ABSTRACT Background Severe acute urticaria with systemic involvement often remains uncontrolled despite systemic corticosteroid therapy, while prolonged high‐dose regimens carry significant safety risks. Objectives This study aimed to evaluate the effectiveness and safety of omalizumab as an adjunctive therapy in patients with refractory acute urticaria. Methods We conducted a single‐centre, retrospective real‐world case–control study of 65 patients with refractory acute urticaria selected from 3006 hospitalised patients with acute urticaria (September 2021–August 2023). Patients aged 12–75 years received either intensified corticosteroids (control group, n = 39) or 300 mg of single‐dose omalizumab as an adjunct treatment to corticosteroids (omalizumab group, n = 26) after ≥ 3 days of prednisone 1 mg (kg day) −1 failure. The primary outcome was postintervention corticosteroid duration. Results After treatment regimen adjustment, the duration of corticosteroid use was 13.00 (11.25, 15.00) days in the omalizumab group and 16.00 (13.00–17.00) days in the corticosteroid group, with a statistically significant difference ( p = 0.035). Further exclusion of covariates with p < 0.05 revealed statistically significant differences in the primary outcome; the omalizumab group had 2.41 (95% CI: −4.44 to −0.37) fewer treatment days ( p = 0.024, < 0.05) compared with controls. Secondary outcomes revealed a 2.41 (95% CI: −4.44 to −0.37)‐day reduction in total prednisone exposure ( p = 0.024), 8.70 (95% CI: −16.70 to −0.71) mg (kg day) −1 lower peak prednisone dosage ( p = 0.037), and cumulative prednisone dosage was reduced by 215.62 (95% CI: −388.51 to −42.73) mg following treatment adjustment ( p = 0.018) in the omalizumab group versus controls. No significant intergroup differences in adverse events, hospitalisation duration, direct medication costs or progression to chronic urticaria were observed. Conclusions These findings suggest that omalizumab may be a safe and effective corticosteroid‐sparing adjunct treatment for patients with refractory acute urticaria.
Zhu et al. (Sun,) studied this question.