Genentech and Novartis announced the results from a Phase 3 study, ASTERIA II, which showed that omalizumab, met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses.
The study was a global, multicenter, randomized, double-blind, placebo-controlled trial that evaluate the efficacy and safety profile of omalizumab compared with placebo in 323 patients 12–75 years of age with moderate to severe CIU for at least six months who were receiving H1 antihistamine therapy at approved doses. Patients were randomized to omalizumab 75mg, 150mg, or 300mg or placebo, given every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). Patients used an electronic diary to report their daily itch severity (0=none, 1=mild, 2=moderate, and 3=severe), with potential weekly scores ranging from 0–21.
The study met its primary endpoint demonstrating that omalizumab 150mg and 300mg administered every four weeks led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (P=0.001) and 9.8 (P<0.001), respectively, compared to a 5.1 improvement in patients on placebo.
XOLAIR (omalizumab; Genentech and Novartis), for subcutaneous use is an injectable, prescription drug for patients 12 years of age and older with moderate to severe persistent allergic asthma caused by year-round allergens in the air, and are uncontrolled on inhaled corticosteroids.
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