Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19

Abstract

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.

Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea

“…In general, similar to our PMS study, reports of serious adverse reactions following anti-SARS-CoV-2 mAb treatment in the clinic are few [ 45 ], and there are conflicting reports in the literature regarding the effect of mAb treatments for COVID-19 on cardiovascular events. Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) revealed an increase in hypertension events with casirivimab/imdevimab, bamlanivimab, bamlanivimab/etesevimab, and bebtelovimab, and ischaemic heart disease for casirivimab/imdevimab and bamlanivimab, but no association between cardiovascular events and treatment with sotrovimab or tixagevimab/cilgavimab [ 46 ]. In contrast, analysis of VigiBase, the safety database of the WHO, discovered an increased risk for arterial and venous thromboembolic events with tixagevimab/cilgavimab as compared with other anti-SARS-CoV-2 mAbs [ 47 ].…”