Omalizumab in Japanese children with severe allergic asthma uncontrolled with standard therapy
Hiroshi Odajima, Motohiro Ebisawa, Toshikazu Nagakura, Takao Fujisawa, Akira Akasawa, Komei Ito, Satoru Doi, Koichi Yamaguchi, Toshio Katsunuma, Kazuyuki Kurihara, Naomi Kondo, Kazuko Sugai, Mitsuhiko Nambu, Akira Hoshioka, Shigemi Yoshihara, Norio Sato, Noriko Seko, Sankei Nishima, Hiroshi Odajima, Motohiro Ebisawa, Toshikazu Nagakura, Takao Fujisawa, Akira Akasawa, Komei Ito, Satoru Doi, Koichi Yamaguchi, Toshio Katsunuma, Kazuyuki Kurihara, Naomi Kondo, Kazuko Sugai, Mitsuhiko Nambu, Akira Hoshioka, Shigemi Yoshihara, Norio Sato, Noriko Seko, Sankei Nishima
Abstract
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.
Keywords: Bronchial asthma; Children; Japanese; Omalizumab; Quality of life.
Copyright © 2015 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.
Source: PubMed