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April 10, 2018; 90 (15 Supplement) April 24, 2018

Serum Neurofilament Light (NfL): Towards a Blood Test for Prognosis and Disease/Treatment Monitoring in Multiple Sclerosis Patients (S24.003)

Peter A. Calabresi, Douglas L. Arnold, R. Philip Kinkel, Carol Singh, Dipen Sangurdekar, Carl de Moor, Bob Engle, Aaron Deykin, Elizabeth Fisher, Alfred Sandrock, Richard A. Rudick, Bernd C. Kieseier, Tatiana Plavina
First published April 9, 2018,
Peter A. Calabresi
1Department of Neurology, Johns Hopkins University School of Medicine Baltimore MD United States
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Douglas L. Arnold
2Montreal Neurological Institute, McGill University Montreal QC Canada
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R. Philip Kinkel
3Department of Neurosciences, University of California San Diego CA United States
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Carol Singh
4Biogen Cambridge MA United States
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Dipen Sangurdekar
4Biogen Cambridge MA United States
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Carl de Moor
4Biogen Cambridge MA United States
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Bob Engle
4Biogen Cambridge MA United States
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Aaron Deykin
4Biogen Cambridge MA United States
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Elizabeth Fisher
4Biogen Cambridge MA United States
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Alfred Sandrock
4Biogen Cambridge MA United States
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Richard A. Rudick
4Biogen Cambridge MA United States
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Bernd C. Kieseier
4Biogen Cambridge MA United States
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Tatiana Plavina
4Biogen Cambridge MA United States
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Citation
Serum Neurofilament Light (NfL): Towards a Blood Test for Prognosis and Disease/Treatment Monitoring in Multiple Sclerosis Patients (S24.003)
Peter A. Calabresi, Douglas L. Arnold, R. Philip Kinkel, Carol Singh, Dipen Sangurdekar, Carl de Moor, Bob Engle, Aaron Deykin, Elizabeth Fisher, Alfred Sandrock, Richard A. Rudick, Bernd C. Kieseier, Tatiana Plavina
Neurology Apr 2018, 90 (15 Supplement) S24.003;

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Abstract

Objective: To evaluate serum neurofilament light (sNfL) as a prognostic and disease/treatment monitoring biomarker in multiple sclerosis (MS) patients utilizing a large well-characterized cohort of MS patients from Biogen Phase III clinical trials.

Background: sNfL is a promising biomarker of disease severity in MS. Evolution of sNfL into a clinical decision-making tool will require comprehensive data from larger well-characterized cohorts.

Design/Methods: sNfL levels were measured using a sensitive Single Molecule Array (SIMOA, Quanterix) assay in serial samples from >750 patients enrolled in three Phase III trials: CHAMPS (IFNβ1a in clinically isolated syndrome, CIS, n=319), ADVANCE (PEGylated-IFNβ1a in relapsing-remitting MS, RRMS, n=310), and SENTINEL (natalizumab in RRMS, n=122). Statistical analyses to evaluate associations between sNfL and key clinical and MRI parameters included Spearman correlation, ANOVA, chi-squared test, Kaplan-Meier analysis and multivariate logistic regression.

Results: sNfL levels were associated concurrently with number of enhancing lesions (p<0.00001) and T2 lesion volume (p<0.00001), as well as long-term with various clinical and paraclinical outcome measures, including EDSS progression (up to 5 years, p<0.05), T2 lesion volume and new T2 lesions (up to 10 years, p<0.00001), and brain atrophy (5 years p<0.00001). In patients with no evident disease activity, sNfL levels remained consistently low and stable (mean 8.4 pg/mL; mean within-patient coefficient of variation, CV=22%). In contrast, in patients with active disease, sNfL levels were elevated (mean 25 pg/mL) and more variable (CV=31%). Finally, sNfL levels were lowered in the experimental treatment arms, with the most pronounced effects observed for natalizumab. Detailed analyses describing effects of the treatments on sNfL will be presented.

Conclusions: These findings support the value of sNfL as a biomarker for disease severity and treatment monitoring in MS patients.

Study Supported by: This study was supported by Biogen (Cambridge, MA, USA).

Disclosure: Dr. Calabresi has nothing to disclose. Dr. Arnold has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Biogen, F. Hoffmann-La Roche Ltd, MedDay, MedImmune, Mitsubishi, Novartis, Receptos/Celgene, Sanofi-Aventis. Dr. Arnold has received compensation for serving on the Board of Directors of NeuroRx Research. Dr. Kinkel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting, Scientific Advisory Board or speaking for Acorda, Biogen, Genzyme/Sanofi, Genentech, Novartis, Imstem, and CorTech. Dr. Singh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Singh holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Sangurdekar has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Sangurdekar holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. DeMoor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. DeMoor holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Engle has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Engle holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Deykin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Deykin holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Fisher has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Fisher holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Sandrock has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Sandrock holds stock and/or stock options in Holds stock/options in Biogen. Dr. Rudick has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Rudick holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Kieseier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Kieseier holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Plavina has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Plavina holds stock and/or stock options in Holds stock/stock options in Biogen.

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