Zou Jingrui, Jing Fuyuan
Department of Scientific Affairs, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
Independent Researcher, Marlboro, NJ 07746, USA.
Pharmaceuticals (Basel). 2022 Nov 26;15(12):1472. doi: 10.3390/ph15121472.
Little is known about cardiovascular safety profiles for monoclonal antibody products that received the FDA Emergency Use Authorization for COVID-19. In this study, data from the FDA Adverse Event Reporting System from the first quarter of 2020 to the second quarter of 2022 were used to investigate cardiovascular safety signals associated with seven monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, sotrovimab, tocilizumab, bebtelovimab, tixagevimab + cilgavimab) in COVID-19 patients. Disproportionality analyses were conducted using reporting odds ratio and information component to identify safety signals. About 10% of adverse events in COVID-19 patients were cardiovascular adverse events. Four monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, and bebtelovimab) were associated with higher reporting of hypertension. Tocilizumab was associated with higher reporting of cardiac failure and embolic and thrombotic event. Casirivimab + imdevimab and bamlanivimab were also associated with higher reporting of ischemic heart disease. No cardiovascular safety signals were identified for sotrovimab and tixagevimab + cilgavimab. The results indicate differential cardiovascular safety profiles in monoclonal antibodies. Careful monitoring of cardiovascular events may be considered for certain COVID-19 patients at risk when they are treated with monoclonal antibodies.
对于获得美国食品药品监督管理局（FDA）新冠病毒病紧急使用授权的单克隆抗体产品，其心血管安全性概况鲜为人知。在本研究中，利用2020年第一季度至2022年第二季度FDA不良事件报告系统的数据，调查了与7种单克隆抗体产品（卡西瑞韦单抗+伊德维单抗、巴姆兰尼单抗、巴姆兰尼单抗+埃特司韦单抗、索托维单抗、托珠单抗、贝博泰洛维单抗、替沙格韦单抗+西加韦单抗）相关的新冠病毒病患者心血管安全信号。使用报告比值比和信息成分进行不成比例分析，以识别安全信号。新冠病毒病患者中约10%的不良事件为心血管不良事件。四种单克隆抗体产品（卡西瑞韦单抗+伊德维单抗、巴姆兰尼单抗、巴姆兰尼单抗+埃特司韦单抗和贝博泰洛维单抗）与高血压报告率较高相关。托珠单抗与心力衰竭以及栓塞和血栓形成事件的报告率较高相关。卡西瑞韦单抗+伊德维单抗和巴姆兰尼单抗也与缺血性心脏病报告率较高相关。未发现索托维单抗和替沙格韦单抗+西加韦单抗有心血管安全信号。结果表明单克隆抗体的心血管安全性概况存在差异。对于某些有风险的新冠病毒病患者，在使用单克隆抗体治疗时，可能需要仔细监测心血管事件。
