The use of ritlecitinib, an oral JAK3/TEC inhibitor, appears effective for the treatment of nonsegmental vitiligo (NSV) and is well-tolerated for over 48 weeks of follow-up, reports a recent study.
A total of 364 patients were randomly allocated to once-daily ritlecitinib with or without a 4-week loading dose, or to placebo. The active drug was given in the following doses: 200/50mg, 100/50 mg, 30 mg, and 10 mg. Treatment lasted for 24 weeks, after which patients were given 200/50-mg ritlecitinib daily over a 24-week extension period.
The primary efficacy endpoint was percent change from baseline in Facial-Vitiligo Area Scoring Index (F-VASI) scores. Treatment with ritlecitinib led to significant improvements.
For instance, those who were given the 30-mg dose saw a 14.6-point decrease in F-VASI, as opposed to a 2.1-point increase in scores among placebo participants (p<0.001). The same was true for 50-mg ritlecitinib with (–21.2 vs 2.1; p<0.001) or without (–18.5 vs 2.1; p<0.001) a loading dose.
Of note, those treated with 50-mg ritlecitinib with a 200-mg loading dose saw accelerated improvements in F-VASI during the 24-week extension period.
Moreover, researchers documented no dose-dependent treatment-emergent or serious adverse events. This safety profile remained favourable throughout the 48-week study period.
“Treatment with ritlecitinib, an oral JAK3/TEC inhibitor, was well-tolerated and efficacious over 48 weeks in patients with active nonsegmental vitiligo, supporting further investigation of ritlecitinib in phase III studies,” the researchers said.