The following is a summary of “Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial,” published in the FEBRUARY 2023 issue of Dermatology by Ezzedine, et al.
Depigmented patches of skin are the hallmark of the chronic autoimmune disease vitiligo. Patients with active nonsegmental vitiligo were being enrolled in a phase 2b trial to assess the effectiveness and safety of the oral JAK3/TEC inhibitor ritlecitinib.
Ritlecitinib (200/50 mg, 100/50 mg, 30 mg, or 10 mg) was given orally once daily for ±4 weeks to patients who were randomly assigned to it or a placebo for 24 weeks (dose-ranging period). Ritlecitinib 200/50 mg was then given to the patients every day for an additional 24 weeks. At week 24, the Facial-Vitiligo Area Scoring Index showed a % change from the baseline, which was the primary effectiveness goal.
During the dose-ranging phase, 364 patients in total were treated. Ritlecitinib 50 mg groups with (−21.2 vs 2.1; P < .001) or without (−18.5 vs 2.1; P < .001) a loading dose experienced significant differences from placebo in percent change from baseline in the Facial-Vitiligo Area Scoring Index, as well as the ritlecitinib 30 mg group (−14.6 vs 2.1; P = .01). After receiving ritlecitinib 200/50 mg during the extension period, there was an accelerated improvement seen (n = 187). Throughout the 48-week treatment period, no dose-dependent trends in treatment-emergent or severe adverse events were seen.
In patients with active nonsegmental vitiligo, oral ritlecitinib was efficient and well tolerated during a 48-week period.