Journal article
Neurofilament light chain in a phase 2 clinical trial of ibudilast in progressive multiple sclerosis
Multiple sclerosis, Vol.27(13), pp.2014-2022
11/2021
DOI: 10.1177/1352458520986956
PMCID: PMC8387506
PMID: 33635141
Abstract
Sensitive and specific biomarkers for use in progressive multiple sclerosis (MS) have not been established. We investigate neurofilament light (NfL) as a treatment response biomarker in progressive MS.
To evaluate whether ibudilast 100 mg/day alters serum and cerebrospinal fluid (CSF) levels of NfL in progressive MS.
In a protocol-defined exploratory analysis from a 2-year, phase 2 clinical trial of ibudilast in progressive MS (NCT01982942), serum samples were collected from 239 subjects and a subset contributed CSF and assayed using single-molecule assay (SIMOA) immunoassay. A mixed model for repeated measurements yielded log(NfL) as the response variable.
The geometric mean baseline serum NfL was 31.9 and 28.8 pg/mL in placebo and ibudilast groups, respectively. The geometric mean baseline CSF NfL was 1150.8 and 1290.3 pg/mL in placebo and ibudilast groups, respectively. Serum and CSF NfL correlations were
= 0.52 and
= 0.78 at weeks 48 and 96, respectively. Over 96 weeks, there was no between-group difference in NfL in either serum (
= 0.76) or CSF (
= 0.46). After controlling for factors that may affect NfL, no effect of ibudilast on NfL in either serum or CSF was observed.
Ibudilast treatment was not associated with a change in either serum or CSF NfL.
Details
- Title: Subtitle
- Neurofilament light chain in a phase 2 clinical trial of ibudilast in progressive multiple sclerosis
- Creators
- Robert J Fox - Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, OH, USAPaola Raska - Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USAChristian Barro - Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, SwitzerlandMatthew Karafa - Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USAVictoria Konig - Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USARobert A Bermel - Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, OH, USAMarianne Chase - Massachusetts General Hospital, Harvard Medical School, Boston, MA, USAChristopher S Coffey - University of Iowa, Iowa City, IA, USAAndrew D Goodman - Department of Neurology, University of Rochester, Rochester, NY, USAEric C Klawiter - Massachusetts General Hospital, Harvard Medical School, Boston, MA, USARobert T Naismith - Department of Neurology, Washington University, St Louis, MO, USAJens Kuhle - Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
- Resource Type
- Journal article
- Publication Details
- Multiple sclerosis, Vol.27(13), pp.2014-2022
- DOI
- 10.1177/1352458520986956
- PMID
- 33635141
- PMCID
- PMC8387506
- NLM abbreviation
- Mult Scler
- ISSN
- 1352-4585
- eISSN
- 1477-0970
- Grant note
- U01 NS082329 / NINDS NIH HHS U01 NS077179 / NINDS NIH HHS U01 NS077352 / NINDS NIH HHS
- Language
- English
- Date published
- 11/2021
- Academic Unit
- Biostatistics
- Record Identifier
- 9984214792202771
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