Departments of Medicine and Biomedical & Molecular Science, Queen's University, Kingston, Ontario, Canada; Allergy Research Unit, Kingston General Hospital, Kingston, Ontario, Canada.
Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
J Allergy Clin Immunol. 2017 Aug;140(2):486-496. doi: 10.1016/j.jaci.2016.11.043. Epub 2017 Feb 21.
Synthetic peptide immunoregulatory epitopes are a new class of immunotherapy to treat allergic rhinoconjunctivitis (ARC). Grass allergen peptides, comprising 7 synthetic T-cell epitopes derived from Cyn d 1, Lol p 5, Dac g 5, Hol l 5, and Phl p 5, is investigated for treatment of grass pollen-induced ARC.
We sought to evaluate the efficacy, safety, and tolerability of intradermally administered grass allergen peptides.
A multicenter, randomized, double-blind, placebo-controlled study evaluated 3 regimens of grass allergen peptides versus placebo in patients with grass pollen-induced allergy (18-65 years). After a 4-day baseline challenge to rye grass in the environmental exposure unit (EEU), subjects were randomized to receive grass allergen peptides at 6 nmol at 2-week intervals for a total of 8 doses (8x6Q2W), grass allergen peptides at 12 nmol at 4-week intervals for a total of 4 doses (4x12Q4W), or grass allergen peptides at 12 nmol at 2-week intervals for a total of 8 doses (8x12Q2W) or placebo and treated before the grass pollen season. The primary efficacy end point was change from baseline in total rhinoconjunctivitis symptom score across days 2 to 4 of a 4-day posttreatment challenge (PTC) in the EEU after the grass pollen season. Secondary efficacy end points and safety were also assessed.
Two hundred eighty-two subjects were randomized. Significantly greater improvement (reduction of total rhinoconjunctivitis symptom score from baseline to PTC) occurred across days 2 to 4 with grass allergen peptide 8x6Q2W versus placebo (-5.4 vs -3.8, respectively; P = .0346). Greater improvement at PTC also occurred for grass allergen peptide 8x6Q2W versus placebo (P = .0403) in patients with more symptomatic ARC. No safety signals were detected.
Grass allergen peptide 8x6Q2W significantly improved ARC symptoms after rye grass allergen challenge in an EEU with an acceptable safety profile.
合成肽免疫调节表位是一种治疗过敏性鼻结膜炎（ARC）的新型免疫疗法。草过敏原肽由来自 Cyn d 1、Lol p 5、Dac g 5、Hol l 5 和 Phl p 5 的 7 个合成 T 细胞表位组成，用于治疗草花粉引起的 ARC。
评估皮内给予草过敏原肽的疗效、安全性和耐受性。
一项多中心、随机、双盲、安慰剂对照研究评估了草过敏原肽 3 种方案与安慰剂在草花粉过敏患者（18-65 岁）中的疗效。在环境暴露单元（EEU）中进行了为期 4 天的黑麦草基础挑战后，受试者被随机分为接受 6nmol 的草过敏原肽，每 2 周 1 次，共 8 剂（8x6Q2W）；每 4 周 12nmol 的草过敏原肽，共 4 剂（4x12Q4W）；或每 2 周 12nmol 的草过敏原肽，共 8 剂（8x12Q2W）或安慰剂，并在草花粉季节前进行治疗。主要疗效终点是草花粉季后 EEU 中为期 4 天的治疗后挑战（PTC）期间第 2 至 4 天总鼻结膜炎症状评分的变化。还评估了次要疗效终点和安全性。
282 名受试者被随机分组。与安慰剂相比，草过敏原肽 8x6Q2W 在第 2 至 4 天的总鼻结膜炎症状评分从基线到 PTC 的改善（从基线到 PTC 的总鼻结膜炎症状评分的降低）更为显著（分别为-5.4 与-3.8，P=.0346）。在 EEU 中，与安慰剂相比，草过敏原肽 8x6Q2W 也在 ARC 症状更严重的患者中在 PTC 时出现了更大的改善（P=.0403）。未发现安全性信号。
在 EEU 中，草过敏原肽 8x6Q2W 可显著改善黑麦草过敏原挑战后的 ARC 症状，安全性良好。
