Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience

Abstract Background Omalizumab is a recombinant humanized anti-IgE monoclonal antibody indicated as an add-on treatment for severe allergic asthma, inadequately controlled despite high dose of inhaled corticosteroids (ICS) and long-acting b2-agonists. Objectives Medical registries were used to evaluate the 4 months, 1 and 4 years effectiveness of omalizumab treatment, in a non-interventional, observational “real-life” study. Methods Sixty patients with severe persistent allergic asthma from 5 South-Eastern Mediterranean centres from Crete and Cyprus were evaluated. Effectiveness outcomes included spirometry, severe asthma exacerbations rate, level of asthma control (ACT), and additional asthma medication (inhaled steroids). Results Outcome variables improved after 4 months and sustained after 1 and 4 years treatment with Omalizumab. FEV1 improved statistically significant at all time points versus baseline [ΔFEV1 (% pred.) = +21 p  = 0.008 at 4 months, ΔFEV1 (% pred.) = +24.5 p p  = 0.002 at 4 months, ΔFVC (% pred.) = +22.6 p  = 0.0002 at 4 years]. The level of asthma control as evaluated by ACT was significantly improved after treatment (+12% p  = 0.001 at 4 months, +24% p p  = 0.0002 at 1 year, and −70% p p  = 0.017), 1 year ( p  = 0.029) and 4 years ( p  = 0.014) of omalizumab treatment. Conclusions This long-term “real-life” study demonstrated significant improvement in lung function and other clinical outcomes after omalizumab treatment, evident at 4 months, and sustained after 1 and 4 years suggesting its efficacy in severe allergic asthma, in the “real-life” practice.