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Addition of Omalizumab to Corticosteroid Therapy Significantly Reduces Allergic Asthma Exacerbations in Children: Presented at ATS By Cathy Yarbrough SAN DIEGO -- May 22, 2009 -- Add-on omalizumab (OMA) reduced the rate of clinically significant asthma exacerbations in children whose allergic (immunoglobulin E-mediated) asthma was inadequately controlled by inhaled corticosteroids (ICS), said researchers here on May 18 at the International Conference of the American Thoracic Society (ATS). During the 52-week treatment period, OMA-treated patients showed a 43% decrease in the rate of clinically significant asthma exacerbations compared with placebo-treated patients (0.78 vs 1.36). The exacerbation reduction reported in this trial is consistent with the rates reported for adolescents and adults, according to Henry Milgrom, MD, National Jewish Medical and Research Center, Denver, Colorado. A total of 576 children aged 6 to 12 years were enrolled in the randomised, double-blind, placebo-controlled, phase 3 study. Despite using fluticasone 200 g/day or equivalent, with or without other controller medications, the children had perennial allergen sensitivity and inadequately controlled moderate to severe asthma. Patients were randomised to OMA 75-375 mg (n = 384) or a placebo (n = 192) administered subcutaneously every 2 or 4 weeks for 52 weeks, which included a 24-week fixed steroid phase, followed by a 28-week adjustable steroid phase. The mean baseline ICS dose was fluticasone 515 g/day. The researchers analysed the rate of clinically significant asthma exacerbations -- which was defined as symptoms requiring doubling the baseline ICS dose and/or systemic steroids -- for 3 days over 24 and 52 weeks. Addition of OMA was found to reduce the exacerbation rate per treatment period by 31% over the 24-week phase (0.45 vs 0.64; relative risk [RR], 0.69; 95% confidence interval [CI], 0.53-0.90; P = .007) and by 43% at 52 weeks (0.78 vs 1.36; RR, 0.57; 95% CI, 0.45-0.73; P < .001) compared with the placebo group. Funding for this study was provided by Novartis Pharmaceuticals Corporation. [Presentation Title: Add-on Omalizumab Significantly Reduces Exacerbation Rates in Children With Inadequately Controlled Moderate to Severe Allergic (IgE-Mediated) Asthma. Poster J35] E-mail this page to a friend or colleague! To print, use this version