靶向BCMA和CD3的双特异性抗体药物不良反应信号的比值失衡分析  

Disproportionality analysis of adverse reaction signals related to CD3/BCMA-directed bispecific antibodies

作　　者：裴雨晴 张莹[1] 冉丽[1] 马卓[1] PEI Yuqing;ZHANG Ying;RAN li;MA Zhuo(Department of Pharmacy,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100043,China)

机构地区：[1]首都医科大学附属北京朝阳医院药事部,北京100043

出　　处：《临床药物治疗杂志》2024年第11期47-51,共5页Clinical Medication Journal

摘　　要：目的 基于上市后特立妥单抗及埃纳妥单抗安全性数据,对比分析两种药物不良反应信号,为提升临床治疗安全性提供依据。方法 收集美国FDA不良事件报告系统(FARES)数据库2014年第一季度至2024年第二季度以特立妥单抗及埃纳妥单抗为首要怀疑药物的报告数据,采用报告比值比法进行不良反应信号分析。结果 分别收集以特立妥单抗和埃纳妥单抗为首要怀疑药物的报告1615份和311份。检测到特立妥单抗、埃纳妥单抗相关不良反应阳性信号分别为150个及43个,二者累及的系统器官分类中信号较强且报告例数最多的均为感染及侵染类疾病。两种药物信号强度较高且报告例数较多的不良反应与药品说明书基本一致,但巨细胞病毒感染相关不良反应在埃纳妥单抗中信号更强。特立妥单抗说明书中未报道的不良反应信号为肿瘤溶解综合征。结论 靶向BCMA和CD3的两种双特异性抗体药物整体安全性较好,但需警惕严重及潜在新的不良反应,如细胞因子释放综合征、感染及肿瘤溶解综合征。Objective This study aims to identify and compare adverse drug reaction signals of teclistamab and elranatamab,based on post-marketing safety data in order to provide insights that could improve clinical treatment safety.Methods Data were collected from the U.S.FDA Adverse Event Reporting System(FAERS)from the first quarter of 2014 to the second quarter of 2024 in which teclistamab and elranatamab were primary suspected drugs,while adverse drug reaction signals were detected using reporting odds ratio(ROR)method.Results A total of 1,615 and 311 reports of teclistamab and elranatamab as primary suspected drugs were collected,respectively.We detected 150 adverse drug reaction signals associated with teclistamab and 43 with elranatamab.The system organ class(SOC)most frequently affected with stronger signal intensity was infection and infestations for both drugs.Most of the high-intensity signals and frequently reported adverse reactions were consistent with the respective drug labels,while cytomegalovirus infection showed a stronger signal for elranatamab.Tumor lysis syndrome is not listed in teclistamab's drug label.Conclusion The two bispecific antibodies targeting BCMA and CD3 are generally safe,but caution should be taken in serious and potential new adverse drug reactions such as cytokine release syndrome,infections and tumor lysis syndrome.

关 键 词：特立妥单抗 埃纳妥单抗 双特异性抗体 FDA不良事件报告系统 数据挖掘 

分 类 号：R979.1[医药卫生—药品]