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Comparative efficacy and safety of biologic therapies in pediatric asthma: a comprehensive systematic review
1Department of Pediatrics, College of Medicine, Imam Mohammad Ibn Saud Islamic University (IMSIU), Riyadh, Saudi Arabia.
Insights
Dupilumab is the most effective biologic therapy for severe pediatric asthma, significantly reducing exacerbations and improving quality of life. This review evaluated five biologics for children with uncontrolled asthma.
Area of Science:
- Pediatric Pulmonology
- Clinical Immunology
- Pharmacology
Background:
- Severe pediatric asthma significantly impacts children's quality of life.
- Biologic therapies offer alternatives for severe asthma unresponsive to conventional treatments.
- Limited comparative data exists for biologics in pediatric populations.
Purpose of the Study:
- To evaluate the efficacy and safety of five major biologic agents in children and adolescents with uncontrolled asthma.
- To compare outcomes of Dupilumab, Omalizumab, Mepolizumab, Lebrikizumab, and Benralizumab.
Main Methods:
- Systematic literature search of PubMed, Web of Science, and Embase up to June 2025.
- Included randomized and open-label extension studies of pediatric asthma patients.
- Assessed exacerbation rates, lung function, asthma control, quality of life, and adverse events.
Main Results:
- Dupilumab demonstrated the most robust outcomes, significantly reducing exacerbations and improving quality of life.
- Omalizumab showed benefits in exacerbations and symptom control; Mepolizumab had moderate benefits with variable efficacy.
- Benralizumab and Lebrikizumab yielded modest improvements; safety profiles were generally favorable across agents.
Conclusions:
- Dupilumab shows the most consistent efficacy for severe pediatric asthma.
- Omalizumab is effective, especially for allergic and virus-induced exacerbations.
- Phenotype-directed therapy is crucial, supporting Dupilumab for long-term management.
Background:
Asthma remains one of the most prevalent chronic diseases among children, with severe cases posing significant challenges to symptom control, and quality of life (QoL). Biologic therapies have emerged as effective alternatives for severe asthma unresponsive to conventional therapies. However, limited evidence exists for their comparative efficacy and safety in pediatric populations. This systematic review aims to evaluate the efficacy and safety of five major biologic agents in children and adolescents with uncontrolled asthma.
Methods:
A systematic literature search was conducted in PubMed, Web of Science, and Embase up to June 2025. Eligible studies included randomized and open label extensions involving pediatric asthma patients treated with at least one of the five biologic therapies including Dupilumab, Omalizumab, Mepolizumab, Lebrikizumab and Benralizumab. Outcomes assessed included exacerbation rates, lung function, asthma control, QoL, and adverse events. Risk of bias was assessed using RoB 2.0 and MINORS tools.
Results:
This review included Twenty-five studies. Dupilumab consistently showed the most robust outcomes, significantly reducing exacerbations (by up to 64.7%), improving ACQ-7 scores, pulmonary function, and QoL. Omalizumab also showed reduced exacerbations and improved symptom control and QoL, with debatable results in pulmonary function. Mepolizumab demonstrated moderate benefits with variable efficacy and higher SAE rates. Benralizumab and Lebrikizumab yielded modest improvements in clinical outcomes. Safety profiles were generally favorable across biologics, with mild-to-moderate adverse events.
Conclusion:
Among the reviewed biologics, Dupilumab showed the most consistent and sustained efficacy across clinical, and patient-reported outcomes in pediatric asthma. Omalizumab also proved effective, particularly in allergic and virus-induced exacerbations. This review underscores the importance of phenotype-directed therapy and supports dupilumab as a preferred option for long-term management of severe pediatric asthma.
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