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Volumn 71, Issue 10, 2008, Pages 766-773

Assessment: The use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology

Author keywords

[No Author keywords available]

Indexed keywords

BETA1A INTERFERON; GLATIRAMER; INTERFERON BETA SERINE; MITOXANTRONE; NATALIZUMAB; PLACEBO; MONOCLONAL ANTIBODY;

EID: 54049087015     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/01.wnl.0000320512.21919.d2     Document Type: Article
Times cited : (115)

References (40)
  • 1
    • 0037154192 scopus 로고    scopus 로고
    • Disease modifying therapies in multiple sclerosis: Report of the Therapeutics and Technology Assessment subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines
    • Goodin DS, Frohman EM, Garmany GP, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology 2002; 58:169-178.
    • (2002) Neurology , vol.58 , pp. 169-178
    • Goodin, D.S.1    Frohman, E.M.2    Garmany, G.P.3
  • 2
    • 0031002545 scopus 로고    scopus 로고
    • Axonal damage in acute multiple sclerosis lesions
    • Ferguson B, Matyszak MK, Esiri MM, Perry VH. Axonal damage in acute multiple sclerosis lesions. Brain 1997;120: 393-399.
    • (1997) Brain , vol.120 , pp. 393-399
    • Ferguson, B.1    Matyszak, M.K.2    Esiri, M.M.3    Perry, V.H.4
  • 3
    • 0034842126 scopus 로고    scopus 로고
    • Transected neurites, apoptotic neurons, and reduced inflammation in cortical multiple sclerosis lesions
    • Peterson JW, Bo L, Mork S, et al. Transected neurites, apoptotic neurons, and reduced inflammation in cortical multiple sclerosis lesions. Ann Neurol 2001;50:389-400.
    • (2001) Ann Neurol , vol.50 , pp. 389-400
    • Peterson, J.W.1    Bo, L.2    Mork, S.3
  • 5
    • 0032994147 scopus 로고    scopus 로고
    • The immunobiology of multiple sclerosis: An autoimmune disease of the central nervous system
    • Conlon P, Oksenberg JR, Zhang J. The immunobiology of multiple sclerosis: an autoimmune disease of the central nervous system. Neurobiol Dis 1999;6:149-166.
    • (1999) Neurobiol Dis , vol.6 , pp. 149-166
    • Conlon, P.1    Oksenberg, J.R.2    Zhang, J.3
  • 6
    • 66949153749 scopus 로고    scopus 로고
    • International Federation of Multiple Sclerosis Societies. Symposium on a minimal record of disability in multiple sclerosis. Acta Neurol Scand 1984;70 (suppl 101):176-181.
    • International Federation of Multiple Sclerosis Societies. Symposium on a minimal record of disability in multiple sclerosis. Acta Neurol Scand 1984;70 (suppl 101):176-181.
  • 7
    • 0025331721 scopus 로고
    • Fibronectin promotes proliferation of naive and memory T cells by signaling through both the VLA-4 and VLA-5 integrin molecules
    • Davis LS, Oppenheimer-Marks N, Bednarczyk JL, McIntyre BW, Lipsky PE. Fibronectin promotes proliferation of naive and memory T cells by signaling through both the VLA-4 and VLA-5 integrin molecules. J Immunol 1990; 145:785-793.
    • (1990) J Immunol , vol.145 , pp. 785-793
    • Davis, L.S.1    Oppenheimer-Marks, N.2    Bednarczyk, J.L.3    McIntyre, B.W.4    Lipsky, P.E.5
  • 8
    • 0027436423 scopus 로고
    • VLA-4 integrin mediates lymphocyte migration on the inducible endothelial cell ligand VCAM-1 and the extracellular matrix ligand fibronectin
    • Chan PY, Aruffo A. VLA-4 integrin mediates lymphocyte migration on the inducible endothelial cell ligand VCAM-1 and the extracellular matrix ligand fibronectin. J Biol Chem 1993;268:24655-24664.
    • (1993) J Biol Chem , vol.268 , pp. 24655-24664
    • Chan, P.Y.1    Aruffo, A.2
  • 9
    • 0033555820 scopus 로고    scopus 로고
    • Osteopontin is associated with T cells in sarcoid granulomas and has T cell adhesive and cytokine-like properties in vitro
    • O'Regan AW, Chupp GL, Lowry JA, Goetschkes M, Mulligan N, Berman JS. Osteopontin is associated with T cells in sarcoid granulomas and has T cell adhesive and cytokine-like properties in vitro. J Immunol 1999;162: 1024-1031.
    • (1999) J Immunol , vol.162 , pp. 1024-1031
    • O'Regan, A.W.1    Chupp, G.L.2    Lowry, J.A.3    Goetschkes, M.4    Mulligan, N.5    Berman, J.S.6
  • 10
    • 0035941106 scopus 로고    scopus 로고
    • The influence of the proinflammatory cytokine, osteopontin, on autoimmune demyelinating disease
    • Chabas D, Baranzini SE, Mitchell D, et al. The influence of the proinflammatory cytokine, osteopontin, on autoimmune demyelinating disease. Science 2001;294: 1731-1735.
    • (2001) Science , vol.294 , pp. 1731-1735
    • Chabas, D.1    Baranzini, S.E.2    Mitchell, D.3
  • 11
    • 0026506799 scopus 로고
    • Prevention of experimental autoimmune encephalomyelitis by antibodies against α4β1 integrin
    • Yednock TA, Cannon C, Fritz LC, Sanchez-Madrid F, Steinman L, Karin N. Prevention of experimental autoimmune encephalomyelitis by antibodies against α4β1 integrin. Nature 1992;356:63-66.
    • (1992) Nature , vol.356 , pp. 63-66
    • Yednock, T.A.1    Cannon, C.2    Fritz, L.C.3    Sanchez-Madrid, F.4    Steinman, L.5    Karin, N.6
  • 12
    • 33646347610 scopus 로고    scopus 로고
    • Immune surveillance in multiple sclerosis patients treated with natalizumab
    • Stuve O, Marra CM, Jerome KR, et al. Immune surveillance in multiple sclerosis patients treated with natalizumab. Ann Neurol 2006;59:743-747.
    • (2006) Ann Neurol , vol.59 , pp. 743-747
    • Stuve, O.1    Marra, C.M.2    Jerome, K.R.3
  • 13
    • 33646347357 scopus 로고    scopus 로고
    • Natalizumab effects on immune cell responses in multiple sclerosis
    • Niino M, Bodner C, Simard ML, et al. Natalizumab effects on immune cell responses in multiple sclerosis. Ann Neurol 2006;59:748-754.
    • (2006) Ann Neurol , vol.59 , pp. 748-754
    • Niino, M.1    Bodner, C.2    Simard, M.L.3
  • 14
    • 0033546663 scopus 로고    scopus 로고
    • The effect of anti-alpha4 integrin antibody on brain lesion activity in MS: The UK Antegren Study Group
    • Tubridy N, Behan PO, Capildeo R, et al. The effect of anti-alpha4 integrin antibody on brain lesion activity in MS: The UK Antegren Study Group. Neurology 1999;53: 466-472.
    • (1999) Neurology , vol.53 , pp. 466-472
    • Tubridy, N.1    Behan, P.O.2    Capildeo, R.3
  • 15
    • 0037413467 scopus 로고    scopus 로고
    • International Natalizumab Multiple Sclerosis Trial Group . A controlled trial of natalizumab for relapsing multiple sclerosis
    • Miller DH, Khan OA, Sheremata WA, et al., International Natalizumab Multiple Sclerosis Trial Group . A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2003;348:15-23.
    • (2003) N Engl J Med , vol.348 , pp. 15-23
    • Miller, D.H.1    Khan, O.A.2    Sheremata, W.A.3
  • 16
    • 2942589194 scopus 로고    scopus 로고
    • Natalizumab Multiple Sclerosis Trial Group. Randomized multicenter trial of natalizumab in acute MS relapses: Clinical and MRI effects
    • O'Connor PW, Goodman A, Willmer-Hulme AJ, et al., Natalizumab Multiple Sclerosis Trial Group. Randomized multicenter trial of natalizumab in acute MS relapses: clinical and MRI effects. Neurology 2004;62:2038-2043.
    • (2004) Neurology , vol.62 , pp. 2038-2043
    • O'Connor, P.W.1    Goodman, A.2    Willmer-Hulme, A.J.3
  • 17
    • 25844462420 scopus 로고    scopus 로고
    • International Natalizumab Trial Group. Relapse rates and enhancing lesions in a phase II trial of natalizumab in multiple sclerosis
    • O'Connor P, Miller D, Riester K, et al., International Natalizumab Trial Group. Relapse rates and enhancing lesions in a phase II trial of natalizumab in multiple sclerosis. Mult Scler 2005;11:568-572.
    • (2005) Mult Scler , vol.11 , pp. 568-572
    • O'Connor, P.1    Miller, D.2    Riester, K.3
  • 18
    • 22844439662 scopus 로고    scopus 로고
    • Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis
    • Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med 2005;353:369-374.
    • (2005) N Engl J Med , vol.353 , pp. 369-374
    • Kleinschmidt-DeMasters, B.K.1    Tyler, K.L.2
  • 19
  • 20
    • 33644584352 scopus 로고    scopus 로고
    • AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis
    • Polman CH, O'Connor PW, Havrdova E, et al. ., AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2006;354:899-910.
    • (2006) N Engl J Med , vol.354 , pp. 899-910
    • Polman, C.H.1    O'Connor, P.W.2    Havrdova, E.3
  • 21
    • 33644608613 scopus 로고    scopus 로고
    • SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis
    • Rudick RA, Stuart WH, Calabresi PA, et al., SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 2006;354:911-923.
    • (2006) N Engl J Med , vol.354 , pp. 911-923
    • Rudick, R.A.1    Stuart, W.H.2    Calabresi, P.A.3
  • 22
    • 85058498533 scopus 로고    scopus 로고
    • The incidence and significance of antibodies to natalizumab over 2 years of treatment in patients with multiple sclerosis
    • Calabresi PA, Giovannoni G, O'Connor PW, et al. The incidence and significance of antibodies to natalizumab over 2 years of treatment in patients with multiple sclerosis. Neurology 2006;66 (suppl 2):A312.
    • (2006) Neurology , vol.66 , Issue.SUPPL. 2
    • Calabresi, P.A.1    Giovannoni, G.2    O'Connor, P.W.3
  • 23
    • 33644605483 scopus 로고    scopus 로고
    • Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy
    • Yousry TA, Major EO, Ryschkewitsch C, et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med 2006;354:924-933.
    • (2006) N Engl J Med , vol.354 , pp. 924-933
    • Yousry, T.A.1    Major, E.O.2    Ryschkewitsch, C.3
  • 24
    • 33845480576 scopus 로고    scopus 로고
    • GLANCE: A double-blind, randomized, placebo-controlled parallel-group safety study of natalizumab in combination with glatiramer acetate in subjects with relapsing-remitting multiple sclerosis
    • Goodman AD, Rossman HS, Bar-Or A, et al. GLANCE: a double-blind, randomized, placebo-controlled parallel-group safety study of natalizumab in combination with glatiramer acetate in subjects with relapsing-remitting multiple sclerosis. Neurology 2005;64 (suppl 1):A277-278.
    • (2005) Neurology , vol.64 , Issue.SUPPL. 1
    • Goodman, A.D.1    Rossman, H.S.2    Bar-Or, A.3
  • 25
    • 0027418515 scopus 로고
    • Interferon beta-1b is effective in relapsing-remitting multiple sclerosis: I: clinical results of a multicenter, randomized, double blind, placebo-controlled trial
    • The IFNB Multiple Sclerosis Study Group
    • 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.
    • (1993) Neurology , vol.43 , pp. 655-661
  • 26
    • 0027521002 scopus 로고
    • Li DKB, the UBC MS/MRI Study Group, the IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in remitting and relapsing multiple sclerosis: II: MRI analysis results of a multicenter, randomized, doubleblind, placebo-controlled trial
    • Paty DW, Li DKB, the UBC MS/MRI Study Group, the IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in remitting and relapsing multiple sclerosis: II: MRI analysis results of a multicenter, randomized, doubleblind, placebo-controlled trial. Neurology 1993;43:662-667.
    • (1993) Neurology , vol.43 , pp. 662-667
    • Paty, D.W.1
  • 27
    • 0029161628 scopus 로고
    • Interferon Beta-1b in the treatment of MS: Final outcome of the randomized controlled trial
    • The IFNB Multiple Sclerosis Study Group and the UBC MS/MRI Analysis Group
    • The IFNB Multiple Sclerosis Study Group and the UBC MS/MRI Analysis Group. Interferon Beta-1b in the treatment of MS: final outcome of the randomized controlled trial. Neurology 1995;45:1277-1285.
    • (1995) Neurology , vol.45 , pp. 1277-1285
  • 28
    • 0008678962 scopus 로고    scopus 로고
    • Intramuscular interferon beta-1a for disease progression in exacerbating-remitting multiple sclerosis
    • Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in exacerbating-remitting multiple sclerosis. Ann Neurol 1996;39:285-294.
    • (1996) Ann Neurol , vol.39 , pp. 285-294
    • Jacobs, L.D.1    Cookfair, D.L.2    Rudick, R.A.3
  • 29
    • 6844250787 scopus 로고    scopus 로고
    • Magnetic resonance studies of intramuscular interferon β-1a for relapsing multiple sclerosis
    • and the Multiple Sclerosis Collaborative Research Group MSCRG
    • Simon JH, Jacobs LD, Campion M, et al., and the Multiple Sclerosis Collaborative Research Group (MSCRG). Magnetic resonance studies of intramuscular interferon β-1a for relapsing multiple sclerosis. Ann Neurol 1996;43: 79-87.
    • (1996) Ann Neurol , vol.43 , pp. 79-87
    • Simon, J.H.1    Jacobs, L.D.2    Campion, M.3
  • 30
    • 0029082566 scopus 로고
    • Copolymer 1 reduces relapse rate and improves disability in relapsing- remitting multiple sclerosis: Results of a phase III multicenter, double-blind, placebo-controlled trial
    • Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing- remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology 1995;45:1268-1276.
    • (1995) Neurology , vol.45 , pp. 1268-1276
    • Johnson, K.P.1    Brooks, B.R.2    Cohen, J.A.3
  • 31
    • 0035091667 scopus 로고    scopus 로고
    • European/Canadian multicenter, double-blind, randomized, placebocontrolled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis
    • Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomized, placebocontrolled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol 2001;49:290-297.
    • (2001) Ann Neurol , vol.49 , pp. 290-297
    • Comi, G.1    Filippi, M.2    Wolinsky, J.S.3
  • 32
    • 0345601517 scopus 로고    scopus 로고
    • Randomized double-blind placebo-controlled study of interferon β-1a in relapsing/ remitting multiple sclerosis
    • PRISMS Study Group
    • PRISMS Study Group. Randomized double-blind placebo-controlled study of interferon β-1a in relapsing/ remitting multiple sclerosis. Lancet 1998;352:1498-1504.
    • (1998) Lancet , vol.352 , pp. 1498-1504
  • 33
    • 0032864616 scopus 로고    scopus 로고
    • Li DK, Paty DW, UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis: prevention of relapses and disability by interferon-beta1a subcutaneously in multiple sclerosis. Ann Neurol 1999;46:197-206.
    • Li DK, Paty DW, UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-beta1a in relapsing-remitting multiple sclerosis: prevention of relapses and disability by interferon-beta1a subcutaneously in multiple sclerosis. Ann Neurol 1999;46:197-206.
  • 34
    • 0037153729 scopus 로고    scopus 로고
    • Mitoxantrone in progressive multiple sclerosis: A placebo-controlled, double-blind, randomised, multicentre trial
    • Hartung HP, Gonsette R, Konig N, et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002; 360:2018-2025.
    • (2002) Lancet , vol.360 , pp. 2018-2025
    • Hartung, H.P.1    Gonsette, R.2    Konig, N.3
  • 35
    • 24644485224 scopus 로고    scopus 로고
    • Effect of mitoxantrone on MRI in progressive MS: Results of the MIMS trial
    • and the MIMS Study Group
    • Krapf H, Morrissey SP, Zenker O, et al., and the MIMS Study Group. Effect of mitoxantrone on MRI in progressive MS: results of the MIMS trial. Neurology 2005;65: 690-695.
    • (2005) Neurology , vol.65 , pp. 690-695
    • Krapf, H.1    Morrissey, S.P.2    Zenker, O.3
  • 36
    • 0034727059 scopus 로고    scopus 로고
    • Jacobs LD, Beck RW, Simon JH, et al.and the CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. . N Engl J Med 2000;343:898-904.
    • Jacobs LD, Beck RW, Simon JH, et al.and the CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. . N Engl J Med 2000;343:898-904.
  • 37
    • 0035912520 scopus 로고    scopus 로고
    • Effect of early interferon treatment on conversion to definite multiple sclerosis: A randomised study
    • Comi G, Filippi M, Barkhof F. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 2001;357:1576-1582.
    • (2001) Lancet , vol.357 , pp. 1576-1582
    • Comi, G.1    Filippi, M.2    Barkhof, F.3
  • 38
    • 33749661011 scopus 로고    scopus 로고
    • Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes
    • and the BENEFIT Study Group
    • Kappos L, Polman CH, Freedman MS, et al., and the BENEFIT Study Group. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 2006;67:1242-1249.
    • (2006) Neurology , vol.67 , pp. 1242-1249
    • Kappos, L.1    Polman, C.H.2    Freedman, M.S.3
  • 39
    • 22844445587 scopus 로고    scopus 로고
    • Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease
    • Van Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease. N Engl J Med 2005;353:362-368.
    • (2005) N Engl J Med , vol.353 , pp. 362-368
    • Van Assche, G.1    Van Ranst, M.2    Sciot, R.3
  • 40
    • 66949125529 scopus 로고    scopus 로고
    • FDA Advisory Hearing, March 7-8, Available at:, Accessed February 2007
    • Center for Drug Evaluation and Research (CDER). Peripheral and Central Nervous System Drugs Advisory Committee; FDA Advisory Hearing, March 7-8, 2006. Available at: www.fda.gov/ohrms/dockets/ac/06/slides/ 2006-4208S1-Slide-Index. htm. Accessed February 2007.
    • (2006) Peripheral and Central Nervous System Drugs Advisory Committee


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