在复发性复发性多发性硬化症中使用ocrelizumab:第二阶段,随机化,安慰剂控制,多中心试验
Ludwig Kappos1, David Li, Peter A Calabresi
1University Hospital, Basel, Switzerland. lkappos@uhbs.ch
Lancet (London, England)
|November 4, 2011
概括
与安慰剂相比,ocrelizumab在复发性复发性多发性硬化症患者中显著减少了加多增强性病变. 这种B细胞枯竭疗法在治疗多发性硬化症方面表现有前途,支持B细胞.
科学领域:
- 神经免疫学 神经免疫学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- B 淋巴细胞在多发性硬化症 (MS) 发病过程中发挥作用.
- 奥克雷利祖马布是一种人性化的抗CD20单克隆抗体,向B细胞.
研究的目的:
- 评估两种ocrelizumab剂量方案在复发性复发性MS患者中的疗效和安全性.
- 为了比较ocrelizumab与安慰剂和干扰素β-1a的影响.
主要方法:
- 一个多中心,随机,双盲,安慰剂对照试验,涉及220名患者.
- 患者接受了安慰剂,低剂量 (600毫克) 或高剂量 (2000毫克) 奥克雷利祖马布,或干扰素β-1a.
- 主要终点:24周的MRI上加多增强病变 (GEL) 的数量.
主要成果:
- 与安慰剂相比,600 mg和2000 mg的奥克雷利祖马布剂量都显著降低了GEL (分别降低了89%和96%).
- 在探索性分析中,ocrelizumab与干扰素β-1a相比,在降低GEL方面表现出更高的疗效.
- 在治疗组中,不良事件的发生率是可比的.
结论:
- 与ocrelizumab一起的B细胞枯竭有效地减少了复发性复发性MS的MRI病变.
- 这些发现支持B细胞在MS病变发生过程中的作用.
- 需要进一步的长期试验来评估ocrelizumab的全部潜力.
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