Odajima Hiroshi, Ebisawa Motohiro, Nagakura Toshikazu, Fujisawa Takao, Akasawa Akira, Ito Komei, Doi Satoru, Yamaguchi Koichi, Katsunuma Toshio, Kurihara Kazuyuki, Kondo Naomi, Sugai Kazuko, Nambu Mitsuhiko, Hoshioka Akira, Yoshihara Shigemi, Sato Norio, Seko Noriko, Nishima Sankei
Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan.
Department of Allergy, Clinical Research Center for Allergology and Rheumatology, Sagamihara National Hospital, Kanagawa, Japan.
Allergol Int. 2015 Oct;64(4):364-70. doi: 10.1016/j.alit.2015.05.006. Epub 2015 Jun 10.
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).
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.
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.
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.
奥马珠单抗已在中重度过敏性哮喘儿童中显示出临床益处。然而，尚未在日本哮喘儿童中开展相关研究。本研究的目的是评估奥马珠单抗在日本重度过敏性哮喘儿童中的疗效，包括对游离IgE的抑制作用以及安全性。主要目的是检验奥马珠单抗是否能将血清游离IgE水平降低至低于25 ng/ml（抑制目标水平）。
在一项为期24周的多中心、非对照、开放标签研究中，38名6至15岁的日本儿童，尽管使用了吸入性糖皮质激素（丙酸氟替卡松>200 μg/天或等效药物）且接受了两种或更多种控制治疗，但仍患有未得到控制的重度过敏性哮喘，他们接受了奥马珠单抗的附加治疗。
24周时血清游离IgE水平的几何平均值为15.6 ng/mL。与基线相比，24周时哮喘总症状评分、日常活动评分和夜间睡眠评分均有显著改善。与基线相比，哮喘加重率和因哮喘住院率分别降低了69.2%和78.2%（p<0.001）。生活质量评分也有显著改善（p<0.001）。此外，11名（28.9%）患者减少了任何哮喘控制药物的剂量。36名（94.7%）患者在治疗期间至少经历了一次不良事件。所有不良事件的严重程度均为轻度或中度，未发现新的安全问题。没有患者退出研究。
在日本重度过敏性哮喘儿童中，奥马珠单抗可将游离IgE水平降低至低于25 ng/mL。奥马珠单抗改善了哮喘控制，且耐受性良好。
