Clinical validation of a novel in vitro diagnostic neurofilament light chain assay for the prognostication of disease activity in people with relapsing multiple sclerosis

Neurofilament light chain (NfL) is a promising marker for predicting disease activity in relapsing multiple sclerosis (RMS). To date, however, there has been no commercially available NfL assay validated in MS and intended for routine clinical use. To identify and validate a single threshold for NfL...

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Detalles Bibliográficos
Autores: Ziemssen, Tjalf|||0000-0001-8799-8202, Freedman, Mark S.|||0000-0003-1255-9701, Bar-Or, Amit|||0000-0001-7179-0335, Montalban, Xavier|||0000-0002-0098-9918, Teunissen, Charlotte E.|||0000-0002-4061-0837, Häring, Dieter A., Kukkaro, Petra, Merschhemke, Martin, Kieseier, Bernd C., Karnik-Henry, Meghana|||0000-0002-2981-7837, Gee, Matthew, Lange, Sascha, Merabet, Eddine, Chitnis, Tanuja|||0000-0002-9897-4422, Bittner, Stefan|||0000-0003-2179-3655, Wiendl, Heinz|||0000-0003-4310-3432, Hauser, Stephen L.|||0000-0002-4932-4001
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:dnet:uabarcelona_::6c114011071271b70c605b5cbdc30f78
Acceso en línea:https://ddd.uab.cat/record/327002
https://dx.doi.org/urn:doi:10.1177/13524585251389797
Access Level:acceso abierto
Palabra clave:Atellica ® IM NfL assay
Blood biomarkers
Disease activity
Multiple sclerosis
Neurofilament light chain
new or enlarging T2 lesions
Prognosis
Threshold
Descripción
Sumario:Neurofilament light chain (NfL) is a promising marker for predicting disease activity in relapsing multiple sclerosis (RMS). To date, however, there has been no commercially available NfL assay validated in MS and intended for routine clinical use. To identify and validate a single threshold for NfL in blood that differentiates RMS patients, aged 18-55 years, at a higher versus lower risk of disease activity over 2 years, using the Atellica ® IM NfL assay. The optimal NfL threshold for this assay/use case was identified and independently validated using ASCLEPIOS I and II data, respectively. The primary endpoint (annualized number of new/enlarging T2 (neT2) lesions) was analyzed using negative binomial models. Threshold optimization used maximum likelihood methodology. Generalizability analyses used data from ASCLEPIOS II, FREEDOMS, and TRANSFORMS. NfL concentration of 12.9 pg/mL was validated as the optimal cutoff for prognosticating disease activity as measured by neT2 lesion over 2 years. This threshold prognosticated individual patient risk for persistent disease activity (>3 neT2 lesions/year over 2 years) and showed prognostic value across relevant subgroups and clinical scenarios. Findings for relapses were similar.

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