. Across Week 24 response cohorts, percentages of patients achieving higher F-VASI and T-VASI response thresholds (i.e., VASI50, VASI75, and VASI90) increased over 2 years, supporting the benefit of continued treatment.