Publications

ASTERIA I was a 40-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy andsafety of subcutaneous omalizumab as add-on therapy for 24 weeks in patients with chronic idiopathicurticaria/spontaneous urticaria (CIU/CSU) who remained symptomatic despite H1antihistamine treatment atlicensed doses. Patients aged 12–75 years with CIU/CSU who remained symptomatic despite treatment withapproved doses of H1antihistamines were randomized (1:1:1:1) in a double-blind manner to subcutaneousomalizumab 75 mg, 150 mg, or 300 mg or placebo every 4 weeks for 24 weeks followed by 16 weeks of follow-up. The primary end point was change from baseline in weekly itch severity score (ISS) at week 12. Amongrandomized patients (N¼319: placebon¼80, omalizumab 75 mgn¼78, 150 mgn¼80, 300 mgn¼81), 262(82.1%) completed the study. Compared with placebo (n¼80), mean weekly ISS was reduced from baseline toweek 12 by an additional 2.96 points (95% confidence interval (CI):4.71 to1.21;P¼0.0010), 2.95 points(95% CI:4.72 to1.18;P¼0.0012), and 5.80 points (95% CI:7.49 to4.10;Po0.0001) in the omalizumab75-mg (n¼77), 150-mg (n¼80), and 300-mg groups (n¼81), respectively. The omalizumab 300-mg group met allnine secondary end points, including a significant decrease in the duration of time to reach minimallyimportant difference response (X5-point decrease) in weekly ISS (Po0.0001) and higher percentages ofpatients with well-controlled symptoms (urticaria activity score over 7 days (UAS7)p6: 51.9% vs. 11.3%;Po0.0001) and complete response (UAS7¼0: 35.8% vs. 8.8%;Po0.0001) versus placebo. During the 24-weektreatment period, 2 (2.9%), 3 (3.4%), 0, and 4 (5.0%) patients in the omalizumab 75-mg, 150-mg, 300-mg, andplacebo groups, respectively, experienced a serious adverse event. Omalizumab 300 mg administeredsubcutaneously every 4 weeks reduced weekly ISS and other symptom scores versus placebo in CIU/CSUpatients who remained symptomatic despite treatment with approved doses of H1antihistamines.