Clinical Response to Low-dose Omalizumab Treatment in Chronic Spontaneous Urticaria: A Retrospective Study of 179 Patients

Omalizumab is effective in chronic spontaneous urticaria unresponsive to antihistamines. Of the licensed dosing schedules, Korean patients prefer a low dose, of 150 mg/month, for financial reasons. However, real-world experiences of low-dose omalizumab consumption have not been reported. The aim of this retrospective study was to assess the treatment outcomes and long-term clinical course of patients with chronic spontaneous urticaria who were treated with low-dose omalizumab. The study included 179 patients aged ≥ 20 years who were treated with omalizumab 150 mg/month for ≥ 12 weeks. Baseline disease activity was mild, moderate, and severe in 54.7%, 35.2%, and 10.1% of patients, respectively. A complete response was observed in 133 patients at 12 weeks, among whom 88 patients showed early responses within 4 weeks. Overall, 158 patients finally achieved a complete response. Multivariate analyses revealed that baseline disease activity is more likely to be mild in patients who experience early and final complete responses. The absence of atopic comorbidities correlated with an early response. Smoking was associated with a final complete response. This study shows that low-dose omalizumab provides favourable treatment outcomes in antihistamine-refractory chronic spontaneous urticaria. Disease severity, atopic comorbidity, and smoking may be predictive factors for studying the response to omalizumab. SIGNIFICANCE This retrospective study identified treatment outcomes of low-dose omalizumab in adult patients with chronic spontaneous urticaria in South Korea. A rapid and affirmative response was obtained with low-dose omalizumab. Mild disease activity at baseline, absence of comorbid atopic disease, and current smoking may be predictors of a better response to omalizumab. This study provides important information on the clinical course of patients both during omalizumab treatment and after discontinuation of treatment due to clinical remission and provides evidence for the prescription of low-dose omalizumab for chronic spontaneous urticaria.