Glatiramer acetate in multiple sclerosis

Expert Review of Neurotherapeutics

Volumn 5, Issue 4, 2005, Pages 451-458

  Mezzapesa, Domenico M ^a   Rovaris, Marco ^a   Filippi, Massimo ^a  

^a SAN RAFFAELE HOSPITAL   (Italy)

Author keywords

Glatiramer acetate; Immunomodulation; Multiple sclerosis

Indexed keywords

AZATHIOPRINE; CYCLOPHOSPHAMIDE; GADOLINIUM; GLATIRAMER; IMMUNOSUPPRESSIVE AGENT; METHOTREXATE; MITOXANTRONE; RECOMBINANT BETA INTERFERON;

ANXIETY; ARTHRALGIA; ASTHENIA; CLINICAL TRIAL; DEPRESSION; DISEASE ACTIVITY; DOSE RESPONSE; DRUG APPROVAL; DRUG EFFICACY; DRUG FEVER; DRUG METABOLISM; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DYSPNEA; EDEMA; ERYTHEMA; FLU LIKE SYNDROME; FLUSHING; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEART PALPITATION; HEMATOLOGIC DISEASE; HUMAN; IMMUNOMODULATION; INFECTION; INFLAMMATION; INJECTION SITE REACTION; LIPOATROPHY; LIVER TOXICITY; MULTIPLE SCLEROSIS; MUSCLE HYPERTONIA; NAUSEA; NEUROPROTECTION; NUCLEAR MAGNETIC RESONANCE IMAGING; PAIN; PARESTHESIA; PATHOGENESIS; PRURITUS; RELAPSE; REVIEW; SIDE EFFECT; TACHYCARDIA; THORAX PAIN; TREATMENT OUTCOME; VASODILATATION;

HUMANS; MAGNETIC RESONANCE IMAGING; MULTIPLE SCLEROSIS; PEPTIDES;

EID: 22544461615     PISSN: 14737175     EISSN: None     Source Type: Journal    
DOI: 10.1586/14737175.5.4.451     Document Type: Review

References (69)

1. Compston A, Matthews WB, Lassmann H, Ebers G, Wekerle H. McAlpines Multiple Sclerosis, Third Edition. Churchill Livingstone, NY, USA (1998).
2. Poser CM. The epidemiology of multiple sclerosis: a general overview. Ann. Neurol. 36 (Suppl. 2), S180-S193 (1994).
3. Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National MS Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology 46, 907-911 (1996).
4. Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology 61 (11), 1528-1532 (2003).
5. Confavreux C, Vukusic S, Moreau T, Adeleine P. Relapse and progression of disability in multiple sclerosis. N. Engl. J. Med. 343, 1430-1438 (2000).
6. Thompson AJ, Polman CH, Miller DH et al. Primary progressive multiple sclerosis. Brain 120, 1085-1096 (1997).
7. Steinman L. Multiple sclerosis: a two-stage disease. Nature Immunol. 2(9), 762-764 (2001).
8. Lucchinetti C, Bruck W, Noseworthy J. Multiple sclerosis: recent developments in neuropathology, pathogenesis, magnetic resonance imaging studies and treatment. Curr. Opin. Neurol. 14(3), 259-269 (2001).
9. Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N. Engl. J. Med. 338(5), 278-285 (1998).
10. Miller D, Barkhof F, Montalban X, Thompson A, Filippi M. Clinically isolated syndromes suggestive of multiple sclerosis, Part I: natural history, pathogenesis, diagnosis, and prognosis. Lancet Neurol. 4(5), 281-288 (2005).
11. Inglese M, Benedetti B, Filippi M. The relation between MRI measures of inflammation and neurodegeneration in multiple sclerosis. J. Neurol. Sci. 233, 15-19 (2005).
12. 1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet 364 (9444), 1489-1496 (2004).
13. Hemmer B, Archelos JJ, Hartung HP. New concepts in the immunopathogenesis of multiple sclerosis. Nature Rev. Neurosci. 3(4), 291-301 (2002).
14. Comi G. Why treat early multiple sclerosis patients? Curr. Opin. Neurol. 13(3), 235-240 (2000).
15. Weiner H. Immunosuppressive treatment in multiple sclerosis. J. Neurol. Sci. 223, 1-11 (2004).
16. Trapp BD, Ransohoff R, Rudick R. Axonal pathology in multiple sclerosis: relationship to neurologic disability. Curr. Opin. Neurol. 12(3), 295-302 (1999).
17. Filippi M, Bozzali M, Rovaris M et al. Evidence for widespread axonal damage at the earliest clinical stage of multiple sclerosis. Brain 126(2), 433-437 (2003).
18. Bjartmar C, Trapp BD. Axonal and neuronal degeneration in multiple sclerosis: mechanisms and functional consequences. Curr. Opin. Neurol. 14(3), 271-278 (2001).
19. Schwartz M, Kipnis J. Multiple sclerosis as a by-product of the failure to sustain protective autoimmunity: a paradigm shift. Neuroscientist 8 (5), 405-413 (2002).
20. Hauben E, Nevo U, Yoles E et al. Autoimmune T-cells as potential neuroprotective therapy for spinal cord injury. Lancet 355 (9200), 286-287 (2000).
21. Moalem G, Leibowitz-Amit R, Yoles E, Mor F, Cohen IR, Schwartz M. Autoimmune T-cells protect neurons from secondary degeneration after central nervous system axotomy. Nature Med. 5(1), 49-55 (1999).
22. Kerschensteiner M, Stadelmann C, Dechant G, Wekerle H, Hohlfeld R. Neurotrophic cross-talk between the nervous and immune systems: implications for neurological diseases. Ann. Neurol. 53(3), 292-304 (2003).
23. Stadelmann C, Kerschensteiner M, Misgeld T, Bruck W, Hohlfeld R, Lassmann H. BDNF and gp145trkB in multiple sclerosis brain lesions: neuroprotective interactions between immune and neuronal cells? Brain 125 (1), 75-85 (2002).
24. Martino G, Adorini L, Rieckmann P et al. Inflammation in multiple sclerosis: the good, the bad, and the complex. Lancet Neurol. 1 (8), 499-509 (2002).
25. Neuhaus O, Kieseier BC, Hartung HP. Mitoxantrone (Novantrone) in multiple sclerosis: new insight. Expert Rev. Neurotherapeutics 4, 17-26 (2004).
26. Jacobs LD, Beck RW, Simon JH et al. Intramuscular interferon beta-1 a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N. Engl. J. Med. 343 (13), 898-904 (2000).
27. Comi G, Filippi M, Barkhof F et al. Early Treatment of Multiple Sclerosis Study Group. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 357 (9268), 1576-1582 (2001).
28. Teitelbaum D, Meshorer A, Hirshfeld T, Arnon R, Sela M. Suppression of experimental allergic encephalomyelitis by a synthetic polypeptide. Eur. J. Immunol. 1(4), 242-248 (1971).
29. Arnon R. The development of Cop 1 (Copaxone), an innovative drug for the treatment of multiple sclerosis: personal reflections. Immunol. Lett. 50 (1-2), 1-15 (1996).
30. Fridkis-Hareli M, Neveu JM, Robinson RA et al. Binding motifs of copolymer 1 to multiple sclerosis- and rheumatoid arthritis-associated HLA-DR molecules. J. Immunol. 162(8), 4697-4704 (1999).
31. Smith KJ, Pyrdol J, Gauthier L, Wiley DC, Wucherpfennig KW. Crystal structure of HLA-DR2 (DRA*0101, DRB1*1501) complexed with a peptide from human myelin basic protein. J. Exp. Med. 188 (8), 1511-1520 (1998).
32. Arnon R, Sela M. Immunomodulation by the copolymer glatiramer acetate. J. Mol. Recognit. 16 (6), 412-421 (2003). Comprehensive and thoughtful review of the mechanisms of action of glatiramer acetate in multiple sclerosis.
33. Arnon R, Sela M, Teitelbaum D. New insights into the mechanism of action of copolymer 1 in experimental allergic encephalomyelitis and multiple sclerosis. J. Neurol. 243 (4 Suppl. 1), S8-S13 (1996).
34. Aharoni R, Teitelbaum D, Arnon R, Sela M. Copolymer 1 acts against the immunodominant epitope 82-100 of myelin basic protein by T-cell receptor antagonism in addition to major histocompatibility complex blocking. Proc. Natl Acad. Sci. 96 (2), 634-639 (1999).
35. Neuhaus O, Farina C, Wekerle H, Hohlfeld R. Mechanisms of action of glatiramer acetate in multiple sclerosis. Neurology 56 (6), 702-708 (2001).
36. Chen M, Gran B, Costello K, Johnson K, Martin R, Dhib-Jalbut S. Glatiramer acetate induces a Th2-biased response and crossreactivity with myelin basic protein in patients with MS. Mult. Scler. 7, 209-219 (2001).
37. Brenner T, Arnon R, Sela A et al. Humoral and cellular immune responses to Copolymer 1 in multiple sclerosis patients treated with Copaxone. J. Neuroimmunol. 115, 152-160 (2001).
38. Biernacki K, Prat A, Blain M, Antel JP. Regulation of Th1 and Th2 lymphocyte migration by human adult brain endothelial cells. J. Neuropathol. Exp. Neurol. 60, 1127-1136 (2001).
39. Kreitman RR, Blanchette F. On the horizon: possible neuroprotective role for glatiramer acetate. Mult. Scler. 10, S81-S89 (2004). Evidence suggesting a neuroprotective role of glatiramer acetate in multiple sclerosis is extensively reviewed in this paper.
40. Ziemssen T, Kumpfel T, Klinkert WE, Heuhaus O, Hohlfeld R. Glatiramer acetate-specific T-helper 1- and 2-type cell lines produce BDNF: implications for multiple sclerosis therapy. Brain-derived neurotrophic factor. Brain 125, 2381-2391 (2002).
41. Johnson KP, US Phase III Copolymer 1 Study Group. Antibodies to copolymer 1 do not interfere with its clinical effect. Ann. Neurol. 38, 973 (1995).
42. Teitelbaum D, Brenner T, Abramsky O et al. Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy. Mult. Scler. 9, 592-599 (2003).
43. Salama HH, Hong J, Zang YCQ, El-Mongui A, Zhang J. Blocking effects of serum reactive antibodies induced by glatiramer acetate treatment in multiple sclerosis. Brain 126, 2638-2647 (2003).
44. Bornstein M, Miller A, Slagle S et al. A pilot trial of GA in exacerbating-remitting multiple sclerosis. N. Engl. J. Med. 317, 408-414 (1987). Report of the results of the first randomized, controlled, double-blind trial of glatiramer acetate in multiple sclerosis.
45. 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. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 45(7), 1268-1276 (1995). Complete report of the US Phase III trial of glatiramer acetate in multiple sclerosis, which was the longest ever organized clinical trial of this disease.
46. Johnson KP, Brooks BR, Cohen JA et al. Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Copolymer 1 Multiple Sclerosis Study Group. Neurology 50 (3), 701-708 (1998).
47. Comi G, Filippi M, Wolinsky JS. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. European/Canadian Glatiramer Acetate Study Group. Ann. Neurol. 49 (3), 290-297 (2001). Final report of the European/Canadian Phase III trial of glatiramer acetate in multiple sclerosis, where magnetic resonance imaging results confirmed previous evidence of treatment efficacy on the inflammatory component of the disease.
48. Martinelli Boneschi F, Rovaris M, Johnson KP et al. Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trials. Mult. Scler. 9 (4), 349-355 (2003).
49. Wolinsky JS, Johnson KP, Comi G et al. The effects of glatiramer acetate on sustained accumulated disability in relapsing multiple sclerosis are evident within one year: meta-analysis results of three double blind, placebo-controlled trials. Proceedings of the 19th Annual Meeting of the European Committee for Treatment and Research in MS (ECTRIMS), Milan, Italy (2003) (Abstract 487).
50. Johnson KP, Brooks BR, Ford CC et al. Glatiramer acetate (Copaxone): comparison of continuous versus delayed therapy in a six-year organized multiple sclerosis trial. Mult. Scler. 9, 585-591 (2003).
51. Johnson KP, Ford CC, Lisak RP et al. Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data. Acta Neurol. Scand. 111, 42-47 (2005).
52. Wolinsky JS for the PROMiSe Trial Study Group. The PROMiSe trial: baseline data review and progress report. Mult. Scler. 10 (Suppl. 1), S65-S72 (2004).
53. Wolinsky JS, Pardo L, Stark Y et al. and the PROMiSe Study Group. Effect of glatiramer acetate on primary progressive multiple sclerosis: initial analysis of the completed PROMiSe trial. Neurology 62 (Suppl. 5), A97-A98 (2004).
54. Mancardi GL, Sardanelli F, Parodi RC et al. Effect of copolymer-1 on serial gadolinium-enhanced MRI in relapsing remitting multiple sclerosis. Neurology 50 (4), 1127-1133 (1998).
55. Ge Y, Grossman RI, Udupa JK et al. Glatiramer acetate (Copaxone) treatment in relapsing-remitting MS: quantitative MR assessment. Neurology 54(4), 813-817 (2000).
56. Wolinsky JS, Narayana PA, Johnson KP. United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates. Multiple Sclerosis Study Group and the MRI Analysis Center. Mult. Scler. 7(1), 33-41 (2001). Cross-sectional clinical and magnetic resonance imaging evaluation of patients participating in the open-label extension of the US glatiramer acetate trial, supporting the notion of the sustained treatment efficacy and safety of glatiramer acetate.
57. Wolinsky JS, Comi G, Filippi M, Ladkani D, Kadosh S, Shifroni G (European/Canadian Glatiramer Acetate Study Group). Copaxone's effect on MRI-monitored disease in relapsing MS is reproducible and sustained. Neurology 59 (8), 1284-1286 (2002).
58. Filippi M, Rovaris M, Capra R et al. A multi-centre longitudinal study comparing the sensitivity of monthly MRI after standard and triple dose gadolinium-DTPA for monitoring disease activity in multiple sclerosis. Implications for Phase II clinical trials. Brain 121, 2011-2020 (1998).
59. Rovaris M, Codella M, Moiola L et al. Effect of glatiramer acetate on MS lesions enhancing at different gadolinium doses. Neurology 59 (9), 1429-1432 (2002).
60. Filippi M, Rovaris M, Rocca MA, Sormani MP, Wolinsky JS, Comi G and the European/Canadian Glatiramer Acetate Study Group. Glatiramer acetate reduces the proportion of new MS lesions evolving to black holes. Neurology 57, 731-733 (2001).
61. Wolinsky JS, Narayana PA, Johnson BCP. United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates. Multiple Sclerosis Study Group and the MRI Analysis Center. Mult. Scler. 7(1), 33-41 (2001).
62. Rovaris M, Comi G, Rocca MA, Wolinsky JS, Filippi M (European/Canadian Glatiramer Acetate Study Group). Short-term brain volume change in relapsing-remitting multiple sclerosis: effect of glatiramer acetate and implications. Brain 124, 1803-1812 (2001).
63. Sormani MP, Rovaris M, Valsasina P, Wolinsky JS, Comi G, Filippi M. Measurement error of two different techniques for brain atrophy assessment in multiple sclerosis. Neurology 62 (8), 1432-1434 (2004).
64. 1b (Betaseron), and glatiramer acetate (Copaxone) on the relapse rate in relapsing-remitting multiple sclerosis. Eur. J. Neurol. 8, 141-148 (2001).
65. 1b (Betaseron), and glatiramer acetate (Copaxone) on the relapse rate in relapsing-remitting multiple sclerosis: results after 18 months of therapy. Mult. Scler. 7, 349-353 (2001).
66. Carra A, Onaha P, Sinay V et al. A retrospective observational study comparing the four available immunomodulatory treatments for relapsing-remitting multiple sclerosis. Eur. J. Neurol. 10, 671-676 (2003).
67. Mancardi GL, Murialdo A, Drago F et al. Localized lipoatrophy after prolonged treatment with copolymer 1. J. Neurol. 247 (3), 220-221 (2000).
68. Hwang L, Orengo I. Lipoatrophy associated with glatiramer acetate injections for the treatment of multiple sclerosis. Cutis 68 (4), 287-288 (2001).
69. Coyle PK, Johnson KP, Pardo L, Stark Y. Pregnancy outcomes in patients with multiple sclerosis treated with glatiramer acetate (Copaxone). Proceedings of the 19th Annual Meeting of the European Committee for Treatment and Research in MS (ECTRIMS). Milan, Italy (2003) (Abstract 268).