Title : Comparative efficacy of omalizumab and dupilumab in children with Chronic Spontaneous Urticaria (CSU): A retrospective cohort analysis
Abstract:
Background: Chronic spontaneous urticaria (CSU) is a mast cell-driven disease characterized by wheals and/or angioedema persisting more than six weeks. Although well-studied in adults, CSU remains under-studied in pediatric populations. This study aimed to compare the efficacy of omalizumab and dupilumab in children with CSU.
Methods: On August 25, 2025, the TriNetX global research database was queried for patients aged ≤18 years with a diagnosis of CSU (ICD-10: L50.1). Patients treated with omalizumab or dupilumab were identified. Propensity score matching (PSM) was applied to balance baseline characteristics. The primary outcome was the risk of CSU recurrence within ten years, assessed using cohort-level statistics, Kaplan Meier survival analysis, and log-rank testing.
Results: A total of 1,237 patients receiving omalizumab and 211 patients receiving dupilumab were identified. After matching, 195 patients remained in each cohort. Omalizumab was associated with significantly higher odds of recurrent CSU (OR = 7.43, 95% CI: 4.507-12.243). Kaplan-Meier analysis demonstrated superior ten-year CSU-free survival with dupilumab compared to omalizumab (77.32% vs. 18.85%, log-rank p < 0.0001). Patients treated with omalizumab had a 4.7-fold higher hazard of recurrence than those treated with dupilumab.
Conclusions: In pediatric CSU, dupilumab demonstrated significantly lower recurrence rates and improved long-term disease control compared to omalizumab.
