'Real-life' experience in asthmatic children treated with omalizumab up to six-years follow-up

Abstract

Introduction and objectives: Omalizumab is present in international guidelines for the control of severe asthma, but data on the long-term effects in children are limited. Our objective was to perform a 'real-life' long-term trial of omalizumab in children with allergic asthma.

Materials and methods: An observational single center 'real-life' study was performed. Data for treatment, lung function, side effect, asthma exacerbations and hospitalizations were recorded at six months and annually.

Results: Forty-eight patients <18 years of age were enrolled. Median treatment period was 2.9 (0.5-6). Fluticasone dose for the maintenance treatment decreases significantly at six months (452mcg/day to 329.89mcg/day, respectively). This difference was maintained throughout the follow-up. Nobody used oral corticosteroid after six months. The rate of hospital admissions and visits to the emergency department for asthma exacerbations decreased significantly in the third years and fourth years follow-up, respectively. There was an improvement in lung function. Mean values of FEV₁ and FEF_25-75% before treatment were 79.88 and 62.94, respectively; after six months of treatment a statistically significant change was seen with a mean FEV₁ of 92.29 and FEF_25-75% of 76.31 (p=0.0001). Lung function values were above normal throughout the six years of treatment. No side effects were reported.

Conclusions: Overall in 'real life' omalizumab in children reduces asthma exacerbations and hospitalizations, improves lung function, and decreases the maintenance therapy. It is shown to be safe for up to six years of treatment in children.

Keywords: Omalizumab; Pediatric asthma; ‘Real-life’.