Liu Zhijing, Wu Dongzhi, Ke Chengjie, Nian Qichun, Chen Yan, Huang Yaping, Chen Maohua
Department of Pharmacy, Affiliated Hospital of Putian University, Pu Tian, China.
Department of Orthopedics Institute, Fuzhou Second General Hospital, Fuzhou, China.
Oncology. 2024;102(12):1084-1096. doi: 10.1159/000540542. Epub 2024 Aug 5.
Asciminib is primarily utilized for treating Philadelphia chromosome-positive chronic myeloid leukemia in its chronic phase among patients harboring the T315I mutation or those who have been previously treated with at least two tyrosine kinase inhibitors. The safety profile of asciminib across a broad patient population over an extended timeframe remains unverified. This study uses a real-world pharmacovigilance database to evaluate the adverse events (AEs) linked with asciminib, providing valuable insights for clinical drug safety.
Data from the FDA Adverse Event Reporting System (FAERS) database, spanning from October 2021 to December 2023, served as the basis for this analysis. The extent of disproportional events was assessed using sophisticated metrics such as the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean.
Within the specified period, the FAERS database documented 3,913,574 AE reports, with asciminib being associated with 966 incidents. Reactions to asciminib spanned 27 system organ categories. Utilizing four distinct analytical algorithms, 663 significant preferred terms exhibiting disproportional frequencies were identified. Notably, this investigation uncovered 26 significant AEs linked to off-label asciminib use, encompassing conditions such as gynecomastia, nephrotic syndrome, orchitis, pyelonephritis, hepatotoxicity, and pancreatitis. The median onset time for asciminib-related AEs was 52.5 days, ranging from 17 to 122.75 days.
The study sheds light on additional potential AEs associated with asciminib use, warranting further research to confirm these findings.
阿伐替尼主要用于治疗携带T315I突变的慢性期费城染色体阳性慢性髓性白血病患者，或先前至少接受过两种酪氨酸激酶抑制剂治疗的患者。在较长时间内，阿伐替尼在广泛患者群体中的安全性尚未得到验证。本研究使用真实世界药物警戒数据库来评估与阿伐替尼相关的不良事件（AE），为临床药物安全性提供有价值的见解。
本分析以2021年10月至2023年12月期间美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的数据为基础。使用复杂指标，如报告比值比、比例报告比、信息成分和经验贝叶斯几何均值，评估不成比例事件的程度。
在指定期间，FAERS数据库记录了3913574份AE报告，其中966起事件与阿伐替尼有关。对阿伐替尼的反应涵盖27个系统器官类别。利用四种不同的分析算法，识别出663个频率不成比例的显著首选术语。值得注意的是，本调查发现26起与阿伐替尼超说明书使用相关的显著AE，包括男性乳房发育、肾病综合征、睾丸炎、肾盂肾炎、肝毒性和胰腺炎等情况。阿伐替尼相关AE的中位发病时间为52.5天，范围为17至122.75天。
该研究揭示了与阿伐替尼使用相关的其他潜在AE，需要进一步研究来证实这些发现。
