| アブストラクト | OBJECTIVES: To establish the association between the therapy of Janus kinase inhibitors and the adverse event of pemphigus in patients with rheumatologic and inflammatory disorders. METHODS: A disproportionality analysis using multi-item gamma Poisson shrinker was conducted to identify signals between medication and adverse events within the FDA Adverse Event Reporting System. RESULTS: The spontaneous reporting system contained 3,032 pemphigus reports associated with two Janus kinase inhibitors, namely Tofacitinib and Upadacitinib. The year/reporter/geographic area/country/age/sex/indication with the highest number of cases were the year of 2021, physician, North America, Canada, age between 40-49, female and rheumatoid arthritis, respectively. A significant signal was detected in the Tofacitinib group. CONCLUSION: Pemphigus, a rare and potentially fatal adverse event, was found to occur more frequently in patients receiving Tofacitinib. High-risk individuals were identified as female, age between 40-49, or with rheumatoid arthritis. Medication, adverse events, and underlying disease conditions were identified as potential contributing factors. Rheumatology and dermatology specialists should exercise increased vigilance in clinical practice. |
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| 組織名 | Clinical Trial Center, Peking University International Hospital, Beijing, China.;Department of Pharmacy, Peking Union Medical College Hospital, Peking Union;Medical College, Chinese Academy of Medical Sciences, Beijing, China. |
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