Journal
MULTIPLE SCLEROSIS JOURNAL
Volume 28, Issue 6, Pages 872-884Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/13524585211039104
Keywords
Multiple sclerosis; cerebrospinal fluid; neurofilament light protein; prognosis; therapy
Categories
Funding
- Swedish State Support for Clinical Research [ALFGBG-720931, ALFGBG-722081]
- Regional FoU grant Vastra Gotalandsregionen [260 101]
- NEURO Sweden
- Edith Jacobsons Foundation
- Swedish Research Council [2018-02532, 201700915]
- Alzheimer Drug Discovery Foundation (ADDF), USA [RDAPB-201809-2016862, RDAPB-201809-2016615]
- Swedish Alzheimer Foundation [AF-742881]
- Hjarnfonden, Sweden [FO2017-0243]
- County Councils, the ALF-agreement [ALFGBG-715986]
- European Union Joint Program for Neurodegenerative Disorders [JPND2019-466-236]
- European Research Council [681712]
- UK Dementia Research Institute at UCL
- Helena Ahlin's Foundation
- Swedish government [ALFGBG-715986]
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This study validates the utility of cerebrospinal fluid NFL (cNFL) as a biomarker in clinical practice of relapsing-remitting multiple sclerosis (RRMS). cNFL can reliably diagnose disease activity, predict treatment response, disability, and conversion from RRMS to SPMS, suggesting its inclusion in the assessment of patients at MS onset.
Background: Neurofilament light (NFL) has been increasingly recognized for prognostic and therapeutic decisions. Objective: To validate the utility of cerebrospinal fluid NFL (cNFL) as a biomarker in clinical practice of relapsing-remitting multiple sclerosis (RRMS). Methods: RRMS patients (n = 757) who had cNFL analyzed as part of the diagnostic work-up in a single academic multiple sclerosis (MS) center, 2001-2018, were retrospectively identified. cNFL concentrations were determined with two different immunoassays and the ratio of means between them was used for normalization. Results: RRMS with relapse had 4.4 times higher median cNFL concentration (1134 [interquartile range (IQR) 499-2744] ng/L) than those without relapse (264 [125-537] ng/L, p < 0.001) and patients with gadolinium-enhancing lesions had 3.3 times higher median NFL (1414 [606.8-3210] ng/L) than those without (426 [IQR 221-851] ng/L, p < 0.001). The sensitivity and specificity of cNFL to detect disease activity was 75% and 98.5%, respectively. High cNFL at MS onset predicted progression to Expanded Disability Status Scale (EDSS) > 3 (p < 0.001, hazard ratios (HR) = 1.89, 95% CI = 1.44-2.65) and conversion to secondary progressive MS (SPMS, p = 0.001, HR = 2.5, 95% CI = 1.4-4.2). Conclusions: cNFL is a robust and reliable biomarker of disease activity, treatment response, and prediction of disability and conversion from RRMS to SPMS. Our data suggest that cNFL should be included in the assessment of patients at MS-onset.
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