Department of Neurology, Focus Program Translational Neuroscience (FTN) and Immunotherapy (FZI), Rhine Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstr. 1, Mainz 55131, Germany.
Department of Neurology, Focus Program Translational Neuroscience (FTN) and Immunotherapy (FZI), Rhine Main Neuroscience Network (rmn(2)), University Medical Center of the Johannes Gutenberg University Mainz, Langenbeckstr. 1, Mainz 55131, Germany.
EBioMedicine. 2020 Jun;56:102807. doi: 10.1016/j.ebiom.2020.102807. Epub 2020 May 24.
We aim to evaluate serum neurofilament light chain (sNfL), indicating neuroaxonal damage, as a biomarker at diagnosis in a large cohort of early multiple sclerosis (MS) patients.
In a multicentre prospective longitudinal observational cohort, patients with newly diagnosed relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) were recruited between August 2010 and November 2015 in 22 centers. Clinical parameters, MRI, and sNfL levels (measured by single molecule array) were assessed at baseline and up to four-year follow-up.
Of 814 patients, 54.7% (445) were diagnosed with RRMS and 45.3% (369) with CIS when applying 2010 McDonald criteria (RRMS[2010] and CIS[2010]). After reclassification of CIS[2010] patients with existing CSF analysis, according to 2017 criteria, sNfL levels were lower in CIS[2017] than RRMS[2017] patients (9.1 pg/ml, IQR 6.2-13.7 pg/ml, n = 45; 10.8 pg/ml, IQR 7.4-20.1 pg/ml, n = 213; p = 0.036). sNfL levels correlated with number of T2 and Gd+ lesions at baseline and future clinical relapses. Patients receiving disease-modifying therapy (DMT) during the first four years had higher baseline sNfL levels than DMT-naïve patients (11.8 pg/ml, IQR 7.5-20.7 pg/ml, n = 726; 9.7 pg/ml, IQR 6.4-15.3 pg/ml, n = 88). Therapy escalation decisions within this period were reflected by longitudinal changes in sNfL levels.
Assessment of sNfL increases diagnostic accuracy, is associated with disease course prognosis and may, particularly when measured longitudinally, facilitate therapeutic decisions.
Supported the German Federal Ministry for Education and Research, the German Research Council, and Hertie-Stiftung.
我们旨在评估血清神经丝轻链（sNfL），其反映神经轴突损伤，作为一项生物标志物，应用于大样本量的早期多发性硬化（MS）患者的诊断中。
在一项多中心前瞻性纵向观察队列研究中，2010 年 8 月至 2015 年 11 月期间在 22 个中心招募了新诊断的复发缓解型 MS（RRMS）或临床孤立综合征（CIS）患者。基线时及 4 年随访时评估临床参数、MRI 和 sNfL 水平（通过单分子阵列法测量）。
814 例患者中，54.7%（445 例）被诊断为 RRMS，45.3%（369 例）为 CIS，当应用 2010 年 McDonald 标准时（RRMS[2010]和 CIS[2010]）。对 CIS[2010]患者进行基于 2017 标准的脑脊液分析后重新分类，根据 2017 年标准，CIS[2017]患者的 sNfL 水平低于 RRMS[2017]患者（9.1pg/ml，IQR 6.2-13.7pg/ml，n=45；10.8pg/ml，IQR 7.4-20.1pg/ml，n=213；p=0.036）。sNfL 水平与基线时和未来临床复发的 T2 和 Gd+病变数量相关。在最初的 4 年内接受疾病修正治疗（DMT）的患者的基线 sNfL 水平高于未接受 DMT 的患者（11.8pg/ml，IQR 7.5-20.7pg/ml，n=726；9.7pg/ml，IQR 6.4-15.3pg/ml，n=88）。在这段时间内的治疗升级决策反映在 sNfL 水平的纵向变化中。
评估 sNfL 增加了诊断准确性，与疾病过程预后相关，特别是当进行纵向测量时，可能有助于治疗决策。
得到德国联邦教育与研究部、德国研究基金会和 Hertie-Stiftung 的支持。
