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Autor
Arnold, Douglas L 1 Cohen, Jeffrey A 1 Coles, Alasdair J 1 Compston, D Alastair S 1 Fox, Edward J 1 Giovannoni, Gavin 1 Hartung, Hans-Peter 1 Havrdova, Eva 1 Hogan, Richard J 1 Jody, Darlene 1 Margolin, David H 1 Panzara, Michael A 1 Rodriguez, Claudio E 1 Schippling, Sven 1 Selmaj, Krzysztof W 1 Thangavelu, Karthinathan 1 Traboulsee, Anthony 1 Xenopoulos, Panos 1
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Arnold, Douglas L 1 Cohen, Jeffrey A 1 Coles, Alasdair J 1 Compston, D Alastair S 1 Fox, Edward J 1 Giovannoni, Gavin 1 Hartung, Hans-Peter 1 Havrdova, Eva 1 Hogan, Richard J 1 Jody, Darlene 1 Margolin, David H 1 Panzara, Michael A 1 Rodriguez, Claudio E 1 Schippling, Sven 1 Selmaj, Krzysztof W 1 Thangavelu, Karthinathan 1 Traboulsee, Anthony 1 Xenopoulos, Panos 1
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Havrdova, Eva
Autor Havrdova, Eva From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA. eva.havrdova@lf1.cuni.cz
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Arnold, Douglas L
Autor Arnold, Douglas L From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Cohen, Jeffrey A
Autor Cohen, Jeffrey A From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Hartung, Hans-Peter
Autor Hartung, Hans-Peter From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Fox, Edward J
Autor Fox, Edward J From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Giovannoni, Gavin
Autor Giovannoni, Gavin From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Schippling, Sven
Autor Schippling, Sven From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Selmaj, Krzysztof W
Autor Selmaj, Krzysztof W From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Traboulsee, Anthony
Autor Traboulsee, Anthony From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
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Compston, D Alastair S
Autor Compston, D Alastair S From the Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General University Hospital in Prague, Czech Republic; NeuroRx Research (D.L.A.), Montréal; Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada; Mellen Center (J.A.C.), Cleveland Clinic, OH; Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany; MS Clinic of Central Texas (E.J.F.), Central Texas Neurology Consultants, Round Rock; Queen Mary University of London (G.G.), Barts and The London School of Medicine, UK; Neuroimmunology and Multiple Sclerosis Research (S.S.), Department of Neurology, University Hospital Zürich and University of Zürich, Switzerland; Department of Neurology (K.W.S.), Medical University of Łódź, Poland; The University of British Columbia (A.T.), Vancouver, Canada; Department of Clinical Neurosciences (D.A.S.C., A.J.C.), University of Cambridge, UK; Sanofi (D.H.M., K.T., C.E.R., D.J., M.A.P.), Cambridge, MA; Evidence Scientific Solutions (R.J.H.), Sydney, NSW, Australia; and Evidence Scientific Solutions (P.X.), Philadelphia, PA. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
PubMed
28835401
PubMed Central
PMC5595278
DOI
10.1212/wnl.0000000000004313
PII: WNL.0000000000004313
Knihovny.cz E-zdroje
OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in treatment-naive patients with active relapsing-remitting MS (RRMS) (CARE-MS I; NCT00530348). METHODS: Alemtuzumab-treated patients received treatment courses at baseline and 12 months later; after the core study, they could enter an extension (NCT00930553) with as-needed alemtuzumab retreatment for relapse or MRI activity. Assessments included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs). RESULTS: Most alemtuzumab-treated patients (95.1%) completing CARE-MS I enrolled in the extension; 68.5% received no additional alemtuzumab treatment. ARR remained low in years 3, 4, and 5 (0.19, 0.14, and 0.15). Over years 0-5, 79.7% were free of 6-month CDW; 33.4% achieved 6-month CDI. Most patients (61.7%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5. Median yearly BVL improved over years 2-4, remaining low in year 5 (years 1-5: -0.59%, -0.25%, -0.19%, -0.15%, and -0.20%). Exposure-adjusted incidence rates of most AEs declined in the extension relative to the core study. Thyroid disorder incidences peaked at year 3 and subsequently declined. CONCLUSIONS: Based on these data, alemtuzumab provides durable efficacy through 5 years in the absence of continuous treatment, with most patients not receiving additional courses. CLINICALTRIALSGOV IDENTIFIER: NCT00530348; NCT00930553. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab durably improves efficacy outcomes and slows BVL in patients with RRMS.
- MeSH
- alemtuzumab MeSH
- časové faktory MeSH
- humanizované monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- imunologické faktory škodlivé účinky terapeutické užití MeSH
- lidé MeSH
- mozek diagnostické zobrazování účinky léků MeSH
- následné studie MeSH
- posuzování pracovní neschopnosti MeSH
- relabující-remitující roztroušená skleróza diagnostické zobrazování farmakoterapie MeSH
- velikost orgánu MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- alemtuzumab MeSH
- humanizované monoklonální protilátky MeSH
- imunologické faktory MeSH
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