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Background <p>Multiple sclerosis (MS) is a chronic autoimmune disease characterized by neurodegeneration and demyelination. This study evaluated the diagnostic value of baseline serum neurofilament light chain (sNFL) levels and their correlation with clinical variables in treatment-naive MS patients. In this cross-sectional study, we assessed 134 treatment-naive MS patients and 37 healthy controls. Clinical evaluations included the Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), 25-Foot Walk Test (25-FWT), Hamilton depression and anxiety scales, and sNFL levels measured using ELSA.</p> Results <p>sNFL levels were significantly higher in MS patients (45.50&#xa0;pg/ml) than in controls (9.20&#xa0;pg/ml) with remarkable diagnostic performance. ROC curve analysis revealed an area under the curve of 0.965, a cut-off value of 15.52&#xa0;pg/ml, 96.3% sensitivity, and 89.2% specificity. SPMS patients exhibited the highest sNFL levels, with significant correlations observed between sNFL and physical disability measures, including EDSS (<i>p</i> = 0.389, <i>p</i> &lt; .001), 9-Hole Peg Test (9-HPT) (<i>p</i> = 0.386, <i>p</i> &lt; .001; moderate positive), and 25-Foot Walk Test (25-FWT) (<i>p</i>  =  0.354, <i>p</i> &lt; .001).</p> Conclusion <p>This study suggests sNFL as a promising biomarker for MS diagnosis, capable of differentiating disease phenotypes and assessing disability in drug-naive patients. The significant correlations between sNFL levels and clinical measures indicate potential for predicting disease progression risk.</p> <p><?qj left?><?noindent??><Emphasis Type="BoldItalic">Trial registration:</Emphasis> The study protocol was registered retrospectively at ClinicalTrials.gov ID&#xa0; NCT06197841. <a href="https://clinicaltrials.gov/study/NCT06197841?cond=NCT06197841&amp;rank=1">https://clinicaltrials.gov/study/NCT06197841?cond=NCT06197841&amp;rank=1</a>.</p>

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Baseline serum neurofilament light chain: a diagnostic biomarker in drug-naïve multiple sclerosis patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月27日

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  • Eman M. Khedr,
  • Mahmoud M. Hassan,
  • Abd Elaziz Shokry,
  • Mohamed Safwat EL-Kady,
  • Mohamed A. El-Mokhtar,
  • Mohammed Y. Ezzeldin

摘要

Background

Multiple sclerosis (MS) is a chronic autoimmune disease characterized by neurodegeneration and demyelination. This study evaluated the diagnostic value of baseline serum neurofilament light chain (sNFL) levels and their correlation with clinical variables in treatment-naive MS patients. In this cross-sectional study, we assessed 134 treatment-naive MS patients and 37 healthy controls. Clinical evaluations included the Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), 25-Foot Walk Test (25-FWT), Hamilton depression and anxiety scales, and sNFL levels measured using ELSA.

Results

sNFL levels were significantly higher in MS patients (45.50 pg/ml) than in controls (9.20 pg/ml) with remarkable diagnostic performance. ROC curve analysis revealed an area under the curve of 0.965, a cut-off value of 15.52 pg/ml, 96.3% sensitivity, and 89.2% specificity. SPMS patients exhibited the highest sNFL levels, with significant correlations observed between sNFL and physical disability measures, including EDSS (p = 0.389, p < .001), 9-Hole Peg Test (9-HPT) (p = 0.386, p < .001; moderate positive), and 25-Foot Walk Test (25-FWT) (p  =  0.354, p < .001).

Conclusion

This study suggests sNFL as a promising biomarker for MS diagnosis, capable of differentiating disease phenotypes and assessing disability in drug-naive patients. The significant correlations between sNFL levels and clinical measures indicate potential for predicting disease progression risk.

Trial registration: The study protocol was registered retrospectively at ClinicalTrials.gov ID  NCT06197841. https://clinicaltrials.gov/study/NCT06197841?cond=NCT06197841&rank=1.