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Review

PRISMS: the story of a pivotal clinical trial series in multiple sclerosis

&
Pages 827-838 | Accepted 08 Jan 2010, Published online: 03 Feb 2010

References

  • PRISMS Study Group. Randomised double-blind placebo-controlled study of interferon ß-1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-504
  • Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-94
  • Pozzilli C, Bastianello S, Koudriavtseva T, et al. Magnetic resonance imaging changes with recombinant human interferon beta-1a: a short term study in relapsing–remitting multiple sclerosis. J Neurol Neurosurg Psychiatry 1996;61:251-8
  • PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 2001;56:1628-36
  • Kappos L, Traboulsee A, Constantinescu C, et al. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing–remitting MS. Neurology 2006;67:944-53
  • Comi G, Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 2001;357:1576-82
  • Filippi M, Rovaris M, Inglese M, et al. Interferon beta-1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet 2004;364:1489-96
  • Panitch H, Goodin D, Francis G et al.; for the EVIDENCE study group and the University of British Columbia MS/MRI Research Group. Benefits of high-dose, high-frequency interferon beta-1a in relapsing–remitting multiple sclerosis are sustained to 16 months: final comparative results of the EVIDENCE trial. J Neurol Sci 2005;239:67-74
  • Schwid SR, Thorpe J, Sharief M, et al. Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE study. Arch Neurol 2005;62:785-92
  • Andersen O, Elovaara I, Farkkila M, et al. Multicentre, randomised, double blind, placebo controlled, phase III study of weekly, low dose, subcutaneous interferon beta-1a in secondary progressive multiple sclerosis. J Neurol Neurosurg Psychiatry 2004;75:706-10
  • The Once Weekly Interferon for MS Study Group. Evidence of Interferon beta-1a dose response in relapsing–remitting MS: the OWIMS Study. Neurology 1999;53:679-86
  • Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs. Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol 2008;7:903-14
  • Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 2001;56:1496-504
  • Li DK, Zhao GJ, Paty DW. University of British Columbia MS/MRI Analysis Research Group. The SPECTRIMS Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology 2001;56:1505-13
  • Goodin DS, Frohman EM, Garmany GP Jr, 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;58:169-78
  • Oger J, Francis G, Chang P. Prospective assessment of changing from placebo to IFN beta-1a in relapsing MS: the PRISMS study. J Neurol Sci 2005;237:45-52
  • Poser CM, Paty DW, Scheinberg L, et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann Neurol 1983;13:227-31
  • Schumacher F, Beeve G, Kibler R. Problems of experimental trials of therapy in multiple sclerosis. Ann N Y Acad Sci 1965;122:552-68
  • Sipe JC, Knobler RL, Braheny SL, et al. A neurologic rating scale (NRS) for use in multiple sclerosis. Neurology 1984;34:1368-72
  • Li DK, Paty DW. 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
  • Francis GS, Rice GP, Alsop JC. Interferon beta-1a in MS: results following development of neutralizing antibodies in PRISMS. Neurology 2005;65:48-55
  • Clanet M, Kappos L, Hartung HP, et al. Interferon beta-1a in relapsing multiple sclerosis: four-year extension of the European IFN beta-1a Dose-Comparison Study. Mult Scler 2004;10:139-44
  • Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Sclerosis Study Group. Mult Scler 2000;6:255-66
  • The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 1995;45:1277-85
  • Weinshenker BG, Ebers GC. The natural history of multiple sclerosis. Can J Neurol Sci 1987;14:255-61
  • Weinshenker BG, Bass B, Rice GP, et al. The natural history of multiple sclerosis: a geographically based study. I. Clinical course and disability. Brain 1989;112(Pt 1):133-46
  • Runmarker B, Andersen O. Prognostic factors in a multiple sclerosis incidence cohort with twenty-five years of follow-up. Brain 1993;116(Pt 1):117-34
  • Schellekens H. The immunogenicity of biopharmaceuticals. Neurology 2003;61:S11-12
  • Ross C, Clemmesen KM, Svenson M, et al. Immunogenicity of interferon-beta in multiple sclerosis patients: influence of preparation, dosage, dose frequency, and route of administration. Danish Multiple Sclerosis Study Group. Ann Neurol 2000;48:706-12
  • Durelli L, Ricci A. Anti-interferon antibodies in multiple sclerosis. Molecular basis and their impact on clinical efficacy. Front Biosci 2004;9:2192-204
  • Schellekens H, Casadevall N. Immunogenicity of recombinant human proteins: causes and consequences. J Neurol 2004;251(Suppl. 2):II4-9
  • Goodin DS, Frohman EM, Hurwitz B, et al. Neutralizing antibodies to interferon beta: assessment of their clinical and radiographic impact: an evidence report: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2007;68:977-84
  • Sominanda A, Rot U, Suoniemi M, et al. Interferon beta preparations for the treatment of multiple sclerosis patients differ in neutralizing antibody seroprevalence and immunogenicity. Mult Scler 2007;13:208-14
  • Abdul-Ahad AK, Galazka AR, Revel M, et al. Incidence of antibodies to interferon-beta in patients treated with recombinant human interferon-beta 1a from mammalian cells. Cytokines Cell Mol Ther 1997;3:27-32
  • Kawade Y. Quantitation of neutralization of interferon by antibody. Methods Enzymol 1986;119:558-73
  • Gold R, Rieckmann P, Chang P, et al. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol 2005;12:649-56
  • Wallin MT, Wilken JA, Turner AP, et al. Depression and multiple sclerosis: review of a lethal combination. J Rehabil Res Dev 2006;43:45-62
  • Janssens AC, Buljevac D, van Doorn PA, et al. Prediction of anxiety and distress following diagnosis of multiple sclerosis: a two-year longitudinal study. Mult Scler 2006;12:794-801
  • Isaksson AK, Gunnarsson LG, Ahlström G. The presence and meaning of chronic sorrow in patients with multiple sclerosis. J Clin Nurs 2007;16:315-24
  • Korostil M, Feinstein A. Anxiety disorders and their clinical correlates in multiple sclerosis patients. Mult Scler 2007;13:67-72
  • Patten SB, Metz LM. Interferon beta-1 a and depression in relapsing-remitting multiple sclerosis: an analysis of depression data from the PRISMS clinical trial. Mult Scler 2001;7:243-8
  • Rudick RA, Cutter GR, Baier M, et al. Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients. Mult Scler 2005;11:626-34
  • Ford CC, Johnson KP, Lisak RP, et al. A prospective open-label study of glatiramer acetate: over a decade of continuous use in multiple sclerosis patients. Mult Scler 2006;12:309-20
  • McDonald WI, Compston A, Edan G, et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Ann Neurol 2001;50:121-7
  • Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the ‘McDonald Criteria’. Ann Neurol 2005;58:840-6
  • Fangerau T, Schimrigk S, Haupts M, et al. Diagnosis of multiple sclerosis: comparison of the Poser criteria and the new McDonald criteria. Acta Neurol Scand 2004;109:385-9
  • Jaber A, Baker M. Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T-cell assays. J Pharm Biomed Analysis 2007;43:1256-61
  • Giovannoni G, Barbarash O, Casset-Semanaz F, et al. Safety and immunogenicity of a new formulation of interferon {beta}-1a (Rebif® New Formulation) in a phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Mult Scler 2009;15:219-28
  • De Stefano N on behalf of the IMPROVE study group. Efficacy of a new formulation of subcutaneous interferon beta-1a in patients with relapsing-remitting multiple sclerosis: results at 16 weeks from a double-blind, placebo-controlled study. Mult Scler 2008;14(Suppl.):S295-8

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