Omalizumab in pediatric chronic spontaneous urticaria: A systematic review and meta-analysis of efficacy and safety

Abstract

Chronic spontaneous urticaria significantly impairs quality of life in children, with limited treatment options beyond antihistamines. Omalizumab, an anti-IgE antibody, has shown promise in adults but data on its use in children, especially those under 12, are scarce. This systematic review and meta-analysis aim to evaluate the efficacy and safety of omalizumab in pediatric chronic spontaneous urticaria, providing insights to inform clinical practice and future guidelines. PubMed, Scopus, Embase, Cochrane, and Web of Science databases have been searched for relevant studies. The "R" software has been utilized to analyze the response and relapse rates, changes in urticaria scores, and adverse event rates. Subgroup analyses were also done based on response rate. The assessment of heterogeneity utilized the I² and chi-squared tests, applying the random effect model. This systematic review included 36 studies met the inclusion criteria. The pooled response rate for omalizumab was 88.0% (95% CI: 80.7%-95.2%; I² = 61.0%; p = .001), with a complete response rate of 51.0% (95% CI: 32.7%-69.2%; I² = 90.0%; p < .001). Good or well-controlled response rates were 50.5% (95% CI: 33.9%-67.1%; I² = 54.2%; p = .068), while poor or partial responses were 20.1% (95% CI: 14.3%-27.3%; I² = 0.0%; p = .787). Relapse rate were 24.3% (95% CI: 8.1%-40.6%; I² = 66.6%; p = .006). The Urticaria Activity Score showed a significant mean reduction in symptoms (SMD = -3.08; 95% CI: -5.45 to -0.71; I² = 89.1%; p < .001). Adverse events occurred in 3.4% of patients, with specific events including urticaria, angioedema, headaches, fatigue, flu-like symptoms, and mild joint pain. In pediatric patients under 12 years, 18 out of 21 achieved complete response, with a median age of 8 years and follow-up durations between 4 and 18 months. Adverse events in this group included serum sickness in one patient. Omalizumab appears to be an effective treatment option for chronic spontaneous urticaria, demonstrating effectiveness in improving symptoms and providing significant relief. The treatment is generally well-tolerated, with adverse events being rare and manageable. Overall, omalizumab contributing to better disease management and quality of life.

Keywords: adolescents; anti‐IgE; biologics; children; kids; omalizumab; pediatric use; urticaria.