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Multiple Sclerosis, Vol. 6, No. 4,
255-266 (2000)
DOI: 10.1177/135245850000600407
Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years
K P Johnson
Department of Neurology, University of Maryland, Baltimore, Maryland, USA
B R Brooks
Department of Neurology, University of Wisconsin, Madison, Wisconsin, USA
C C Ford
Department of Neurology, University of New Mexico, Albuquerque, New Mexico, USA
A Goodman
Department of Neurology, University of Rochester, Rochester, New York, USA
J Guarnaccia
Department of Neurology, Yale University, New Haven, Connecticut, USA
R P Lisak
Department of Neurology, Wayne State University, Detroit, Michigan, USA
L W Myers
Department of Neurology, University of California, Los Angeles, California, USA
H S Panitch
Department of Neurology, University of Maryland, Baltimore, Maryland, USA
A Pruitt
Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA
J W Rose
Department of Neurology, University of Utah and the Veterans Administration Medical Center, Salt Lake City, Utah, USA
N Kachuck
Department of Neurology, University of Southern California, Los Angeles, California, USA
J S Wolinsky
Department of Neurology, University of Texas, Houston, Texas, USA
Copolymer 1 Multiple Sclerosis Study Group
In a randomized, placebo-controlled, double-blind study, glatiramer acetate (Copaxone®) reduced the relapse rate and slowed accumulation of disability for patients with relapsing-remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug. The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse. The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months. Daily subcutaneous injections of 20 mg glatiramer acetate were well tolerated. The mean annual relapse rate of the patients who received glatiramer acetate since randomization and continued into the open-label study was 0.42 (95% confidence interval (CI), CI=0.34-0.51). The rate per year has continued to drop and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one step on the Expanded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded, providing information about their current status and reasons for dropping out. This study demonstrates the sustained efficacy of glatiramer acetate in reducing the relapse rate and in slowing the accumulation of disability in patients with relapsing forms of multiple sclerosis.
Key Words: relapsing-remitting multiple sclerosis • glatiramer acetate • copolymer 1
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|
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|
|
|
|
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|
|
|
|
|
|
|
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13(4):
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|
|
|
|
|
|
|
F. Blanchette
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13(1_suppl):
28 - 35.
[Abstract]
[PDF]
|
|
|
|
|
|
|
L. Kappos, A. Traboulsee, C. Constantinescu, J. -P. Eralinna, F. Forrestal, P. Jongen, J. Pollard, M. Sandberg-Wollheim, C. Sindic, B. Stubinski, et al.
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67(6):
944 - 953.
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[Full Text]
[PDF]
|
|
|
|
|
|
|
C C Ford, K P Johnson, R P Lisak, H S Panitch, G Shifroni, J S Wolinsky, and The Copaxone(R) Study Group
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12(3):
309 - 320.
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[PDF]
|
|
|
|
|
|
|
D. K. Tennakoon, R. S. Mehta, S. B. Ortega, V. Bhoj, M. K. Racke, and N. J. Karandikar
Therapeutic Induction of Regulatory, Cytotoxic CD8+ T Cells in Multiple Sclerosis.
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June 1, 2006;
176(11):
7119 - 7129.
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[Full Text]
[PDF]
|
|
|
|
|
|
|
R A Rudick, G R Cutter, M Baier, B Weinstock-Guttman, M K Mass, E Fisher, D M Miller, and A W Sandrock
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December 1, 2005;
11(6):
626 - 634.
[Abstract]
[PDF]
|
|
|
|
|
|
|
R. A. Marrie, G. Cutter, T. Tyry, O. Hadjimichael, D. Campagnolo, and T. Vollmer
Changes in the ascertainment of multiple sclerosis
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65(7):
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[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. M. Frohman, O. Stuve, E. Havrdova, J. Corboy, A. Achiron, R. Zivadinov, P. S. Sorensen, J. T. Phillips, B. Weinshenker, K. Hawker, et al.
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62(10):
1519 - 1530.
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|
|
|
|
|
|
|
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[Full Text]
[PDF]
|
|
|
|
|
|
|
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Therapeutic vaccines in autoimmunity
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101(suppl_2):
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[Full Text]
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|
|
|
|
|
|
|
R. Hohlfeld and H. Wekerle
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October 5, 2004;
101(suppl_2):
14599 - 14606.
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[Full Text]
[PDF]
|
|
|
|
|
|
|
J. N. H. Stern, Z. Illes, J. Reddy, D. B. Keskin, E. Sheu, M. Fridkis-Hareli, H. Nishimura, C. F. Brosnan, L. Santambrogio, V. K. Kuchroo, et al.
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August 10, 2004;
101(32):
11743 - 11748.
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[Full Text]
[PDF]
|
|
|
|
|
|
|
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J. Antimicrob. Chemother.,
July 1, 2004;
54(1):
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[Full Text]
[PDF]
|
|
|
|
|
|
|
M. S. Weber, M. Starck, S. Wagenpfeil, E. Meinl, R. Hohlfeld, and C. Farina
Multiple sclerosis: glatiramer acetate inhibits monocyte reactivity in vitro and in vivo
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June 1, 2004;
127(6):
1370 - 1378.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
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,
June 1, 2004;
10(1_suppl):
S58 - S61.
[Abstract]
[PDF]
|
|
|
|
|
|
|
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]
|
|
|
|
|
|
|
K P Johnson, B R Brooks, C C Ford, A D Goodman, R P Lisak, L W Myers, A A Pruitt, M A Rizzo, J W Rose, L P Weiner, et al.
Glatiramer acetate (Copaxone): comparison of continuous versus delayed therapy in a six-year organized multiple sclerosis trial
Multiple Sclerosis,
December 1, 2003;
9(6):
585 - 591.
[Abstract]
[PDF]
|
|
|
|
|
|
|
D Teitelbaum, T Brenner, O Abramsky, R Aharoni, M Sela, and R Arnon
Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy
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December 1, 2003;
9(6):
592 - 599.
[Abstract]
[PDF]
|
|
|
|
|
|
|
C. Weir, C. C. A. Bernard, and B. T. Backstrom
IL-5-deficient mice are susceptible to experimental autoimmune encephalomyelitis
Int. Immunol.,
November 1, 2003;
15(11):
1283 - 1289.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. M. Boneschi, M. Rovaris, K. P Johnson, A. Miller, J. S Wolinsky, D. Ladkani, G. Shifroni, G. Comi, and M. Filippi
Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trials
Multiple Sclerosis,
August 1, 2003;
9(4):
349 - 355.
[Abstract]
[PDF]
|
|
|
|
|
|
|
P. L. Vieira, H. C. Heystek, J. Wormmeester, E. A. Wierenga, and M. L. Kapsenberg
Glatiramer Acetate (Copolymer-1, Copaxone) Promotes Th2 Cell Development and Increased IL-10 Production Through Modulation of Dendritic Cells
J. Immunol.,
May 1, 2003;
170(9):
4483 - 4488.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y P Jin, J de Pedro-Cuesta, Y H Huang, and M Soderstrom
Predicting multiple sclerosis at optic neuritis onset
Multiple Sclerosis,
April 1, 2003;
9(2):
135 - 141.
[Abstract]
[PDF]
|
|
|
|
|
|
|
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]
|
|
|
|
|
|
|
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]
|
|
|
|
|
|
|
S Chabot, F P Yong, D M Le, L M Metz, T Myles, and V W Yong
Cytokine production in T lymphocyte-microglia interaction is attenuated by glatiramer acetate: a mechanism for therapeutic efficacy in multiple sclerosis
Multiple Sclerosis,
August 1, 2002;
8(4):
299 - 306.
[Abstract]
[PDF]
|
|
|
|
|
|
|
K. Bashir and J. N. Whitaker
Current Immunotherapy for Demyelinating Diseases
Arch Neurol,
May 1, 2002;
59(5):
726 - 731.
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. A. Calabresi
Considerations in the treatment of relapsing-remitting multiple sclerosis
Neurology,
April 23, 2002;
58(90084):
S10 - 22.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
J. S Wolinsky, P. A Narayana, K. P Johnson, and Copolymer 1 Multiple Sclerosis Study Group and the
United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates
Multiple Sclerosis,
February 1, 2001;
7(1):
33 - 41.
[Abstract]
[PDF]
|
|
|
|
