Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Abstract

Asthma is a chronic inflammatory condition that affects the lung airways. Chronic use of oral glucocorticoids in patients with severe asthma is associated with several adverse events (AEs). Biologics (omalizumab, benralizumab, mepolizumab, reslizumab, and dupilumab) have been developed as alternative therapies for the treatment of asthma. The aim of this study was to evaluate the risk of anaphylactic reactions associated with these five biologics based on a large global database. We utilized individual case reports from the Uppsala Monitoring Center from 1968 to December 29, 2019. A disproportionality analysis of all drugs and monoclonal antibodies. Anaphylactic reactions were defined according to the "anaphylactic reaction” of the standardized MedDRA queries. Contrary to dupilumab, omalizumab, benralizumab, and mepolizumab demonstrated positive signals related to anaphylactic reactions among all drugs and monoclonal antibodies. Reslizumab, which represented only 315 cases of all AEs, required more reports to determine its association with anaphylactic reactions. This was an important study since the majority (96.2%) of the cases of anaphylactic reactions were reported serious. In conclusion, the results indicate that omalizumab, benralizumab, and mepolizumab are associated with a high risk of anaphylactic reactions, and careful monitoring in the post-injection period is recommended.