在复发性多发性硬化症患者中,GA Depot是一种长效的格拉蒂拉默酸盐与安慰剂:一个随机的第三期临床试验
Aaron Miller1, Jeffrey A Cohen2, Arnon Karni3
1Icahn School of Medicine at Mount Sinai, New York, NY, USA.
在复发性多发性硬化症 (RMS) 患者中,GA Depot显著减少了复发和MRI病变. 这种新的glatiramer酸盐配方提供了有利的安全性,注射频率较低.
科学领域:
- 神经学 神经学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 格拉蒂拉默酸 (GA) 仓库是一种新的,长效的GA配方.
- 与现有的GA治疗相比,设计用于延长剂量间隔.
- 旨在提高多发性硬化症患者的坚持和治疗方便性.
研究的目的:
- 为了评估GA Depot的疗效,安全性和耐受性.
- 与被诊断患有复发性多发性硬化症 (RMS) 的患者的安慰剂进行比较.
主要方法:
- 一个52周的,多中心,双盲,安慰剂控制的第三期试验.
- 1016名RMS患者 (18-55岁,EDSS ≤5.5) 每4周接受肌肉内GA Depot 40mg或安慰剂.
- 主要终点:年复发率 (ARR) 在52周.
主要成果:
- 与安慰剂相比,GA Depot显示ARR的相对风险降低30.1% (0.18对0.26,p=0.0066).与安慰剂相比,GA Depot显示ARR的相对风险降低了30.1%.
- 显著减少了增强对比度的MRI病变的数量 (p=0.0083).
- 最常见的不良事件是轻微的注射部位反应 (46.1%对28.7%).
结论:
- 在RMS患者中,GA Depot有效降低临床和放射性疾病活性.
- 提供了有利的安全性和耐受性,类似于皮下GA.
- 代表了一种有前途的治疗选择,不太频繁地使用.
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