MIAMI — Omalizumab maintained control of severe allergic asthma and reduced the need for inhaled corticosteroids during 3 years of treatment in an analysis of data from a 52-week open-label extension study.
The findings extend the results of previous studies by showing that asthma control and a favorable safety and tolerability profile were maintained during long-term treatment with the anti-IgE monoclonal antibody, Dr. Jacques Hébert and associates reported in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The study was supported by Genentech Inc. and Novartis Pharmaceuticals Corp., which comarket omalizumab (Xolair). The drug gained federal approval in June 2003 for the treatment of moderate to severe asthma in patients age 12 years and older.
In the core 32-week study of 341 patients, omalizumab significantly reduced the use of inhaled corticosteroids and rescue medications while improving symptom scores and quality of life, compared with placebo. A first extension to this trial showed that these favorable efficacy and safety findings were sustained for a further 96 weeks of treatment.
In a second extension of the trial, researchers enrolled 178 patients, of whom 149 (84%) completed the study. Patients underwent a washout period of 12 weeks or more before receiving omalizumab subcutaneously at a dose of 0.016 mg/kg or more per IU/mL of IgE every 2 weeks or 4 weeks for up to 52 weeks. Mean forced expiratory volume in 1 second (FEV1) showed no decline between the start of the first extension (baseline) and week 52 of the second extension (2.24 L vs. 2.26 L). Good or excellent asthma control, based on the physician's overall assessment, was sustained from baseline to week 52 in 121 of the 149 (81%) patients.
During the same period, inhaled corticosteroid doses decreased about 20% among 96 patients who received the same inhaled corticosteroid throughout the first and second extensions and were not taking oral corticosteroids, reported Dr. Hébert, director of the Centre de Recherche Appliquée en Allergie, Quebec City. He has no financial interest in either of the study's sponsors.
Of the 178 patients who enrolled in the second extension, 134 (75%) had at least one adverse event, generally of mild or moderate severity.