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Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey
Antoine Deschildre1, Christophe Marguet, Julia Salleron
1Pôle Enfant, Clinique de Pédiatrie Jeanne de Flandre, CHRU de Lille, Université Nord de France, Lille.
Insights
Omalizumab significantly improved asthma control and reduced exacerbations in severe allergic pediatric asthma patients in a real-world setting. This biologic therapy demonstrated greater benefits than previously reported in clinical trials.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Pharmacology
Background:
- Severe allergic asthma in children poses significant challenges to control and quality of life.
- Omalizumab is an established biologic therapy for moderate to severe allergic asthma, but real-world data in pediatric populations are limited.
Purpose of the Study:
- To evaluate the efficacy and safety of omalizumab in children with severe allergic asthma in a real-life clinical setting.
- To assess changes in asthma control, exacerbation rates, medication use, and lung function over one year of treatment.
Main Methods:
- A prospective study included 104 children (6-18 years) with severe allergic asthma initiating omalizumab treatment.
- Data collected over 1 year included asthma control levels, exacerbation frequency, inhaled corticosteroid dosage, lung function (FEV1), and adverse events.
Main Results:
- Asthma control significantly improved, with good control rising from 0% to 67% by week 52 (p<0.0001).
- Exacerbation and hospitalization rates decreased by 72% and 88.5%, respectively.
- Forced expiratory volume in 1s (FEV1) improved by 4.9% (p=0.023), and inhaled corticosteroid dose reduced by 30% (p<0.001).
Conclusions:
- Omalizumab demonstrated significant improvements in asthma control and reduced exacerbations in children with severe allergic asthma in a real-world setting.
- The observed benefits in this pediatric cohort exceeded those reported in clinical trials, highlighting its effectiveness.
- Omalizumab was generally well-tolerated, although six patients discontinued treatment due to significant adverse events.
Abstract:
Omalizumab has been shown to reduce exacerbation rates in moderate to severe allergic asthma. Our aim was to evaluate omalizumab efficacy and safety in a real-life setting in severe asthmatic children. 104 children (aged 6-18 years), followed up in paediatric pulmonary tertiary care centres, were included at the beginning of omalizumab treatment. Asthma control levels, exacerbations, inhaled corticosteroid dose, lung function and adverse events were evaluated over 1 year. Children were characterised by allergic sensitisation to three or more allergens (66%), high IgE levels (mean 1125 kU · L(-1)), high rate of exacerbations (4.4 per year) and healthcare use during the previous year, and high inhaled corticosteroid dose (mean 703 μg equivalent fluticasone per 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%, respectively. At 12 months, forced expiratory volume in 1 s improved by 4.9% (p=0.023), and inhaled corticosteroid dose decreased by 30% (p<0.001). Six patients stopped omalizumab for related significant adverse events. 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.
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