The FDA has approved Opzelura (ruxolitinib) as the first topical treatment for vitiligo. The 1.5% cream is approved for continuous topical use twice daily to affected areas of up to 10% of body surface area in patients aged 12 and older. More than 24 weeks of treatment may be needed for satisfactory patient response. Approval was based on results from the TRuE-V clinical trials, in which more than 600 patients were randomly assigned to ruxolitinib or placebo. At week 24, 30% of patients treated with ruxolitinib achieved at least 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75) versus 8% to 13% of patients treated with placebo. Approximately one half of ruxolitinib-treated patients achieved F-VASI75 at week 52. “There have been no FDA-approved therapies available to date and the approval of [ruxolitinib] therefore marks a significant milestone,” David Rosmarin, MD, said in a statement. “I welcome a medical treatment that helps my patients with non-segmental vitiligo who are interested in potentially reversing the depigmentation caused by their disease.”
