Jeffery Douglas R, Di Cantogno Elisabetta Verdun, Ritter Shannon, Meier Daniela Piani, Radue Ernst-Wilhelm, Camu William
Piedmont Health Care, Mooresville, NC, USA.
Novartis Pharma AG, Basel, Switzerland.
J Neurol. 2016 Feb;263(2):299-305. doi: 10.1007/s00415-015-7959-1. Epub 2015 Nov 14.
Clinical evidence in patients with relapsing-remitting multiple sclerosis suggests an association between MRI outcome measures and disability progression (DP). Post hoc analysis to investigate the association and potential predictive value of brain volume loss (BVL) with long-term DP in FREEDOMS. Patients were categorized into quartiles by SIENA-calculated percent brain volume change from baseline to month (M) 24. Patient characteristics at baseline were determined for each quartile, as were the proportions of patients at M24 and M48 reaching Expanded Disability Status Scale (EDSS) scores of ≥4.0 or ≥6.0 or DP confirmed at 3 months (CDP3) or 6 months (CDP6), and change in EDSS and Multiple Sclerosis Functional Composite. MS disease activity and severity as well as brain volume at baseline were predictive of subsequent BVL over 24 months. The quartiles of patients with greater BVL at 24 months were at highest risk (odds ratio, p value) for reaching EDSS ≥4 (2.8, p = 0.001) or ≥6 (5.73, p = 0.0005) and experienced more DP at M24 (CDP3 2.13, p = 0.002; CDP6 2.17, p = 0.003) and M48 (CDP3 1.98, p = 0.006; CDP6 1.87, p = 0.018) compared to the quartile of patients with the least amount of BVL. These findings confirm the clinical relevance of early brain volume changes for long-term DP.
复发缓解型多发性硬化症患者的临床证据表明,MRI结果测量与残疾进展(DP)之间存在关联。在FREEDOMS研究中进行事后分析,以调查脑容量损失(BVL)与长期DP之间的关联及潜在预测价值。根据SIENA计算的从基线到第24个月脑容量变化百分比,将患者分为四分位数。确定每个四分位数的基线患者特征,以及在第24个月和第48个月达到扩展残疾状态量表(EDSS)评分≥4.0或≥6.0或在3个月(CDP3)或6个月(CDP6)确认有DP的患者比例,以及EDSS和多发性硬化功能综合评分的变化。MS疾病活动度和严重程度以及基线脑容量可预测随后24个月的BVL。在第24个月BVL较大的患者四分位数达到EDSS≥4(优势比,p值为2.8,p = 0.001)或≥6(5.73,p = 0.0005)的风险最高,并且与BVL最少的患者四分位数相比,在第24个月(CDP3为2.13,p = 0.002;CDP6为2.17,p = 0.003)和第48个月(CDP3为1.98,p = 0.006;CDP6为1.87,p = 0.018)经历更多DP。这些发现证实了早期脑容量变化对长期DP的临床相关性。