Interferon-β Treatment for Multiple Sclerosis

Neurotherapeutics

Volumn 4, Issue 4, 2007, Pages 633-646

  Bermel, Robert A ^a   Rudick, Richard A ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

clinical trials; interferon; multiple sclerosis

Indexed keywords

BETA INTERFERON; BETA1A INTERFERON; INTERFERON BETA SERINE; NEUTRALIZING ANTIBODY; PLACEBO;

ANTIINFLAMMATORY ACTIVITY; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; FLU LIKE SYNDROME; HUMAN; IMAGING; IMMUNOLOGY; IN VIVO STUDY; MULTIPLE SCLEROSIS; NONHUMAN; PRIORITY JOURNAL; TREATMENT RESPONSE;

CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOLOGIC FACTORS; INTERFERON-BETA; MULTIPLE SCLEROSIS;

EID: 34848898855     PISSN: 19337213     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.nurt.2007.07.001     Document Type: Article

References (94)

1. Whetten-Goldstein K., Sloan F.A., Goldstein L.B., and Kulas E.D. A comprehensive assessment of the cost of multiple sclerosis in the United States. Mult Scler 4 (1998) 419-425
2. Charcot J.M. Histologie de la sclérose en plaques. [In French] (1868), Gazette des hôpitaux, Paris 41:554-555
3. Weinstock-Guttman B., Ransohoff R.M., Kinkel R.P., and Rudick R.A. The interferons: biological effects, mechanisms of action, and use in multiple sclerosis. Ann Neurol 37 (1995) 7-15
4. Isaacs A., and Lindenmann J. Virus interference. I. The interferon. Proc R Soc Lond B Biol Sci 147 (1957) 258-267
5. Tourtellotte W.W., Walsh M.J., Baumhefner R.W., Staugaitis S.M., and Shapshak P. The current status of multiple sclerosis intra-blood-brain-barrier IgG synthesis. Ann N Y Acad Sci 436 (1984) 52-67
6. Neighbour P.A., Miller A.E., and Bloom B.R. Interferon responses of leukocytes in multiple sclerosis. Neurology 31 (1981) 561-566
7. Panitch H.S., Hirsch R.L., Schindler J., and Johnson K.P. Treatment of multiple sclerosis with gamma interferon: exacerbations associated with activation of the immune system. Neurology 37 (1987) 1097-1102
8. Jacobs L., and Johnson K.P. A brief history of the use of interferons as treatment of multiple sclerosis. Arch Neurol 51 (1994) 1245-1252
9. Jacobs L., O'Malley J., Freeman A., Ekes R., and Reese P.A. Intrathecal interferon in multiple sclerosis. Arch Neurol 39 (1982) 609-615
10. Trapp B.D., Ransohoff R.M., Fisher E., and Rudick R.A. Neurodegeneration in multiple sclerosis: relationship to neurological disability. Neuroscientist 5 (1999) 48-57
11. Yong V.W., Chabot S., Stuve O., and Williams G. Interferon beta in the treatment of multiple sclerosis: mechanisms of action. Neurology 51 (1998) 682-689
12. Noronha A., Toscas A., and Jensen M.A. Interferon beta decreases T cell activation and interferon gamma production in multiple sclerosis. J Neuroimmunol 46 (1993) 145-153
13. Karp C.L., van Boxel-Dezaire A.H., Byrnes A.A., and Nagelkerken L. Interferon-beta in multiple sclerosis: altering the balance of interleukin-12 and interleukin-10?. Curr Opin Neurol 14 (2001) 361-368
14. Ransohoff R.M. Biological responses to type I interferons: relationship to therapeutic effects in multiple sclerosis (2003), Martin Dunitz, London
15. Stone L.A., Frank J.A., Albert P.S., et al. The effect of interferon-beta on blood-brain barrier disruptions demonstrated by contrast-enhanced magnetic resonance imaging in relapsing-remitting multiple sclerosis. Ann Neurol 37 (1995) 611-619
16. Calabresi P.A., Tranquill L.R., Dambrosia J.M., et al. Increases in soluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b. Ann Neurol 41 (1997) 669-674
17. Petereit H.F., Nolden S., Schoppe S., Bamborschke S., Pukrop R., and Heiss W.D. Low interferon gamma producers are better treatment responders: a two-year follow-up of interferon beta-treated multiple sclerosis patients. Mult Scler 8 (2002) 492-494
18. Killestein J., Hintzen R.Q., Uitdehaag B.M., et al. Baseline T cell reactivity in multiple sclerosis is correlated to efficacy of interferon-beta. J Neuroimmunol 133 (2002) 217-224
19. Bielekova B., and Martin R. Development of biomarkers in multiple sclerosis. Brain 127 (2004) 1463-1478
20. Wandinger K.P., Lunemann J.D., Wengert O., et al. TNF-related apoptosis inducing ligand (TRAIL) as a potential response marker for interferon-beta treatment in multiple sclerosis. Lancet 361 (2003) 2036-2043
21. Alam J., Goelz S., Rioux P., et al. Comparative pharmacokinetics and pharmacodynamics of two recombinant human interferon beta-1a (IFNβ-1a) products administered intramuscularly in healthy male and female volunteers. Pharm Res 14 (1997) 546-549
22. Siddiqui M.A., and Wellington K. Intramuscular interferon-beta-1a: in patients at high risk of developing clinically definite multiple sclerosis. CNS Drugs 19 (2005) 55-61 discussion 63-64
23. 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 43 (1993) 655-661
24. IFNB Multiple Sclerosis Study Group, and 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 45 (1995) 1277-1285
25. Jacobs L.D., Cookfair D.L., Rudick R.A., et al., Multiple Sclerosis Collaborative Research Group (MSCRG). Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 39 (1996) 285-294
26. PRISMS (Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 352 (1998) 1498-1504 Erratum in: Lancet 1999;353:678
27. PRISMS Study Group, and University of British Columbia MS/MRI Analysis Group. PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 56 (2001) 1628-1636
28. Schwid S.R., and Bever Jr. C.T. The cost of delaying treatment in multiple sclerosis: what is lost is not regained. Neurology 56 (2001) 1620
29. McDonald W.I., Compston A., Edan G., et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the international panel on the diagnosis of multiple sclerosis. Ann Neurol 50 (2001) 121-127
30. Jacobs L.D., Beck R.W., Simon J.H., et al., CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. N Engl J Med 343 (2000) 898-904
31. Kinkel R.P., Kollman C., O'Connor P., et al. IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology 66 (2006) 678-684
32. Comi G., Filippi M., Barkhof F., et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 357 (2001) 1576-1582
33. Filippi M., Rovaris M., Inglese M., et al. Interferon beta-1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet 364 (2004) 1489-1496
34. Kappos L., Polman C.H., Freedman M.S., et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 67 (2006) 1242-1249
35. Lublin F.D., Reingold S.C., and National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Defining the clinical course of multiple sclerosis: results of an international survey. Neurology 46 (1996) 907-911
36. European Study Group on Interferon Beta-1b in Secondary Progressive MS. Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. Lancet 352 (1998) 1491-1497
37. Panitch H., Miller A., Paty D., Weinshenker B., and North American Study Group on Interferon beta-1b in Secondary Progressive MS. Interferon beta-1b in secondary progressive MS: results from a 3-year controlled study. Neurology 63 (2004) 1788-1795
38. Kappos L., Weinshenker B., Pozzilli C., et al., European (EU-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent Advisory Board, North American (NA-SPMS) Interferon beta-1b in Secondary Progressive Multiple Sclerosis Trial Steering Committee and Independent Advisory Board. Interferon beta-1b in secondary progressive MS: a combined analysis of the two trials. Neurology 63 (2004) 1779-1787
39. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: clinical results. Neurology 56 (2001) 1496-1504
40. Li D.K., Zhao G.J., Paty D.W., University of British Columbia MS/MRI Analysis Research Group, and SPECTRIMS Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology 56 (2001) 1505-1513
41. Andersen O., Elovaara I., Färkkilä M., et al. Multicentre, randomised, double blind, placebo controlled, phase III study of weekly, low dose, subcutaneous interferon beta-1a in secondary progressive multiple sclerosis. J Neurol Neurosurg Psychiatry 75 (2004) 706-710
42. Cohen J.A., Cutter G.R., Fischer J.S., et al., IMPACT investigators. Benefit of interferon beta-1a on MSFC progression in secondary progressive MS. Neurology 59 (2002) 679-687
43. Cohen J.A., Cutter G.R., Fischer J.S., et al. Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial. Arch Neurol 58 (2001) 961-967
44. Leary S.M., Miller D.H., Stevenson V.L., Brex P.A., Chard D.T., and Thompson A.J. Interferon beta-1a in primary progressive MS: an exploratory, randomized, controlled trial. Neurology 60 (2003) 44-51
45. Banwell B., Reder A.T., Krupp L., et al. Safety and tolerability of interferon beta-1b in pediatric multiple sclerosis. Neurology 66 (2006) 472-476
46. Waubant E., Hietpas J., Stewart T., et al. Interferon beta-1a in children with multiple sclerosis is well tolerated. Neuropediatrics 32 (2001) 211-213
47. Mikaeloff Y., Moreau T., Debouverie M., et al. Interferon-beta treatment in patients with childhood-onset multiple sclerosis. J Pediatr 139 (2001) 443-446
48. Ghezzi A., Ruggieri M., Trojano M., et al. Italian studies on early-onset multiple sclerosis: the present and the future. Neurol Sci 25 Suppl 4 (2004) S346-S349
49. Pohl D., Rostasy K., Gartner J., and Hanefeld F. Treatment of early onset multiple sclerosis with subcutaneous interferon beta-1a. Neurology 64 (2005) 888-890
50. Tenembaum S.N., and Segura M.J. Interferon beta-1a treatment in childhood and juvenile-onset multiple sclerosis. Neurology 67 (2006) 511-513
51. Pohl D., Waubant E., Banwell B., et al. Treatment of pediatric multiple sclerosis and variants. Neurology 68 (2007) S54-S65
52. Lucchinetti C.F., Mandler R.N., McGavern D., et al. A role for humoral mechanisms in the pathogenesis of Devic's neuromyelitis optica. Brain 125 (2002) 1450-1461
53. Papeix C., Vidal J.S., de Seze J., et al. Immunosuppressive therapy is more effective than interferon in neuromyelitis optica. Mult Scler 13 (2007) 256-259
54. Warabi Y., Matsumoto Y., and Hayashi H. Interferon beta-1b exacerbates multiple sclerosis with severe optic nerve and spinal cord demyelination. J Neurol Sci 252 (2007) 57-61
55. Biogen Idec. Product information: Avonex®, interferon beta-1a (2007), Biogen Idec, Cambridge, MA
56. Serono. Product information: Rebif®, interferon beta-1a (2007), Serono, Geneva
57. Berlex Laboratories. Product information: Betaseron®, interferon beta-1b (2007), Berlex Laboratories, Montville, NJ
58. Bayas A., and Rieckmann P. Managing the adverse effects of interferon-beta therapy in multiple sclerosis. Drug Saf 22 (2000) 149-159
59. Frohman E.M., Brannon K., Alexander S., et al. Disease modifying agent related skin reactions in multiple sclerosis: prevention, assessment, and management. Mult Scler 10 (2004) 302-307
60. Tremlett H., and Oger J. Hepatic injury, liver monitoring and the beta-interferons for multiple sclerosis. J Neurol 251 (2004) 1297-1303
61. Tremlett H.L., Yoshida E.M., and Oger J. Liver injury associated with the beta-interferons for MS: a comparison between the three products. Neurology 62 (2004) 628-631
62. Durelli L., Verdun E., Barbero P., et al., Independent Comparison of Interferon (INCOMIN) Trial Study Group. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 359 (2002) 1453-1460
63. Noseworthy J.H., Ebers G.C., Vandervoort M.K., Farquhar R.E., Yetisir E., and Roberts R. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 44 (1994) 16-20
64. Rask C. Comparative study of Rebif to Avonex and orphan exclusivity (2002), U.S. Department of Health and Human Services, Rockville, MD
65. Schwid S.R., Thorpe J., Sharief M., et al., EVIDENCE (Evidence of Interferon Dose-Response: European North American Comparative Efficacy) Study Group, University of British Columbia MS/MRI Research Group. Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE study. Arch Neurol 62 (2005) 785-792
66. Clanet M., Radue E.W., Kappos L., et al., European IFNbeta-1a (Avonex) Dose-Comparison Study Investigators. A randomized, double-blind, dose-comparison study of weekly interferon beta-1a in relapsing MS. Neurology 59 (2002) 1507-1517
67. Bertolotto A., Gilli F., Sala A., et al. Persistent neutralizing antibodies abolish the interferon beta bioavailability in MS patients. Neurology 60 (2003) 634-639
68. Rudick R.A., Simonian N.A., Alam J.A., et al., Multiple Sclerosis Collaborative Research Group (MSCRG). Incidence and significance of neutralizing antibodies to interferon beta-1a in multiple sclerosis. Neurology 50 (1998) 1266-1272
69. Polman C.H., Kappos L., Petkau J., and Thompson A. Neutralising antibodies to interferon beta during the treatment of multiple sclerosis. J Neurol Neurosurg Psychiatry 74 (2003) 1162 author reply 1162-3
70. Sorensen P.S., Ross C., Clemmesen K.M., et al. Clinical importance of neutralising antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis. Lancet 362 (2003) 1184-1191
71. Francis G.S., Rice G.P., Alsop J.C., and PRISMS Study Group. Interferon beta-1a in MS: results following development of neutralizing antibodies in PRISMS. Neurology 65 (2005) 48-55
72. Panitch H., Goodin D.S., Francis G., et al., EVIDENCE Study Group. Evidence of interferon dose-response: European North American Comparative Efficacy; University of British Columbia MS/MRI Research Group. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 59 (2002) 1496-1506
73. Perini P., Facchinetti A., Bulian P., et al. Interferon-beta (INF-β) antibodies in interferon-β1a- and interferon-β1b-treated multiple sclerosis patients: prevalence, kinetics, cross-reactivity, and factors enhancing interferon-beta immunogenicity in vivo. Eur Cytokine Netw 12 (2001) 56-61
74. Goodin D.S., Frohman E.M., Hurwitz B., et al. Neutralizing antibodies to interferon beta: 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 (2007) 977-984
75. Fisher E., Rudick R.A., Cutter G., et al. Relationship between brain atrophy and disability: an 8-year follow-up study of multiple sclerosis patients. Mult Scler 6 (2000) 373-377
76. Rudick R.A. Impact of disease-modifying therapies on brain and spinal cord atrophy in multiple sclerosis [Review]. J Neuroimaging 14 (2004) 54S-64S
77. Rudick R.A., Fisher E., Lee J.C., et al., Multiple Sclerosis Collaborative Research Group. Use of the brain parenchymal fraction to measure whole brain atrophy in relapsing-remitting MS. Neurology 53 (1999) 1698-1704
78. Hardmeier M., Wagenpfeil S., Freitag P., et al. Rate of brain atrophy in relapsing MS decreases during treatment with IFNβ-1a. Neurology 64 (2005) 236-240
79. Jones C.K., Riddehough A., Li D.K.B., et al. MRI cerebral atrophy in relapsing-remitting MS: results from the PRISMS trial. [Abstract]. Neurology 56 suppl 3 (2001) A379
80. Gasperini C., Paolillo A., Giugni E., et al. MRI brain volume changes in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a. Mult Scler 8 (2002) 119-123
81. + patients. Neurology 62 (2004) 719-725
82. Molyneux P.D., Kappos L., Polman C., et al., European Study Group on Interferon Beta-1b in Secondary Progressive Multiple Sclerosis. The effect of interferon beta-1b treatment on MRI measures of cerebral atrophy in secondary progressive multiple sclerosis. Brain 123 (2000) 2256-2263
83. Yong V.W., Chabot S., Stuve O., and Williams G. Interferon beta in the treatment of multiple sclerosis: mechanisms of action. Neurology 51 (1998) 682-689
84. Biernacki K., Antel J.P., Blain M., Narayanan S., Arnold D.L., and Prat A. Interferon beta promotes nerve growth factor secretion early in the course of multiple sclerosis. Arch Neurol 62 (2005) 563-568
85. Bermel R.A., Puli S.R., Rudick R.A., et al. Prediction of longitudinal brain atrophy in multiple sclerosis by gray matter magnetic resonance imaging T2 hypointensity. Arch Neurol 62 (2005) 1371-1376
86. Rudick R.A., Cutter G.R., Baier M., et al. Estimating long-term effects of disease-modifying drug therapy in multiple sclerosis patients. Mult Scler 11 (2005) 626-634
87. Kappos L., Traboulsee A., Constantinescu C., et al. Long-term subcutaneous interferon beta-1a therapy in patients with relapsing-remitting MS. Neurology 67 (2006) 944-953
88. Ebers G., Traboulsee A., Li D., et al. Final results from the interferon beta-1b 16-year long-term follow-up study. Mult Scler 12 (2006) S228
89. Trojano M., Pellegrini F., Fuiani A., et al. New natural history of interferon-beta-treated relapsing multiple sclerosis. Ann Neurol 61 (2007) 300-306
90. Bell C., Graham J., Earnshaw S., Oleen-Burkey M., Castelli-Haley J., and 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 (2007) 245-261
91. Kobelt G., Jönsson L., and Fredrikson S. Cost-utility of interferon beta1b in the treatment of patients with active relapsing-remitting or secondary progressive multiple sclerosis. Eur J Health Econ 4 (2003) 50-59
92. Phillips C.J. The cost of multiple sclerosis and the cost effectiveness of disease-modifying agents in its treatment. CNS Drugs 18 (2004) 561-574
93. Coyle P.K., and Johnson K.P. Relapses matter: the costs & consequences of multiple sclerosis relapses. J Neurol Sci 256 Suppl 1 (2007) S1-S4
94. Chilcott J., McCabe C., Tappenden P., et al., Cost Effectiveness of Multiple Sclerosis Therapies Study Group. Modelling the cost effectiveness of interferon beta and glatiramer acetate in the management of multiple sclerosis. Commentary: evaluating disease modifying treatments in multiple sclerosis. BMJ 326 (2003) 522 discussion 522