Serum Neurofilament Levels and PML Risk in Patients With Multiple Sclerosis Treated With Natalizumab.
Adult
Female
Follow-Up Studies
Humans
Immunologic Factors
/ administration & dosage
Leukoencephalopathy, Progressive Multifocal
/ blood
Male
Middle Aged
Multiple Sclerosis
/ blood
Multiple Sclerosis, Relapsing-Remitting
/ blood
Natalizumab
/ administration & dosage
Neurofilament Proteins
/ blood
Prognosis
Sensitivity and Specificity
Young Adult
Journal
Neurology(R) neuroimmunology & neuroinflammation
ISSN: 2332-7812
Titre abrégé: Neurol Neuroimmunol Neuroinflamm
Pays: United States
ID NLM: 101636388
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
23
11
2020
accepted:
03
03
2021
entrez:
27
4
2021
pubmed:
28
4
2021
medline:
22
1
2022
Statut:
epublish
Résumé
The study aimed to assess the potential for serum neurofilament light chain (NFL) levels to predict the risk of progressive multifocal leukoencephalopathy (PML) in natalizumab (NTZ)-treated patients with multiple sclerosis (MS) and to discriminate PML from MS relapses. NFL levels were measured with single molecule array (Simoa) in 4 cohorts: (1) a prospective cohort of patients with MS who developed PML under NTZ therapy (pre-PML) and non-PML NTZ-treated patients (NTZ-ctr); (2) a cohort of patients whose blood was collected during PML; (3) an independent cohort of non-PML NTZ-treated patients with serum NFL determinations at 2 years (replication cohort); and (4) a cohort of patients whose blood was collected during exacerbations. Serum NFL levels were significantly increased after 2 years of NTZ treatment in pre-PML patients compared with NTZ-ctr. The prognostic performance of serum NFL levels to predict PML development at 2 years was similar in the NTZ-ctr group and replication cohort. Serum NFL levels also distinguished PML from MS relapses and were 8-fold higher during PML compared with relapses. These results support the use of serum NFL levels in clinical practice to identify patients with relapsing-remitting MS at higher PML risk and to differentiate PML from clinical relapses in NTZ-treated patients. This study provides Class I evidence that serum NFL levels can identify NTZ-treated patients with MS who will develop PML with a sensitivity of 67% and specificity of 80%.
Identifiants
pubmed: 33903203
pii: 8/4/e1003
doi: 10.1212/NXI.0000000000001003
pmc: PMC8105883
pii:
doi:
Substances chimiques
Immunologic Factors
0
Natalizumab
0
Neurofilament Proteins
0
neurofilament protein L
0
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
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