Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis
Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis
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DOI：
10.1016/j.jaci.2013.11.012
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发表时间：
2014-06-01
影响因子：
14.2
通讯作者：
Zeldin, Robert K.
中科院分区：
文献类型：
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作者：
Bergmann, Karl-Christian;Demoly, Pascal;Zeldin, Robert K.
背景资料：初步研究表明，舌下片的屋尘螨（HDM）提取物在成人过敏性鼻炎的疗效。目的：我们试图评估2剂量的HDM舌下片在1个治疗年和随后的免疫治疗年的疗效和安全性。方法：在一项双盲、安慰剂对照研究中，将患有HDM相关过敏性鼻炎的成年人随机接受500片反应指数（IR）片剂，300 IR片剂或安慰剂每日给药一次，持续1年，并在随后的一年进行随访。主要疗效变量为第1年主要阶段（即10月1日至12月31日）的平均校正症状评分。症状和补救药物评分、起效时间、患者报告的结局和安全性是次要变量。在无免疫治疗的一年中评估了相同的终点。主要疗效终点进行了分析，采用协方差analysis of covariance.Results：509名参与者被随机分组，427人继续在免免疫治疗的一年。与安慰剂相比，500 IR和300 IR HDM舌下片剂均显著降低了平均校正症状评分，分别为-20.2%（P = .0066）和-17.9%（P = .0150）。在无治疗随访期内，两种剂量的疗效均得以维持。4个月时起效。与安慰剂组相比，500 IR和300 IR组参与者对治疗成功的总体评价显著更高（分别为P = .0206和P = .0001）。不良事件通常为给药部位反应。没有过敏反应的报告。结论：12个月的治疗与500 IR和300 IR舌下片的HDM过敏原提取物是有效的，耐受性良好。在无治疗随访年期间维持疗效。
Background: Preliminary studies have suggested the efficacy of sublingual tablets of house dust mite (HDM) extracts in adults with allergic rhinitis.Objectives: We sought to assess the efficacy and safety of 2 doses of HDM sublingual tablets over 1 treatment year and the subsequent immunotherapy-free year.Methods: Adults with HDM-associated allergic rhinitis were randomized in a double-blind, placebo-controlled study to receive 500 index of reactivity (IR) tablets, 300IR tablets, or placebo administered once daily for 1 year and were followed for the subsequent year. The primary efficacy variable was the Average Adjusted Symptom Score over the year 1 primary period (ie, October 1 to December 31). Symptoms and rescue medication scores, onset of action, patient-reported outcomes, and safety were secondary variables. The same end points were evaluated during the immunotherapy-free year. The primary efficacy end point was analyzed by using analysis of covariance.Results: Five hundred nine participants were randomized, and 427 continued in the immunotherapy-free year. Both the 500IR and 300IR HDM sublingual tablets significantly reduced mean Average Adjusted Symptom Scores compared with placebo by -20.2% (P = .0066) and -17.9% (P = .0150), respectively. Efficacy of both doses was maintained during the treatment-free follow-up phase. The onset of action was at 4 months. Participants' global evaluation of treatment success was significantly higher in the 500IR and 300IR groups compared with the placebo group (P = .0206 and P = .0001, respectively). Adverse events were generally application-site reactions. There were no reports of anaphylaxis.Conclusions: Twelve months of treatment with 500IR and 300IR sublingual tablets of HDM allergen extracts was efficacious and well tolerated. Efficacy was maintained during the treatment-free follow-up year.