| アブストラクト | BACKGROUND AND OBJECTIVE: Although tumor lysis syndrome was reported with obinutuzumab and rituximab, the association with CD20 monoclonal antibodies for chronic lymphocytic leukemia is unclear. METHODS: A disproportionality analysis was conducted to investigate the link between CD20 monoclonal antibodies and tumor lysis syndrome by accounting for known confounders and comparing with other anticancer drugs, using data from the US Food and Drug Administration Adverse Event Reporting System. Reporting odds ratios and the information component were calculated as disproportionality measures. A stepwise sensitivity analysis was conducted to test the robustness of disproportionality signals. Bradford Hill criteria were adopted to globally assess the potential causal relationship. RESULTS: From 2004 to 2022, 197, 368, 41, and 14 tumor lysis syndrome reports were detected for obinutuzumab, rituximab, ofatumumab, and alemtuzumab (CD52 monoclonal antibody), respectively. Disproportionality signals were found for the above four monoclonal antibodies when compared with other anticancer drugs. Sensitivity analyses confirmed robust disproportionality signals for obinutuzumab, rituximab, and ofatumumab. The median onset time was 4.5, 1.5, and 2.5 days for rituximab, obinutuzumab, and ofatumumab, respectively. A potential causal relationship was fulfilled by assessing Bradford Hill criteria. CONCLUSIONS: This pharmacovigilance study on the FDA Adverse Event Reporting System detected a plausible association between CD20 monoclonal antibodies (but not CD52) and tumor lysis syndrome by assessing the adapted Bradford Hill criteria. Urgent clarification of drug- and patient-related risk factors is needed through large comparative population-based studies. |
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| 投稿者 | Xia, Shuang; Ma, Jia-Ting; Raschi, Emanuel; Ma, Rui; Zhang, Bi-Kui; Guo, Linna; Noguchi, Yoshihiro; Sarangdhar, Mayur; Gong, Hui; Yan, Miao |
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| 組織名 | Department of Pharmacy, The Second Xiangya Hospital, Central South University,;139# Renmin Middle Road, Furong District, Changsha, 410011, China.;International Research Center for Precision Medicine, Transformative Technology;and Software Services, Changsha, 410011, China.;Toxicology Counseling Center of Hunan Province, Changsha, China.;Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater;Studiorum-University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.;Department of Stomatology, The Second Xiangya Hospital, Central South University,;Changsha, 410011, China.;Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, 501-1196,;Japan.;Division of Biomedical Informatics, Cincinnati Children's Hospital Medical;Center, Cincinnati, OH, 45229, USA.;Division of Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati,;OH, 45229, USA.;Department of Pediatrics, University of Cincinnati College of Medicine,;Cincinnati, OH, 45229, USA.;feelgonghui@csu.edu.cn.;and Software Services, Changsha, 410011, China. feelgonghui@csu.edu.cn.;yanmiao@csu.edu.cn.;and Software Services, Changsha, 410011, China. yanmiao@csu.edu.cn. |
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