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Background <p>Biologic therapies have transformed the management of severe asthma, particularly for patients with Type 2 (T2) inflammation. These targeted monoclonal antibodies offer a personalized approach for patients with eosinophilic or allergic phenotypes who remain uncontrolled despite high-dose inhaled corticosteroids and additional controller medications. Recent updates in guidelines, such as GINA 2025, reflect the growing integration of these therapies into asthma treatment algorithms.</p> Objective <p>To provide a comprehensive review of current biologic options for severe asthma, including patient selection strategies, clinical efficacy, safety profiles, and areas of ongoing investigation.</p> Methods <p>We performed a narrative synthesis of pivotal trials, real-world evidence, and recent guideline updates on five FDA-approved biologics—omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab—alongside emerging data on depemokimab. Clinical eligibility criteria, mechanism of action, biomarker guidance, and outcome measures were compared. Emphasis was placed on individualized therapy and endotype-driven decision-making.</p> Results <p>All biologics demonstrated significant reductions in exacerbation rates, oral corticosteroid (OCS) use, and improved asthma control in appropriate T2-high populations. Dupilumab and tezepelumab showed additional benefits on lung function and broader applicability across biomarker thresholds. Depemokimab, a long-acting anti-IL-5 agent, has shown promising efficacy in the SWIFT-1 and SWIFT-2 trials, supporting semi-annual dosing and sustained eosinophil suppression. Real-world studies reinforce clinical trial data, and safety profiles were favorable, with minor adverse events in a limited number of patients.</p> Conclusion <p>Biologic therapies have redefined care for patients with severe T2 asthma, enabling biomarker-guided precision medicine. Despite significant progress, gaps remain in treating T2-low asthma, pediatric populations, and long-term treatment strategies. Ongoing research into omics-based predictors, dual-target therapies, and cost-accessibility will shape future asthma management paradigms.</p>

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Biologic Therapies in Severe Asthma: Current Landscape, Clinical Evidence, and Future Directions

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月28日

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  • Yanki K. Okuducu,
  • T. Bernard Kinane

摘要

Background

Biologic therapies have transformed the management of severe asthma, particularly for patients with Type 2 (T2) inflammation. These targeted monoclonal antibodies offer a personalized approach for patients with eosinophilic or allergic phenotypes who remain uncontrolled despite high-dose inhaled corticosteroids and additional controller medications. Recent updates in guidelines, such as GINA 2025, reflect the growing integration of these therapies into asthma treatment algorithms.

Objective

To provide a comprehensive review of current biologic options for severe asthma, including patient selection strategies, clinical efficacy, safety profiles, and areas of ongoing investigation.

Methods

We performed a narrative synthesis of pivotal trials, real-world evidence, and recent guideline updates on five FDA-approved biologics—omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab—alongside emerging data on depemokimab. Clinical eligibility criteria, mechanism of action, biomarker guidance, and outcome measures were compared. Emphasis was placed on individualized therapy and endotype-driven decision-making.

Results

All biologics demonstrated significant reductions in exacerbation rates, oral corticosteroid (OCS) use, and improved asthma control in appropriate T2-high populations. Dupilumab and tezepelumab showed additional benefits on lung function and broader applicability across biomarker thresholds. Depemokimab, a long-acting anti-IL-5 agent, has shown promising efficacy in the SWIFT-1 and SWIFT-2 trials, supporting semi-annual dosing and sustained eosinophil suppression. Real-world studies reinforce clinical trial data, and safety profiles were favorable, with minor adverse events in a limited number of patients.

Conclusion

Biologic therapies have redefined care for patients with severe T2 asthma, enabling biomarker-guided precision medicine. Despite significant progress, gaps remain in treating T2-low asthma, pediatric populations, and long-term treatment strategies. Ongoing research into omics-based predictors, dual-target therapies, and cost-accessibility will shape future asthma management paradigms.