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Comparison of plasma and cerebrospinal fluid neurofilament light in a multiple sclerosis trial
Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience.ORCID iD: 0000-0003-3927-9726
Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience.ORCID iD: 0000-0002-7504-8354
Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience.
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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 and 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 up for 2 years. Thirty patients from the extension trial (STRIX-MS extension), accepting repeated lumbar punctures, were followed up for an additional 3 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 optimize the use in clinical trials.

Place, publisher, year, edition, pages
2019. Vol. 139, no 5, p. 462-468
Keywords [en]
cerebrospinal fluid, clinical trial, multiple sclerosis, neurofilament light, plasma, rituximab, treatment
National Category
Neurology
Identifiers
URN: urn:nbn:se:umu:diva-158568DOI: 10.1111/ane.13078ISI: 000464338600008PubMedID: 30740668OAI: oai:DiVA.org:umu-158568DiVA, id: diva2:1318446
Available from: 2019-05-27 Created: 2019-05-27 Last updated: 2019-05-27Bibliographically approved

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de Flon, PierreLaurell, KatarinaSundström, PeterSvenningsson, Anders

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