Post-Marketing Safety Signals of Four JAK Inhibitors for Alopecia Areata: An Indication-Restricted FAERS Pharmacovigilance Study

    Jinshan Zhan, Ziyi Lei, Yantao Xu, Junjie Cen, Xin Tang, Miaojian Wan
    TLDR JAK inhibitors for alopecia areata have different safety risks, requiring specific monitoring for each drug.
    The study evaluated 1,905 adverse event reports from the FDA Adverse Event Reporting System to assess the safety of four JAK inhibitors—baricitinib, ritlecitinib, tofacitinib, and ruxolitinib—used for alopecia areata. Each drug showed distinct safety signals: tofacitinib was linked to neuropsychiatric and autoimmune events, baricitinib to thrombocytosis and breast cancer, ruxolitinib to pyrexia and elevated cholesterol, and ritlecitinib to gastrointestinal issues. Serious outcomes were mostly infection-related, varying by drug. The findings underscore the need for drug-specific monitoring and personalized risk assessment in clinical practice, highlighting the importance of individualized drug selection and monitoring for alopecia areata patients.
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