Efficacy of Standard‐Dose Omalizumab Against Chronic Urticaria: A Real‐World Study

Background: Omalizumab has been recommended for the treatment of CU. Meanwhile, real‐world data are available on the efficacy and safety of omalizumab in patients with CSU, but there is a relative paucity of data on the use of the drug in the treatment of CIndU and CSU combined with CIndU. Objective: To evaluate the efficacy and safety of omalizumab in Chinese patients with CSU, CholU, SDerm, or both, who had an inadequate response to H1‐antihistamine treatment. Methods: This was an observational, retrospective chart review of patients with CU initiating omalizumab treatment. Results: In total, 78.4% ( n = 80/102) of patients showed a response to omalizumab at the end of the study period, and 36.3% ( n = 37/102) showed a complete response. Among patients with different subtypes, 84.8% ( n = 38/45) of CSU, 37.5% ( n = 3/8) of CholU, 50% ( n = 1/2) of SDerm and 80.9% ( n = 38/47) of CSU + SDerm comorbidity subgroup patients showed a response. The mean of tIgE levels of responders were significantly higher than nonresponders (649.48 ± 814.69 vs. 264.27 ± 262.49 ng/mL, p = 0.004). Patients with isolated CSU exhibited significantly lower relapse rates compared to the CSU + SDerm comorbidity subgroup (42.9% vs. 57.1%, p = 0.042). In total, 12 patients reinitiated omalizumab treatment after a relapse and all of them showed an early response. The mean response time was 1.33 ± 0.65 months. The response mode was similar with their first treatment. Conclusion: Omalizumab is effective in difficult‐to‐treat patients with CSU and CSU + SDerm comorbidity subgroup, but the response rates in patients with isolated CholU or SDerm are unsatisfactory. The mean of tIgE levels of responders were significantly higher than nonresponders at baseline. Patients in the CSU + SDerm comorbidity subgroup demonstrate an elevated risk of relapse. These findings support omalizumab’s role in refractory CSU and comorbid CSU + SDerm, but highlight unmet needs in isolated CIndU subtypes.