NEW YORK (Reuters Health) – Adjunctive treatment with omalizumab can help patients with moderate to severe persistent allergic asthma achieve a lasting reduction in the amount of corticosteroids they need, while improving asthma control, according to pooled data from two studies.
Maintaining asthma control while minimizing corticosteroid exposure is an important goal of guideline-based asthma management, the study team notes in the December Annals of Allergy, Asthma and Immunology.
Omalizumab is approved for inadequately controlled allergic (IgE-mediated) asthma in adults and adolescents. The goal of the current analysis was to quantify the reduction in the corticosteroid burden (both inhaled and oral) during long-term treatment with omalizumab and the impact of this reduction on asthma control, lung function and inflammation.
The researchers pooled data from two similarly designed randomized double-blind placebo-controlled studies and their extension phases. In both studies, patients with persistent allergic asthma (1,071 altogether) were randomly assigned to subcutaneous omalizumab every 4 weeks or placebo every 2 to 4 weeks for 52 weeks.
Doses of inhaled corticosteroids (ICS) were kept constant during the initial 16 weeks and then were tapered over the next 12 weeks. During the 24-week extension phase, patients were maintained on their assigned treatment and the lowest possible ICS dose established during the steroid-reduction phase.
By the end of the extension phase, the median reduction from baseline in ICS dose was greater for the omalizumab group than the placebo group (minus 420.0 vs minus 2.52.0 micrograms per day; P < 0.001).
During this time, patients on omalizumab required fewer oral corticosteroid bursts for acute asthma exacerbation (mean, 0.2 vs 0.3; relative risk, 0.56; P < 0.001). They also demonstrated greater improvements in clinical measures of asthma control, including lung function (change from baseline in FEV1), peripheral blood eosinophil counts, and scores on the 32-item Asthma Quality of Life Questionnaire.
In an e-mail to Reuters Health, first author Dr. Jill Karpel, director of the Asthma Center, North Shore Medical Arts LLP in Great Neck, Long Island, and Albert Einstein College of Medicine, Bronx, New York said: “The take home message is that patients with moderate to severe persistent allergic asthma who are experiencing poor asthma control despite treatment with inhaled corticosteroids (and other medications) may benefit from treatment with omalizumab.”
In these patients, “the addition of omalizumab to the asthma regimen improves asthma control and quality of life,” she added.
The analysis was funded in part by Novartis Pharmaceuticals, which markets omalizumab. Several of the authors either work for Novartis or have received financial support from Novartis and other pharmaceutical companies.
Effectiveness of omalizumab in reducing corticosteroid burden in patients with moderate to severe persistent allergic asthma
Ann Allergy Asthma Immunol 2010;105:465-470.