Tumor Lysis Syndrome Associated with Monoclonal Antibodies in Patients with Multiple Myeloma: A Pharmacovigilance Study Based on the FAERS Database

作者：Shuang Xia, Hui Gong, Yi‐Chang Zhao, Lin Guo, Yikun Wang, Rui Ma, Bikui Zhang, Mayur Sarangdhar, Yoshihiro Noguchi, Miao Yan · 发表于：Clinical Pharmacology & Therapeutics · 年份：2023 · DOI：10.1002/cpt.2920 · 被引用次数：33 · 研究领域：Methemoglobinemia and Tumor Lysis Syndrome、Blood disorders and treatments、Neonatal Health and Biochemistry

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 increas...