Methods: Subjects (n=323) were randomized 1:1:1:1 to receive placebo or omaliziumab 75, 150 or 300 mg at Baseline and Weeks 4 and 8. Angioedema and angioedema management were assessed via the Urticaria Patient Daily Diary. We summarized the percent of patients with angioedema, the mean number of days with angioedema, and how patients managed angioedema (response categories: did nothing; took medication; contacted health care provider; visited health care provider; went to the hospital emergency room; was hospitalized).
Results: During the week prior to Baseline, angioedema was a prevalent symptom with 37.8% to 46.3% of patients reporting it; for those with angioedema, they reported having it for approximately half of the days during that week (3.4 to 3.7 days). During the last week of the 12-week treatment period, fewer patients reported angioedema across all treatment arms (6.8% to 28.4%) and had it for fewer days during that week (1.8 to 2.5 days); however, the reduction in patient-reported angioedema was higher in omalizumab treated patients. Angioedema management at Baseline and throughout the course of the treatment period generally consisted of low intensity interventions, if any: most patients reported doing nothing or taking medication, and few patients reported having called or visited their health care provider; none reported visiting the hospital emergency room nor being hospitalized.
Conclusions: Omalizumab was efficacious in reducing patient-reported angioedema in CIU/CSU patients who were symptomatic despite H1 antihistamine treatment.