Biologic Therapies and Biomarkers in Severe Childhood Asthma: A Systematic Review of Omalizumab and Mepolizumab.

INTRODUCTION

Severe asthma in children is challenging to manage due to high exacerbation rates and significant impacts on quality of life. Despite corticosteroids and bronchodilators, many patients remain symptomatic, highlighting the need for alternative treatments. Biologic therapies, such as omalizumab and mepolizumab, offer potential to reduce exacerbations and oral corticosteroid use. This study aimed to evaluate the efficacy of novel biologic therapies in managing severe pediatric asthma.

METHODS

A systematic review was conducted following the PRISMA protocol and registered on PROSPERO (CRD42025634956). Studies published between January 2019 and December 2024 were included. Eligible articles were randomized clinical trials, cohort, and case-control studies involving biologic therapies, excluding those with adults, animals, or unrelated topics. Data extraction was performed in Microsoft Excel, and bias was assessed using the Newcastle-Ottawa tool and the Jadad scale.

RESULTS

Most trials analyzed omalizumab, with only one evaluating mepolizumab. These therapies significantly reduced asthma exacerbations, with effects sustained up to 6 years. Reductions in hospitalizations, PICU admissions, and ED visits were noted. Most studies used manufacturer-recommended doses, while some adjusted doses based on weight and/or IgE levels. Pulmonary function improved in seven studies (increased FEV1), while three showed no significant changes. A reduction in inhaled and oral corticosteroid use, FeNO, and eosinophil levels was observed, suggesting reduced airway inflammation. Most patients tolerated therapies well, with mild adverse events reported.

CONCLUSION

Biologic therapies, particularly omalizumab, show promising clinical benefits for managing severe pediatric asthma. Further studies are needed to assess their long-term safety and effectiveness.