Efficacy and safety of biologics in children and adolescents with eosinophilic asthma: A systematic review and meta-Analysis

Yulin Geng, Junmei Xu

Affiliation: Department of Pediatrics, Beijing Friendship Hospital, Capital Medical University, Beijing, China

Abstract

Background: Eosinophilic asthma is a severe phenotype in pediatrics, often refractory to conventional therapy. Biologic agents targeting Type 2 inflammatory pathway are increasingly used in children and adolescents.
Objective: To evaluate the efficacy and safety of omalizumab, mepolizumab, benralizumab, and dupilumab in pediatric eosinophilic asthma.
Methods: We systematically searched eight databases to March 31, 2025 (PROSPERO: CRD420251017602). Eligible studies were randomized controlled or controlled observational trials in patients ≤ 18 years. Outcomes included lung function, asthma control, quality of life (QoL), and adverse events (AEs).
Results: Twenty-two studies (n = 2,468) were included. Biologics significantly improved predicted FEV1 (SMD = 0.97, 95%CI: 0.38–1.57), asthma control also improved (SMD = 2.84, 95%CI: 1.40–4.28), as did quality of life (SMD = 1.72, 95%CI: 0.39–3.05). Overall AEs were more frequent (OR 1.48, 95%CI 1.22–1.81), but serious AEs were rare and not increased. Evidence was strongest for omalizumab; data for other biologics remain limited.
Conclusion: Biologic therapies are associated with improvements in clinical outcomes in children and adolescents with eosinophilic asthma, with an increased incidence of predominantly mild adverse events. However, the current evidence is largely driven by studies of omalizumab, and data for other biologics remain limited in pediatric populations. Further long-term and comparative studies are warranted to better define the efficacy and safety profiles of individual biologic agents.