Updated Integrated Safety Analysis of Ritlecitinib up to ~5 Years in Adolescents With Alopecia Areata From the ALLEGRO Clinical Trials

    November 2025 in “ SKIN The Journal of Cutaneous Medicine ”
    Lidia Rudnicka, J. Mazereeuw‐Hautier, Ilka Arun Netravali, Kazutoshi Harada, Cheng Zhou, Katya Harfmann, Dalia Wajsbrot, Edward Nagy, Alanna Chaudhry, Robert Wołk, Helen Tran
    TLDR Ritlecitinib is generally safe for adolescents with alopecia areata over 5 years.
    The updated integrated safety analysis of ritlecitinib in adolescents with alopecia areata from the ALLEGRO clinical trials indicates that the drug is well-tolerated over a period of up to approximately 5 years. In the study, 172 adolescents received a 50-mg dose, with a median exposure of 1111.5 days. Adverse events (AEs) were reported in 83.7% of participants, with the most common being SARS-CoV-2 positive test, acne, headache, and nasopharyngitis. Serious AEs were reported in 5.8% of adolescents, and 7.6% discontinued due to AEs. Importantly, there were no deaths or serious conditions such as opportunistic infections or malignancies. The study was funded by Pfizer Inc.
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