Khedr Eman M, Nasreldein Ahmed, El-Deen Hussein Bahey, El-Mokhtar Mohamed A, Mahmoud Doaa M
Department of Neurology and Psychiatry, Faculty of Medicine Assiut University, Assiut, Egypt; Department of Neurology and Psychiatry, Faculty of Medicine Aswan University, Aswan, Egypt.
Department of Neurology and Psychiatry, Faculty of Medicine Assiut University, Assiut, Egypt.
Mult Scler Relat Disord. 2025 Feb;94:106286. doi: 10.1016/j.msard.2025.106286. Epub 2025 Jan 22.
Serum neurofilament light chain (sNFL) is a promising biomarker for neuroaxonal injury in multiple sclerosis (MS). Traditional clinical and radiological examinations often fail to capture the underlying neurodegeneration, particularly in the absence of clinical relapses or gadolinium-enhanced lesions. This study aims to assess sNFL levels in real-world MS patients who have no evidence of activity, to evaluate the potential of sNFL as a biomarker for smoldering-associated worsening (SAW).
A cross-sectional study, involved 162 MS patients without evidence of disease activity and 40 healthy, age, sex, and education matched controls (HCs). Patients were classified according to MS subtype, DMT status, and type. sNFL levels were measured using an enzyme-linked immunosorbent assay (ELISA) and levels were compared in each group.
sNFL levels were significantly higher in MS patients compared to (HCs) (p < 0.001). Median sNFL levels were lowest in the clinically isolated (CIS) group and steady increase in RRMS and reaching the highest levels in the SPMS group (p < 0.001). Despite a slight decrease in sNFL levels in patients who started DMT for a year or less than in the naïve group, sNFL levels were highest in patients who were on DMTs for longer durations (p = 0.003). EDSS score was the sole independent predictor of sNFL levels (B = 0.415, p = 0.002). A cut-off value of 23.25 pg/ml was set to distinguish cases and HCs (92 % specificity and 90 % sensitivity), and 75.48 pg/ml was set to distinguish progressive forms (70.00 % sensitivity and 78.30 % specificity).
sNFL is sensitive for detecting subclinical neurodegeneration in the absence of relapse or gadolinium-enhanced lesions, supporting the utility of sNFL measurements into routine clinical practice to improve monitoring and management of MS.
血清神经丝轻链（sNFL）是多发性硬化症（MS）神经轴突损伤的一种很有前景的生物标志物。传统的临床和影像学检查常常无法发现潜在的神经退行性变，尤其是在没有临床复发或钆增强病灶的情况下。本研究旨在评估无疾病活动证据的真实世界MS患者的sNFL水平，以评估sNFL作为隐匿性相关病情恶化（SAW）生物标志物的潜力。
一项横断面研究，纳入了162例无疾病活动证据的MS患者以及40名年龄、性别和教育程度匹配的健康对照者（HCs）。患者根据MS亚型、疾病修正治疗（DMT）状态和类型进行分类。使用酶联免疫吸附测定（ELISA）测量sNFL水平，并在每组中比较水平。
与HCs相比，MS患者的sNFL水平显著更高（p < 0.001）。临床孤立综合征（CIS）组的sNFL水平中位数最低，复发缓解型多发性硬化症（RRMS）组稳步上升，在继发进展型多发性硬化症（SPMS）组达到最高水平（p < 0.001）。尽管开始DMT治疗一年或更短时间的患者的sNFL水平比未治疗组略有下降，但接受DMT治疗时间更长的患者的sNFL水平最高（p = 0.003）。扩展残疾状态量表（EDSS）评分是sNFL水平的唯一独立预测因素（B = 0.415，p = 0.002）。设定23.25 pg/ml的临界值以区分病例和HCs（特异性92%，敏感性90%），设定75.48 pg/ml以区分进展型（敏感性70.00%，特异性78.30%）。
sNFL对于在无复发或钆增强病灶的情况下检测亚临床神经退行性变很敏感，支持将sNFL测量纳入常规临床实践以改善MS的监测和管理。
