Late Breaking Abstract - Cardiovascular adverse events of drugs targeting IL-5 in severe asthma: a pharmacovigilance study

Abstract

Background: Over the past few years, drugs targeting IL-5 (DT IL-5) have revolutionized the management of severe eosinophilic asthma. However, little is known about their safety. Objectives: We investigated cardiovascular adverse effects on post marketing safety data of DT IL-5 (mepolizumab, reslizumab, or benralizumab) compared to omalizumab. Methods: We performed a pharmacovigilance study within VigiBase, the World Health Organization9s global database, from 2000 to 2019 in patients older than 12 years. We conducted disproportionality analyses (case non-case method) allowing the estimation of reporting odds ratios (RORs) with 95% Confidence Intervals (95% CI) which calculate the odds of cardiovascular events occurring with DT IL-5 compared to omalizumab. Results: We identified 4,791 reports of cardiovascular effects with DT IL-5 and 16,261 with omalizumab. No differences in terms of cardiovascular effects were observed except for hypertension and central nervous system (CNS) ischemic events. Compared to omalizumab, hypertension was less likely to be reported with DT IL-5 (ROR 0.26; 95% CI 0.22-0.30). Consistent results were observed when the analysis was restricted to reports generated from health professionals or occurring from 2016 to 2019. Furthermore, we have also found a significant increased risk of reporting CNS ischemic events with DT IL-5 compared to omalizumab (ROR 1.69; 95% CI 1.02-2.74) but results were not consistent using sensitivity analysis. Conclusion: Apart from CNS ischemic events for whom a long-term study is needed, this real world study found no higher risk of cardiovascular events with DT IL-5 compared to omalizumab.