| アブストラクト | Graft-versus-host disease (GVHD) remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation, and while ruxolitinib, a JAK1/2 inhibitor, is approved for steroid-refractory acute and chronic GVHD, its real-world safety profile requires comprehensive evaluation. Using the FAERS database from Q1 2012 to Q4 2024, 3615 reports listing ruxolitinib as the primary suspect drug for GVHD were selected for multidimensional analysis via four signal detection methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayesian geometric mean. The analysis identified adverse event (AE) signals across 26 system organ classes, with common AE reports including infections and infestations (e.g., pneumonia, cytomegalovirus), blood and lymphatic system disorders (e.g., thrombocytopenia, anemia), and gastrointestinal disorders (e.g., diarrhea). The median time to AE onset was 74 days (IQR 21-197), and 27% of AE reports occurred beyond 180 days after treatment initiation. Subgroup analysis revealed higher frequencies of hematologic AE reports such as cytopenia and thrombocytopenia in acute GVHD, and more undefined disorders in chronic GVHD; designated medical event analysis highlighted significant renal (e.g., acute kidney injury) and hematologic reporting signals. Sensitivity analyses confirmed the robustness of these signals. In conclusion, ruxolitinib demonstrates significant reported AE concerns in GVHD treatment, particularly infections and cytopenias, necessitating vigilant monitoring and long-term pharmacovigilance to optimize its risk-benefit profile. |
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| ジャーナル名 | Naunyn-Schmiedeberg's archives of pharmacology |
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| Pubmed追加日 | 2026/7/31 |
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| 投稿者 | Li, Yuan-Yuan; Xie, Wen-Long; Zhao, Yang; Zhang, Deng-Zheng; Mao, Bing; Zhou, Qing; Lai, Yong-Ji |
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| 組織名 | Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College,;Huazhong University of Science and Technology, Wuhan, 430014, China.;Department of Neurology, Daping Hospital, Army Medical University, Chongqing,;China.;Department of Pharmacy, Xianning Central Hospital, The First Affiliated Hospital;Of Hubei University Of Science And Technology, Xianning, Hubei, 437000, China.;Medical Department, The Central Hospital of Wuhan, Tongji Medical College,;mbwh@sohu.com.;851946847@qq.com.;laiyongji1024@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42533070/ |
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