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'Real-life' experience in asthmatic children treated with omalizumab up to six-years follow-up
M M Folqué1, J Lozano1, C Riggioni1
1Allergy and Clinical Immunology Department, Hospital Sant Joan de Déu, Barcelona, Spain.
Insights
Long-term use of omalizumab in children with allergic asthma significantly reduced exacerbations and hospitalizations. This real-world study found improved lung function and decreased maintenance therapy, with no reported side effects up to six years.
Area of Science:
- Pediatric Allergy and Immunology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- International guidelines recommend omalizumab for severe asthma.
- Limited long-term data exist for omalizumab's effects in pediatric populations.
- Allergic asthma in children poses significant management challenges.
Purpose of the Study:
- To evaluate the long-term, real-life effectiveness and safety of omalizumab in children with allergic asthma.
- To assess changes in lung function, medication use, and exacerbation rates.
- To provide data on omalizumab's impact in a pediatric cohort over an extended period.
Main Methods:
- An observational, single-center, real-life study design.
- Data collection included treatment details, lung function (FEV1, FEF25-75%), side effects, exacerbations, and hospitalizations.
- Patients were monitored at six-month intervals and annually for up to six years.
Main Results:
- Forty-eight pediatric patients with allergic asthma were enrolled.
- Significant reductions in fluticasone maintenance dose and cessation of oral corticosteroids were observed.
- Hospital admissions and emergency department visits for asthma exacerbations decreased significantly.
- Lung function (FEV1, FEF25-75%) showed statistically significant improvement and remained above normal throughout treatment.
- No adverse side effects were reported during the six-year follow-up.
Conclusions:
- Real-life omalizumab treatment in children with allergic asthma is effective in reducing exacerbations and hospitalizations.
- Omalizumab improves lung function and allows for decreased maintenance therapy in pediatric patients.
- The treatment demonstrates a favorable safety profile for up to six years in children.
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 FEF25-75% 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 FEF25-75% 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.
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