Abstract

Severe asthma in children is a chronic and heterogeneous condition that is unresponsive to high-dose inhaled corticosteroids and long-acting beta2-agonists (LABAs), and is associated with significant morbidity, frequent use of systemic corticosteroids, and reduced quality of life. The advent of biologic therapies has transformed the management of severe asthma by targeting specific immunological pathways. This review examines the mechanisms of action, clinical efficacy, and safety of mepolizumab (anti-IL-5) and dupilumab (anti-IL-4Rα), approved for children aged ≥ 6 years, omalizumab (anti-IgE), the first biologic approved for asthma, and tezepelumab (anti-TSLP), recently authorized from age 12 also for patients with non-T2-high phenotypes. The analysis is based on a structured review of the literature in the PubMed database, including articles published between 2010 and 2025 and selected for their relevance to the management of severe pediatric asthma, the efficacy of biologic treatments, and clinical outcomes. Accurate identification of asthma phenotypes and endotypes – guided by biomarkers such as eosinophils, IgE, and FeNO measurement – is essential to personalize therapy and avoid ineffective treatments. Biologics provide proven benefits in reducing exacerbations, improving lung function and quality of life, and managing associated comorbidities. A thorough clinical and immunological evaluation remains essential to implement a precision medicine approach in the care of pediatric patients with severe asthma.

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Authors

Carolina Grella - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

Cristiana Indolfi - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

Angela Klain - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

Alessandra Perrotta - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

Fabio Decimo - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

Giulio Dinardo - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

Michele Miraglia del Giudice - Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli,” Naples, Italy

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Copyright (c) 2026 Italian Journal of Pediatric Allergy and Immunology

How to Cite
Grella, C., Indolfi, C., Klain, A., Perrotta, A., Decimo, F., Dinardo, G., & Miraglia del Giudice, M. (2026). Biologic Therapies in Severe Pediatric Asthma: Mechanisms, Clinical Efficacy, and Precision Medicine Approaches. Italian Journal of Pediatric Allergy and Immunology, 39(4). https://doi.org/10.53151/2531-3916/2025-1733
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