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Comparison of plasma and cerebrospinal fluid neurofilament light in a multiple sclerosis trial
Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.
Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.
Department of Pharmacology and Clinical Neuroscience, Umeå University, Umeå, Sweden.
Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.
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2019 (English)In: Acta Neurologica Scandinavica, ISSN 0001-6314, E-ISSN 1600-0404, Vol. 139, no 5, p. 462-468Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: The main objective of this study was to evaluate the axonal component neurofilament light protein (NFL) in plasma and cerebrospinal fluid (CSF) as an outcome measure in a clinical trial on disease-modifying treatments in multiple sclerosis.

MATERIALS & METHODS: Seventy-five patients with clinically stable relapsing-remitting multiple sclerosis (RRMS) participating in the clinical trial "Switch-To RItuXimab in MS" (STRIX-MS) were switched to rituximab from first-line injectable therapy and then followed for two years. Thirty patients from the extension trial (STRIX-MS extension), accepting repeated lumbar punctures, were followed for an additional three years. Plasma and CSF samples were collected yearly during the follow-up. NFL concentration in plasma was measured by an in-house NF-light assay on the Simoa platform with a Homebrew kit. NFL concentration in CSF was measured by sandwich ELISA.

RESULTS: The mean levels of NFL, in both CSF and plasma, were low. The reduction of CSF-NFL was 25% during the first year of follow-up (from a mean of 471 (SD 393) to 354 (SD 174) pg/mL; p=0.006) and was statistically significant. The corresponding reduction in plasma-NFL was 18% (from 9.73 (SD 7.04) to 7.94 (SD 3.10) pg/mL; p=0.055) and did not reach statistical significance.

CONCLUSION: This study indicates that NFL in plasma is less sensitive as an endpoint in group comparisons than NFL in CSF. Given that plasma NFL is far easier to access, it is a promising and awaited method but further studies are needed to optimise the use in clinical trials.

Place, publisher, year, edition, pages
John Wiley & Sons, 2019. Vol. 139, no 5, p. 462-468
Keywords [en]
Multiple sclerosis, cerebrospinal fluid, clinical trial, neurofilament light, plasma, rituximab, treatment
National Category
Neurology
Identifiers
URN: urn:nbn:se:oru:diva-72477DOI: 10.1111/ane.13078ISI: 000464338600008PubMedID: 30740668Scopus ID: 2-s2.0-85062548724OAI: oai:DiVA.org:oru-72477DiVA, id: diva2:1288870
Note

Funding Agencies:

County Council of Västerbotten  

County Council of Jämtland/Härjedalen  

County Council of Örebro  

Unit of Research, Education and Development, Region Jämtland Härjedalen  JLL-379731  JLL-649011  JLL 467731 

Syskonen Perssons Donationsfond  JLL-467381  JLL-652541 

Available from: 2019-02-14 Created: 2019-02-14 Last updated: 2019-06-18Bibliographically approved

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Gunnarsson, Martin

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