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作为复发性复发性多发性硬化症的试验结果,独立于复发活动的进展的实用性

Eva M M Strijbis¹, Jop Mostert², Jacynthe Comtois³

¹Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Centers, the Netherlands.

|February 17, 2025

概括

在多发性硬化症 (MS) 中,不依赖复发活动的进展 (PIRA) 和复发相关恶化 (RAW) 尚未被验证的临床试验结果. 这些测量显示了随机变化和测量误差的问题,无法区分炎症活动和神经退行.

科学领域:

神经学神经学
临床试验临床试验
神经免疫学神经免疫学

背景情况:

复发活动独立的进展 (PIRA) 和复发相关恶化 (RAW) 是多发性硬化症 (MS) 中残疾恶化的新兴指标.
假设这些指标分别代表慢性神经退行 (PIRA) 和炎症活性 (RAW).
然而,它们作为临床试验结果指标的验证仍在等待.

研究的目的:

在临床试验环境中调查MRI活动与PIRA和RAW同时发生的情况.
通过检查随机变化和测量误差,评估PIRA和RAW作为结果指标的可靠性.
将残疾恶化事件 (PIRA,RAW) 与类似定义的改善事件进行对比.

主要方法:

重新分析来自AFFIRM和SENTINEL随机对照试验 (RCT) 的个体患者数据.
基于扩展残疾状况表 (EDSS) 和功能测试的3个月确认残疾恶化 (3M-CDW),PIRA和RAW事件的计算.
恶化和改善事件与MRI活动的相关性,以及PIRA/RAW和改善结果之间的比较.

主要成果:

在2,113名参与者中,42.4%的人表现出放射性疾病活动;只有8%的人经历了3M-CDW.
PIRA事件 (6.8%) 比RAW事件 (0.9%) 更常见,但42.2%的PIRA病例具有并发的MRI活动.
在具有和没有放射性疾病活动的参与者之间没有观察到PIRA的时间有显著差异.

结论:

目前的PIRA和RAW定义不能可靠地区分残疾恶化与炎症活动相比的神经退行在复发性复发性多发性硬化 (RRMS).
作为现有的试验结果措施,PIRA和RAW表现出类似的问题,随机变化和测量误差.
需要使用全面的MRI监测进行进一步的验证,以完善这些结果指标.

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