Matsuoka Tomokazu, Bernstein David I, Masuyama Keisuke, Nolte Hendrik, Okamiya Kazuhiro, Seitzberg Dorthe, Nelson Harold S
Department of Otorhinolaryngology, Head & Neck Surgery, Faculty of Medicine, Graduate Faculty of Interdisciplinary Research, University of Yamanashi, Yamanashi, Japan.
Bernstein Clinical Research Center and Division of Allergy and Immunology, University of Cincinnati, Cincinnati, OH, USA.
Pediatr Allergy Immunol. 2017 Nov;28(7):661-667. doi: 10.1111/pai.12747. Epub 2017 Aug 31.
House dust mite (HDM) respiratory allergy is a common and burdensome disease in children and adolescents. There are few HDM allergy immunotherapy trials in children with perennial allergic rhinitis. This post hoc analysis used pooled data to evaluate efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT) tablet in adolescents (12-17 years).
In two double-blind, placebo-controlled trials conducted in North America and Japan, respectively, subjects aged 12+ years with HDM allergic rhinitis were randomized to up to 1 year of treatment. The primary end-point in both trials was the average total combined rhinitis score (TCRS) during the last 8 weeks of treatment in the active group compared with placebo. Data from subjects aged 12-17 years were pooled (N=395).
In the pooled adolescent subpopulation, average TCRS improved 22% with 12 SQ HDM vs placebo (absolute treatment difference of 1.04; P<.01). Rhinitis daily symptom score (DSS), conjunctivitis DSS and rhinitis daily medication score (DMS) were also significantly improved vs placebo in the pooled adolescent subpopulation (all P<.05). There were no new safety signals for adolescents. The frequency of adverse events was similar in adolescents and adults with the majority being mild application site-related events.
Treatment with 12 SQ HDM appears to be effective and well tolerated in adolescents with HDM allergic rhinitis.
屋尘螨（HDM）引起的呼吸道过敏在儿童和青少年中是一种常见且负担沉重的疾病。针对常年性变应性鼻炎儿童进行的HDM过敏免疫疗法试验较少。这项事后分析使用汇总数据来评估SQ HDM舌下免疫疗法（SLIT）片剂在青少年（12至17岁）中的疗效和安全性。
在分别于北美和日本进行的两项双盲、安慰剂对照试验中，将12岁及以上患有HDM变应性鼻炎的受试者随机分组，接受长达1年的治疗。两项试验的主要终点均为活性组与安慰剂组相比，在治疗的最后8周内的平均总鼻炎综合评分（TCRS）。汇总了12至17岁受试者的数据（N = 395）。
在汇总的青少年亚组中，与安慰剂相比，12 SQ HDM治疗使平均TCRS改善了22%（绝对治疗差异为1.04；P <.01）。在汇总的青少年亚组中，鼻炎每日症状评分（DSS）、结膜炎DSS和鼻炎每日用药评分（DMS）与安慰剂相比也有显著改善（均P <.05）。青少年没有新的安全信号。青少年和成人不良事件的发生率相似，大多数为轻度的与用药部位相关的事件。
12 SQ HDM治疗似乎对患有HDM变应性鼻炎的青少年有效且耐受性良好。
