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Omalizumab in Japanese children with severe allergic asthma uncontrolled with standard therapy
Hiroshi Odajima1, Motohiro Ebisawa2, Toshikazu Nagakura3
1Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan.
Insights
Omalizumab effectively reduced free IgE levels in Japanese children with severe allergic asthma, achieving target suppression. The treatment significantly improved asthma control and was well-tolerated in this population.
Area of Science:
- Pediatric Allergy and Immunology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Omalizumab is clinically effective for moderate to severe allergic asthma in children.
- No prior studies evaluated omalizumab in Japanese pediatric asthma patients.
- This study aimed to assess omalizumab's efficacy and safety in Japanese children with severe allergic asthma.
Purpose of the Study:
- To evaluate the efficacy of omalizumab in Japanese children with severe allergic asthma.
- To assess the impact of omalizumab on serum free IgE levels, aiming for suppression below 25 ng/mL.
- To determine the safety profile of omalizumab in this patient group.
Main Methods:
- A 24-week, open-label, multicenter study.
- Included 38 Japanese children (6-15 years) with uncontrolled severe allergic asthma.
- Add-on treatment with omalizumab for patients on inhaled corticosteroids and multiple controller therapies.
Main Results:
- Mean serum free IgE levels decreased to 15.6 ng/mL at 24 weeks.
- Significant improvements observed in asthma symptom, daily activity, and nocturnal sleep scores.
- Asthma exacerbations and hospitalizations reduced by 69.2% and 78.2%, respectively.
- Quality of life scores significantly improved; 28.9% of patients reduced controller medication doses.
- 94.7% experienced mild/moderate adverse events; no new safety concerns or discontinuations.
Conclusions:
- Omalizumab successfully reduced free IgE levels below 25 ng/mL in Japanese children with severe allergic asthma.
- The treatment demonstrated significant improvements in asthma control and quality of life.
- Omalizumab was well-tolerated and safe for use in this pediatric population.
Background:
Omalizumab has demonstrated clinical benefits in children with moderate to severe allergic asthma. However, no studies have been performed in Japanese asthmatic children. The aim of this study was to evaluate the efficacy including free IgE suppression and safety of omalizumab in Japanese children with severe allergic asthma. The primary objective was to examine whether omalizumab decreases serum free IgE levels to less than 25 ng/ml (target level of suppression).
Methods:
Thirty-eight Japanese children (6-15 years) with uncontrolled severe allergic asthma despite inhaled corticosteroids (>200 μg/day fluticasone propionate or equivalent) and two or more controller therapies received add-on treatment with omalizumab in a 24-week, multicenter, uncontrolled, open-label study.
Results:
The geometric mean serum free IgE level at 24 weeks was 15.6 ng/mL. Compared with baseline, total asthma symptom scores, daily activity scores and nocturnal sleep scores at 24 weeks were significantly improved. The rates of asthma exacerbation and hospitalization due to asthma were reduced by 69.2% and 78.2%, respectively (p < 0.001), versus baseline. Quality-of-life scores were also significantly improved (p < 0.001). In addition, 11 (28.9%) patients reduced the dose of any asthma controller medications. Thirty-six (94.7%) patients experienced at least one adverse event during the treatment period. All adverse events were mild or moderate in severity and no new safety concerns were detected. No patients discontinued the study.
Conclusions:
In Japanese children with severe allergic asthma, omalizumab decreased free IgE levels to less than 25 ng/mL. Omalizumab improved asthma control and was well-tolerated, as well.
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