Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA.
Biogen, Cambridge, MA, USA.
Mult Scler. 2024 May;30(6):687-695. doi: 10.1177/13524585241235055. Epub 2024 Mar 12.
Loss of brain gray matter fractional volume predicts multiple sclerosis (MS) progression and is associated with worsening physical and cognitive symptoms. Within deep gray matter, thalamic damage is evident in early stages of MS and correlates with physical and cognitive impairment. Natalizumab is a highly effective treatment that reduces disease progression and the number of inflammatory lesions in patients with relapsing-remitting MS (RRMS).
To evaluate the effect of natalizumab on gray matter and thalamic atrophy.
A combination of deep learning-based image segmentation and data augmentation was applied to MRI data from the AFFIRM trial.
This analysis identified a reduction of 64.3% ( = 0.0044) and 64.3% ( = 0.0030) in mean percentage gray matter volume loss from baseline at treatment years 1 and 2, respectively, in patients treated with natalizumab versus placebo. The reduction in thalamic fraction volume loss from baseline with natalizumab versus placebo was 57.0% at year 2 ( < 0.0001) and 41.2% at year 1 ( = 0.0147). Similar findings resulted from analyses of absolute gray matter and thalamic fraction volume loss.
These analyses represent the first placebo-controlled evidence supporting a role for natalizumab treatment in mitigating gray matter and thalamic fraction atrophy among patients with RRMS.
CLINICALTRIALS.GOV IDENTIFIER: NCT00027300URL: https://clinicaltrials.gov/ct2/show/NCT00027300.
脑灰质体积分数的丧失预示着多发性硬化症（MS）的进展，并与身体和认知症状的恶化有关。在深部灰质中，MS 的早期阶段就会出现丘脑损伤，并且与身体和认知障碍相关。那他珠单抗是一种非常有效的治疗方法，可减少复发缓解型多发性硬化症（RRMS）患者的疾病进展和炎症病变数量。
评估那他珠单抗对灰质和丘脑萎缩的影响。
将基于深度学习的图像分割与数据增强相结合，应用于 AFFIRM 试验的 MRI 数据。
这项分析发现，与安慰剂相比，接受那他珠单抗治疗的患者在治疗第 1 年和第 2 年，平均灰质体积损失百分比分别减少了 64.3%（=0.0044）和 64.3%（=0.0030）。与安慰剂相比，那他珠单抗治疗第 2 年和第 1 年的丘脑分数体积损失分别减少了 57.0%（<0.0001）和 41.2%（=0.0147）。从绝对灰质和丘脑分数体积损失的分析中也得到了类似的发现。
这些分析结果代表了首次支持那他珠单抗治疗在减轻 RRMS 患者灰质和丘脑分数萎缩方面具有作用的安慰剂对照证据。
临床试验.gov 标识符：NCT00027300URL：https://clinicaltrials.gov/ct2/show/NCT00027300。
