Safety and Tolerability of Omalizumab in Children with Allergic (IgE-Mediated) Asthma: A Systematic Review and Meta-Analysis.

Background: Omalizumab is a recombinant humanized monoclonal antibody against immunoglobulin E., which can specifically bind to IgE in blood and inhibit the release of inflammatory mediators to improve the symptoms of IgE-mediated asthma effectively. This meta-analysis was used to retrieve the studies in recent years to provide a clinical reference for the omalizumab in treating allergic asthma (AA).

Methods: The databases Ovid, Embase, Pubmed, the Cochrane Library of clinical trials, CNKI (China National Knowledge Infrastructure) (China), and Wangfang Data (China) were searched for all studies on omalizumab involvement in treating allergic childhood asthma up to January 2022. Effectiveness, rate of exacerbation within 24 weeks (and 52 weeks), and the incidence of adverse reactions and serious adverse reactions were used as the primary data analysis indicators.

Results: Seven eligible pieces of literature were included. Meta-analysis indicated that omalizumab could significantly improve the treatment efficacy in children with asthma [RR (Risk Ratio) = 1.24, 95% CI (Confidential Interval) (1.09, 1.41), Z = 3.30, p = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 24 weeks [RR = 0.55, 95% CI (0.35, 0.85), Z = -2.67, p = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 52 weeks [RR = 0.52, 95% CI (0.39, 0.71), Z = -4.2, p < 0.0001], and the incidence of total serious adverse reactions was not statistically different from placebo [RR = 1.00, 95% CI (0.98, 1.03), Z = 0.71, p = 0.479], the incidence of serious adverse reactions was significantly decreased [RR = 0.53, 95% CI (0.36, 0.77), Z = -3.35, p = 0.001].

Conclusions: In treating IgE (immunoglobulin E)-mediated asthma in children, adding oral (or subcutaneous) omalizumab to a glucocorticoid regimen can enhance the effectiveness of treatment, reduce the probability of significant exacerbation during treatment, and reduce the incidence of serious adverse reactions.