Drug Survival of Omalizumab and Factors Associated With Discontinuation in Chronic Urticaria

Importance Omalizumab is a recommended second-line therapy for chronic urticaria (CU), yet clinical evidence regarding long-term drug survival and determinants of discontinuation remains limited. Understanding drug survival patterns may inform clinical decision-making and patient stratification. Objective To evaluate the long-term drug survival of omalizumab in patients with CU and identify factors associated with discontinuation. Data Sources PubMed, Embase, and Web of Science were systematically searched from database inception to January 20, 2026. Study Selection Observational clinical studies that reported on time to discontinuation or drug survival outcomes for omalizumab in patients with CU were included. Studies lacking survival data or sufficient information for reconstruction of survival curves were excluded. Data Extraction and Synthesis Time-to-event data were reconstructed from published Kaplan-Meier curves using a validated algorithm implemented in the IPDfromKM framework. Pooled hazard ratios (HRs) were synthesized using a random-effects meta-analysis. Analyses followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Main Outcomes and Measures Primary outcomes included overall drug survival and reasons for discontinuation. Secondary outcomes included predictors of discontinuation, expressed as HRs with 95% CIs. Results Eight studies comprising 4516 patients with CU (3167 female individuals [70.1%]; 3276 with chronic spontaneous urticaria [CSU]) were included. The median drug survival for omalizumab was 3.1 years (95% CI, 2.8-3.4). Over a 7-year follow-up period, patients continued to receive treatment for a mean of 3.75 years (95% CI, 3.62-3.87). Long-term drug survival appeared higher in chronic inducible urticaria (with or without concomitant CSU) than in CSU alone (7-year survival, 43%-49% vs 30%). Early discontinuation was primarily due to well-controlled disease. Discontinuation due to adverse events was uncommon. Autoimmune comorbidity was associated with a higher risk of discontinuation due to lack of efficacy (HR, 2.03; 95% CI, 1.20-3.41), while an atopic background was associated with an increased risk of discontinuation due to well-controlled disease. Conclusions and Relevance The results of this systematic review and meta-analysis suggest that omalizumab demonstrates long-term drug survival in CU, with discontinuation more often due to disease control than adverse events. Autoimmune comorbidities (mainly thyroid-related) were associated with reduced drug survival, primarily due to lack of efficacy, whereas atopic comorbidities were associated with discontinuation after disease control, underscoring the need for improved endotype-driven treatment strategies.