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Background <p>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.<!--Query ID="Q1" Text="Please check if article title was captured and presented correctly." Resolved="yes"--></p> Methods <p>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).<!--Query ID="Q2" Text="Please confirm if the author names are presented accurately and in the correct sequence. Otherwise amend if necessary." Resolved="yes"--></p> Results <p>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], <i>P</i> &lt; 0.01), particularly during the steroid reduction phase (RR 95%CI = 0.52 [0.43,0.64], <i>P</i> &lt; 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], <i>P</i> &lt; 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.<!--Query ID="Q3" Text=" Please check if affiliations were captured and presented correctly. " Resolved="yes"--></p> Conclusion <p>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.</p>

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Safety and efficacy of omalizumab in children aged 6 to 11 years with asthma: a systematic review and meta-analysis of randomized controlled trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月7日

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  • Yi Yang,
  • Cuiyun Fang,
  • Zhongli Jiang,
  • Xiaoxue Su,
  • Wei Fan

摘要

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.