Oral ritlecitinib safe, effective for treatment of active nonsegmental vitiligo
Treatment with oral ritlecitinib improves outcomes in patients with active nonsegmental vitiligo, without any serious adverse events over 48 weeks, results of a study have shown.
This phase IIb clinical trial evaluated the efficacy and safety of ritlecitinib, an oral Janus kinase (JAK3)/tyrosine kinase expressed in hepatocellular carcinoma (TEC) inhibitor, in patients with active nonsegmental vitiligo.
The authors randomized patients to once-daily oral ritlecitinib ±4-week loading dose (200/50 mg, 100/50 mg, 30 mg, or 10 mg) or placebo for 24 weeks (dose-ranging period). Participants then received ritlecitinib 200/50 mg daily in a 24-week extension period. Percent change from baseline in Facial-Vitiligo Area Scoring Index at week 24 was the primary efficacy endpoint.
Overall, 364 patients received treatment during the dose-ranging period. Significant differences in the primary endpoint were seen for the ritlecitinib 50-mg groups with (‒21.2 vs 2.1; p<0.001) or without (‒18.5 vs 2.1; p<0.001) a loading dose and ritlecitinib 30-mg group (‒14.6 vs 2.1; p=0.01) when compared to placebo.
Accelerated improvement was also noted in 187 patients who underwent treatment with ritlecitinib 200/50 mg in the extension period. Of note, dose-dependent trends in treatment-emergent or serious adverse events were not observed across the 48-week treatment.
The trial was limited by the exclusion of patients with stable vitiligo only.
“Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin,” the authors said.