Abstract
Objective. Approved by the FDA in 2003, omalizumab is the first recombinant humanized monoclonal anti-immunoglobulin E antibody developed for the treatment of allergic asthma. Due to the heterogeneity of asthma symptoms, investigation of the efficacy of omalizumab in patients outside controlled trials is particularly important. The purpose of the current study was to evaluate the efficacy of omalizumab as an add-on treatment for allergic asthma in a real-life setting in Israel. Methods. This was a retrospective study based on patient records and computerized database for drug dispensing, emergency room visits, and hospital admissions. Results. The sample comprised 33 individuals (18 men, 15 women; mean age 50.0 ± 12.2, range 25–79) who were treated with omalizumab for severe allergic asthma for a duration of at least 16 weeks. After the initiation of omalizumab therapy, the number of patients who used oral or injected corticosteroids decreased (p < .003, .03, respectively), as did the median dosage of oral corticosteroids (p < .02). Visits to the emergency room decreased from an incidence of 0.526 visits per person-year to an incidence of 0.246 per person-year (p < .05). No adverse reactions to omalizumab were observed. Conclusion. Omalizumab as an add-on therapy reduced the use of corticosteroids and improved the control of asthma, as evidenced by reduced asthma-related emergency room visits. This study supports both controlled and uncontrolled studies that have demonstrated the efficacy and safety of omalizumab, and particularly those that demonstrated effectiveness among severe asthma patients. “Real-life” studies are important to identify patients who will most benefit from omalizumab therapy.
Acknowledgments
The author thanks Mrs Paula Herer for the statistical analysis of the data in this study and Mrs Cindy Cohen for editorial support.
Declaration of Interest
The author reports no conflicts of interest. The authors alone are responsible for the content and writing of this article.