This systematic review and meta-analysis evaluated long-term drug survival of omalizumab in chronic urticaria (CU) and identified factors associated with discontinuation, pooling data from 8 observational studies (n=4,516) with up to 7 years of follow-up.
Median omalizumab drug survival was 3.1 years (95% CI, 2.8–3.4); mean treatment duration over 7 years was 3.75 years. Discontinuation was more often due to disease control than adverse events. Autoimmune comorbidity (mainly thyroid-related) doubled the risk of discontinuation due to lack of efficacy (HR 2.03; 95% CI, 1.20–3.41). Chronic inducible urticaria showed higher 7-year survival (43–49%) vs. chronic spontaneous urticaria alone (30%).
All included studies were observational, limiting causal inference. Individual patient-level data were reconstructed from Kaplan-Meier curves rather than sourced directly, introducing potential reconstruction error. The analysis was limited to 8 studies, and heterogeneity in study populations and follow-up durations may affect pooled estimates.
Patients with autoimmune comorbidities (especially thyroid disease) are at higher risk of omalizumab failure in CU — consider closer monitoring and earlier reassessment in this group. Atopic patients who discontinue are more likely doing so due to disease control, suggesting a watch-and-wait approach may be appropriate after remission.
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