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Pracoviště: MS Clinic of Central Texas Central Texas Neurol...

2 záznamů v Medvik Filtry

Článek

Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings

Coles, Alasdair J
Autor Coles, Alasdair J From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA. ajc1020@medschl.cam.ac.uk
Cohen, Jeffrey A
Autor Cohen, Jeffrey A From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Fox, Edward J
Autor Fox, Edward J From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Giovannoni, Gavin
Autor Giovannoni, Gavin From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Hartung, Hans-Peter
Autor Hartung, Hans-Peter From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Havrdova, Eva
Autor Havrdova, Eva From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Schippling, Sven
Autor Schippling, Sven From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Selmaj, Krzysztof W
Autor Selmaj, Krzysztof W From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Traboulsee, Anthony
Autor Traboulsee, Anthony From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA
Compston, D Alastair S
Autor Compston, D Alastair S From the Department of Clinical Neurosciences (A.J.C., D.A.S.C.), University of Cambridge, UK Mellen Center (J.A.C.), Cleveland Clinic, OH 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 Department of Neurology and Center for Neuropsychiatry (H.-P.H.), Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany Department of Neurology and Center for Clinical Neuroscience (E.H.), First Faculty of Medicine, Charles University and General Hospital in Prague, Czech Republic Neuroimmunology and Multiple Sclerosis Research, Department of Neurology (S.S.), 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 Sanofi (D.H.M., K.T., M.C.C., D.J., M.A.P.), Cambridge, MA Envision Scientific Solutions (P.X.), Philadelphia, PA Envision Scientific Solutions (R.J.H.), Sydney, NSW, Australia NeuroRx Research (D.L.A.), Montréal Department of Neurology and Neurosurgery (D.L.A.), Montréal Neurological Institute, McGill University, Québec, Canada. M.A.P. is currently affiliated with Wave Life Sciences, Cambridge, MA

Neurology. 2017 ; 89 (11) : 1117-1126. [pub] 20170823

ISSN 1526-632X
Medvik
Zdroj

OBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. METHODS: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. 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) were assessed. RESULTS: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3-5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1-5: -0.48%, -0.22%, -0.10%, -0.19%, -0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. CONCLUSIONS: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years.

Článek

Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy

Neurology. 2017 ; 89 (11) : 1107-1116. [pub] 20170823

ISSN 1526-632X
Medvik
Zdroj

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.

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