Total Vitiligo Area Scoring Index Response Maintenance or Shift During 52 Weeks of Ruxolitinib Cream Treatment for Vitiligo: Pooled Analysis of the TRuE-V Phase 3 Studies

Background: Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated statistically superior repigmentation to vehicle at Week 24 on the primary and all key secondary endpoints in two phase 3 vitiligo studies. The multinational TRuE-V1/TRuE-V2 (NCT04052425/NCT04057573) studies enrolled 674 patients aged 2:12 years with nonsegmental vitiligo and depigmentation covering <10% total body surface area, including facial and total Vitiligo Area Scoring Index (F-VASI/T-VASI) scores 2:0.5/2:3. 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. We examined T-VASI responses (eg, T- VASI50 represents 2:50% improvement from baseline) among patients who applied ruxolitinib cream and had nonmissing evaluations at Week 12. In total, 401 patients who applied ruxolitinib cream had T-VASI evaluations at Week 12, of whom 10.7% achieved T-VASI50 or better. Over half (58.4%) of patients remained stable in their responses at Week 24, and 34.4% improved in their response. At Week 52, 33.7% remained stable in responses previously attained at Week 24, notably in T-VASI50–<75 (24/65), T- VASI75–<90 (9/23), and 2:T-VASI90 (3/3). Response at Week 52 was decreased in 3.2% of patients; 14.7% had missing T-VASI evaluations. Improved response from Week 24 to 52 was observed in 48.4% of patients, with notable improvements from T-VASI25–<50 (58/103), T-VASI50–<75 (32/65), and T-VASI75–<90 (8/23). Adolescents and adults with nonsegmental vitiligo applying ruxolitinib cream largely improved or remained stable in their T-VASI responses over 52 weeks per pooled data from the TRuE- V1/TRuE-V2 phase 3 studies.