JavaScript is NOT enabled !

* Show help

2 hits in Medvik Filters

Article

Temporal Relationship Between Serum Neurofilament Light Chain and Radiologic Disease Activity in Patients With Multiple Sclerosis

Fox, Robert J
Author Fox, Robert J ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Cree, Bruce A C
Author Cree, Bruce A C ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
de Sèze, Jérôme
Author de Sèze, Jérôme ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Gold, Ralf
Author Gold, Ralf ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Hartung, Hans-Peter
Author Authority ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Jeffery, Douglas
Author Jeffery, Douglas From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Kappos, Ludwig
Author Authority ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Montalban, Xavier
Author Montalban, Xavier ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Weinstock-Guttman, Bianca
Author Weinstock-Guttman, Bianca ORCID From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA
Singh, Carol M
Author Singh, Carol M From the Mellen Center for Multiple Sclerosis (R.J.F.), Neurological Institute, Cleveland Clinic, OH Department of Neurology (B.A.C.C.), Weill Institute for Neurosciences, University of California San Francisco Department of Neurology (J.S.), Hôpital Civil, Strasbourg, France Department of Neurology (R.G.), St. Josef Hospital, Ruhr University, Bochum, Germany Department of Neurology (H.-P.H.), Heinrich Heine University, Düsseldorf, Germany Brain and Mind Center, University of Sydney, Australia Department of Neurology, Palacky University Olomouc, Czech Republic Piedmont HealthCare (D.J.), Mooresville, NC Research Center for Clinical Neuroimmunology and Neuroscience and MS Center (L.K.) Departments of Head, Spine and Neuromedicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Switzerland Vall d'Hebron University Hospital (X.M.), Barcelona, Spain Jacobs Multiple Sclerosis Center and Pediatric Multiple Sclerosis Center of Excellence (B.W.-G.), Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY and Biogen (C.M.S., A.A., N.B., R.L.A., P.-R.H., R.S., R.E., D.S., C.M., E.F., B.C.K., R.A.R.), Cambridge, MA

Neurology. 2024 ; 102 (9) : e209357. [pub] 20240422

ISSN 1526-632X
Medvik
Source

BACKGROUND AND OBJECTIVES: Serum neurofilament light chain (sNfL) levels correlate with multiple sclerosis (MS) disease activity, but the dynamics of this correlation are unknown. We evaluated the relationship between sNfL levels and radiologic MS disease activity through monthly assessments during the 24-week natalizumab treatment interruption period in RESTORE (NCT01071083). METHODS: In the RESTORE trial, participants with relapsing forms of MS who had received natalizumab for ≥12 months were randomized to either continue or stop natalizumab and followed with MRI and blood draws every 4 weeks to week 28 and again at week 52 The sNfL was measured, and its dynamics were correlated with the development of gadolinium-enhancing (Gd+) lesions. Log-linear trend in sNfL levels were modeled longitudinally using generalized estimating equations with robust variance estimator from baseline to week 28. RESULTS: Of 175 patients enrolled in RESTORE, 166 had serum samples for analysis. Participants with Gd+ lesions were younger (37.7 vs 43.1, p = 0.001) and had lower Expanded Disability Status Scale scores at baseline (2.7 vs 3.4, p = 0.017) than participants without Gd+ lesions. sNfL levels increased in participants with Gd+ lesions (n = 65) compared with those without (n = 101, mean change from baseline to maximum sNfL value, 12.1 vs 3.2 pg/mL, respectively; p = 0.003). As the number of Gd+ lesions increased, peak median sNfL change also increased by 1.4, 3.0, 4.3, and 19.6 pg/mL in the Gd+ lesion groups of 1 (n = 12), 2-3 (n = 18), 4-9 (n = 21), and ≥10 (n = 14) lesions, respectively. However, 46 of 65 (71%) participants with Gd+ lesions did not increase above the 95th percentile threshold of the group without Gd+ lesions. The initial increase of sNfL typically trailed the first observation of Gd+ lesions, and the peak increase in sNfL was a median [interquartile range] of 8 [0, 12] weeks after the first appearance of the Gd+ lesion. DISCUSSION: Although sNfL correlated with the presence of Gd+ lesions, most participants with Gd+ lesions did not have elevations in sNfL levels. These observations have implications for the use and interpretation of sNfL as a biomarker for monitoring MS disease activity in controlled trials and clinical practice.

MeSH
Biomarkers blood MeSH
Time Factors MeSH
Adult MeSH
Gadolinium MeSH
Immunologic Factors therapeutic use blood MeSH
Middle Aged MeSH
Humans MeSH
Magnetic Resonance Imaging * MeSH
Brain diagnostic imaging pathology MeSH
Natalizumab * therapeutic use MeSH
Neurofilament Proteins * blood MeSH
Disability Evaluation MeSH
Disease Progression MeSH
Multiple Sclerosis, Relapsing-Remitting blood drug therapy diagnostic imaging MeSH
Multiple Sclerosis blood diagnostic imaging drug therapy MeSH
Check Tag
Adult MeSH
Middle Aged MeSH
Humans MeSH
Male MeSH
Female MeSH
Publication type
Journal Article MeSH
Research Support, Non-U.S. Gov't MeSH
Randomized Controlled Trial MeSH

Online article

Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis

The New England journal of medicine. 2015 ; 373 (15) : 1418-28.

N Engl J Med
ISSN 1533-4406
Medvik
Source

BACKGROUND: Daclizumab high-yield process (HYP) is a humanized monoclonal antibody that binds to CD25 (alpha subunit of the interleukin-2 receptor) and modulates interleukin-2 signaling. Abnormalities in interleukin-2 signaling have been implicated in the pathogenesis of multiple sclerosis and other autoimmune disorders. METHODS: We conducted a randomized, double-blind, active-controlled, phase 3 study involving 1841 patients with relapsing-remitting multiple sclerosis to compare daclizumab HYP, administered subcutaneously at a dose of 150 mg every 4 weeks, with interferon beta-1a, administered intramuscularly at a dose of 30 μg once weekly, for up to 144 weeks. The primary end point was the annualized relapse rate. RESULTS: The annualized relapse rate was lower with daclizumab HYP than with interferon beta-1a (0.22 vs. 0.39; 45% lower rate with daclizumab HYP; P<0.001). The number of new or newly enlarged hyperintense lesions on T2-weighted magnetic resonance imaging (MRI) over a period of 96 weeks was lower with daclizumab HYP than with interferon beta-1a (4.3 vs. 9.4; 54% lower number of lesions with daclizumab HYP; P<0.001). At week 144, the estimated incidence of disability progression confirmed at 12 weeks was 16% with daclizumab HYP and 20% with interferon beta-1a (P=0.16). Serious adverse events, excluding relapse of multiple sclerosis, were reported in 15% of the patients in the daclizumab HYP group and in 10% of those in the interferon beta-1a group. Infections were more common in the daclizumab HYP group than in the interferon beta-1a group (in 65% vs. 57% of the patients, including serious infection in 4% vs. 2%), as were cutaneous events such as rash or eczema (in 37% vs. 19%, including serious events in 2% vs. <1%) and elevations in liver aminotransferase levels that were more than 5 times the upper limit of the normal range (in 6% vs. 3%). CONCLUSIONS: Among patients with relapsing-remitting multiple sclerosis, daclizumab HYP showed efficacy superior to that of interferon beta-1a with regard to the annualized relapse rate and lesions, as assessed by means of MRI, but was not associated with a significantly lower risk of disability progression confirmed at 12 weeks. The rates of infection, rash, and abnormalities on liver-function testing were higher with daclizumab HYP than with interferon beta-1a. (Funded by Biogen and AbbVie Biotherapeutics; DECIDE ClinicalTrials.gov number, NCT01064401.).

Collections

Published

Filters

* Show help

* Show help

Refine by MeSH