Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Anergis SA, Epalinges, Switzerland.
J Allergy Clin Immunol. 2016 Jul;138(1):162-8. doi: 10.1016/j.jaci.2016.02.044. Epub 2016 May 6.
An immunotherapy formulation consisting of 3 contiguous overlapping peptides (COPs) derived from Bet v 1, the major birch pollen allergen, showed good clinical tolerability in a previous phase I/IIa clinical trial.
We sought to evaluate the efficacy and safety of allergen-specific immunotherapy using 2 dose regimens of Bet v 1 COPs versus placebo in subjects with birch pollen-induced allergic rhinoconjunctivitis.
A randomized, double-blind, placebo-controlled phase IIb clinical trial was performed to assess the efficacy of Bet v 1 COP immunotherapy during the 2013 birch pollen season. Before the season, Bet v 1 COPs (50 and 100 μg in aluminum hydroxide) or placebo (saline and aluminum hydroxide) were administered as 5 subcutaneous injections to 239 adults with allergic rhinoconjunctivitis to birch pollen. Bet v 1 COPs at 25 or 50 μg were administered on day 1, and 50 or 100 μg was administered on days 8, 15, 29, and 57, respectively. Patients were monitored for adverse events during the treatment period and assessed for combined rhinoconjunctivitis symptom and medication scores, as well as quality of life.
Rhinoconjunctivitis symptom and medication scores improved in both Bet v 1 COP-treated groups, reaching statistical significance over placebo in the 50-μg group (least squares mean, -0.23; 26% improvement; P = .015). Both active groups showed significant improvement in quality of life and nighttime nasal symptom scores, supporting the primary end point findings. Bet v 1 COP injections were well tolerated, with a higher frequency of systemic adverse events in the 100-μg group.
Two months of preseasonal immunotherapy with 3 COPs derived from Bet v 1 at a 50-μg dose showed promising efficacy, small risk for systemic reactions, and immunomodulatory changes in this single-season, dose-finding, phase IIb trial in patients allergic to birch pollen.
一种由 3 个连续重叠肽（COPs）组成的免疫疗法制剂，来源于主要的桦树花粉过敏原 Bet v 1，在之前的 I/IIa 期临床试验中表现出良好的临床耐受性。
我们旨在评估使用两种剂量的 Bet v 1 COPs 与安慰剂在桦树花粉诱发的过敏性鼻炎-结膜炎患者中的变应原特异性免疫治疗的疗效和安全性。
进行了一项随机、双盲、安慰剂对照的 IIb 期临床试验，以评估在 2013 年桦树花粉季节中 Bet v 1 COP 免疫治疗的疗效。在季节开始前，将 Bet v 1 COPs（50 和 100μg 氢氧化铝）或安慰剂（生理盐水和氢氧化铝）以 5 次皮下注射的方式给予 239 名患有桦树花粉过敏的成年人。Bet v 1 COPs 以 25 或 50μg 的剂量在第 1 天给药，以 50 或 100μg 的剂量在第 8、15、29 和 57 天给药。在治疗期间监测患者的不良反应，并评估联合鼻炎-结膜炎症状和药物评分以及生活质量。
在接受 Bet v 1 COP 治疗的两组中，鼻炎-结膜炎症状和药物评分均有所改善，在 50μg 组中达到统计学意义（最小二乘均值，-0.23；26%改善；P=0.015）。两组均显示出生活质量和夜间鼻部症状评分的显著改善，支持了主要终点发现。Bet v 1 COP 注射具有良好的耐受性，100μg 组的全身性不良反应发生率更高。
在这项单季节、剂量发现的 IIb 期试验中，桦树花粉过敏患者在花粉季节前接受 3 个源自 Bet v 1 的 COPs 治疗 2 个月，以 50μg 剂量给药，显示出有前景的疗效、较低的全身性反应风险和免疫调节变化。
