RESUMO
INTRODUCTION: Omalizumab is a humanized monoclonal anti-IgE for the treatment of moderate to severe allergic asthma. Although the treatment has been available for several years, there are some concerns about its safety and efficacy. AIM: To assess the efficacy and safety of Omalizumab in all asthmatic patients who were treated with Omalizumab during at least 3 months in the Pulmonary Department at the Meir Medical Center. METHODS: Retrospective analysis was conducted for all our asthmatic patients. Demographic and clinical characteristics of the patients were recorded from the computerized system of the Clalit Medical Service. Data collected included the degree of severity of the asthma, steroids usage, rate of asthma exacerbations, hospitalizations before and with Omalizumab treatment, as well as the safety profile. RESULTS: Forty seven patients were included in the study; 70% were female; mean age was 61 +/- 12 years. Duration of asthma was 25 +/- 17 years. Asthma exacerbations rate decLined from 70.2% to 38.3% (p=0.007). Pulmonary functions improved from 58 +/- 14% FEV1 to 63 +/- 17% (p=0.002). Forty five percent of the patients had no hospitalizations during the Omalizumab treatment; 25% had one hospitalization, 17% two and 13% had 3 or more hospitalizations. No anaphylaxis or malignancies were observed. No serious adverse events were noticed except for 4 patients with injection site pain. CONCLUSIONS: Data indicates that the high efficacy of add-on Omalizumab in patients with moderate to severe allergic asthma is accompanied by an acceptable safety profile.