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Background  Approximately 50% of patients with chronic idiopathic/spontaneous urticaria ( CIU / CSU ) report hives and angioedema; some experience hives/angioedema only.    Objective  Assess omalizumab's effect on angioedema and quality of life (QoL) in subgroups with refractory  CIU / CSU : those with and without angioedema.    Methods  Patients received omalizumab (75, 150 or 300 mg) or placebo every 4 weeks for 12/24 weeks. Angioedema and QoL were assessed [Urticaria Patient Daily Diary and Dermatology Quality of Life Index ( DLQI )]. Subgroups were based on the presence/absence of baseline angioedema 7 days prior to randomization.    Results  Patients with baseline angioedema randomized to omalizumab 300 mg had a greater reduction in mean weekly incidence of angioedema and mean number of days/week with angioedema vs. placebo at 12 and 24 weeks. A 3.3‐ to 4.5‐point greater mean reduction in  DLQI  score was achieved with omalizumab 300 mg treatment vs. placebo, above the minimal clinically important difference threshold. Results with lower doses vs. placebo were variable.    Conclusion  Compared with placebo, omalizumab 300 mg treatment over 12–24 weeks resulted in marked reduction in incidence and number of days/week with angioedema accompanied by clinically relevant improvement in QoL.

journal of the european academy of dermatology and venereology

Positive impact of omalizumab on angioedema and quality of life in patients with refractory chronic idiopathic/spontaneous urticaria: analyses according to the presence or absence of angioedema