在早期复发性多发性硬化症患者中使用ocrelizumab的长期治疗:来自OPERA研究的九年数据 开放式扩展标签
João J Cerqueira1, Achim Berthele2, Bruce A C Cree3
1Life and Health Sciences Research Institute, School of Medicine, University of Minho, Braga, Portugal.
Neurology
|January 30, 2025
概括
与干扰素相比,Ocrelizumab (OCR) 作为复发性多发性硬化症 (RMS) 的一线治疗方法,在9年内证明没有持续的疾病活性证据 (NEDA) 和减少残疾进展. 支持早期使用OCR治疗.
科学领域:
- 神经免疫学 神经免疫学
- 临床神经学 临床神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 早期启动高效疾病修饰疗法 (DMT) 可能改善多发性硬化症 (MS) 的疾病控制.
- 奥克雷利祖马布 (OCR) 是一种高效的DMT,向B细胞.
- 需要对OCR作为早期复发性MS (RMS) 的一线治疗方法的长期数据.
研究的目的:
- 评估ocrelizumab (OCR) 作为一线治疗的长期疗效和安全性,用于早期复发性多发性硬化症 (RMS) 的未经治疗的患者.
- 在9年的时间内评估持续没有疾病活动 (NEDA-3),残疾进展和MRI活动的证据.
主要方法:
- 从OPERA I/II研究中对从未接受过治疗的RMS患者的一个子组进行特异性探索性分析.
- 患者接受了OCR或干扰素β-1a96周,随后接受了OCR的开放式延期治疗 (OLE).
- 疗效终点包括NEDA-3,24周确认残疾进展 (CDP),MRI病变活性和9年全脑体积变化.
主要成果:
- 与双盲期内接受干扰素治疗的患者相比,接受OCR治疗的患者的比例显著更高,达到NEDA-3 (72.5%vs43.8%),这一差异在整个7年的OLE (48.2%vs25.7%) 中保持不变.
- 在78.7%的9年内接受OCR治疗的患者中,没有观察到24周的CDP.
- 在后来转换为OCR的患者中,大脑体积损失在数值上更高;安全性概况在各组之间相似,在OLE期间没有发现新的安全信号.
结论:
- 在早期复发性多发性硬化症 (RMS) 中,用ocrelizumab (OCR) 进行一线治疗,导致9年内持续没有疾病活性的证据 (NEDA) 和减少残疾进展.
- 虽然转换为OCR改善了干扰素治疗患者的结果,但在初始干扰素治疗期间积累的残疾和大脑体积损失并没有恢复.
- 这些发现支持使用OCR作为早期RMS患者的第一线治疗.
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