Tanaka Akihiko, Tohda Yuji, Okamiya Kazuhiro, Azuma Ryuji, Terada Ichiro, Adachi Mitsuru
Division of Respiratory Medicine and Allergology, Department of Medicine, School of Medicine, Showa University, Tokyo, Japan.
Department of Respiratory Medicine and Allergology, Kindai University Faculty of Medicine, Osakasayama, Japan.
J Allergy Clin Immunol Pract. 2020 Feb;8(2):710-720.e14. doi: 10.1016/j.jaip.2019.09.002. Epub 2019 Sep 18.
The standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT) tablet has demonstrated efficacy and safety for allergic asthma (AA) in European trials.
To evaluate the efficacy and safety of SQ HDM SLIT tablet treatment for up to 19 months in Japanese adults with AA.
In this randomized, double-blind, placebo-controlled trial, patients aged 18 to 64 years with AA were randomly assigned (1:1:1) to SQ HDM SLIT doses of 10,000 or 20,000 Japanese Allergy Unit or placebo. Subjects had Asthma Control Questionnaire score of 1.0 to 1.5 and daily inhaled corticosteroid use of 200 to 400 μg of fluticasone propionate at randomization. The primary end point was the time from randomization to the first asthma exacerbation as the inhaled corticosteroid dose was being reduced.
Of the 826 randomized subjects, 693 (84%) completed the trial. No statistically significant differences between the active groups and the placebo group were observed for the primary or any other efficacy end points. However, post hoc analysis indicated a significant difference between the 20,000 Japanese Allergy Unit and placebo groups among subjects who used a short-acting β-agonist during the baseline period (hazard ratio, 0.70; 95% CI, 0.48-1.00; P = .04997). No deaths or anaphylactic reactions were reported. Most adverse events were mild to moderate in severity.
The trial demonstrated a favorable safety profile of the SQ HDM SLIT tablet in Japanese adult patients with AA. The treatment appeared to be efficacious in patients requiring rescue medication (ie, short-acting β-agonist) at baseline in the efficacy assessment using asthma exacerbation during inhaled corticosteroid reduction (JapicCTI number 121847).
标准化质量（SQ）屋尘螨（HDM）舌下免疫治疗（SLIT）片剂在欧洲试验中已证明对过敏性哮喘（AA）有效且安全。
评估SQ HDM SLIT片剂治疗日本成年AA患者长达19个月的疗效和安全性。
在这项随机、双盲、安慰剂对照试验中，18至64岁的AA患者被随机分配（1:1:1）至10,000或20,000日本过敏单位的SQ HDM SLIT剂量或安慰剂组。受试者在随机分组时哮喘控制问卷评分为1.0至1.5，每日吸入200至400μg丙酸氟替卡松。主要终点是从随机分组到在减少吸入糖皮质激素剂量时首次哮喘发作的时间。
826名随机受试者中，693名（84%）完成了试验。在主要终点或任何其他疗效终点方面，活性组与安慰剂组之间未观察到统计学显著差异。然而，事后分析表明，在基线期使用短效β受体激动剂的受试者中，20,000日本过敏单位组与安慰剂组之间存在显著差异（风险比，0.70；95%CI，0.48 - 1.00；P = 0.04997）。未报告死亡或过敏反应。大多数不良事件的严重程度为轻度至中度。
该试验证明了SQ HDM SLIT片剂在日本成年AA患者中具有良好的安全性。在使用减少吸入糖皮质激素期间哮喘发作进行疗效评估时，该治疗在基线时需要急救药物（即短效β受体激动剂）的患者中似乎有效（日本药物临床试验编号121847）。
