The asthma medication omalizumab helps to calm chronic urticaria in patients who had failed standard therapy, according to results of a phase 3 study.
The asthma medication omalizumab helps to calm chronic urticaria in patients who fail to respond to standard therapy, according to results of a phase 3 study.
Investigators with Creighton University, Omaha, Neb., conducted the multicenter, randomized, double-blind study, which included 323 patients with moderate-to-severe chronic idiopathic urticaria, according to the study abstract.
The patients were randomized to receive three subcutaneous injections of 75 mg of omalizumab four weeks apart, or 150 mg, 300 mg or placebo. Researchers followed up with patients for 16 weeks.
The primary efficacy outcome was the change from baseline in a weekly itch severity score, ranging from 0 to 21, with higher scores indicating more severe itching. Patients receiving 75 mg demonstrated a mean change from baseline in the itch severity score of -5.9± (P=0.46), those receiving 150 mg had a mean score of -8.1±6.4 (P=0.001) and those receiving 300 mg had a mean score of -9.8±6.0 (P<0.001). Patients receiving placebo had a mean score of -5.1±5.6.
“Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H1-antihistamines,” study authors concluded.
The phase 3 study results were presented at the American Academy of Allergy, Asthma & Immunology annual meeting in San Antonio and were published online in the New England Journal of Medicine, PR Newswire reports.
Genentech and Novartis Pharma, manufacturers of the omalizumab drug Xolair, funded the study.