埃沃布鲁丁尼布在复发性多发性硬化症 (evolutionRMS1和evolutionRMS2) 的安全性和有效性:两个多中心,随机,双盲,主动受控,第三期试验
Xavier Montalban1, Patrick Vermersch2, Douglas L Arnold3
1Department of Neurology, Centre d'Esclerosi Múltiple de Catalunya, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
The Lancet. Neurology
|September 22, 2024
概括
与teriflunomide相比,evobrutinib在复发性多发性硬化症中没有表现出更高的疗效. 安全问题,特别是肝酶升高,表明埃沃布鲁丁尼布不推用于这种情况.
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:
- 埃沃布鲁丁尼布是一种布鲁顿的氨酸激酶 (BTK) 抑制剂,此前已经证明了在复发性多发性硬化症 (RMS) 中的初步疗效.
- 这项研究旨在在RMS患者中比较evobrutinib与teriflunomide的安全性和有效性.
研究的目的:
- 在复发性多发性硬化症患者中比较埃沃布鲁丁尼布与特里弗卢诺米德的疗效.
- 评估和比较evoBrutinib和teriflunomide在这个患者群体中的安全性.
主要方法:
- 两个多中心,随机,双盲,主动控制的第三期试验 (evolutionRMS1和evolutionRMS2) 招募了患有RMS的成年人.
- 参与者接受了埃沃布鲁丁尼布 (45毫克每天两次) 或特里弗卢诺米德 (14毫克每天一次) 156周.
- 主要终点是年度复发率,使用负二项式模型进行评估.
主要成果:
- 埃沃布鲁丁尼布的疗效与特里弗卢诺米德无差,两项试验的年复发率相似 (RR 1.02和1.00).
- 治疗出现的不良事件是可比的,但严重的不良事件与evobrutinib高.
- 肝酶升高 (≥5x ULN) 在埃沃布鲁丁尼布治疗中更频繁,特别是在前12周内.
结论:
- 在复发性多发性硬化症患者中,埃沃布鲁丁尼布的疗效并不优于特里弗卢诺米德.
- 肝酶升高和严重不良事件发生率较高的evobrutinib不支持其使用.
- 这些发现表明,埃沃布鲁丁尼布不是复发性多发性硬化症的推治疗选择.
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