Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients

Neurology

Volumn 87, Issue 19, 2016, Pages 1985-1992

  Giovannoni, Gavin ^a   Cohen, Jeffrey A ^b   Coles, Alasdair J ^c   Hartung, Hans Peter ^d   Havrdova, Eva ^e   Selmaj, Krzysztof W ^f   Margolin, David H ^g   Lake, Stephen L ^g   Kaup, Susan M ^h   Panzara, Michael A ^g   Compston, D Alastair S ^c  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b LERNER RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^d HEINRICH HEINE UNIVERSITY   (Germany)

^e CHARLES UNIVERSITY   (Czech Republic)

^f MEDICAL UNIVERSITY OF LODZ   (Poland)

^g GENZYME CORPORATION   (United States)

^h Evidence Scientific Solutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; BETA1A INTERFERON; ANTINEOPLASTIC AGENT; BETA INTERFERON; IMMUNOLOGICAL ADJUVANT; MONOCLONAL ANTIBODY;

ARTICLE; CONTROLLED STUDY; DISABILITY; DISEASE EXACERBATION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; EXPANDED DISABILITY STATUS SCALE; HUMAN; MOTOR COORDINATION; MULTIPLE SCLEROSIS; MULTIPLE SCLEROSIS FUNCTIONAL COMPOSITE; NEUROLOGIC DISEASE ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SLOAN LOW CONTRAST LETTER ACUITY; TREATMENT OUTCOME; TREATMENT RESPONSE; ANALYSIS OF VARIANCE; CLINICAL TRIAL; DISABLED PERSON; FEMALE; KAPLAN MEIER METHOD; LONGITUDINAL STUDY; MALE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PATHOPHYSIOLOGY; SEVERITY OF ILLNESS INDEX;

ADJUVANTS, IMMUNOLOGIC; ANALYSIS OF VARIANCE; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; DISABILITY EVALUATION; DISABLED PERSONS; FEMALE; HUMANS; INTERFERON-BETA; KAPLAN-MEIER ESTIMATE; LONGITUDINAL STUDIES; MALE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84994910655     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0000000000003319     Document Type: Article

References (27)

1. Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-1107.
2. Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsingremitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial: The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995;45: 1268-1276.
3. Kappos L, Radue EW, O'Connor P, et al. A placebocontrolled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401.
4. O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365:1293-1303.
5. Polman CH, O'Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006;354:899-910.
6. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-1504.
7. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis: I: clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993; 43:655-661.
8. Julian LJ, Vella L, Vollmer T, Hadjimichael O, Mohr DC. Employment in multiple sclerosis: exiting and re-entering the work force. J Neurol 2008;255:1354-1360.
9. Naci H, Fleurence R, Birt J, Duhig A. The impact of increasing neurological disability of multiple sclerosis on health utilities: a systematic review of the literature. J Med Econ 2010;13:78-89.
10. Rudick RA, Cutter G, Baier M, et al. Use of the Multiple Sclerosis Functional Composite to predict disability in relapsing MS. Neurology 2001;56:1324-1330.
11. Coles AJ, Fox E, Vladic A, et al. Alemtuzumab versus interferon beta-1a in early relapsing-remitting multiple sclerosis: post-hoc and subset analyses of clinical efficacy outcomes. Lancet Neurol 2011;10:338-348.
12. Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after diseasemodifying therapy: a randomised controlled phase 3 trial. Lancet 2012;380:1829-1839.
13. Hobart J, Freeman J, Thompson A. Kurtzke scales revisited: the application of psychometric methods to clinical intuition. Brain 2000;123:1027-1040.
14. Kragt JJ, Nielsen JM, van der Linden FA, Polman CH, Uitdehaag BM. Disease progression in multiple sclerosis: combining physicians' and patients' perspectives? Mult Scler 2011;17:234-240.
15. Phillips JT, Giovannoni G, Lublin FD, et al. Sustained improvement in Expanded Disability Status Scale as a new efficacy measure of neurological change in multiple sclerosis: treatment effects with natalizumab in patients with relapsing multiple sclerosis. Mult Scler 2011;17:970-979.
16. Cutter GR, Baier ML, Rudick RA, et al. Development of a Multiple Sclerosis Functional Composite as a clinical trial outcome measure. Brain 1999;122:871-882.
17. Fischer JS, Jak AJ, Kniker JE, Rudick RA, Cutter G. Administration and Scoring Manual for the Multiple Sclerosis Functional Composite (MSFC). New York: National Multiple Sclerosis Society; 2001.
18. Rudick RA, Polman CH, Cohen JA, et al. Assessing disability progression with the Multiple Sclerosis Functional Composite. Mult Scler 2009;15:984-997.
19. Talman LS, Bisker ER, Sackel DJ, et al. Longitudinal study of vision and retinal nerve fiber layer thickness in multiple sclerosis. Ann Neurol 2010;67:749-760.
20. Balcer LJ, Baier ML, Cohen JA, et al. Contrast letter acuity as a visual component for the Multiple Sclerosis Functional Composite. Neurology 2003;61:1367-1373.
21. Liu C, Blumhardt LD. Disability outcome measures in therapeutic trials of relapsing-remitting multiple sclerosis: effects of heterogeneity of disease course in placebo cohorts. J Neurol Neurosurg Psychiatry 2000;68: 450-457.
22. Jones JL, Anderson JM, Phuah CL, et al. Improvement in disability after alemtuzumab treatment of multiple sclerosis is associated with neuroprotective autoimmunity. Brain 2010;133:2232-2247.
23. Kragt JJ, van der Linden FA, Nielsen JM, Uitdehaag BM, Polman CH. Clinical impact of 20% worsening on Timed 25-Foot Walk and 9-Hole Peg Test in multiple sclerosis. Mult Scler 2006;12:594-598.
24. Lachin JM. Power and sample size evaluation for the McNemar test with application to matched case-control studies. Stat Med 1992;11:1239-1251.
25. Compston DA, Confavreux C, Lassmann H, et al. McAlpine's Multiple Sclerosis. 4th ed. London: Elsevier; 2006.
26. Kerschensteiner M, Gallmeier E, Behrens L, et al. Activated human T cells, B cells, and monocytes produce brain-derived neurotrophic factor in vitro and in inflammatory brain lesions: a neuroprotective role of inflammation? J Exp Med 1999;189:865-870.
27. Menge T, Stúve O, Kieseier BC, Hartung HP. Alemtuzumab: the advantages and challenges of a novel therapy in MS. Neurology 2014;83:87-97.