Abstract
Omalizumab was shown to reduce exacerbation rate in moderate to severe allergic asthma.
To evaluate omalizumab efficacy and safety in a real life setting in severe asthmatic children.
104 children (6–18 y), followed-up in paediatric pulmonary tertiary care centres were included at omalizumab onset. Asthma control levels, exacerbations, inhaled corticosteroids (ICS) dose, lung function and adverse events (AEs) were evaluated over one year.
Children were characterized by allergic sensitisation to ≥3 allergens (66%), high IgE levels (mean: 1125 kU·l−1), high rate of exacerbations (4.4/year) and health care use during the previous year, high ICS dose (mean: 703 μg equivalent fluticasone/day). Asthma control levels defined as good, partial or poor, improved from 0%, 18%, and 82% at entry to 53%, 30% and 17% at week 20, and to 67%, 25% and 8% at week 52, respectively (p<0.0001). Exacerbation and hospitalisation rates dropped by 72 and 88.5%. At 12 months, FEV1 improved by 4.9% (p=0.023), and ICS dose decreased by 30% (p<0.001). Six patients stopped omalizumab for related significantAEs.
Omalizumab improved asthma control in children with severe allergic asthma and was generally well tolerated. The observed benefit was greater than that reported in clinical trials.
- ERS