Italian real-life experience of omalizumab

Omalizumab is a humanized murine monoclonal antibody directed toward a portion of the IgE indicated in Europe for the treatment of severe persistent allergic asthma, inadequately controlled despite high-dose of ICS (mean BDP equivalent dose of inhaled corticosteroid 2224.68 μg/die) in association with long acting ß2 agonists. Our aim was to describe the experience, efficacy and safety in a cohort of Italian patients treated with omalizumab in a real-life clinical setting. One hundred and forty two patients from 13 italian Centers were observed and analysed. The dosage of omalizumab was estabilished according to the labelling indication, with a median dose of IgE of 297.38 IU/ml or KU/l. During the previous year, all patients experienced frequent exacerbations (mean = 4.87), emergency visits (mean = 4.45) and hospitalisation (mean = 1.53). Following treatment with omalizumab, the annual rate of exacerbations, emergency visits and hospitalization decreased by 79%, 88% and 95%, respectively. The proportion of patients without exacerbation, not needing emergency visits and hospitalization increased by 610%, 154% and 28%, respectively. The response of omalizumab measured with the GETE (global evaluation of treatment effectiveness) scale rated as good to excellent in 77% of patients. Overall, 9.6% (n= 9) of the patients experienced one single adverse effect. Only one patient reported a serious adverse event (local reaction at the site of injection) leading to interruption of treatment. The observed reduction of asthma-related events in particulary poorly controlled patients in this Italian real-life setting is consistent with the results of other observational studies.