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NEUROLOGY 1995;45:1268-1276
© 1995 American Academy of Neurology

Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis

Results of a phase III multicenter, double-blind, placebo-controlled trial K. P. Johnson, MD, B. R. Brooks, MD, J. A. Cohen, MD, C. C. Ford, MD, J. Goldstein, MD, R. P. Lisak, MD, L. W. Myers, MD, H. S. Panitch, MD, J. W. Rose, MD, R. B. Schiffer, MD, T. Vollmer, MD, L. P. Weiner, MD, J. S. Wolinsky, MD and Copolymer 1 Multiple Sclerosis Study Group

From the Department of Neurology (Drs. Johnson and Panitch), University of Maryland, Baltimore, MD; the Department of Neurology (Dr. Brooks), University of Wisconsin, Madison, WI; the Department of Neurology (Dr. Cohen), University of Pennsylvania, Philadelphia, PA the Department of Neurology (Dr. Ford), University of New Mexico, Albuquerque, NM; the Department of Neurology (Drs. Goldstein and Vollmer), Yale University, New Haven, CT; the Department of Neurology (Dr. Lisak), Wayne State University, Detroit, MI; the Department of Neurology (Dr. Myers), University of California, Los Angeles, CA; the Department of Neurology (Dr. Rose), University of Utah and the Veterans Administration Medical Center, Salt Lake City, UT; the Department of Neurology (Dr. Schiffer), University of Rochester, Rochester, NY; the Department of Neurology (Dr. Weiner), University of Southern California, Los Angeles, CA; and the Department of Neurology (Dr. Wolinsky), University of Texas, Houston, TX.

Address correspondence and reprint requests to Dr. Kenneth P. Johnson, Department of Neurology, N4W46, University of Maryland Hospital, 22 South Greene Street, Baltimore, MD 21201.

we studied copolymer 1 (Copaxone) in a multicenter (11-university) phase III trial of patients with relapsing-remitting multiple sclerosis (MS). Two hundred fifty-one patients were randomized to receive copolymer 1 (n = 125) or placebo (n = 126) at a dosage of 20 mg by daily subcutaneous injection for 2 years. The primary end point was a difference in the MS relapse rate. The final 2-year relapse rate was 1.19 ± 0.13 for patients receiving copolymer 1 and 1.68 ± 0.13 for those receiving placebo, a 29% reduction in favor of copolymer 1 (p = 0.007) (annualized rates = 0.59 for copolymer 1 and 0.84 for placebo). Trends in the proportion of relapse-free patients and median time to first relapse favored copolymer 1. Disability was measured by the Expanded Disability Status Scale (EDSS), using a two-neurologist (examining and treating) protocol. When the proportion of patients who improved, were unchanged, or worsened by ≥1 EDSS step from baseline to conclusion (2 years) was evaluated, significantly more patients receiving copolymer 1 were found to have improved and more receiving placebo worsened (p = 0.037). Patient withdrawals were 19 (15.2%) from the copolymer 1 group and 17 (13.5%) from the placebo group at approximately the same intervals. The treatment was well tolerated. The most common adverse experience was an injection-site reaction. Rarely, a transient self-limited systemic reaction followed the injection in 15.2% of those receiving copolymer 1 and 3.2% of those receiving placebo. This reaction was characterized by flushing or chest tightness with palpitations, anxiety, or dyspnea and commonly lasted for 30 seconds to 30 minutes. This rigorous study confirmed the findings of a previous pilot trial and demonstrated that copolymer 1 treatment can significantly and beneficially alter the course of relapsing-remitting MS in a well-tolerated fashion.

*See pages 1275 and 1276 for the Copolymer 1 Multiple Sclerosis Study Group participants.

Supported by the Federal Food and Drug Administration Orphan Drug Program no. FD-R000559-01, the National Multiple Sclerosis Society no. RG 2202-A-6, and Teva Pharmaceutical Industries, Ltd., Petah Tiqva, Israel.

Presented a t the annual meeting of the American Neurological Association, San Francisco, October 1994.

Received April 27, 1995. Accepted in final form May 1, 1995




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U. Held, L. Heigenhauser, C. Shang, L. Kappos, C. Polman, and for the Sylvia Lawry Centre for MS Research
Predictors of relapse rate in MS clinical trials
Neurology, December 13, 2005; 65(11): 1769 - 1773.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
R A Rudick, G R Cutter, M Baier, B Weinstock-Guttman, M K Mass, E Fisher, D M Miller, and A W Sandrock
Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients
Multiple Sclerosis, December 1, 2005; 11(6): 626 - 634.
[Abstract] [PDF]

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 Mult SclerHome page
J Haas, M Maas-Enriquez, and H P Hartung
Intravenous immunoglobulins in the treatment of relapsing remitting multiple sclerosis - results of a retrospective multicenter observational study over five years
Multiple Sclerosis, October 1, 2005; 11(5): 562 - 567.
[Abstract] [PDF]

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 Arch NeurolHome page
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.
Therapeutic Considerations for Disease Progression in Multiple Sclerosis: Evidence, Experience, and Future Expectations
Arch Neurol, October 1, 2005; 62(10): 1519 - 1530.
[Abstract] [Full Text] [PDF]

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 Postgrad. Med. J.Home page
J Zajicek
Diagnosis and disease modifying treatments in multiple sclerosis
Postgrad. Med. J., September 1, 2005; 81(959): 556 - 561.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
A Ghezzi, M P Amato, M Capobianco, P Gallo, G Marrosu, V Martinelli, N Milani, C Milanese, L Moiola, F Patti, et al.
Disease-modifying drugs in childhood-juvenile multiple sclerosis: results of an Italian co-operative study
Multiple Sclerosis, August 1, 2005; 11(4): 420 - 424.
[Abstract] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
C. E. Smith, T. N. Eagar, J. L. Strominger, and S. D. Miller
Differential induction of IgE-mediated anaphylaxis after soluble vs. cell-bound tolerogenic peptide therapy of autoimmune encephalomyelitis
PNAS, July 5, 2005; 102(27): 9595 - 9600.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
D. R Jeffery, N. Chepuri, D. Durden, and J. Burdette
A pilot trial of combination therapy with mitoxantrone and interferon beta-1b using monthly gadolinium-enhanced magnetic resonance imaging
Multiple Sclerosis, June 1, 2005; 11(3): 296 - 301.
[Abstract] [PDF]

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 Mult SclerHome page
J. Rio, J. Porcel, N. Tellez, A. Sanchez-Betancourt, M a. Tintore, M J. Arevalo, C. Nos, and X. Montalban
Factors related with treatment adherence to interferon b and glatiramer acetate therapy in multiple sclerosis
Multiple Sclerosis, June 1, 2005; 11(3): 306 - 309.
[Abstract] [PDF]

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 Arch NeurolHome page
N. J. Karandikar and M. K. Racke
Glatiramer Acetate Therapy: The Plot Thickens
Arch Neurol, June 1, 2005; 62(6): 858 - 859.
[Full Text] [PDF]

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 Mult SclerHome page
S Nolden, C Casper, A Kuhn, and H F Petereit
Jessner-Kanof lymphocytic infiltration of the skin associated with glatiramer acetate
Multiple Sclerosis, April 1, 2005; 11(2): 245 - 248.
[Abstract] [PDF]

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 J. Immunol.Home page
C. D. Margot, M. L. Ford, and B. D. Evavold
Amelioration of Established Experimental Autoimmune Encephalomyelitis by an MHC Anchor-Substituted Variant of Proteolipid Protein 139-151
J. Immunol., March 15, 2005; 174(6): 3352 - 3358.
[Abstract] [Full Text] [PDF]

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M. Blair, M. E. Pease, J. Hammond, D. Valenta, J. Kielczewski, H. Levkovitch-Verbin, and H. Quigley
Effect of Glatiramer Acetate on Primary and Secondary Degeneration of Retinal Ganglion Cells in the Rat
Invest. Ophthalmol. Vis. Sci., March 1, 2005; 46(3): 884 - 890.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
J. N. H. Stern, Z. Illes, J. Reddy, D. B. Keskin, M. Fridkis-Hareli, V. K. Kuchroo, and J. L. Strominger
Peptide 15-mers of defined sequence that substitute for random amino acid copolymers in amelioration of experimental autoimmune encephalomyelitis
PNAS, February 1, 2005; 102(5): 1620 - 1625.
[Abstract] [Full Text] [PDF]

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 NeurologyHome page
B. A. Cohen, O. Khan, D. R. Jeffery, K. Bashir, S. A. Rizvi, E. J. Fox, M. Agius, R. Bashir, T. E. Collins, R. Herndon, et al.
Identifying and treating patients with suboptimal responses
Neurology, December 28, 2004; 63(12_suppl_6): S33 - S40.
[Abstract] [Full Text]

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 NeurologyHome page
W. H. Stuart
Current clinical perspectives on the treatment of multiple sclerosis
Neurology, December 14, 2004; 63(11_suppl_5): S1 - S2.
[Full Text]

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 NeurologyHome page
W. H. Stuart, S. Cohan, J. R. Richert, and A. Achiron
Selecting a disease-modifying agent as platform therapy in the long-term management of multiple sclerosis
Neurology, December 14, 2004; 63(11_suppl_5): S19 - S27.
[Abstract] [Full Text]

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 NeurologyHome page
A. Langer-Gould, H. H. Moses, and T. J. Murray
Strategies for managing the side effects of treatments for multiple sclerosis
Neurology, December 14, 2004; 63(11_suppl_5): S35 - S41.
[Abstract] [Full Text]

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 Proc. Natl. Acad. Sci. USAHome page
M. Sela and E. Mozes
Therapeutic vaccines in autoimmunity
PNAS, October 5, 2004; 101(suppl_2): 14586 - 14592.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
R. Hohlfeld and H. Wekerle
Autoimmune concepts of multiple sclerosis as a basis for selective immunotherapy: From pipe dreams to (therapeutic) pipelines
PNAS, October 5, 2004; 101(suppl_2): 14599 - 14606.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
T L Vollmer, J T Phillips, A D Goodman, M A Agius, M A Libonati, J L Giacchino, and J S Grundy
An open-label safety and drug interaction study of natalizumab (AntegrenTM) in combination with interferon-beta (Avonex(R)) in patients with multiple sclerosis
Multiple Sclerosis, October 1, 2004; 10(5): 511 - 520.
[Abstract] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
Z. Illes, J. N. H. Stern, J. Reddy, H. Waldner, M. P. Mycko, C. F. Brosnan, S. Ellmerich, D. M. Altmann, L. Santambrogio, J. L. Strominger, et al.
Modified amino acid copolymers suppress myelin basic protein 85-99-induced encephalomyelitis in humanized mice through different effects on T cells
PNAS, August 10, 2004; 101(32): 11749 - 11754.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
M J Tullman, R J Oshinsky, F D Lublin, and G R Cutter
Clinical characteristics of progressive relapsing multiple sclerosis
Multiple Sclerosis, August 1, 2004; 10(4): 451 - 454.
[Abstract] [PDF]

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 J. Neurol. Neurosurg. PsychiatryHome page
L M Metz, S B Patten, C J Archibald, J I Bakker, C J Harris, D G Patry, R B Bell, M Yeung, W F Murphy, C A Stoian, et al.
The effect of immunomodulatory treatment on multiple sclerosis fatigue
J. Neurol. Neurosurg. Psychiatry, July 1, 2004; 75(7): 1045 - 1047.
[Abstract] [Full Text] [PDF]

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 Mult SclerHome page
F G Maggs and J Palace
The pathogenesis of multiple sclerosis: is it really a primary inflammatory process?
Multiple Sclerosis, June 1, 2004; 10(3): 326 - 329.
[Abstract] [PDF]

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 BrainHome page
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
Brain, June 1, 2004; 127(6): 1370 - 1378.
[Abstract] [Full Text] [PDF]

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 J. Immunol.Home page
H. J. Kim, I. Ifergan, J. P. Antel, R. Seguin, M. Duddy, Y. Lapierre, F. Jalili, and A. Bar-Or
Type 2 Monocyte and Microglia Differentiation Mediated by Glatiramer Acetate Therapy in Patients with Multiple Sclerosis
J. Immunol., June 1, 2004; 172(11): 7144 - 7153.
[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, June 1, 2004; 10(1_suppl): S58 - S61.
[Abstract] [PDF]

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 Arch NeurolHome page
S. J. Pittock, W. T. Mayr, R. L. McClelland, N. W. Jorgensen, S. D. Weigand, J. H. Noseworthy, and M. Rodriguez
Quality of Life Is Favorable for Most Patients With Multiple Sclerosis: A Population-based Cohort Study
Arch Neurol, May 1, 2004; 61(5): 679 - 686.
[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
P. Rudge
Interferon antibodies: do they alter the beneficial effects of beta-interferon upon relapse rate in multiple sclerosis?
Multiple Sclerosis, April 1, 2004; 10(2): 123 - 125.
[PDF]

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 NeurologyHome page
S. J. Pittock, W. T. Mayr, R. L. McClelland, N. W. Jorgensen, S. D. Weigand, J. H. Noseworthy, and M. Rodriguez
Disability profile of MS did not change over 10 years in a population-based prevalence cohort
Neurology, February 24, 2004; 62(4): 601 - 606.
[Abstract] [Full Text] [PDF]