Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Via Olgettina, 60, Milan, 20132, Italy.
Neurology Unit, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Via Olgettina, 48, Milan, 20132, Italy.
Neurotherapeutics. 2020 Jan;17(1):208-217. doi: 10.1007/s13311-019-00781-w.
Studies comparing the effects of natalizumab and fingolimod in relapsing-remitting multiple sclerosis (RRMS) are limited. We aimed to compare natalizumab and fingolimod effects on clinical, neuropsychological, and MRI measures in RRMS patients after 2 years of treatment. RRMS patients starting natalizumab (n = 30) or fingolimod (n = 25) underwent neurologic, neuropsychological, and brain MRI assessments at baseline, month (M) 6, M12, and M24. Volumes of lesions, brain, gray matter (GM), white matter (WM), and deep GM were measured. Fifteen healthy controls (HC) were also scanned at baseline and M24. Treatment groups were matched for baseline variables. At M24 versus baseline, both drugs reduced the relapse rate (p value < 0.001), stabilized disability, and improved cognitive function (fingolimod: p value = 0.03; natalizumab: p value = 0.01), without between-group differences. The natalizumab group had a higher proportion of freedom from MRI activity (67% vs 36%, p value = 0.02) and no evidence of disease activity-3 (NEDA-3) (57% vs 28%, p value = 0.04). At M24 vs M6, brain (- 0.35%, p value = 0.002 [fingolimod]; - 0.42%, p value < 0.001 [natalizumab]), GM (- 0.62%, p value < 0.001 [fingolimod]; - 0.64%, p value < 0.001 [natalizumab]), and WM (- 0.98%, p value < 0.001 [fingolimod]; - 0.99%, p value < 0.001 [natalizumab]) atrophy progressed at higher rates than in HC, but similarly between treatment groups, whereas only the natalizumab group showed deep GM atrophy (- 0.79%, p value = 0.02) (p value vs fingolimod not significant). In both groups, atrophy progression was correlated with lesion accumulation (r from - 0.49 to - 0.36, p values from 0.013 to 0.05), whereas no correlation was found between clinical and MRI changes. Natalizumab and fingolimod reduce disease activity and improve cognition in RRMS. Natalizumab seems superior to limit lesion accumulation, whereas both drugs similarly modify atrophy progression.
比较那他珠单抗和芬戈莫德在复发缓解型多发性硬化症（RRMS）中的作用的研究有限。我们旨在比较 RRMS 患者在接受 2 年治疗后那他珠单抗和芬戈莫德对临床、神经心理学和 MRI 测量的影响。开始接受那他珠单抗（n = 30）或芬戈莫德（n = 25）治疗的 RRMS 患者在基线、第 6 个月、第 12 个月和第 24 个月进行神经学、神经心理学和脑 MRI 评估。测量病变、脑、灰质（GM）、白质（WM）和深部 GM 的体积。还对 15 名健康对照者（HC）在基线和第 24 个月进行了扫描。治疗组在基线变量上相匹配。与基线相比，两种药物均降低了复发率（p 值<0.001），稳定了残疾程度，并改善了认知功能（芬戈莫德：p 值=0.03；那他珠单抗：p 值=0.01），但组间无差异。那他珠单抗组有更高比例的 MRI 活动无进展（67% vs 36%，p 值=0.02）和无疾病活动-3（NEDA-3）（57% vs 28%，p 值=0.04）。与第 6 个月相比，在第 24 个月时，脑（-0.35%，p 值=0.002 [芬戈莫德]；-0.42%，p 值<0.001 [那他珠单抗]）、GM（-0.62%，p 值<0.001 [芬戈莫德]；-0.64%，p 值<0.001 [那他珠单抗]）和 WM（-0.98%，p 值<0.001 [芬戈莫德]；-0.99%，p 值<0.001 [那他珠单抗]）萎缩的进展速度高于 HC，但两组间无差异，而只有那他珠单抗组显示深部 GM 萎缩（-0.79%，p 值=0.02）（与芬戈莫德相比，p 值无显著差异）。在两组中，萎缩进展与病变积累相关（r 值范围为-0.49 至-0.36，p 值范围为 0.013 至 0.05），而临床和 MRI 变化之间无相关性。那他珠单抗和芬戈莫德可降低 RRMS 的疾病活动度并改善认知功能。那他珠单抗似乎更能限制病变积累，而两种药物同样可改变萎缩进展。
