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
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