Disease-modifying agents in the treatment of multiple sclerosis: A review of long-term outcomes

CNS and Neurological Disorders - Drug Targets

Volumn 8, Issue 6, 2009, Pages 512-519

  Katrych, Oleksandra ^a   Simone, Tessa M ^a   Azad, Shara ^a   Mousa, Shaker A ^a  

^a ALBANY COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

Author keywords

Demylinating; Disease modifying agents; Glatiramer acetate; Interferon; Multiple sclerosis; Relapse

Indexed keywords

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

ANXIETY; CHEST TIGHTNESS; CLINICAL EVALUATION; CLINICAL TRIAL; COHORT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DISEASE COURSE; DRUG EFFECT; DRUG WITHDRAWAL; DYSPNEA; EXPANDED DISABILITY STATUS SCALE; FLUSHING; HEART PALPITATION; HUMAN; INJECTION SITE REACTION; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PATHOGENESIS; PATIENT MONITORING; PROSPECTIVE STUDY; RELAPSE; REVIEW; RISK REDUCTION; SIDE EFFECT; TREATMENT DURATION; TREATMENT FAILURE;

CLINICAL TRIALS, PHASE III AS TOPIC; COHORT STUDIES; DOUBLE-BLIND METHOD; HUMANS; IMMUNOLOGIC FACTORS; INTERFERON-BETA; MAGNETIC RESONANCE IMAGING; MULTIPLE SCLEROSIS; PEPTIDES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 75849157991     PISSN: 18715273     EISSN: None     Source Type: Journal    
DOI: 10.2174/187152709789824598     Document Type: Review

References (50)

1. Noseworthy, J.H.; Lucchinetti, C.; Rodriguez, M.; Weinshenker, B.G. Multiple sclerosis. N. Engl. J. Med., 2000, 343(13), 938-952.
2. Anderson, D.W.; Ellenberg, J.H.; Leventhal, C.M.; Reingold, S.C.; Rodriguez, M.; Silberberg, D.H. Revised estimate of the prevalence of multiple sclerosis in the United States. Ann. Neurol., 1992, 31(3), 333-336.
3. Noonan, C.W.; Kathman, S.J.; White, M.C. Prevalence estimates for MS in the United States and evidence of an increasing trend for women. Neurology, 2002, 58(1), 136-138.
4. Hernan, M.A.; Olek, M.J.; Ascherio, A. Cigarette smoking and incidence of multiple sclerosis. Am. J. Epidemiol., 2001, 154(1), 69-74.
5. Pugliatti, M.; Harbo, H.F.; Holmoy, T.; Kampman, M.T.; Myhr, K.M.; Riise, T.; Wolfson, C. Environmental risk factors in multiple sclerosis. Acta Neurol. Scand. Suppl., 2008, 188, 34-40.
6. Levin, L.I.; Munger, K.L.; Rubertone, M.V.; Peck, C.A.; Lennette, E.T.; Spiegelman, D.; Ascherio, A. Temporal relationship between elevation of epstein-barr virus antibody titers and initial onset of neurological symptoms in multiple sclerosis. JAMA, 2005, 293(20), 2496-2500.
7. Ascherio, A.; Munger, K.L.; Lennette, E.T.; Spiegelman, D.; Hernan, M.A.; Olek, M.J.; Hankinson, S.E.; Hunter, D.J. Epstein-Barr virus antibodies and risk of multiple sclerosis: a prospective study. JAMA, 2001, 286(24), 3083-3088.
8. Hauser, S.L.; Oksenberg, J.R. The neurobiology of multiple sclerosis: genes, inflammation, and neurodegeneration. Neuron, 2006, 52(1), 61-76.
9. Weinshenker, B.G.; Sibley, W.A. Natural history and treatment of multiple sclerosis. Curr. Opin. Neurol. Neurosurg., 1992, 5(2), 203-211.
10. Kurtzke, J.F. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology, 1983, 33(11), 1444-1452.
11. Kurtzke, J.F. Natural history and clinical outcome measures for multiple sclerosis studies. Why at the present time does EDSS scale remain a preferred outcome measure to evaluate disease evolution? Neurol. Sci., 2000, 21(6), 339-341.
12. Pittock, S.J.; Mayr, W.T.; Mcclelland, R.L.; Jorgensen, N.W.; Weigand, S.D.; Noseworthy, J.H.; Weinshenker, B.G.; Rodriguez, M. Change in MS-related disability in a population-based cohort: a 10-year follow-up study. Neurology, 2004, 62(1), 51-59.
13. Kappos, L.; Moeri, D.; Radue, E.W.; Schoetzau, A.; Schweikert, K.; Barkhof, F.; Miller, D.; Guttmann, C.R.; Weiner, H.L.; Gasperini, C.; Filippi, M.; Gadolinium MRI Meta-analysis Group. Predictive value of gadolinium-enhanced magnetic resonance imaging for relapse rate and changes in disability or impairment in multiple sclerosis: a meta-analysis. Lancet, 1999, 353(9157), 964-969.
14. Held, U.; Heigenhauser, L.; Shang, C.; Kappos, L.; Polman, C. Predictors of relapse rate in MS clinical trials. Neurology, 2005, 65(11), 1769-1773.
15. McDonald, W.I.; Compston, A.; Edan, G.; Goodkin, D.; Hartung, H.P.; Lublin, F.D.; Mcfarland, H.F.; Paty, D.W.; Polman, C.H.; Reingold, S.C.; Sandberg-Wollheim, M.; Sibley, W.; Thompson, A.; Van Den Noort, S.; Weinshenker, B.Y.; Wolinsky, J.S. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann. Neurol., 2001, 50(1), 121-127.
16. Young, P.J.; Lederer, C.; Eder, K.; Daumer, M.; Neiss, A.; Polman, C.; Kappos, L. Relapses and subsequent worsening of disability in relapsing-remitting multiple sclerosis. Neurology, 2006, 67(5), 804-808.
17. Confavreux, C.; Vukusic, S.; Moreau, T.; Adeleine, P. Relapses and progression of disability in multiple sclerosis. N. Engl. J. Med., 2000, 343(20), 1430-1438.
18. Chataway, J.; Feakes, R.; Coraddu, F.; Gray, J.; Deans, J.; Fraser, M.; Robertson, N.; Broadley, S.; Jones, H.; Clayton, D.; Goodfellow, P.; Sawcer, S.; Compston, A. The genetics of multiple sclerosis: principles, background and updated results of the United Kingdom systematic genome screen. Brain, 1998, 121(Pt 10), 1869-1887.
19. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I: clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology, 1993, 43(4), 655-661.
20. Lublin, F.D.; Baier, M.; Cutter, G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology, 2003, 61(11), 1528-1532.
21. Bornstein, M.B.; Miller, A.; Slagle, S.; Weitzman, M.; Crystal, H.; Drexler, E.; Keilson, M.; Merriam, A.; Wassertheil-Smoller, S.; Spada, V.; Weiss, W.; Arnon, R.; Jacobson, I.; Teitelbaum, D.; Sela, M. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N. Engl. J. Med., 1987, 317(7), 408-414.
22. Miller, D.H.; Grossman, R.I.; Reingold, S.C.; Mcfarland, H.F. The role of magnetic resonance techniques in understanding and managing multiple sclerosis. Brain, 1998, 121(Pt 1), 3-24.
23. Weinshenker, B.G.; Bass, B.; Rice, G.P.; Noseworthy, J.; Carriere, W.; Baskerville, J.; Ebers, G.C. The natural history of multiple sclerosis: a geographically based study. I: clinical course and disability. Brain, 1989, 112(Pt 1), 133-146.
24. Weinshenker, B.G.; Rice, G.P.; Noseworthy, J.H.; Carriere, W.; Baskerville, J.; Ebers, G.C. The natural history of multiple sclerosis: a geographically based study. 3: multivariate analysis of predictive factors and models of outcome. Brain, 1991, 114(Pt 2), 1045-1056.
25. Weinshenker, B.G.; Rice, G.P.; Noseworthy, J.H.; Carriere, W.; Baskerville, J.; Ebers, G.C. The natural history of multiple sclerosis: a geographically based study. 4: applications to planning and interpretation of clinical therapeutic trials. Brain, 1991, 114(Pt 2), 1057-1067.
26. Weinshenker, B.G.; Bass, B.; Rice, G.P.; Noseworthy, J.; Carriere, W.; Baskerville, J.; Ebers, G.C. The natural history of multiple sclerosis: a geographically based study. 2: predictive value of the early clinical course. Brain, 1989, 112(Pt 6), 1419-1428.
27. Whetten-Goldstein, K.; Sloan, F.A.; Goldstein, L.B.; Kulas, E.D. A comprehensive assessment of the cost of multiple sclerosis in the United States. Mult. Scler., 1998, 4(5), 419-425.
28. Henriksson, F.; Fredrikson, S.; Masterman, T.; Jonsson, B. Costs, quality of life and disease severity in multiple sclerosis: a cross-sectional study in Sweden. Eur. J. Neurol., 2001, 8(1), 27-35.
29. Phillips, C.J. The cost of multiple sclerosis and the cost effectiveness of disease-modifying agents in its treatment. CNS Drugs, 2004, 18(9), 561-574.
30. 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., 2007, 13(3), 245-261.
31. Amato, M.P. Pharmacoeconomic considerations of multiple sclerosis therapy with the new disease-modifying agents. Expert Opin. Pharmacother., 2004, 5(10), 2115-2126.
32. Truyen, L.; Van Waesberghe, J.H.; Van Walderveen, M.A.; Van Oosten, B.W.; Polman, C.H.; Hommes, O.R.; Ader, H.J.; Barkhof, F. Accumulation of hypointense lesions ("black holes") on T1 spin-echo MRI correlates with disease progression in multiple sclerosis. Neurology, 1996, 47(6), 1469-1476.
33. Clegg, A.; Bryant, J.; Milne, R. Disease-modifying drugs for multiple sclerosis: a rapid and systematic review. Health Technol. Assess., 2000, 4(9), 1-101.
34. Bertolotto, A.; Deisenhammer, F.; Gallo, P.; Solberg S.P. Immunogenicity of interferon beta: differences among products. J. Neurol., 2004, 251(Suppl 2), II15-II24.
35. Paty, D.W.; Li, D.K.; UBC MS/MRI Study Group and the IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. II: MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology, 1993, 43(4), 662-667.
36. PRISMS Study Group and the University of British Columbia MS/MRI Analysis Group. PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology, 2001, 56(12), 1628-1636.
37. Kappos, L.; Traboulsee, A.; Constantinescu, C.; Eralinna, J.P.; Forrestal, F.; Jongen, P.; Pollard, J.; Sandberg-Wollheim, M.; Sindic, C.; Stubinski, B.; Uitdehaag, B.; Li, D. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology, 2006, 67(6), 944-953.
38. Manova, M.G.; Kostadinova, I.I.; Akabaliev, V.C. A clinical study of multiple sclerosis patients treated with betaferon. Folia Med. (Plovdiv.), 2008, 50(3), 24-29.
39. Comi, G.; Filippi, M.; Wolinsky, J.S.; 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., 2001, 49(3), 290-297.
40. Johnson, K.P.; Brooks, B.R.; Cohen, J.A.; Ford, C.C.; Goldstein, J.; Lisak, R.P.; Myers, L.W.; Panitch, H.S.; Rose, J.W.; Schiffer, R.B.; 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, 1995, 45(7), 1268-1276.
41. Johnson, K.P.; Brooks, B.R.; Cohen, J.A.; Ford, C.C.; Goldstein, J.; Lisak, R.P.; Myers, L.W.; Panitch, H.S.; Rose, J.W.; Schiffer, R.B.; Vollmer, T.; Weiner, L.P.; Wolinsky, J.S.; 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, 1998, 50(3), 701-708.
42. Johnson, K.P.; Brooks, B.R.; Ford, C.C.; Goodman, A.; Guarnaccia, J.; Lisak, R.P.; Myers, L.W.; Panitch, H.S.; Pruitt, A.; Rose, J.W.; Kachuck, N.; Wolinsky, J.S.; Copolymer 1 Multiple Sclerosis Study Group. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Mult. Scler., 2000, 6(4), 255-266.
43. Johnson, K.P.; Ford, C.C.; Lisak, R.P.; Wolinsky, J.S. Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data. Acta Neurol. Scand., 2005, 111(1), 42-47.
44. Ford, C.C.; Johnson, K.P.; Lisak, R.P.; Panitch, H.S.; Shifronis, G.; Wolinsky, J.S. A prospective open-label study of glatiramer acetate: over a decade of continuous use in multiple sclerosis patients. Mult. Scler., 2006, 12(3), 309-320.
45. Wolinsky, J.S.; 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, 2002, 59(8), 1284-1286.
46. Rovaris, M.; Comi, G.; Rocca, M.A.; Valsasina, P.; Ladkani, D.; Pieri, E.; Weiss, S.; Shifroni, G.; Wolinsky, J.S.; Filippi, M. 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., 2007, 13(4), 502-508.
47. Picken, M.; Cooper, C.L.; Chater, T.; O'hagan, A.; Abrams, K.R.; Cooper, N.J.; Boggild, M.; Palace, J.; Ebers, G.; Chilcott, J.B.; Tappenden, P.; Nicholl, J. The Multiple Sclerosis Risk Sharing Scheme Monitoting Study - early results and lessons for the future. BMC Neurol., 2009, 9(1), 1-9.
48. The IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology, 1995, 45(7), 1277-1285.
49. Jacobs, L.D.; Cookfair, D.L.; Rudick, R.A.; Herndon, R.M.; Richert, J.R.; Salazar, A.M.; Fischer, J.S.; Goodkin, D.E.; Granger, C.V.; Simon, J.H.; Alam, J.J.; Bartoszak, D.M.; Bourdette, D.N.; Braiman, J.; Brownscheidle, C.M.; Coats, M.E.; Cohan, S.L.; Dougherty, D.S.; Kinkel, R.P.; Mass, M.K.; Munschauer, F.E., 3rd; Priore, R.L.; Pullicino, P.M.; Scherokman, B.J.; Whitham, R.H.; Campion, M.; Wende, K.; Simonian, N. The Multiple Sclerosis Collaborative Research Group (MSCRG). Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann. Neurol., 1996, 39(3), 285-294.
50. Rudick, R.A.; Cutter, G.R.; Baier, M.; Weinstock-Guttman, B.; Mass, M.K.; Fisher, E.; Miller, D.M.; Sandrock, A.W. Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients. Mult. Scler., 2005, 11(6), 626-634.