Biostatistics Unit, Department of Health Sciences, University of Genoa, Italy.
Mult Scler. 2011 May;17(5):630-3. doi: 10.1177/1352458510393770. Epub 2010 Dec 21.
Recent studies have provided evidence for using magnetic resonance imaging (MRI) active lesions as surrogate for relapses and disability progression in multiple sclerosis (MS). However, the validity of MRI metrics as surrogate endpoints in MS is controversial. Furthermore, the extrapolation of previous results to novel therapies is not warranted. We tested here the validity of MRI surrogacy in MS studies on recently published trials of oral drugs. The 92% of observed effects of oral drugs on clinical outcomes resulted close to those predicted by MRI active lesions. This further validates MRI surrogacy in MS, with important implications for future trials planning.
最近的研究为使用磁共振成像（MRI）活跃病变作为多发性硬化症（MS）复发和残疾进展的替代指标提供了证据。然而，MRI 指标作为 MS 替代终点的有效性存在争议。此外，以前的结果外推到新的治疗方法是没有根据的。我们在这里测试了 MRI 替代物在最近发表的口服药物试验的 MS 研究中的有效性。观察到的口服药物对临床结局的 92%影响与 MRI 活跃病变预测的结果非常接近。这进一步验证了 MRI 替代物在 MS 中的有效性，对未来的试验计划具有重要意义。
