Updated Integrated Safety Analysis of Ritlecitinib Over 72 Months in Patients with Alopecia Areata from the Allegro Clinical Trial Program

The updated integrated safety analysis of ritlecitinib over 72 months in patients with alopecia areata (AA) from the ALLEGRO clinical trial program indicates that ritlecitinib is generally well tolerated. The study pooled safety data from four studies, involving 1,294 patients in the any-ritlecitinib group and 1,228 in the 50-mg ± 200-mg group. Adverse events (AEs) were reported in 89.5% and 87.1% of patients in these groups, respectively, with common AEs including headache, positive SARS-CoV-2 test, and nasopharyngitis. Serious AEs occurred in 6.8% of patients in both groups, with two deaths reported in the 50-mg ± 200-mg group. Discontinuations due to AEs were 7.0% and 6.6% in the respective groups. The incidence rates for opportunistic infections, herpes zoster, malignancies, and major adverse cardiovascular events were low, supporting the consistent safety profile of ritlecitinib with previous data.