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Neurology 2001;56:1628-1636
© 2001 American Academy of Neurology
Articles

PRISMS-4: Long-term efficacy of interferon-ß-1a in relapsing MS

The PRISMS (Prevention of Relapses and Disability by Interferon-ß-1a Subcutaneously in Multiple Sclerosis) Study Group*;the University of British Columbia MS/MRI Analysis Group,*

Address correspondence to Dr. Richard Hughes, Department of Neuroimmunology, Guy’s, King’s and St. Thomas’ School of Medicine, Guy’s Hospital, London SE1 9RT, UK; e-mail: richard.a.hughes{at}kcl.ac.ukAddress reprint requests to Dr. Gordon Francis, 15 ch des Mines, Geneva, Switzerland 1202; e-mail: gordon.francis@serono.com.

BACKGROUND: The PRISMS study demonstrated significant clinical and MRI benefit at 2 years for interferon-ß-1a, 22 and 44 mcg thrice weekly (tiw), compared with placebo in relapsing–remitting MS. Years 3 and 4 extension study results are reported.

METHODS: Patients initially receiving placebo were randomized to blinded interferon-ß-1a, 22 or 44 mcg tiw (n = 172; crossover group); others continued blinded treatment with their originally assigned dose, 22 mcg (Rx22 group) or 44 mcg (Rx44 group) tiw (n = 167 per group). Patients had 3- to 6-month clinical and annual MRI assessments.

RESULTS: Relapse rates for 4 years were 1.02 (crossover), 0.80 (Rx22, p < 0.001), and 0.72 (Rx44, p < 0.001); the dose effect approached significance (p = 0.069; risk ratio, 0.88; 95% CI, 0.76–1.01). Crossover groups showed reductions in relapse count, MRI activity, and lesion-burden accumulation with interferon-ß-1a compared with their placebo period (p < 0.001 both doses). Time to sustained disability progression was prolonged by 18 months in the Rx44 group compared with the crossover group (p = 0.047). Rx22 and Rx44 reduced new T2 lesion number and lesion burden compared with crossover (p < 0.001); Rx44 was superior to Rx22 on several clinical and MRI outcomes. Persistent neutralizing antibodies developed in 14.3% (Rx44) and 23.7% (Rx22) of patients and were associated with reduced efficacy.

CONCLUSIONS: Clinical and MRI benefit continued for both doses up to 4 years, with evidence of dose response. Outcomes were consistently better for patients treated for 4 years than for patients in crossover groups. Efficacy decreased with neutralizing antibody formation.




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[Abstract] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
O Andersen, I Elovaara, M Farkkila, H J Hansen, S I Mellgren, K-M Myhr, M Sandberg-Wollheim, and P Soelberg Sorensen
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, May 1, 2004; 75(5): 706 - 710.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
O. Stuve, M. Kita, D. Pelletier, R. J Fox, J. Stone, D. E Goodkin, and S. S Zamvil
Mitoxantrone as a potential therapy for primary progressive multiple sclerosis
Multiple Sclerosis, May 1, 2004; 10(3_suppl): S58 - S61.
[Abstract] [PDF]

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 Mult SclerHome page
M Clanet, L Kappos, H-P Hartung, R Hohlfeld, and The European IFNss-1a Dose-Comparison Study Invest
Interferon {beta}-1a in relapsing multiple sclerosis: four-year extension of the European IFN{beta}-1a Dose-C omparison Study
Multiple Sclerosis, April 1, 2004; 10(2): 139 - 144.
[Abstract] [PDF]

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 NeurologyHome page
J. A. Frank, N. Richert, C. Bash, L. Stone, P. A. Calabresi, B. Lewis, R. Stone, T. Howard, and H. F. McFarland
Interferon-{beta}-1b slows progression of atrophy in RRMS: Three-year follow-up in NAb- and NAb+ patients
Neurology, March 9, 2004; 62(5): 719 - 725.
[Abstract] [Full Text] [PDF]

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 BrainHome page
F. Gilli, A. Bertolotto, A. Sala, F. Hoffmann, M. Capobianco, S. Malucchi, T. Glass, L. Kappos, R. L.P. Lindberg, and D. Leppert
Neutralizing antibodies against IFN-{beta} in multiple sclerosis: antagonization of IFN-{beta} mediated suppression of MMPs
Brain, February 1, 2004; 127(2): 259 - 268.
[Abstract] [Full Text] [PDF]

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 Toxicol SciHome page
M. Stickler, N. Rochanayon, O. J. Razo, J. Mucha, W. Gebel, N. Faravashi, R. Chin, S. Holmes, and F. A. Harding
An In Vitro Human Cell-Based Assay to Rank the Relative Immunogenicity of Proteins
Toxicol. Sci., February 1, 2004; 77(2): 280 - 289.
[Abstract] [Full Text] [PDF]

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 BrainHome page
H. H. Salama, J. Hong, Y. C. Q. Zang, A. El-Mongui, and J. Zhang
Blocking effects of serum reactive antibodies induced by glatiramer acetate treatment in multiple sclerosis
Brain, December 1, 2003; 126(12): 2638 - 2647.
[Abstract] [Full Text] [PDF]

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 NeurologyHome page
P. S. Sorensen
Antibodies to IFN-beta: The Danish National IFN-beta Project
Neurology, November 11, 2003; 61(90095): S27 - 28.
[Full Text]

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 NeurologyHome page
M. Kremenchutzky
Long-term evolution of anti-INF{beta} antibodies in IFN{beta}-treated MS patients: The London, Canada, MS Clinic experience
Neurology, November 11, 2003; 61(90095): S29 - 30.
[Full Text]

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 NeurologyHome page
R. A. Rudick
Biologic impact of interferon antibodies, and complexities in assessing their clinical significance
Neurology, November 11, 2003; 61(90095): S31 - 34.
[Abstract] [Full Text]

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 J. Neurol. Neurosurg. PsychiatryHome page
N Lawrence, J Oger, T Aziz, J Palace, and A Vincent
A sensitive radioimmunoprecipitation assay for assessing the clinical relevance of antibodies to IFN {beta}
J. Neurol. Neurosurg. Psychiatry, September 1, 2003; 74(9): 1236 - 1239.
[Abstract] [Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
X Lin, C R Tench, B Turner, L D Blumhardt, and C S Constantinescu
Spinal cord atrophy and disability in multiple sclerosis over four years: application of a reproducible automated technique in monitoring disease progression in a cohort of the interferon {beta}-1a (Rebif) treatment trial
J. Neurol. Neurosurg. Psychiatry, August 1, 2003; 74(8): 1090 - 1094.
[Abstract] [Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
C H Polman, L Kappos, J Petkau, and A Thompson
Neutralising antibodies to interferon {beta} during the treatment of multiple sclerosis
J. Neurol. Neurosurg. Psychiatry, August 1, 2003; 74(8): 1162 - 1162.
[Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
C Ortenzi, G Giovannoni, F Deisenhammer, and F E Munschauer
Neutralising antibodies to interferon {beta}
J. Neurol. Neurosurg. Psychiatry, August 1, 2003; 74(8): 1162 - 1163.
[Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
B D Dubois, E Keenan, B E Porter, R Kapoor, P Rudge, A J Thompson, D H Miller, and G Giovannoni
Interferon beta in multiple sclerosis: experience in a British specialist multiple sclerosis centre
J. Neurol. Neurosurg. Psychiatry, July 1, 2003; 74(7): 946 - 949.
[Abstract] [Full Text] [PDF]

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 NeurologyHome page
A. Bertolotto, F. Gilli, A. Sala, M. Capobianco, S. Malucchi, E. Milano, F. Melis, F. Marnetto, R. L.P. Lindberg, R. Bottero, et al.
Persistent neutralizing antibodies abolish the interferon {beta} bioavailability in MS patients
Neurology, February 25, 2003; 60(4): 634 - 639.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
B. Turner, X. Lin, G. Calmon, N. Roberts, and L. D Blumhardt
C erebral atrophy and disability in relapsing-remitting and secondary progressive multiple sclerosis over four years
Multiple Sclerosis, February 1, 2003; 9(1): 21 - 27.
[Abstract] [PDF]

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 Mult SclerHome page
M Kob, J Harvey, F Schautzer, S Kascha, D Bibl, R Egg, M Reindl, T Berger, and F Deisenhammer
A novel and rapid assay for the detection of neutralizing antibodies against interferon-beta
Multiple Sclerosis, February 1, 2003; 9(1): 32 - 35.
[Abstract] [PDF]

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 NeurologyHome page
C. Polman, L. Kappos, R. White, F. Dahlke, K. Beckmann, C. Pozzilli, A. Thompson, J. Petkau, and D. Miller
Neutralizing antibodies during treatment of secondary progressive MS with interferon {beta}-1b
Neurology, January 14, 2003; 60(1): 37 - 43.
[Abstract] [Full Text] [PDF]

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 NeurologyHome page
H. Panitch, D.S. Goodin, G. Francis, P. Chang, P.K. Coyle, P. O'Connor, E. Monaghan, D. Li, and B. Weinshenker
Randomized, comparative study of interferon {beta}-1a treatment regimens in MS: The EVIDENCE Trial
Neurology, November 26, 2002; 59(10): 1496 - 1506.
[Abstract] [Full Text] [PDF]

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 NeurologyHome page
M. Clanet, E.W. Radue, L. Kappos, H.P. Hartung, R. Hohlfeld, M. Sandberg-Wollheim, M.F. Kooijmans-Coutinho, E.C. Tsao, and A.W. Sandrock
A randomized, double-blind, dose-comparison study of weekly interferon {beta}-1a in relapsing MS
Neurology, November 26, 2002; 59(10): 1507 - 1517.
[Abstract] [Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
G Giovannoni, F E Munschauer 3rd, and F Deisenhammer
Neutralising antibodies to interferon beta during the treatment of multiple sclerosis
J. Neurol. Neurosurg. Psychiatry, November 1, 2002; 73(5): 465 - 469.
[Full Text] [PDF]

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 Arch Intern MedHome page
S. L. Galetta, C. Markowitz, and A. G. Lee
Immunomodulatory Agents for the Treatment of Relapsing Multiple Sclerosis: A Systematic Review
Arch Intern Med, October 28, 2002; 162(19): 2161 - 2169.
[Abstract] [Full Text] [PDF]

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 NeurologyHome page
P. O'Connor
Key issues in the diagnosis and treatment of multiple sclerosis: An overview
Neurology, September 24, 2002; 59(90063): S1 - 33.
[Full Text]

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 NeurologyHome page
W. Pollmann, L. -P. Erasmus, W. Feneberg, F. T. Bergh, and A. Straube
Interferon beta but not glatiramer acetate therapy aggravates headaches in MS
Neurology, August 27, 2002; 59(4): 636 - 639.
[Abstract] [Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
A Bertolotto, S Malucchi, A Sala, G Orefice, P B Carrieri, M Capobianco, E Milano, F Melis, and M T Giordana
Differential effects of three interferon betas on neutralising antibodies in patients with multiple sclerosis: a follow up study in an independent laboratory
J. Neurol. Neurosurg. Psychiatry, August 1, 2002; 73(2): 148 - 153.
[Abstract] [Full Text] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
A J Coles
Neutralising antibodies to the beta interferons
J. Neurol. Neurosurg. Psychiatry, August 1, 2002; 73(2): 110 - 111.
[Full Text]


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