Omalizumab demonstrates efficacy and safety in Chinese children under 12 with chronic urticaria: a case series

Background: Omalizumab, an anti-IgE antibody, is recommended as a second-line therapy for chronic spontaneous urticaria in patients aged ≥12 years; however, real-world evidence for its use in younger Chinese children remains limited. Therefore, this study aimed to evaluate its clinical efficacy, safety, and associated characteristics of omalizumab in this underserved pediatric population under 12 years of age. Methods: We conducted a retrospective analysis of 13 Chinese children (aged <12 years) with refractory chronic urticaria treated with omalizumab. Effectiveness was assessed by the Urticaria Activity Score over 7 days (UAS7), and safety was evaluated by monitoring adverse events. Results: = 0.001). All 74 administered doses were well tolerated, with no adverse events reported; notably, nearly half of the cohort had comorbid allergic conditions. Conclusion: The rapid symptom control and excellent safety profile observed support omalizumab as an effective and well-tolerated therapeutic option for children under 12 with chronic urticaria.