Benefits of glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis

Expert Review of Pharmacoeconomics and Outcomes Research

Volumn 9, Issue 3, 2009, Pages 205-214

  Johnson, Kenneth P ^a,c   Due, Deborah L ^b  

^a UNIVERSITY OF MARYLAND   (United States)

^b NeuroScribe Medical Writing LLC   (United States)

^c NONE   (United States)

Author keywords

Cost effectiveness; Glatiramer acetate; IFN s; Multiple sclerosis; Natalizumab; Pharmacoeconomics; Productivity; Quality of life; Relapse rate

Indexed keywords

BETA1A INTERFERON; GLATIRAMER; INTERFERON BETA SERINE; NATALIZUMAB; PLACEBO;

ANAPHYLAXIS; ANXIETY; ARTICLE; BLOOD DYSCRASIA; CHEST TIGHTNESS; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ERYTHEMA; FLU LIKE SYNDROME; FLUSHING; HEADACHE; HEART PALPITATION; HUMAN; INFLAMMATION; INJECTION SITE INDURATION; INJECTION SITE PRURITUS; INJECTION SITE REACTION; LIPOATROPHY; LIVER TOXICITY; MULTIPLE SCLEROSIS; MYALGIA; PAIN; PRODUCTIVITY; PRURITUS; QUALITY OF LIFE; SELF REPORT; SIDE EFFECT; SKIN NECROSIS; SWELLING; TACHYCARDIA; TREATMENT OUTCOME;

ADJUVANTS, IMMUNOLOGIC; CONTROLLED CLINICAL TRIALS AS TOPIC; COST-BENEFIT ANALYSIS; HUMANS; INTERFERON-BETA; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PEPTIDES; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 68749088915     PISSN: 14737167     EISSN: 17448379     Source Type: Journal    
DOI: 10.1586/erp.09.20     Document Type: Article

References (66)

1. Alonso A, Hernan MA. Temporal trends in the incidence-of multiple sclerosis: a systematic review. Neurology 71, 129-135 (2008).
2. Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the "common" neurologic disorders? Neurology 68, 326-337(2007).
3. Ascherio A, Munger K. Epidemiology of multiple sclerosis: from risk factors to prevention. Semin. Neurol. 28, 17-28 (2008).
4. Compston A, Coles A. Multiple sclerosis. Lancet 359, 1221-1231 (2002).
5. Goodin DS, Frohman EM, Garmany CP 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 58, 169-178 (2002).
6. Dutta R, Trapp BD. Pathogenesis of axonal and neuronal damage in multiple sclerosis. Neurology 68, S22-S31; discussion S43-S54 (2007).
7. Confavreux C, Vukusic S. Natural history of multiple sclerosis: a unifying concept. Brain 129, 606-616 (2006).
8. Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch. Neurol. 58, 1602-1606 (2001).
9. NMSS. Disease management consensus statement - treatment recommendations for physicians. US Neurology Review, Touch Briefings, London, UK, 47-50 (2005).
10. Bombardier C, Maetzel A. Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies? Ann. Rheum. Dis. 58(Suppl. 1), 182-185 (1999).
11. Blanchette F, Neuhaus O. Glatiramer acetate: evidence for a dual mechanism of action. J. Neurol. 255(Suppl. 1), 26-36 (2008).
12. Bornstein MB, Miller A, Slagle S et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N. Engl. Med. 317, 408-414 (1987).
13. Johnson KP, Brooks BR, Cohen JA et al. The Copolymer 1 Multiple Sclerosis Study Group. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a Phase III multicenter, double-blind placebo-controlled trial. Neurology 45, 1268-1276 (1995).
14. Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 Multiple Sclerosis Study Group. Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Neurology 50, 701-708 (1998).
15. Comi G, Filippi M, Wolinsky JS; European/Canadian Glatiramer Acetate Study Group. 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. Ann. Neurol. 49, 290-297 (2001).
16. Ge Y, Grossman RI, Udupa JK et al. Glatiramer acetate (Copaxone) treatment in relapsing-remitting MS: quantitative MR assessment. Neurology 54, 813-817 (2000).
17. Tintore M. Early MS treatment. Int. MS J. 14, 5-10 (2007).
18. Comi G. Treatment with glatiramer acetate delays conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndromes (CIS). American Academy of Neurology 60th Annual Meeting. Chicago, IL, USA, LBS.003 (2008).
19. Boneschi FM, 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, 349-355 (200).
20. Munari L, Lovati R, Boiko A. Therapy with glatiramer acetate for multiple sclerosis. Cochrane Database Syst. Rev. 4, CDO04678 (2003).
21. Mikol DD, Barkhof F, Chang P et al. Comparison of subcutaneous interferon β-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. 7, 903-914 (2008).
22. Cadavid D, Wolansky L, Skurnick S et al. Efficacy of treatment of MS with IFNβ-1b or glatiramer acetate by monthly brain MRI in the BECOME study. Neurology (2009) (Epub ahead of print).
23. O'Connor P, Arnason B, Comi G et al. Inteferon β-1b 500mcg, interferon β-1b 250 mcg and glatiramer acetate: primary outcomes of the Bferon/Bseron Efficacy Yielding Outcomes of a New Dose study. Presented at: American Academy of Neurology 60th Annual Meeting. Chicago, IL, USA, LBS.004 (2008).
24. Wolinsky JS. The use of glatiramer acetate in the treatment of multiple sclerosis. Adv. Neurol. 98, 273-292 (2006).
25. Edgar CM, Brunet DG, Fenton P, McBride EV, Green P. Lipoatrophy in patients with multiple sclerosis on glatiramer acetate. Can. J. Neurol. Sci. 31, 58-63 (2004).
26. Johnson KP. Control of multiple sclerosis relapses with immunomodulating agents. J. Neurol. Sci. 256(Suppl. 1), S23-S28 (2007).
27. Rauschka H, Farina C, Sator P, Gudek S, Breier F, Schmidbauer M. Severe anaphylactic reaction to glatiramer acetate with specific IgE. Neurology 64, 1481-1482 (2005).
28. Ford CC, Johnson KP, Lisak RP, Panitch HS, Shifronis G, Wolinsky JS. A prospective open-label study of glatiramer acetate: over a decade of continuous use in multiple sclerosis patients. Mult. Scler. 12, 309-320 (2006).
29. Flechter S, Vardi J, Pollak L, Rabey JM. Comparison of glatiramer acetate (Copaxone) and interferon β-1b (betaferon) in multiple sclerosis patients: an open-label 2-year follow-up. J. Neurol. Sci. 197, 51-55 (2002).
30. Rolak LA, Brown S. Headaches and multiple sclerosis: a clinical study and review of the literature. J. Neurol. 237, 300-302 (1990).
31. Johnson SL. The concept of fatigue in multiple sclerosis. J. Neurosci. Nurs. 40, 72-77 (2008).
32. Pollmann W, Erasmus LP, Feneberg W, Then Bergh F, Straube A. Interferon β but not glatiramer acetate therapy aggravates headaches in MS. Neurology 59, 636-639 (2002).
33. Pollmann W, Erasmus LP, Feneberg W, Straube A. The effect of glatiramer acetate treatment on pre-existing headaches in patients with MS. Neurology 66, 275-277 (2006).
34. Metz LM, Patten SB, Archibald CJ et al. The effect of immunomodulatory treatment on multiple sclerosis fatigue. J. Neurol. Neurosurg. Psychiatr. 75, 1045-1047 (2004).
35. Hadjimichael O, Vollmer T, Oleen-Burkey M. Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey. Health Qual. Life Outcomes 6, 100 (2008).
36. Goodin DS, Frohman EM, Hurwitz B et al. Neutralizing antibodies to interferon β: 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 68, 977-984 (2007).
37. Teitelbaum D, Brenner T, Abramsky O, Aharoni R, Sela M, Arnon R. Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy. Mult. Scler. 9, 592-599 (2003).
38. Brenner T, Arnon R, Sela M et al. Humoral and cellular immune response to Copolymer 1 in multiple sclerosis patients treated with Copaxone. J. Neuroimmunol. 115, 152-160 (2001).
39. Hopman WM, Coo H, Edgar CM, McBride EV, Day AG, Brunet DG. Factors associated with health-related quality of life in multiple sclerosis. Can. J. Neurol. Sci. 34, 160-166 (2007).
40. Kobelt G, Berg J, Atherly D, Hadjimichael O. Costs and quality of life in multiple sclerosis: a cross-sectional study in the United States. Neurology 66, 1696-1702 (2006).
41. Miller A, Dishon S. Health-related quality of life in multiple sclerosis: The impact of disability, gender and employment status. Qual. Life Res. 15, 259-271 (2006).
42. Grima DT, Torrance GW, Francis G, Rice G, Rosner AJ, Lafortune L. Cost and health related quality of life consequences of multiple sclerosis. Mult. Scler. 6, 91-98 (2000).
43. Kobelt G, Berg J, Lindgren P, Fredrikson S, Jonsson B. Costs and quality of life of patients with multiple sclerosis in Europe. J. Neurol. Neurosurg. Psychiatr. 77, 918-926 (2006).
44. Johnson KP, Oleen-Burkey M, Denney D. Quality of life in multiple sclerosis: relationship between EDSS and health status. Presented at: 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis. Prague, Czech Republic, 866 (2007).
45. Oleen-Burkey M, Johnson K, Hadjimichael O, Vollmer T. Improved quality of life among patients treated long-term with glatiramer acetate. Presented at: 22nd Consortim of Multiple Sclerosis Centers Annual Meeting. Denver, CO, USA, S56 (2008).
46. Dennett S, Castelli-Haley J, Oleen-Burkey M. The impact of multiple sclerosis on patient employment: a review of the medical literature. J. Health Productivity, 12-18 (2007).
47. Lage MJ, Castelli-Haley J, Oleen-Burkey MA. Effect of immunomodulatory therapy and other factors on employment loss time in multiple sclerosis. Work 27, 143-151 (2006).
48. Ziemssen T, Hoffman J, Apfel R, Kern S. Effects of glatiramer acetate on fatigue and days of absence from work in first-time treated relapsing-remitting multiple sclerosis. Health Qual. Life Outcomes 6, 67 (2008).
49. 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, 33-41 (2001).
50. Wolinsky JS, Comi G, Filippi M, Ladkani D, Kadosh S, Shifroni G. Copaxone's effect on MRI-monitored disease in relapsing MS is reproducible and sustained. Neurology 59, 1284-1286 (2002).
51. Rovaris M, Comi G, Rocca MA et al. Long-term follow-up of patients treated with glatiramer acetate: a multicentre, multinational extension of the European/Canadian double-blind, placebo-controlled, MRI-monitored trial. Mult. Scler. 13, 502-508 (2007).
52. Mancardi GL, Sardanelli F, Parodi RC et al. Effect of copolymer-1 on serial gadolinium-enhanced MRI in relapsing remitting multiple sclerosis. Neurology 50, 1127-1133 (1998).
53. Rovaris M, Codella M, Moiola L et al. Effect of glatiramer acetate on MS lesions enhancing at different gadolinium doses. Neurology 59, 1429-1432 (2002).
54. Khan O, Shen Y, Caon C et al. Axonal metabolic recovery and potential neuroprotective effect of glatiramer acetate in relapsing-remitting multiple sclerosis. Mult. Scler. 11, 646-651 (2005).
55. Khan O, Shen Y, Bao F et al. Long-term study of brain 1H-MRS study in multiple sclerosis: effect of glatiramer acetate therapy on axonal metabolic function and feasibility of long-Term H-MRS monitoring in multiple sclerosis. J. Neuroimaging 18, 314-319 (2008).
56. Khan OA, Tselis AC, Kamholz JA, Garbern JY, Lewis RA, Lisak RP. A prospective, open-label treatment trial to compare the effect of IFNβ-1a (Avonex), IFNβ-1b (Bseron), 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).
57. Haas J, Firzlaff M. Twenty-four-month comparison of immunomodulatory treatments - a retrospective open label study in 308 RRMS patients treated with β interferons or glatiramer acetate (Copaxone). Eur. J. Neurol. 12, 425-431 (2005).
58. Castelli-Haley J, Oleen-Burkey MK, Lage MJ, Johnson KP. Glatiramer acetate versus interferon β-1a for subcutaneous administration: Comparison of outcomes among multiple sclerosis patients. Adv. Ther. 25, 658-673 (2008).
59. Ollendorf DA, Jilinskaia E, Oleen-Burkey M. Clinical and economic impact of glatiramer acetate versus β interferon therapy among patients with multiple sclerosis in a managed care population. J. Manag. Care Pharm. 8, 469-476 (2002).
60. Prescott JD, Factor S, Pill M, Levi GW. Descriptive analysis of the direct medical costs of multiple sclerosis in 2004 using administrative claims in a large nationwide database. J. Manag. Care Pharm. 13, 44-52 (2007).
61. Castelli-Haley J, Oleen-Burkey M, Lage MJ, Johnson K. Glatiramer acetate versus interferon β-1b for subcutaneous administration: a comparison of outcomes among multiple sclerosis patients. Presented at: International Society for Pharmacoeconomics and Outcomes Research 11th Annual European Congress. Athens, Greece, PND4 (2008).
62. Castelli-Haley J, Oleen-Burkey M, Lage MJ, Johnson K. Glatiramer acetate versus interferon β-1a for intramuscular administration: a comparison of outcomes among multiple sclerosis patients. Presented at: International Society for Pharmacoeconomics and Outcomes Research 11th Annual European Congress. Athens, Greece, PND6 (2008).
63. Prosser LA, Kuntz KM, Bar-Or A, Weinstein MC. Cost-effectiveness of interferon β-1a, interferon β-1b, and glatiramer acetate in newly diagnosed non-primary progressive multiple sclerosis. Value Health 7, 554-568 (2004).
64. Chilcott J, McCabe C, Tappenden P et al. Modelling the cost effectivenes of interferon β and glatiramer acetate in the management of multiple sclerosis. BMJ 326, 522 (2003).
65. Bell C, Graham J, Earnshaw S, Oleen-Burkey M, Castelli-Haley J, Johnson K. Cost-effectiveness of four immunomodulatory therapies for relapsing-remitting multiple sclerosis: a Markov model based on long-term clinical data. J. Manag. Care Pharm. 13, 245-261 (2007).
66. Graham J, Earnshaw S, Castelli-Haley J, Oleen-Burkey M, Johnson KP. Cost-effectiveness of glatiramer acetate and natalizumab in relapsing-remitting multiple sclerosis in the presence of long-term clinical evidence. Presented at: International Society for Pharmacoeconomics and Outcomes Research 10th Annual European Congress. Dublin, Ireland, 20-23 October 2007.