Efficacy and Safety of Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic on H1 Antihistamines: A Randomized, Placebo-Controlled Study
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 H1 antihistamine treatment at licensed doses. Patients aged 12–75 years with CIU/CSU who remained symptomatic despite treatment with approved doses of H1 antihistamines were randomized (1:1:1:1) in a double-blind manner to subcutaneous omalizumab 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. Among randomized patients (N=319: placebo n=80, omalizumab 75 mg n=78, 150 mg n=80, 300 mg n=81), 262 (82.1%) completed the study. Compared with placebo (n=80), mean weekly ISS was reduced from baseline to week 12 by an additional 2.96 points (95% confidence interval (CI): -4.71 to -1.21; P=0.0010), 2.95 points (95% CI: -4.72 to -1.18; P=0.0012), and 5.80 points (95% CI: -7.49 to -4.10; P<0.0001) in the omalizumab 75-mg (n=77), 150-mg (n=80), and 300-mg groups (n=81), respectively. The omalizumab 300-mg group met all nine secondary end points, including a significant decrease in the duration of time to reach minimally important difference response (⩾5-point decrease) in weekly ISS (P<0.0001) and higher percentages of patients with well-controlled symptoms (urticaria activity score over 7 days (UAS7) ⩽6: 51.9% vs. 11.3%; P<0.0001) and complete response (UAS7=0: 35.8% vs. 8.8%; P<0.0001) versus placebo. During the 24-week treatment period, 2 (2.9%), 3 (3.4%), 0, and 4 (5.0%) patients in the omalizumab 75-mg, 150-mg, 300-mg, and placebo groups, respectively, experienced a serious adverse event. Omalizumab 300 mg administered subcutaneously every 4 weeks reduced weekly ISS and other symptom scores versus placebo in CIU/CSU patients who remained symptomatic despite treatment with approved doses of H1 antihistamines.
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SSS has received research support from Astra-Zeneca, Genentech, Inc., the National Institutes of Health, and Novartis, and has served as a consultant to Array, Genentech, Inc., Kendle, Medimmune, Novartis, and Pharmacyclics. SSS also serves as an interest section leader for American Academy of Allergy, Asthma and Immunology, section editor for UpToDate, and section editor for the Journal of Investigative Dermatology. CB-J has received research funding from Genentech, Inc., Meda, MSD, Novartis, Schering-Plough, Shire, Stallergenes, and Termo Fisher and has served as a speaker for Faes Farma, MSD, and Termo Fisher. MM has received research funding from Almirall, Faes Farma, Novartis, MSD, UCB, and Uriach and has served as a speaker and/or advisor for Almirall, Genentech, Inc., Merckle Recordati, Moxie, MSD, Novartis, Sanofi-Aventis, Schering-Plough, UCB, and Uriach. J-JG has received funding and/or honoraria for advisor or speaker functions from Almirall, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Meda, Merck, and Roche. SS has received research funding from Array, Astra-Zeneca, Forest, Genentech, Inc., GlaxoSmithKline, Johnson and Johnson, KaloBios, Merck, Mylan, Novartis, Revalesio, Rigel, Roxane, Sanofi-Aventis, Teva, and Vectura. KR is employed by Genentech, Inc. and receives stock/stock options from Roche. AR is employed by Genentech, Inc. and receives stock/stock options from Roche. MSB is employed by Genentech, Inc. and receives stock options from Roche. JC is employed by and receives stock/stock options from Novartis Pharma. PG is employed by and receives stock/stock options from Novartis Pharma AG. The remaining authors declare no conflict of interest.
