Ritlecitinib yields high repigmentation rates in nonsegmental vitiligo

Ritlecitinib significantly out-performed placebo across various doses in safety and efficacy for the treatment of nonsegmental vitiligo, according to a clinical trial.

“Vitiligo has an unpredictable clinical course. ... Treatment goals for vitiligo include arresting progression, repigmentation of existing lesions, and maintenance of repigmentation,” Khaled Ezzedine, MD, PhD, professor of public assistance at the Hospital of Paris, and colleagues wrote. “Treatment options for vitiligo are limited and often require lengthy treatment and/or have limited efficacy.”

The phase 2b, randomized, double-blind, multicenter study analyzed the efficacy and safety of ritlecitinib, an inhibitor of Janus kinase 3, in the treatment of 364 patients with nonsegmental vitiligo. Eligible patients were aged 18 to 65 years with a clinical diagnosis of nonsegmental vitiligo for at least 3 months and body surface area involvement of 4% to 50%.

Patients were randomly assigned to one of six groups. Two groups received a loading dose of ritlecitinib 100 mg or 200 mg daily for 4 weeks followed by 50 mg daily for 20 weeks. Four groups without a loading dose received ritlecitinib 50 mg, 30 mg or 10 mg or matching placebo daily for 24 weeks. Also, 187 patients were assigned to treatment in a blinded 200 mg/50 mg ritlecitinib group for a 24-week extension period based on response at week 16.

The researchers observed significant differences vs. placebo for the primary efficacy endpoint, which was the percent change from baseline in Facial-Vitiligo Area Scoring Index at week 24, in the 50 mg groups with (–21.2 vs. 2.1; P < .001) or without a loading dose (–18.5 vs. 2.1; P < .001), as well as in the 30 mg group (–14.6 vs. 2.1; P = .01). Researchers also observed accelerated improvement among all patients during the extension period.

Across the 48-week treatment, no dose-dependent adverse events were observed.

“This phase 2 trial suggests ritlecitinib is an effective and well tolerated treatment for patients with active [nonsegmental vitiligo],” Ezzedine and colleagues wrote. “As indicated by data during the extension period, longer treatment duration may be required for optimal repigmentation.”