چکیده (انگلیسی):

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 (6e15 years) with uncontrolled severe allergic asthma despite
inhaled corticosteroids (>200 mg/day fluticasone propionate or equivalent) and two or more controller
therapies received add-on treatment with omalizumab in a 24-week, multicenter, uncontrolled, openlabel
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.