A COMPREHENSIVE REVIEW OF ADVERSE EFFECTS OF BIOLOGICAL TREATMENT IN ASTHMA
TL;DR
Current evidence indicates that the clinical benefits of biologic therapies in severe asthma substantially outweigh their potential risks, and improved awareness of their safety profiles may reduce patient concerns and facilitate earlier treatment initiation, reduce corticosteroid-related complications, and contribute to better long-term outcomes and quality of life in patients with severe asthma.
Abstract
Background: Biologic therapies have revolutionized the treatment of severe asthma by targeting specific inflammatory pathways, reducing exacerbation rates, improving lung function, and decreasing dependence on systemic corticosteroids. Despite their proven efficacy, concerns regarding adverse effects may limit their acceptance and early implementation in clinical practice. Objective: This review aimed to evaluate and summarize the adverse effects associated with currently approved biologic agents for asthma treatment, including omalizumab, benralizumab, mepolizumab, dupilumab, and tezepelumab. Methods: A narrative literature review was conducted using the PubMed database. English-language studies published between January 2011 and May 2026 were analyzed, including randomized controlled trials, systematic reviews, meta-analyses, observational studies, and selected case reports. Particular attention was paid to the incidence and clinical significance of hypersensitivity reactions, infections, eosinophilia, cardiovascular events, and malignancies. Results: The reviewed biologics demonstrated favorable safety profiles, with most adverse events being mild to moderate and rarely leading to treatment discontinuation. Omalizumab was associated with a rare risk of anaphylaxis, while dupilumab was linked to transient eosinophilia and uncommon eosinophilic complications. Benralizumab, mepolizumab, and tezepelumab showed reassuring long-term safety data, with no significant increase in severe infections, malignancies, or cardiovascular events. Across all agents, the incidence of serious adverse reactions remained low. Conclusions: Current evidence indicates that the clinical benefits of biologic therapies in severe asthma substantially outweigh their potential risks. Improved awareness of their safety profiles may reduce patient concerns and facilitate earlier treatment initiation, reduce corticosteroid-related complications, and contribute to better long-term outcomes and quality of life in patients with severe asthma.