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

Arnold, Douglas L
Autor Arnold, Douglas L From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA. douglas.arnold@mcgill.ca
Fisher, Elizabeth
Autor Fisher, Elizabeth From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Brinar, Vesna V
Autor Brinar, Vesna V From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Cohen, Jeffrey A
Autor Cohen, Jeffrey A From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Coles, Alasdair J
Autor Coles, Alasdair J From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Giovannoni, Gavin
Autor Giovannoni, Gavin From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Hartung, Hans-Peter
Autor Hartung, Hans-Peter From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Havrdova, Eva
Autor Havrdova, Eva From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Selmaj, Krzysztof W
Autor Selmaj, Krzysztof W From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Stojanovic, Miroslav
Autor Stojanovic, Miroslav From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Weiner, Howard L
Autor Weiner, Howard L From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Lake, Stephen L
Autor Lake, Stephen L From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Margolin, David H
Autor Margolin, David H From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Thomas, David R
Autor Thomas, David R From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Panzara, Michael A
Autor Panzara, Michael A From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
Compston, D Alastair S
Autor Compston, D Alastair S From NeuroRx Research (D.L.A.) and Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Department of Biomedical Engineering (E.F.) and Mellen Center (J.A.C.), Cleveland Clinic, OH; Zagreb Medical School and University Hospital Center (V.V.B.), Croatia; Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK; Queen Mary University of London (G.G.), Barts and the London School of Medicine, UK; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Heinrich-Heine University, Düsseldorf, Germany; Department of Neurology (E.H.), First Medical Faculty, Charles University in Prague, Czech Republic; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; Clinical Centre Kragujevac (M.S.), Clinic of Neurology, Serbia; Brigham and Women's Hospital Center for Neurologic Diseases (H.L.W.), Boston, MA; Sanofi Genzyme (S.L.L., D.H.M., M.A.P.), Cambridge, MA; and Evidence Scientific Solutions (D.R.T.), Horsham, West Sussex, UK. Dr. Panzara is currently with Wave Life Sciences, Cambridge, MA
CARE-MS I and CARE-MS II Investigators
Autor CARE-MS I and CARE-MS II Investigators

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

ISSN 1526-632X | 0028-3878
Zdroj

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, randomizované kontrolované studie

Perzistentní odkaz https://www.medvik.cz/link/pmid27590291

Online Plný text

PubMed 27590291
PubMed Central PMC5075976
DOI 10.1212/wnl.0000000000003169
PII: WNL.0000000000003169
Knihovny.cz E-zdroje

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.

From NeuroRx Research Horsham West Sussex UK Dr Panzara is currently with Wave Life Sciences Cambridge MA

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