在复发性多发性硬化症 (AFFINITY Part 1) 的参与者中,opicinumab的安全性和有效性:一个随机的,受控的,第二阶段试验
Peter A Calabresi1, Gavin Giovannoni2, Hans-Peter Hartung3,4
1Johns Hopkins Hospital, Baltimore, MD, USA.
概括
在复发性多发性硬化症患者中,opicinumab没有显著改善残疾分数. 未来的复髓化试验可能会从这些发现和以前的研究数据中受益.
科学领域:
- 神经科学是一个神经科学.
- 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:
- 针对LINGO-1的单克隆抗体Opicinumab旨在通过增强寡头基细胞原生细胞分化来促进复髓化.
- 复发性多发性硬化症 (RMS) 的特征是炎症复发和逐渐残疾.
研究的目的:
- 评估在RMS患者中作为疾病修饰疗法 (DMT) 的附加疗法,opicinumab的疗效和安全性.
- 评估opicinumab对72周内残疾进展的影响.
主要方法:
- 一个随机,双盲,安慰剂对照试验 (NCT03222973) 涉及263名RMS参与者 (18-58岁).
- 参与者在72周内每隔4周内接受安慰剂或奥皮努马布的静脉注射.
- 主要终点是72周的整体残疾响应得分 (ODRS).
主要成果:
- 该研究没有达到其主要终点,在欧皮努马布和安慰剂组之间的平均ODRS没有显著差异 (p=0.148).
- 在子组中观察到有利于欧皮努马布的数字上更大的益处:年龄在40岁的患者,扩大残疾状况尺度为3.0和疾病持续时间为6年,服用二甲基烟酸盐.
- 不良事件发生率在各组之间是相似的 (85%安慰剂,86%opicinumab).
结论:
- 在AFFINITY研究中,没有显示出在奥皮努马布和安慰剂之间ODRS的显著差异.
- 这些发现,结合先前的SYNERGY研究数据,可以指导未来的临床试验设计,用于多发性硬化症的复髓化疗法.
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