Integrated Safety Analysis of Ritlecitinib for the Treatment of Alopecia Areata From the Phase 2 and Phase 3 ALLEGRO Clinical Trial Program

The integrated safety analysis of ritlecitinib, a JAK3/TEC family kinase inhibitor, for the treatment of alopecia areata (AA) was conducted using data from four studies within the ALLEGRO clinical trial program. The analysis included a placebo-controlled pool of 881 patients for up to 24 weeks and an all-exposure pool of 1,294 patients for up to 36 months. Participants were aged 12 years and older, with at least 25% scalp hair loss, and were not receiving other AA treatments. The study evaluated various doses of ritlecitinib, including 10 mg, 30 mg, 50 mg, and combinations with a 200 mg loading dose. Safety data were summarized using counts and percentages of adverse events and lab abnormalities, with incidence rates adjusted for study size reported per 100 patient-years. The findings support the safety of ritlecitinib for up to 48 weeks in treating AA.