BIOLOGIC THERAPY IN SEVERE ASTHMA: A REVIEW OF EFFICACY, SAFETY, AND PRACTICE-ORIENTED SELECTION
Main Article Content
Abstract
Objective: To synthesize current evidence on the efficacy and safety of biologic therapies in severe asthma and to provide practice-oriented guidance for treatment selection based on phenotype and biomarkers.
Methods: This narrative review searched PubMed, Embase, the Cochrane Library, and Google Scholar up to October 31, 2025, using keywords related to severe asthma, difficult-to-treat asthma, and biologic agents. Eligible publications included practice guidelines, systematic reviews, umbrella reviews, and pivotal phase III clinical trials in patients aged 12 years and older.
Results: Biologic agents, including omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab, consistently reduced exacerbations, improved lung function, lowered oral corticosteroid requirements, and enhanced quality of life in appropriately selected patients. Omalizumab showed particular value in severe allergic asthma; mepolizumab and benralizumab were effective in eosinophilic asthma; dupilumab was suitable for patients with high type 2 inflammation and allergic comorbidities; and tezepelumab expanded treatment options for less typical phenotypes.
Conclusion: Biologic therapy has fundamentally changed the management of severe asthma, but optimal benefit depends on selecting the right agent according to phenotype, biomarkers, treatment goals, comorbidities, and affordability.
Article Details
Keywords
severe asthma, biologic therapy, efficacy, safety, biomarkers
References
[2] Krings JG, McGregor MC, Bacharier LB, Castro M. Biologics for severe asthma: Treatment-specific effects are important in choosing a specific agent. J Allergy Clin Immunol Pract. 2019;7(5):1379-1392. doi:10.1016/j.jaip.2019.03.008.
[3] Gyawali B, Georas SN, Khurana S. Biologics in severe asthma: a state-of-the-art review. Eur Respir Rev. 2025;34(175):240088. doi:10.1183/16000617.0088-2024.
[4] Xiao Q, Huang Y, Xue B, Wang M. The efficacy and safety of biologics for patients with severe asthma: an umbrella review of systematic reviews and meta-analyses. Front Med (Lausanne). 2025;12:1573596. doi:10.3389/fmed.2025.1573596.
[5] Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-659. doi:10.1016/S0140-6736(12)60988-X.
[6] Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207. doi:10.1056/NEJMoa1403290.
[7] FitzGerald JM, Bleecker ER, Menzies-Gow A, Zangrilli JG, Hirsch I, Metcalfe P, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018;6(1):51-64. doi:10.1016/S2213-2600(17)30344-2.
[8] Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486-2496. doi:10.1056/NEJMoa1804092.
[9] Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809. doi:10.1056/NEJMoa2034975.
[10] D’Amato M, Pastore D, Lupia C, Candia C, Bruni A, Garofalo E, et al. Biologic therapy in severe asthma: a phenotype-driven and targeted approach. J Clin Med. 2025;14(13):4749. doi:10.3390/jcm14134749.