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עמוד בית
Sat, 02.03.24

Allergy And Clinical Immunology

IMAJ | volume

Journal 6, June 2007
pages: 472-475

The Beneficial Effects of Xolair® (Omelizumab) 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

    Summary

    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[1] and inhaled corticosteroids (GINA 2002 step 4), Xolair® is a safe and effective treatment



    [1] LABA = long-active beta-2 agonists

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