达拉图穆马
不良事件报告系统
医学
多发性骨髓瘤
药物警戒
单克隆抗体
肿瘤科
内科学
药理学
数据库
药品
硼替佐米
免疫学
抗体
计算机科学
作者
Shuang Xia,Hui Gong,Yi Zhao,Lin Guo,Yikun Wang,Rui Ma,Bikui Zhang,Mayur Sarangdhar,Yoshihiro Noguchi,Miao Yan
摘要
Although some tumor lysis syndrome (TLS) cases have been reported with patients with multiple myeloma (MM) taking monoclonal antibodies (mAbs), the association between TLS and mAbs remains mostly unknown. We aim to investigate the association between TLS and mAbs and describe clinical features. We conducted a disproportionality analysis to investigate the link between mAbs and TLS by excluding known confounders and compared with other anticancer drugs. The association between mAbs and TLS was evaluated using information component (IC). Drug–drug interaction signals were calculated based on the Ω shrinkage measure. Parametric distribution with the goodness‐of‐fit test was used for the reported time‐to‐onset analysis. From 2016 Q1, to 2022 Q4, a total of 274 TLS with mAbs were reported in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. There were 27% of patients with TLS with mAbs who died and 20.1% occurred a life‐threatening situation. Daratumumab, elotuzumab, and belantamab mafodotin presented a robust disproportionate signal of TLS after excluding known confounders (IC 025 > 0). Daratumumab had the highest disproportionate signal of TLS among all anticancer drugs for MM. Reported time‐to‐onset analysis showed the median days for TLS with daratumumab, isatuximab, elotuzumab, and belantamab mafodotin were 1.5, 14.5, 5.5, and 5.5 days, respectively. The drug–drug interaction analysis showed the co‐administration of drugs known to increase urate, induce hyperkalemia, or hypocalcemia elevated the reporting frequency for TLS with mAbs (Ω 025 > 0). Our postmarketing pharmacovigilance analysis detected the reporting association of TLS and mAbs in patients with MM. Additional studies with robust epidemiological study designs that can validate these findings are warranted.
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