Impact of Natalizumab on Ambulatory Improvement in Secondary Progressive and Disabled Relapsing-Remitting Multiple Sclerosis

PLoS ONE

Volumn 8, Issue 1, 2013, Pages

  Cadavid, Diego ^a   Jurgensen, Stephanie ^b   Lee, Sophia ^a  

^a BIOGEN   (United States)

^b GENZYME CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; NATALIZUMAB; PLACEBO;

ARTICLE; CLINICAL TRIAL (TOPIC); DISABILITY; DISEASE COURSE; DRUG EFFICACY; DRUG MECHANISM; EXPANDED DISABILITY STATUS SCALE; HUMAN; MOBILIZATION; MULTIPLE SCLEROSIS; RETROSPECTIVE STUDY; TREATMENT DURATION; TREATMENT RESPONSE; WALKING SPEED;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; FEMALE; HUMANS; INTERFERON-BETA; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; WALKING;

EID: 84871881788     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0053297     Document Type: Article

References (36)

1. Sutliff MH, (2010) Contribution of impaired mobility to patient burden in multiple sclerosis. Curr Med Res Opin 26: 109-119.
2. Larocca NG, (2011) Impact of walking impairment in multiple sclerosis: perspectives of patients and care partners. Patient 4: 189-201.
3. Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, et al. (2010) A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol 68: 494-502.
4. Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, et al. (2009) Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet 373: 732-738.
5. Polman C, O'Connor P, Havrdova E, Hutchinson M, Kappos L, et al. (2006) A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 354: 899-910.
6. Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, et al. (2006) Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 354: 911-923.
7. Phillips JT, Giovannoni G, Lublin FD, O'Connor PW, Polman CH, et al. (2011) 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 17: 970-979.
8. Vermersch P, Kappos L, Gold R, Foley JF, Olsson T, et al. (2011) Clinical outcomes of natalizumab-associated progressive multifocal leukoencephalopathy. Neurology 76: 1697-1704.
9. Kurtzke JF, (1983) Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 33: 1444-1452.
10. Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, et al. (1999) Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain 122 (Pt 5): 871-882.
11. Cadavid D, Tang Y, O'Neill G, (2010) Responsiveness of the Expanded Disability Status Scale (EDSS) to disease progression and therapeutic intervention in progressive forms of multiple sclerosis. Rev Neurol 51: 321-329.
12. Orbach R, Zhao Z, Wang YC, O'Neill G, Cadavid D, (2012) Comparison of disease activity in SPMS and PPMS in the context of multicenter clinical trials. PLoS ONE 7: e45409.
13. Miller DH, Khan OA, Sheremata WA, Blumhardt LD, Rice GP, et al. (2003) A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 348: 15-23.
14. Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, et al. (2002) Benefit of interferon beta-1a on MSFC progression in secondary progressive MS. Neurology 59: 679-687.
15. Fischer JS, Jak AJ, Knicker JE, Rudick RA, Cutter G (1999) Administration and scoring manual for the multiple sclerosis functional composite (MSFC). New York: Demos.
16. Fischer JS, Rudick RA, Cutter GR, Reingold SC, (1999) The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler 5: 244-250.
17. Paltamaa J (2008) Assessment of physical functioning in ambulatory persons with multiple sclerosis. Helsinki, Finland: Kela, Research Department.
18. Paltamaa J, Sarasoja T, Leskinen E, Wikstrom J, Malkia E, (2008) Measuring deterioration in international classification of functioning domains of people with multiple sclerosis who are ambulatory. Phys Ther 88: 176-190.
19. Goldman M, Marrie R, Cohen J, (2008) Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler 14: 383-390.
20. Goldman MD, Motl RW, Rudick RA, (2010) Possible clinical outcome measures for clinical trials in patients with multiple sclerosis. Ther Adv Neurol Disord 3: 229-239.
21. Hoogervorst EL, Kalkers NF, Cutter GR, Uitdehaag BM, Polman CH, (2004) The patient's perception of a (reliable) change in the Multiple Sclerosis Functional Composite. Mult Scler 10: 55-60.
22. Kragt JJ, van der Linden FA, Nielsen JM, Uitdehaag BM, Polman CH, (2006) Clinical impact of 20% worsening on timed 25-foot walk and 9-hole peg test in multiple sclerosis. Mult Scler 12: 594-598.
23. Rudick RA, Polman CH, Cohen JA, Walton MK, Miller AE, et al. (2009) Assessing disability progression with the Multiple Sclerosis Functional Composite. Mult Scler 15: 984-997.
24. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group (2001) Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 56: 1496-1504.
25. European Study Group on Interferon β-1b in Secondary Progressive MS (1998) Placebo-controlled multicentre randomized trial of interferon β-1b in treatment of secondary progressive multiple sclerosis. Lancet 352: 1491-1497.
26. Panitch H, Miller A, Paty D, Weinshenker B, (2004) Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study. Neurology 63: 1788-1795.
27. Hobart J, Kalkers N, Barkhof F, Uitdehaag B, Polman C, et al. (2004) Outcome measures for multiple sclerosis clinical trials: relative measurement precision of the Expanded Disability Status Scale and Multiple Sclerosis Functional Composite. Mult Scler 10: 41-46.
28. Munschauer F, Giovannoni G, O'Connor P, Phillips JT, Polman CH, et al. (2009) Natalizumab improves disability on the Multiple Sclerosis Functional Composite in a randomized, double-blind, placebo-controlled study of patients with relapsing multiple sclerosis. Poster presented at: 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; Düsseldorf, Germany.
29. Meuth SG, Bittner S, Seiler C, Göbel K, Wiendl H, (2011) Natalizumab restores evoked potential abnormalities in patients with relapsing-remitting multiple sclerosis. Mult Scler 17: 198-203.
30. Magliozzi R, Howell OW, Reeves C, Roncaroli F, Nicholas R, et al. (2010) A gradient of neuronal loss and meningeal inflammation in multiple sclerosis. Ann Neurol 68: 477-493.
31. Aloisi F, Columba-Cabezas S, Franciotta D, Rosicarelli B, Magliozzi R, et al. (2008) Lymphoid chemokines in chronic neuroinflammation. J Neuroimmunol 198: 106-112.
32. Magliozzi R, Howell O, Vora A, Serafini B, Nicholas R, et al. (2007) Meningeal B-cell follicles in secondary progressive multiple sclerosis associate with early onset of disease and severe cortical pathology. Brain 130: 1089-1104.
33. Howell OW, Reeves CA, Nicholas R, Carassiti D, Radotra B, et al. (2011) Meningeal inflammation is widespread and linked to cortical pathology in multiple sclerosis. Brain 134 (Pt 9): 2755-2771.
34. Frischer JM, Bramow S, Dal-Bianco A, Lucchinetti CF, Rauschka H, et al. (2009) The relation between inflammation and neurodegeneration in multiple sclerosis brains. Brain 132 (Pt 5): 1175-1189.
35. Sellebjerg F, Bornsen L, Khademi M, Krakauer M, Olsson T, et al. (2009) Increased cerebrospinal fluid concentrations of the chemokine CXCL13 in active MS. Neurology 73: 2003-2010.
36. Leung G, Sun W, Brookes S, Smith D, Shi R, (2011) Potassium channel blocker, 4-aminopyridine-3-methanol, restores axonal conduction in spinal cord of an animal model of multiple sclerosis. Exp Neurol 227: 232-235.