Safety Assessment of Ritlecitinib Based on the FDA Adverse Event Reporting System (FAERS) Database: A Real-World Pharmacovigilance Study

    July 2025 in “ The Journal of Dermatology ”
    Yaping Huang, Chengjie Ke, Maohua Chen
    Studysummary This study identified common and unexpected adverse events associated with ritlecitinib in real-world use, providing insights into its safety profile for treating severe alopecia areata.
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    Research cited in this study 12

    1. Efficacy And Safety Of Ritlecitinib In Asian Patients With Alopecia Areata: A Subgroup Analysis Of The ALLEGRO Phase 2b/3 Trial The Journal of Dermatology · 2025
    2. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program American journal of clinical dermatology · 2024
    3. Efficacy and Safety of Ritlecitinib in Adults and Adolescents With Alopecia Areata: A Randomised, Double-Blind, Multicentre, Phase 2b–3 Trial The Lancet · 2023
    4. Adverse Events in Patients Treated With Jak-Inhibitors for Alopecia Areata: A Systematic Review JEADV. Journal of the European Academy of Dermatology and Venereology/Journal of the European Academy of Dermatology and Venereology · 2023
    5. Alopecia Areata: An Update on Etiopathogenesis, Diagnosis, and Management Clinical Reviews in Allergy & Immunology · 2021
    6. A Phase 2a Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Oral Janus Kinase Inhibitors Ritlecitinib and Brepocitinib in Alopecia Areata: 24-Week Results Journal of the American Academy of Dermatology · 2021
    7. Psychosomatic Aspects of Alopecia Areata Clinics in Dermatology · 2018
    8. Comorbidities in Alopecia Areata: A Systematic Review and Meta-Analysis Journal of The American Academy of Dermatology · 2018
    9. Alopecia Areata: Overview and Insights from January 2018 Journal of The American Academy of Dermatology · 2017
    10. Extensive Alopecia Areata Is Reversed by IL-12/IL-23p40 Cytokine Antagonism The Journal of Allergy and Clinical Immunology · 2015
    11. Alopecia Areata Profiling Shows TH1, TH2, and IL-23 Cytokine Activation Without Parallel TH17/TH22 Skewing ˆThe ‰journal of allergy and clinical immunology/Journal of allergy and clinical immunology/˜The œjournal of allergy and clinical immunology · 2015
    12. A Case of Widespread Non-Pigmented Hair Regrowth in Diffuse Alopecia Areata Australasian Journal of Dermatology · 2007