The results of a phase III study on a new type of drug for treating asthma were announced this week. The drug is called omalizumab. It is a monoclonal antibody designed to target immunoglobulin E (IgE), an antibody that triggers the allergic reaction in asthma.
The study was reported on August 31 at the European Respiratory Society congress in Florence. It involved 546 patients aged 12-75 who had moderate to severe asthma and were symptomatic despite treatment with inhaled steroids. They received either subcutaneous omalizumab (every two to four weeks) or placebo. For the first 16 weeks, patients continued to use steroids and rescue bronchodilator; for the next 12 weeks, the dose of inhaled steroids was gradually reduced. Patients in the omalizumab group were reported to have a significant reduction in incidence of asthma exacerbations (defined as episodes requiring a doubling of inhaled steroids or initiation of oral or intravenous steroids). In the first phase, 13 per cent of omalizumab patients had exacerbations compared with 30 per cent in the placebo group. In the steroid reduction phase, 16 per cent of omalizumab patients and 30 per cent of placebo patients had exacerbations. The researchers also reported a "clinically meaningful" increase in quality of life meaures in the omalizumab group.
Licence applications for use of omalizumab in asthma and in seasonal allergic rhinitis have been submitted to the regulatory authorities. In the UK, the drug will be marketed, as Xolair, by Novartis.