Background: Benralizumab and mepolizumab are IL-5Rα/IL-5-targeted monoclonal antibodies indicated as add-on treatments for patients with uncontrolled severe eosinophilic asthma (SEA).
Objective: To evaluate and compare the safety of benralizumab and mepolizumab among patients with SEA treated in MELTEMI and COLUMBA open-label, long-term extension studies, respectively.
Methods: MELTEMI was an extension study of benralizumab Q4W or Q8W for adults (aged 18-75 years) with SEA. MELTEMI participants transitioned from the BORA extension, preceded by participation in 1 of 3 placebo-controlled studies (SIROCCO, CALIMA, or ZONDA). COLUMBA was an extension study of mepolizumab for patients (aged ≥12 years) with SEA who transitioned from the dose-ranging DREAM study. Safety endpoints were presented as drug exposure patient years (MELTEMI, Q4W 784.28, Q8W 797.03; COLUMBA 1,201) for nonserious adverse events (AEs), serious adverse events (SAEs), and infections; malignancies were counted numerically.
Results: This analysis included 446 MELTEMI patients (benralizumab Q4W, 220; benralizumab Q8W, 226) and 347 COLUMBA patients (mepolizumab Q4W). Viral upper respiratory tract infection was the most common nonserious AE in both studies (MELTEMI Q8W, 46.5%; Q4W, 47.3%; COLUMBA, 48.7%). Asthma-related events were the most common SAE in both studies: MELTEMI 8.0% (Q8W) and 8.6% (Q4W) and COLUMBA 9.5%. Serious infections included pneumonia (MELTEMI Q8W, 2 [0.9%]; COLUMBA, 6 [1.7%]); cellulitis (MELTEMI Q8W, 1 [0.4%]; COLUMBA, 2 [0.6%]); and respiratory tract infections (COLUMBA, 2 [0.6%]). COLUMBA reported 6 malignancies and MELTEMI reported 4 malignancies in each group.
Conclusions: This analysis demonstrated generally similar safety events between mepolizumab and benralizumab in patients with SEA.
Keywords: Eosinophils; adverse events; asthma; biologic agents; injection site adverse reaction; patient safety; respiratory infections.
Copyright © 2024. Published by Elsevier Inc.