27568 Maintenance of repigmentation after discontinuation of ruxolitinib cream in patients with vitiligo

Abstract

Treatment with ruxolitinib cream (Janus kinase [JAK] 1/JAK2 inhibitor) in adult patients with vitiligo resulted in substantial repigmentation over 52 weeks in a phase 2 dose-ranging study (NCT03099304). We assessed maintenance of repigmentation among responders from the phase 2 study following ruxolitinib discontinuation after 104 weeks of treatment. Patients initially randomized to ruxolitinib cream (1.5% twice daily [BID], 1.5% once daily [QD], 0.5% QD, or 0.15% QD) with evidence of facial repigmentation at Week 24 who completed ≥1 follow-up visit 1, 3, or 6 months after an additional 52 weeks of 1.5% ruxolitinib cream BID monotherapy (Weeks 52-104) were analyzed. Loss of repigmentation was defined as an increase in Vitiligo Area Severity Index score during the last follow-up visit vs Week 104 on ruxolitinib cream. Sixteen patients were included in the analysis (1.5% BID, n = 3; 1.5% QD, n = 5; 0.5% QD, n = 3; 0.15% QD, n = 5 [including 2 patients rerandomized to 1.5% BID/0.5% QD after Week 24]). Four patients (25.0%; 1.5% QD, n = 1; 0.5% QD, n = 1; 0.15% QD, n = 2) had repigmentation loss over 1-6 months of follow-up; no patients from the 1.5% ruxolitinib BID treatment group (with 2 years’ exposure) experienced repigmentation loss. There were no significant differences in baseline serum levels of chemokine (C-X-C motif) ligand (CXCL) 9, CXCL10, or interleukin-15 in patients who experienced loss vs maintenance of repigmentation after ruxolitinib cream discontinuation. This exploratory analysis suggests that repigmentation with ruxolitinib cream monotherapy may be maintained postdiscontinuation; larger follow-up studies are required to confirm these findings.