Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada.
Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada.
Mult Scler. 2021 Oct;27(12):1884-1893. doi: 10.1177/1352458520983584. Epub 2021 Jan 6.
We recently compared clinical outcomes in secondary progressive MS (SPMS) clinical trials and found an association of timed 25 foot walk (T25FW) worsening events and baseline disability scores. It is unclear whether disability worsening in clinical trials is comparable to that seen in clinical practice.
The objective of this study is to compare disability worsening between the IMPACT and ASCEND data sets and data from the Calgary MS clinic and to characterize the association of baseline T25FW and expanded disability status scale (EDSS) scores with disability worsening.
We combined the three data sets and investigated the impact of baseline characteristics on disability worsening with a logistic regression model. We calculated T25FW, EDSS, and 'EDSS or T25FW' worsening events as a function of ascending cut-off baseline disability scores.
Data source was not associated with T25FW worsening at 12 months. There was a strong association of baseline T25FW and EDSS cut-off scores with T25FW worsening. No such association was present for the EDSS and 'EDSS or T25FW'.
Our results suggest that it is possible to 'enrich' a trial cohort for expected T25FW worsening events using specific baseline T25FW and EDSS cut-off scores. These analyses inform the selection of inclusion criteria for clinical trials in SPMS.
我们最近比较了继发进展型多发性硬化症（SPMS）临床试验中的临床结局，发现定时 25 英尺步行（T25FW）恶化事件与基线残疾评分有关。目前尚不清楚临床试验中的残疾恶化是否与临床实践中所见的残疾恶化相当。
本研究旨在比较 IMPACT 和 ASCEND 数据集以及卡尔加里 MS 诊所的数据之间的残疾恶化情况，并描述基线 T25FW 和扩展残疾状况量表（EDSS）评分与残疾恶化的关系。
我们合并了这三个数据集，并通过逻辑回归模型研究了基线特征对残疾恶化的影响。我们计算了 T25FW、EDSS 和“EDSS 或 T25FW”恶化事件作为基线残疾评分递增的函数。
数据来源与 12 个月时的 T25FW 恶化无关。基线 T25FW 和 EDSS 截止评分与 T25FW 恶化有很强的关联。EDSS 和“EDSS 或 T25FW”则没有这种关联。
我们的结果表明，使用特定的基线 T25FW 和 EDSS 截止评分，有可能“富集”临床试验中的预期 T25FW 恶化事件队列。这些分析为 SPMS 临床试验的纳入标准选择提供了信息。
