Background: Anti-IgE treatment represents a major breakthrough in the therapeutic management of severe allergic asthma. To date, omalizumab is the only biological drug currently licensed as add-on therapy in children aged ≥ 6 years with moderate-to-severe and severe allergic asthma uncontrolled after treatment with high dose of inhaled corticosteroids plus long-acting inhaled beta2-agonist. The clinical efficacy and safety of omalizumab treatment in the pediatric population has been extensively documented in specific trials and consistently expanded from real-life studies. Our aim is to describe the impact of omalizumab on asthma management, by reporting the results of the first Italian multicenter observational study conducted in children and adolescents with severe allergic asthma.
Methods: The study was a 1-year real-life multicenter survey conducted in 13 pediatric allergy and pulmonology tertiary centers in Italy. All patients with confirmed severe allergic asthma from whom Omalizumab add-on treatment was initiated between 2007 and 2015 were included in the study.
Results: Forty-seven patients with severe allergic asthma were included in the study. A significant reduction in the number of asthma exacerbations was observed during treatment with omalizumab, when compared with the previous year (1.03 vs 7.2 after 6 months (p<0.001) and 0.8 after 12 months (p<0.001), respectively). Hospital admissions were reduced by 96%. At 12 months , forced expiratory volume in 1 s improved and a corticosteroid sparing effect was observed.
No serious adverse events were reported during the follow-up period of 12 months.
Conclusion: The results of the first Italian multicenter observational study confirmed that omalizumab is an effective and safe add-on therapy in uncontrolled severe allergic asthma in children.