Benefit-risk assessment of interferon-β therapy for relapsing multiple sclerosis

Expert Opinion on Drug Safety

Volumn 3, Issue 4, 2004, Pages 289-303

  Francis, Gordon ^a  

^a NONE   (United States)

Author keywords

Benefit risk ratio; Evidence based medicine; IFN ; Relapsing multiple sclerosis

Indexed keywords

ALEMTUZUMAB; AMINOTRANSFERASE; AZATHIOPRINE; BETA INTERFERON; BETA1A INTERFERON; CD52 ANTIGEN; CLADRIBINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; CYTOKINE ANTIBODY; DACLIZUMAB; GLATIRAMER; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMMUNOSUPPRESSIVE AGENT; INTERFERON BETA SERINE; LAQUINIMOD; LEFLUNOMIDE; LIGAND; MESOPRAM; METHOTREXATE; MITOXANTRONE; MONOCLONAL ANTIBODY; MYCOPHENYLLATE; NATALIZUMAB; PEPTIDE; PLACEBO; RECOMBINANT BETA INTERFERON; RITUXIMAB; TERIFLUNOMIDE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ABNORMAL SUBSTRATE CONCENTRATION IN BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; DATA ANALYSIS; DISABILITY; DISEASE COURSE; DOSE RESPONSE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEVER; FLU LIKE SYNDROME; HUMAN; INJECTION SITE; INJECTION SITE REACTION; LEUKOCYTE DISORDER; LIVER DISEASE; LIVER DYSFUNCTION; MULTIPLE SCLEROSIS; NUCLEAR MAGNETIC RESONANCE IMAGING; RELAPSE; REVIEW; RISK BENEFIT ANALYSIS; SIDE EFFECT;

ANTIBODY FORMATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; INJECTIONS, INTRAMUSCULAR; INJECTIONS, SUBCUTANEOUS; INTERFERON-BETA; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RANDOMIZED CONTROLLED TRIALS; RISK ASSESSMENT;

EID: 3543102546     PISSN: 14740338     EISSN: None     Source Type: Journal    
DOI: 10.1517/14740338.3.4.289     Document Type: Review

References (64)

1. COMPSTON A, COLES A. Multiple sclerosis. Lancet (2002) 359(9313):1221-1231.
2. ARNOLD DL, MATTHEWS PM, FRANCIS G, ANTEL J: Proton magnetic resonance spectroscopy of human brain in vivo in the evaluation of multiple sclerosis: assessment of the load of disease. Magn. Reson. Med. (1990) 14(1):154-159.
3. FERGUSON B, MATYSZAK MK, ESIRI MM, PERRY VH: Axonal damage in acute multiple sclerosis lesions. Brain (1997) 120(3):393-399.
4. TRAPP BD, PETERSON J, RANSOHOFF RM et al.: Axonal transection in the lesions of multiple sclerosis. N. Engl. J. Med. (1998) 338:278-285.
5. WEINSHENKER BG, BASS B, RICE GP et al.: The natural history of multiple sclerosis: a geographically based study. I. Clinical course and disability. Brain (1989) 112(1):133-146.
6. GOODIN DS, FROHMAN EM, GARMANY GP 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 (2002) 58(2):169-178.
7. PRISMS STUDY GROUP: Randomised double-blind placebo-controlled study of interferon β-1a in relapsing/remitting multiple sclerosis. Lancet (1998) 352(9139):1498-1504.
8. LI DK, PATY DW: Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon-β1a in relapsing-remitting multiple sclerosis. Prevention of Relapses and Disability by Interferon-β1a Subcutaneously in Multiple Sclerosis. Ann. Neurol. (1999) 46(2):197-206.
9. PRISMS-4: Long-term efficacy of interferon-β-1a in relapsing MS. Neurology (2001) 56(12):1628-1636.
10. SACKETT DL (Ed.): Evidence Based Medicine: how to practice and teach EBM. Churchill Livingstone, Edinburgh, UK (2000):113-118.
11. COOK RJ, SACKETT DL: The number needed to treat: a clinically useful measure of treatment effect. Br. Med. J. (1995) 310(6977):452-454.
12. BJERRE LM, LELORIER J: Expressing the magnitude of adverse effects in case-control studies: 'the number of patients needed to be treated for one additional patient to be harmed'. Br. Med. J. (2000) 320(7233):503-506.
13. IFN-β MULTIPLE SCLEROSIS STUDY GROUP: Interferon β-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.
14. PATY DW, LI DK: Interferon β-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-β Multiple Sclerosis Study Group. Neurology (1993) 43(4):662-667.
15. JACOBS LD, COOKFAIR DL, RUDICK RA et al.: Intramuscular interferon β-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. (1996) 39(3):285-294.
16. SIMON JH, JACOBS LD, CAMPION M et al.: Magnetic resonance studies of intramuscular interferon β-1a for relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. (1998) 43(1):79-87.
17. RUDICK RA, GOODKIN DE, JACOBS LD et al.: Impact of interferon β-1a on neurologic disability in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Neurology (1997) 49(2):358-363.
18. RUDICK RA, FISHER E, LEE JC, SIMON J, JACOBS L: Use of the brain parenchymal fraction to measure whole brain atrophy in relapsing-remitting MS. Multiple Sclerosis Collaborative Research Group (MSCRG). Neurology (1999) 53:1698-1704.
19. FILIPPINI G, MUNARI L, INCORVAIA B et al.: Interferons in relapsing remitting multiple sclerosis: a systematic review. Lancet (2003) 361(9357):545-552.
20. JONES CA, RIDDEHOUGH A, LI DK et al.: MRI cerebral atrophy in relapsing remitting MS: results from the PRISMS trial. Neurology (2002) 56(Suppl. 3):A379. Abstract 47.002.
21. JACOBS LD, BECK RW, SIMON JH et al.: Intramuscular interferon β-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N. Engl. J. Med. (2000) 343(13 ):898-904.
22. COMI G, FILIPPI M, BARKHOF F et al.: Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet (2001) 357(9268):1576-1582.
23. FILIPPI M, ROVARIS M, INGLESE M et al.: Reduced brain tissue loss during randomised study of Interferon β-1a in patients at presentation with syndromes suggestive of multiple sclerosis. Lancet (In Press).
24. THE ONCE WEEKLY INTERFERON FOR MS STUDY GROUP: Evidence of interferon β-1a dose response in relapsing-remitting MS: the OWIMS Study. Neurology (1999) 53(4):679-686.
25. IFN-β MULTIPLE SCLEROSIS STUDY GROUP AND THE UNIVERSITY OF BRITISH COLUMBIA MS/MRI ANALYSIS GROUP: Interferon β-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology (1995) 45(7):1277-1285.
26. CLANET M, RADUE EW, KAPPOS L et al.: A randomized, double-blind, dose-comparison study of weekly interferon β-1a in relapsing MS. Neurology (2002) 59(10):1507-1517.
27. PATY DW: Long-term observational efficacy and safety follow-up of the PRISMS cohort. Mult. Scler. (2003) 9(Suppl. 1):S138. Abstract P555.
28. RUNMARKER B, ANDERSEN O: Prognostic factors in a multiple sclerosis incidence cohort with twenty-five years of follow-up. Brain (1993) 116(1):117-134.
29. EUROPEAN STUDY GROUP ON INTERFERON β-1B IN SECONDARY PROGRESSIVE MS: Placebo-controlled multi-centre randomised trial of interferon β-1b in treatment of secondary progressive multiple sclerosis. Lancet (1998) 352(9139):1491-1497.
30. KAPPOS L, POLMAN C, POZZILLI C et al.: Final analysis of the European multicenter trial on IFN-β-1b in secondary-progressive MS. Neurology (2001) 57(11):1969-1975.
31. MILLER DH, MOLYNEUX PD, BARKER GJ et al.: Effect of Interferon-1b on magnetic resonance imaging outcomes in secondary progressive multiple sclerosis: results of a European multicenter, randomized, double-blind, placebo-controlled trial. Ann. Neurol. (1999) 46:850-859.
32. GOODKIN DE: Interferon β-1b in secondary progressive MS: clinical and MRI results of a 3-year randomised controlled trial. Neurology (2000) 54:2352. Abstract.
33. SPECTRIMS STUDY GROUP: Randomized controlled trial of interferon-β-1a in secondary progressive MS: clinical results. Neurology (2001) 56(11):1496-1504.
34. LI DK, ZHAO GJ, PATY DW. Randomized controlled trial of interferon-β-1a in secondary progressive MS: MRI results. Neurology (2001) 56(11):1505-1513.
35. COHEN JA, CUTTER GR, FISCHER JS et al.: Benefit of interferon β-1a on MSFC progression in secondary progressive MS. Neurology (2002) 59(5):679-687.
36. FISCHER JS, RUDICK RA, CUTTER GR, REINGOLD SC: The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult. Scler. (1999) 5(4):244-250.
37. WILLIAMS GJ, WITT PL: Comparative study of the pharmacodynamic and pharmacologic effects of Betaseron and Avonex. J. Interferon Cytokine Res. (1998) 18(11):967-975.
38. STURZEBECHER S, MAIBAUER R, HEUNER A, BECKMANN K, AUFDEMBRINKE B: Pharmacodynamic comparison of single doses of IFN-β 1a and IFN-β1b in healthy volunteers. J. Interferon Cytokine Res. (1999) 19(11):1257-1264.
39. ROTHUIZEN LE, BUCLIN T, SPERTINI F et al.: Influence of interferon β-1a dose frequency on PBMC cytokine secretion and biological effect markers. J. Neuroimmunol. (1999) 99(1):131-141.
40. DURELLI L, VERDUN E, BARBERO P et al.: Every-other-day interferon β-1b versus once-weekly interferon β-1a for multiple sclerosis: results of a 2-year prospective randomised multi-centre study (INCOMIN). Lancet (2002) 359(9316):1453-1460.
41. PANITCH H, GOODIN DS, FRANCIS G et al.: Randomized, comparative study of interferon β-1a treatment regimens in MS: the EVIDENCE Trial. Neurology (2002) 59(10):1496-1506.
42. PANITCH H: Differences between IFN β-1a 44 mcg t.i.w. and 30 mcg q.w. sustained to 16 months: final EVIDENCE results. Int. J. MS Care (2003) 5:80.
43. SHARIEF M: The impact of change in interferon β-1a dose regimen (30mcg q.w. to 44mcg t.i.w.) in patients with relapsing MS - crossover results from the EVIDENCE study. J. Neurol. (2003) 250(Suppl. 2):II/58. Abstract 194.
44. WALTHER EU, HOHLFELD R: Multiple sclerosis: side effects of interferon β therapy and their management. Neurology (1999) 53(8):1622-1627.
45. FRANCIS GS, GRUMSER Y, ALTERI E et al.: Hepatic reactions during treatment of multiple sclerosis with interferon-β-1a: incidence and clinical significance. Drug Saf. (2003) 26(11):815-827.
46. YOSHIDA EM, RASMUSSEN SL, STEINBRECHER UP et al.: Fulminant liver failure during interferon β treatment of multiple sclerosis. Neurology (2001) 56(10):1416.
47. GOTTBERG K, GARDULF A, FREDRIKSON S: Interferon-β treatment for patients with multiple sclerosis: the patients' perceptions of the side effects. Mult. Scler. (2000) 6(5):349-354.
48. SANDBERG-WOLLHEIM M, BEVER C, CARTER J et al.: Comparative tolerance of IFN β-1a in-patients with relapsing-remitting multiple sclerosis: EVIDENCE Study. J. Neurol. (In press).
49. LUBLIN FD, WHITAKER JN, EIDELMAN BH et al.: Management of patients receiving interferon β-1b for multiple sclerosis: report of a consensus conference. Neurology (1996) 46(1):12-18.
50. MUNSCHAUER FE III, KINKEL RP: Managing side effects of interferon-β in patients with relapsing-remitting multiple sclerosis. Clin. Ther. (1997) 19(5):883-893.
51. RIECKMANN P, O'CONNOR P, FRANCIS G et al.: Haematological effects of interferon β-1a (Rebif®) therapy in multiple sclerosis. (In press).
52. WOLINSKY JS, TOYKA KV, KAPPOS L, GROSSBERG SE: Interferon-β antibodies: implications for the treatment of MS. Lancet Neurol. (2003) 2(9):528.
53. ANTONETTI F, FINOCCHIARO O, MASCIA M, TERLIZZESE MG, JABER A: A comparison of the biologic activity of two recombinant IFN-β preparations used in the treatment of relapsing-remitting multiple sclerosis. J. Interferon Cytokine Res. (2002) 22(12):1181-1184.
54. GIOVANNONI G, MUNSCHAUER FE III, DEISENHAMMER F: Neutralising antibodies to interferon β during the treatment of multiple sclerosis. J. Neurol. Neurosurg. Psychiatr. (2002) 73(5):465-469.
55. IFN-P MULTIPLE SCLEROSIS STUDY GROUP AND THE UNIVERSITY OF BRITISH COLUMBIA MS/MRI ANALYSIS GROUP: Neutralizing antibodies during treatment of multiple sclerosis with interferon β-1b: experience during the first three years. Neurology (1996) 47:889-894.
56. RUDICK R, SIMONIAN N, ALAM J er al.: Incidence and significance of neutralizing antibodies to interferon β-1a in multiple sclerosis. Neurology (1998) 50:1266-1272.
57. SORENSEN PS, ROSS C, CLEMMESEN KM et al.: Clinical importance of neutralising antibodies against interferon β in patients with relapsing-remitting multiple sclerosis. Lancet (2003) 362(9391):1184-1191.
58. POLMAN C, KAPPOS L, WHITE R et al.: Neutralizing antibodies during treatment of secondary progressive MS with interferon β-1b. Neurology (2003) 60(1):37-43.
59. WEINSHENKER BG: The natural history of multiple sclerosis. Neurol. Clin. (1995) 13(1):119-146.
60. ARNOLDUS JH, KILLESTEIN J, PFENNINGS LE et al.: Quality of life during the first 6 months of interferon-β treatment in patients with MS. Mult. Scler. (2000) 6(5):338-342.
61. ZEUZEM S, FEINMAN SV, RASENACK J et al.: Peginterferon α-2a in patients with chronic hepatitis C. N. Engl. J. Med. (2000) 343(23):1666-1672.
62. PEPINSKY RB, LEPAGE DJ, GILL A et al.: Improved pharmacokinetic properties of a polyethylene glycol-modified form of interferon-β-1a with preserved in vitro bioactivity. J. Pharmacol. Exp. Ther. (2001) 297(3):1059-1066.
63. GOGGIN T, VIGNA E, NEUTEBOOM B, TRINCHARD-LUGAN I, KLETZL H: Non-covalent complex of interferon-β-1a and recombinant human Type I interferon receptor subunit 2a: preclinical and Phase I results. Mult. Scler. (2003) 9(Suppl. 1):S138. Abstract P553.
64. MILLER DH, KHAN OA, SHEREMATA WA et al.: A controlled trial of natalizumab for relapsing multiple sclerosis. N. Engl. J. Med. (2003) 348(1):15-23.