| アブストラクト | 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 Omega 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 (Omega(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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| ジャーナル名 | Clinical pharmacology and therapeutics |
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| 投稿日 | 2023/4/22 |
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| 投稿者 | Xia, Shuang; Gong, Hui; Zhao, Yichang; Guo, Lin; Wang, Yikun; Ma, Rui; Zhang, Bikui; Sarangdhar, Mayur; Noguchi, Yoshihiro; Yan, Miao |
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| 組織名 | Department of Pharmacy, The Second Xiangya Hospital, Central South University,;Changsha, China.;International Research Center for Precision Medicine, Transformative Technology;and Software Services, Changsha, China.;Toxicology Counseling Center of Hunan Province, Changsha, China.;Division of Biomedical Informatics, Cincinnati Children's Hospital Medical;Center, Cincinnati, Ohio, USA.;Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati,;Ohio, USA.;Department of Pediatrics, University of Cincinnati College of Medicine,;Cincinnati, Ohio, USA.;Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37086211/ |
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