Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study.

摘要: ASTERIA I was a 40-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous omalizumab as add-on therapy for 24 weeks in patients with chronic idiopathic urticaria/spontaneous urticaria (CIU/CSU) who remained symptomatic despite H 1 antihistamine treatment at licensed doses. Patients aged 12–75 years CIU/CSU approved doses antihistamines were randomized (1:1:1:1) double-blind manner 75 mg, 150 mg, or 300 mg placebo every 4 followed by 16 follow-up. The primary end point change from baseline weekly itch severity score (ISS) week 12. Among ( N =319: n =80, 75 mg =78, 150 mg =81), 262 (82.1%) completed study. Compared =80), mean ISS reduced 12 an additional 2.96 points (95% confidence interval (CI): -4.71 -1.21; P =0.0010), 2.95 CI: -4.72 -1.18; =0.0012), 5.80 -7.49 -4.10; =77), 150-mg 300-mg groups respectively. group met all nine secondary points, including significant decrease duration time reach minimally important difference response (⩾5-point decrease) antihistamines.