Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program

The integrated safety analysis of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, for treating alopecia areata (AA) in patients aged ≥ 12 years, demonstrated that the drug is well tolerated with an acceptable safety profile up to 24 months. In the placebo-controlled cohort (n = 881), adverse events (AEs) were reported in 70.2–75.4% of ritlecitinib-treated patients compared to 69.5% in the placebo group, with serious AEs occurring in 0-3.2% versus 1.9% for placebo. In the all-exposure cohort (n = 1294), AEs were reported in 84.5% of patients, with serious AEs in 4.4% and 6.0% discontinuing due to AEs. Common AEs included headache, SARS-CoV-2 positive test, and nasopharyngitis. There were two deaths and low incidence rates for opportunistic infections, herpes zoster, malignancies, and major adverse cardiovascular events.