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首页> 外文期刊>Allergy >Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy
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Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy

机译：随机对照试验定义了Pollinex Quattro桦木过牙免疫治疗剂量反应的形状

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Abstract Background The Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A ( POLLINEX ? Quattro Plus 1.0 ml Birch 100%) is an effective, well‐tolerated short course subcutaneous immunotherapy. We performed 2 phase II studies to determine its optimal cumulative dose. Methods The studies were conducted in Germany, Austria and Poland (Eudra CT numbers: 2012‐004336‐28 PQB irch203 and 2015‐000984‐15 PQB irch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season. Conjunctival Provocation Tests were performed at screening, baseline and 3‐4 weeks after completing treatment, to quantify the reduction in Total Symptom Scores (as the primary endpoint) with each cumulative dose. Multiple Comparison Procedure and Modeling analysis was used to test for the dose response, shape of the curve and estimation of the median effective dose ( ED 50 ), a measure of potency. Results Statistically significant dose responses ( P .01 & .001) were seen, respectively. The highest cumulative dose in PQB irch204 (27 300 standardized units [ SU ]) approached a plateau. Potency of the PQ Birch was demonstrated by an ED 50 2723 SU , just over half the current dose. Prevalence of treatment‐emergent adverse events was similar for active doses, most being short‐lived and mild. Compliance was over 85% in all groups. Conclusion Increasing the cumulative dose of PQ Birch 5.5‐fold from 5100 to 27 300 SU achieved an absolute point difference from placebo of 1.91, a relative difference 32.3% and an increase in efficacy of 50%, without compromising safety. The cumulative dose response was confirmed to be curvilinear in shape.
机译：摘要背景桦木静脉曲粒剂，酪氨酸吸附剂，单磷虾脂质A（Pollinex？Quattro加上1.0 ml桦木100％）是一种有效的，耐受性的短疗程皮下免疫疗法。我们进行了2期II研究以确定其最佳累积剂量。方法采用各种累积剂量在德国，奥地利和波兰（EUDRA CT编号：2012-004336-28 PQB IRCH203和2015-30984-15 PQB IRCH204）进行了研究。在这两项研究中，受试者在花粉季节外每周施用6种治疗注射。结膜挑衅试验在完成治疗后在筛选，基线和3-4周进行，以通过每种累积剂量量化总症状评分（作为主要终点）的减少。多重比较过程和建模分析用于测试剂量响应，曲线形状和中值有效剂量（ED 50）的估计，效力的衡量标准。结果分别统计显着的剂量反应（P＆ 01＆amp; .001）。 PQB IRCH204中最高的累积剂量（27 300标准化单位[SU]）接近高原。 PQ桦木的效力由ED 50 2723 SU证明，仅在当前剂量超过一半。活性剂量的治疗引发不良事件的患病率类似，最短和轻度。所有群体的合规性超过85％。结论从5100至27倍的PQ桦蛋白的累积剂量增加5.5倍，从安慰剂的安慰剂的绝对点差异为1.91，相对差异32.3％，效果的增加50％，不损害安全性。确认累积剂量反应是曲线形状的。

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