FRIDAY, May 6 (HealthDay News) -- Omalizumab appears to provide additional clinical benefits in patients with severe allergic asthma that is inadequately controlled with inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABAs), according to a study published in the May 3 issue of the Annals of Internal Medicine.
Nicola A. Hanania, M.D., of the Baylor College of Medicine in Houston, and colleagues randomized 850 patients, aged 12 to 75 years, who had inadequately controlled asthma despite treatment with high-dose ICS and LABAs, with or without another controller, to the addition of omalizumab or placebo for 48 weeks.
The investigators found that the rate of protocol-defined asthma exacerbations was significantly lower for omalizumab (0.66 per patient) versus placebo (0.88). Compared with placebo, omalizumab also improved mean Asthma Quality of Life Questionnaire scores, reduced mean daily albuterol puffs, and decreased mean asthma symptom scores. Both adverse events and serious adverse events were similar in the omalizumab and placebo groups.
"In conclusion, this study demonstrated that omalizumab conferred clinically meaningful efficacy when added to high-dose ICS and LABA therapy in patients with severe allergic asthma that is inadequately controlled," the authors write. "This study also indicated that omalizumab was not associated with an increased rate of common adverse events compared with placebo."
The study was funded by Genentech and Novartis Pharmaceuticals.
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