Abstract
BACKGROUND: Asthma is a prevalent chronic respiratory, significantly impacting their quality of life. Omalizumab, an anti-IgE monoclonal antibody, was approved for children aged 6 to 11 years in 2016, but its safety and efficacy in this age group have not been thoroughly studied. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) published before October 20, 2024, that evaluated the safety and efficacy of omalizumab in pediatric patients aged 6 to 11 years. The review adhered to the PRISMA guidelines and was registered with PROSPERO (CRD42024531092). RESULTS: Our systematic review and meta-analysis included 4 RCTs with a total of 1078 pediatric patients. Adverse events did not significantly increase with omalizumab compared to placebo. Omalizumab reduced asthma exacerbations (risk ratio (RR) 95% confidence interval (CI) = 0.60 [0.52,0.69], P < 0.01), particularly during the steroid reduction phase (RR 95%CI = 0.52 [0.43,0.64], P < 0.01). Omalizumab also decreased the need to inhaled corticosteroid (ICS) doses and increased the number of patients completely stopping ICS compared to placebo (RR 95%CI = 1.44 [1.10,1.88], P < 0.01). Improvements in pulmonary function indices were observed in the omalizumab group, and analysis of fractional exhaled nitric oxide (FeNO) levels indicated reduced airway inflammation. CONCLUSION: These results advocate for the use of omalizumab as an effective therapeutic option for children with allergic asthma aged 6-11 years, highlighting its potential to optimize asthma management and enhance clinical outcomes in this vulnerable age group. Further research is warranted to confirm these findings and explore long-term outcomes.