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Článek

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

Fox, Robert J
Autor 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
Autor 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
Autor 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
Autor 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
Autor Hartung, Hans-Peter 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
Autor 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
Autor Kappos, Ludwig 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
Autor 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
Autor 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
Autor 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 May 14 ; 102 (9) : e209357. [epub] 20240422

ISSN 1526-632X | 0028-3878
Zdroj

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.

Článek

Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon β-1a in MS

Neurology. 2016 Oct 04 ; 87 (14) : 1464-1472. [epub] 20160902

ISSN 1526-632X | 0028-3878
Zdroj

OBJECTIVE: To describe detailed MRI results from 2 head-to-head phase III trials, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis Study I (CARE-MS I; NCT00530348) and Study II (CARE-MS II; NCT00548405), of alemtuzumab vs subcutaneous interferon β-1a (SC IFN-β-1a) in patients with active relapsing-remitting multiple sclerosis (RRMS). METHODS: The impact of alemtuzumab 12 mg vs SC IFN-β-1a 44 μg on MRI measures was evaluated in patients with RRMS who were treatment-naive (CARE-MS I) or who had an inadequate response, defined as at least one relapse, to prior therapy (CARE-MS II). RESULTS: Both treatments prevented T2-hyperintense lesion volume increases from baseline. Alemtuzumab was more effective than SC IFN-β-1a on most lesion-based endpoints in both studies (p < 0.05), including decreased risk of new/enlarging T2 lesions over 2 years and gadolinium-enhancing lesions at year 2. Reduced risk of new T1 lesions (p < 0.0001) and gadolinium-enhancing lesion conversion to T1-hypointense black holes (p = 0.0078) were observed with alemtuzumab vs SC IFN-β-1a in CARE-MS II. Alemtuzumab slowed brain volume loss over 2 years in CARE-MS I (p < 0.0001) and II (p = 0.012) vs SC IFN-β-1a. CONCLUSIONS: Alemtuzumab demonstrated greater efficacy than SC IFN-β-1a on MRI endpoints in active RRMS. The superiority of alemtuzumab was more prominent during the second year of both studies. These findings complement the superior clinical efficacy of alemtuzumab over SC IFN-β-1a in RRMS. CLINICALTRIALSGOV IDENTIFIER: NCT00530348 and NCT00548405. CLASSIFICATION OF EVIDENCE: The results reported here provide Class I evidence that, for patients with active RRMS, alemtuzumab is superior to SC IFN-β-1a on multiple MRI endpoints.

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