Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
Global Biostatistics, Merck KGaA, Darmstadt, Germany.
Mult Scler. 2018 Feb;24(2):222-226. doi: 10.1177/1352458517690269. Epub 2017 Jan 31.
Neuroimaging studies have used magnetic resonance imaging-derived methods to assess brain volume loss in multiple sclerosis (MS) as a reliable measure of diffuse tissue damage.
In the CLARITY study ( ClinicalTrials.gov NCT00213135), the effect of 2 years' treatment with cladribine tablets on annualized percentage brain volume change (PBVC/y) was evaluated in patients with relapsing MS (RMS).
Compared with placebo (-0.70% ± 0.79), PBVC/y was reduced in patients treated with cladribine tablets 3.5 mg/kg (-0.56% ± 0.68, p = 0.010) and 5.25 mg/kg (-0.57% ± 0.72, p = 0.019). After adjusting for treatment group, PBVC/y showed a significant correlation with the cumulative probability of disability progression (HR = 0.67, 95% CI = 0.571, 0.787; p < 0.001), with patients with lower PBVC/y showing the highest probability of remaining free from disability progression at 2 years and vice versa.
Cladribine tablets given annually for 2 years in short-duration courses in patients with RMS in the CLARITY study significantly reduced brain atrophy in comparison with placebo treatment, with residual rates in treated patients being close to the physiological rates.
神经影像学研究采用磁共振成像衍生方法评估多发性硬化症（MS）中的脑体积损失，作为弥漫性组织损伤的可靠指标。
在 CLARITY 研究（ClinicalTrials.gov NCT00213135）中，评估了氯法拉滨片治疗 2 年对复发型多发性硬化症（RMS）患者的年度脑容量变化百分比（PBVC/y）的影响。
与安慰剂组（-0.70%±0.79%）相比，氯法拉滨片 3.5mg/kg 治疗组（-0.56%±0.68，p=0.010）和 5.25mg/kg 治疗组（-0.57%±0.72，p=0.019）的 PBVC/y 降低。在校正治疗组后，PBVC/y 与残疾进展累积概率呈显著相关性（HR=0.67，95%CI=0.571，0.787；p<0.001），PBVC/y 较低的患者在 2 年内残疾进展无进展的可能性最高，反之亦然。
CLARITY 研究中，氯法拉滨片每年治疗 2 年，在 RMS 患者中进行短期疗程治疗，与安慰剂治疗相比，显著减少脑萎缩，治疗患者的残留率接近生理率。
