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Background: Chronic spontaneous urticaria (CSU) severely impacts quality of life(QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied.

Objective: The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives.

Methods: X-ACT was a phase III, randomized, double-blind study conducted in24 centres (Germany), which selectively included CSU patients with angioedema and wheals. Patients were randomized (1 : 1) to omalizumab 300 mg or placebo(every 4 weeks up to week 24) (ClinicalTrials.gov number: NCT01723072).

Results: Of the 91 patients randomized to omalizumab (n=44) or placebo(n=47) at baseline, 68 completed the 28-week treatment phase (omalizumab, 35;placebo, 33). Omalizumab was superior to placebo in improving CU-Q2oL scoresat week 28 (P<0.001). There was a threefold improvement in angioedema-burdened days/week with omalizumab (0.3) vs placebo (1.1). The median time to firstrecurrence of angioedema was 57–63 days with omalizumab and<5 days withplacebo. Omalizumab significantly improved angioedema-specific QoL(P<0.001). The adverse events reported are in line with the established safety profile of omalizumab.

Conclusion: Omalizumab was an effective treatment option for patients with moderate-to-severe CSU symptoms and angioedema unresponsive to high doses of antihistamine treatment.