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Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy

CORRESPONDENCE: R. Buhl, Pulmonary Dept, Mainz University Hospital, Langenbeckstrasse 1, D – 55131 Mainz, Germany. Fax: 49 6131175545. E-mail: r.buhl{at}3-med.klinik.uni-mainz.de

The efficacy of omalizumab has been extensively investigated in clinical trials in patients with severe persistent allergic (pre-treatment total immunoglobulin E 30–700 IU·mL^–1) asthma including the Investigation of Omalizumab in Severe Asthma Treatment (INNOVATE) study, which enrolled patients with inadequately controlled severe persistent allergic asthma despite receiving high-dose inhaled corticosteroid in combination with a long-acting ß₂-agonist, and also additional controller medication if required.

In the INNOVATE study, add-on omalizumab significantly reduced clinically significant exacerbation rates by 26% (0.68 versus 0.91), severe exacerbation rates by 50% (0.24 versus 0.48) and emergency visit rates by 44% (0.24 versus 0.43) and significantly improved asthma-related quality of life (QoL) compared with placebo. In a pooled analysis of data from seven studies, add-on omalizumab significantly reduced asthma exacerbation rates by 38% (0.91 versus 1.47) and total emergency visits by 47% (0.332 versus 0.623). In addition, omalizumab significantly improved QoL versus current asthma therapy in a pooled analysis of data from six studies.

Omalizumab has demonstrated a good safety and tolerability profile in completed phase-I, -II and -III studies involving >7,500 patients with asthma, rhinitis or related conditions. Omalizumab represents a major advance for the treatment of severe persistent allergic asthma that is inadequately controlled despite treatment with inhaled corticosteroids and a long-acting ß₂-agonist.

KEYWORDS: Allergy, anti-immunoglobulin E, asthma, exacerbation, omalizumab, therapy