| アブストラクト | BACKGROUND AND OBJECTIVES: Emicizumab has fundamentally changed the clinical management of hemophilia A. Despite its benefits, concerns about adverse events (AEs) have risen. This retrospective study used disproportionality analysis of FAERS data from 2017 to 2023 to examine AEs associated with emicizumab, either alone or in combination with activated prothrombin complex concentrate (aPCC) or recombinant activated factor VII (rFVIIa), as well as the timing of these AEs. METHODS: Established algorithms (ROR, PRR, BCPNN, and MGPS) were used to assess correlations and calibrated p-values. RESULTS: Based on 1198 AEs, we identified 126 cases that met four algorithmic criteria. AEs associated with emicizumab included primarily joint pain and injection site reactions (ISRs), consistent with the drug label. Additionally, we observed thrombotic events related to emicizumab's black box warning. Specifically, we found that emicizumab poses increased risks of thrombosis when used in conjunction with aPCC or rFVIIa to treat breakthrough bleeds. After excluding reports related to the progression of hemophilia, we obtained 850 AEs with reported onset times. The median onset time for AEs was 106 days, with 46.59 % occurring within the first 90 days of emicizumab treatment. CONCLUSION: Our study demonstrates the importance of early monitoring and interventions to minimize AEs and alleviate patient suffering. |
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| ジャーナル名 | Thrombosis research |
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| Pubmed追加日 | 2025/8/22 |
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| 投稿者 | Li, Tianyi; Huang, Dongping; Jiang, Yizhi |
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| 組織名 | Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of;Medicine, Shanghai 200011, China; Jiangsu Institute of Hematology, NHC Key;Laboratory of Thrombosis and Hemostasis, The First Affiliated Hospital of Soochow;University, Suzhou 215006, China.;Department of Hematology, The First Affiliated Hospital of Wannan Medical;College, Wuhu 241001, China. Electronic address: hdp_9713@163.com.;College, Wuhu 241001, China; Jiangsu Institute of Hematology, NHC Key Laboratory;of Thrombosis and Hemostasis, The First Affiliated Hospital of Soochow;University, Suzhou 215006, China. Electronic address: yzjiang2019@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40840069/ |
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