Review of interferon beta-1b in the treatment of early and relapsing multiple sclerosis

Biologics: Targets and Therapy

Volumn 3, Issue , 2009, Pages 369-376

  Paolicelli, Damiano ^a   Direnzo, Vita ^a   Trojano, Maria ^a  

^a UNIVERSITY OF BARI   (Italy)

Author keywords

Clinically isolated syndromes; Efficacy; Interferon beta 1b; Neutralizing antibodies; Relapsing remitting multiple sclerosis; Safety

Indexed keywords

EID: 77953458011     PISSN: 11775475     EISSN: 11775491     Source Type: Journal    
DOI: 10.2147/BTT.S4038     Document Type: Review

References (57)

1. 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;43:655-661.
2. Paty DW, Li DK. Interferon beta-1b is effective in relapsing remitting multiple sclerosis. II. MRI analysis results of a multicenter, randomized, double blind, placebo controlled trial. UBC MS/MRI Study Group and The IFN beta multiple sclerosis study group. Neurology. 1993;43:662-667.
3. 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 MS. Lancet. 1998;352:1491-1497.
4. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67: 1242-1249.
5. Kappos L, Freedman MS, Polman CH, et al. BENEFIT Study Group. Effect of early vs delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007;370:89-97.
6. Polman C, Reingold S, Edan G, et al. Diagnostic criteria for Multiple Sclerosis: 2005 Revisions to the "McDonald Criteria". Ann Neurol. 2005;58:840-846.
7. Mark DF, Lu SD, Creasey AA, Yamamoto R, Lin LS. Site-specific mutagenesis of the human fibroblast interferon gene. Proc Natl Acad Sci U S A. 1984;81:5662-5666.
8. Chiang J, Gloff CA, Yoshizawa CN, Williams GJ. Pharmacokinetics of recombinant interferon-beta ser in healthy volunteers and its effect on serum neopterin. Pharm Res. 1993;10:567-572.
9. Wills RJ. Clinical pharmacokinetics of interferons. Clin Pharmacokinet. 1990;19:390-399.
10. Noronha A, Toscas A, Jensen MA. Interferon beta decreases T cell activation and interferon gamma production in multiple sclerosis. J Neuroimmunol. 1993;46:145-153.
11. Lu HT, Riley JL, Babcock GT, et al. Interferon (IFN) beta acts downstream of IFN-gamma-induced class II transactivator messenger RNA accumulation to block major histocompatibility complex class II gene expression and requires the 48-kd DNA-binding protein, ISGF3-gamma. J Exp Med. 1995;182:1517-1525.
12. Leppert D, Waubant E, Burk MR, Oksenbert JR, Hauser SL. Interferon beta-1b inhibits gelatinase secretion and in vitro migration of human T cells: a possible mechanism for treatment efficacy in multiple sclerosis. Ann Neurol. 1996;40:846-852.
13. Stuve O, Dooley NP, Uhm JH, et al. Interferon beta-1b decreases the migration of T lymphocytes in vitro: effects on matrix metalloproteinase-9. Ann Neurol. 1996;40:853-863.
14. Calabresi PA, Tranquill LR, Dambrosia JM, et al. Increases in soluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b. Ann Neurol. 1997;41:669-674.
15. Rudick RA, Ransohoff RM, Lee JC, et al. In vivo effects of interferon beta-1a on immunosuppressive cytokines in multiple sclerosis. Neurology. 1998;50:1294-1300.
16. Rep MHG, Hintzen RQ, Polman CH, van Lier RAW. Recombinant interferon-beta blocks proliferation but enhances interleukin-10 secretion by activated human T-cells. J Neuroimmunol. 1996;67:111-118.
17. Sega S, Wraber B, Mesec A, Horvat A, Ihan A. IFN-beta 1a and IFNbeta 1b have different patterns of influence on cytokines. Clin Neurol Neurosurg. 2004;106:255-258.
18. Noronha A, Toscas A, Arnason BG, Jensen MA. Interferon beta augments suppressor cell function in multiple sclerosis. Ann Neurol. 1990;27:207-210.
19. Noronha A, Toscas A, Arnason BG, Jensen MA. IFN beta augments in vivo suppressor function in MS. Neurology. 1994;44 Suppl 2:A212.
20. Knobler RL, Greenstein JI, Johnson KP, et al. Systemic Recombinant Human Interferon beta treatment of relapsing remitting multiple sclerosis: pilot study analysis and six-year follow up. J Interferon Res. 1993;13:333-340.
21. 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;45:1277-1285.
22. Arnason BG, for the IFNB Multiple Sclerosis Study Group and the UBC MS/MRI Analysis Group High dose, high frequency interferon beta-1b (Betaferon/Betaseron) treatment is effective in early stage relapsing remitting multiple sclerosis. Neurology. 2003;60 Suppl 1:A481.
23. Frank JA, Richert N, Bash C, et al. Interferon-beta-1b slows progression of atrophy in RRMS: Three-year follow-up in NAb-and NAboopatients. Neurology. 2004;62:719-725.
24. Ebers G, Traboulsee A, Langdon D, and the LTF Study Group. The interferon beta-1b 16-year long-term follow-up study: the results. Neurology. 2006; suppl AAN 58th Meeting San Diego, CA A32 Po1. 079.
25. Trojano M, Pellegrini F, Fuiani A, et al. New natural history of interferon beta-treated relapsing multiple sclerosis. Ann Neurol. 2007; 61:300-306.
26. De Stefano N, Narayanan S, Francis GS, et al. Evidence of axonal damage in the early stages of multiple sclerosis and its relevance to disability. Arch Neurol. 2001;58:65-70.
27. Kuhlmann T, Lingfeld G, Bitsch A, Schuchardt J, Bruck W. Acute axonal damage in multiple sclerosis is most extensive in early disease stages and decreases over time. Brain. 2002;125:2202-2212.
28. Barnett MH, Prineas JW. Relapsing and remitting multiple sclerosis: pathology of the newly forming lesion. Ann Neurol. 2004;55: 458-68.
29. Trapp BD, Peterson J, Ransoho RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med. 1998;338:278-285.
30. Jacobs LD, Beck RW, Simon JH, et al. Intramuscular interferon beta-1a therapy initiated during a fi{ligature}rst demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med. 2000;343:898-904.
31. Comi G, Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multple sclerosis: a randomized study. Lancet. 2001;357:1576-1582.
32. Poser CM, Paty DW, Scheinberg L, et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann Neurol. 1983;13:227-231.
33. Barkhof F, Polman CH, Radue EW, et al. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol. 2007;64:1292-1298.
34. Polman C, Kappos L, Freedman MS, et al. BENEFIT investigators. Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. J Neurol. 2008;255:480-487.
35. Goodkin DE and the North American SP MS Study Group. Interferon beta-1b in secondary progressive MS: clinical and MRI results of a 3 year randomized controlled trial [abstract]. Neurology. 2000; 54:2352.
36. Kappos L, Polman C, Pozzilli C, Thomson A, Beckmann K, Dahlke F. Final analysis of the European multicenter trial of IFNbeta-1b in secondary progressive MS. Neurology. 2001;57:1969-1975.
37. Durelli L, Verdun E, Barbero P, et al; Independent Comparison of Interferon (INCOMIN) Trial Study Group. Every-other-day interferon beta-1b vs once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicenter study. Lancet. 2002;27:1453-1460.
38. O'Connor P, Arnason B, Comi G, et al. Interferon beta-1b 500 mcg, interferon beta-1b 250 mcg and glatiramer acetate: primary outcomes of the BEYOND. (Betaferon/Betaseron Efficacy Yielding Outcomes of New Dose) study. Neurology. 2008;70(11; Late Breaking Science Suppl):S004.
39. Kappos L, Arnason B, Comi G, et al. High proportion of patients free from disease activity in all 3 arms of the high-dose Betaferon trial. J Neurol. 2008;255 Suppl 2:36.
40. Filippi M, Arnason B, Comi G, et al. Magnetic resonance imaging findings of a phase III trial comparing Betaferon with Copaxone treatments in relapsing-remitting multiple sclerosis. J Neurol. 2008; 255 Suppl 2:9.
41. Koch-Henriksen N, Sørensen PS, Christensen T, et al; Danish Multiple Sclerosis Group. A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis. Neurology. 2006;66:1056-1060.
42. IFNB Multiple Sclerosis Study Group and The University of British Columbia MS/MRI Analysis Group. Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: experience during the first three years. Neurology. 1996;47:889-894.
43. The IFNB Multiple Sclerosis Study Group I. Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: experience during the first three years. Neurology. 1996;47:889-894.
44. The PRISMS Study Group. Interferon neutralizing antibodies reduce clinical and magnetic resonance efficacy in multiple sclerosis patients treated with IFNβ-1a (Rebif): observations from the PRISMS 4-year extension study (abstract). Ann Neurol. 2000;48:477.
45. Polman CH, Kappos L, White R, et al. Neutralizing antibodies during treatment of secondary progressive MS with interferon β-1b. Neurology. 2003;60:37-43.
46. Kappos L, Clanet M, Sndberg-Wollheim, the European Interferon Beta-1a IM dose-Comparison Study investigators, et al. Neutralizing antibodies and efficacy in interferon β-1a: a 4 year controlled study. Neurology. 2005;65:40-47.
47. Rice GP, Paszner B, Oger J, Lesaux J, Paty D, Ebers G. The evolution of neutralizing antibodies in multiple sclerosis patients treated with interferon beta-1b. Neurology. 1999;52:1277-1279.
48. Petkau AJ, White RA, Ebers GC, et al. IFNB Multiple Sclerosis Study Group. Longitudinal analyses of the effects of neutralizing antibodies on interferon beta-1b in relapsing-remitting multiple sclerosis. Mult Scler. 2004;10:126-138.
49. Sorensen PS, Ross C, Clemmesen KM, Bendtzen K, Frederiksen JL, et al. Clinical importance of neutralising antibodies against interferon beta in patients with relapsing remitting multiple sclerosis. Lancet. 2003;362:1184-1191.
50. Durelli L, Barbero P, Bergui M, et al. MRI activity and neutralising antibody as predictors of response to interferon beta treatment in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2008;79: 646-651.
51. Malucchi S, Gilli F, Caldano M, et al. A Predictive markers for response to interferon therapy in patients with multiple sclerosis. Neurology. 2008;70:1119-1127.
52. Goodin DS, Hurwitz B and Noronha A. Neutralizing antibodies to interferon β-1b are not associated with disease worsening in multiple sclerosis. J Int Med Res. 2007;35:173-187.
53. Bayas A, Rieckmann P. Managing the adverse effects of interferon beta therapy in multiple sclerosis. Drug Saf. 2000;22:149-1594.
54. Walther EU, Hohlfeld R. Multiple sclerosis: side effects of interferon beta therapy and their management. Neurology. 1999;53: 1622-1627.
55. Hartung HP. Early treatment and dose optimisation BENEFIT and BEYOND. J Neurol. 2005;252 Suppl 3:44-50.
56. Comi G, Arnason B, Cook S, et al. Tolerability and adherence to Betaferon and Copaxone in a phase III clinical trial. J Neurol. 2008; 255 Suppl 2:111.
57. Achiron A, Fredrikson S. Lesson from randomised direct comparative trials. J Neurol Sci. 2009; 277 Suppl 1:S19-S24.