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 constitutes 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 (53% 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.