The beneficial effects of Xolair® (Omalizumab) as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available treatment (GINA 2002 step IV - The Israeli arm of the INNOVATE study

Background: Patients with severe persistent asthma despite GINA 2002 step 4 treatment are at risk for asthma-related morbidity and mortality. This study contitutes the Israeli arm of the international INNOVATE study. Objectives: To determine the efficacy and safety of Xolair® as an add-on treatment in patients with severe persistent asthma. Methods: Asthma patients (age 12-75 years) not controlled with high dose inhaled corticosteroids and long-active beta-2 agonists were randomized to receive either Xolair® or placebo for 28 weeks in a double-blind study in two Israeli centers. Results: Thirty-three patients, 20 females and 13 males, mean age 54 ± 11.7 years, were included in the Israeli arm of the INNOVATE study. There were neither major adverse events nor withdrawals from the study. Xolair® (omalizumab) significantly reduced the rate of clinically significant asthma exacerbations (55% reduction) and all asthma-related emergency visits (63% reduction). Conclusions: In patients with severe persistent difficult-to-treat asthma, despite regular treatment with LABA and inhaled corticosteroids (GINA 2002 step 4), Xolair® is a safe and effective treatment.