Randomized, comparative study of interferon β-1a treatment regimens in MS: The evidence trial

Neurology

Volumn 59, Issue 10, 2002, Pages 1496-1506

  Panitch, Hillel ^a   Goodin, D S ^b   Francis, G ^g   Chang, P ^g   Coyle, P K ^c   O'Connor, P ^e   Monaghan, E ^g   Li, D ^f   Weinshenker, B ^d  

^a UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c STONY BROOK UNIVERSITY MEDICAL CENTER   (United States)

^d MAYO CLINIC   (United States)

^e ST MICHAEL'S HOSPITAL   (Canada)

^f UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^g EMD SERONO INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; BETA1A INTERFERON; LIVER ENZYME; NEUTRALIZING ANTIBODY;

ADULT; ARTICLE; BRAIN INJURY; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIPLOPIA; DISABILITY; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; HUMAN; IMAGE ANALYSIS; INFLAMMATION; INJECTION SITE; LEUKOCYTE COUNT; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE SCLEROSIS; MYALGIA; NEUROLOGIC EXAMINATION; NUCLEAR MAGNETIC RESONANCE IMAGING; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RIGOR; SIDE EFFECT; SINGLE BLIND PROCEDURE; SKIN BRUISING; SPONTANEOUS ABORTION; SUICIDAL BEHAVIOR; THORAX PAIN; TREATMENT OUTCOME;

EID: 0037180479     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.WNL.0000034080.43681.DA     Document Type: Article

References (46)

1. Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med 1998;338:278-285.
2. Ferguson B, Matyszak MK, Esiri MM, Perry VH. Axonal damage in acute multiple sclerosis lesions. Brain 1997;120:393-399.
3. 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.
4. Morrissey SP, Miller DH, Kendall BE, et al. The significance of brain magnetic resonance imaging abnormalities at presentation with clinically isolated syndromes suggestive of multiple sclerosis. Brain 1993;116:135-146.
5. Koudriavtseva T, Thompson AJ, Fiorelli M, et al. Gadolinium enhanced MRI predicts clinical and MRI disease activity in relapsing-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry 1997;62:285-287.
6. Sailer M, O'Riordan JI, Thompson AJ, et al. Quantitative MRI in patients with clinically isolated syndrome suggestive of demyelination. Neurology 1999;52:599-606.
7. O'Riordan JI, Thompson AJ, Kingsley DPE, et al. The prognostic value of brain MRI in clinically isolated syndromes of the CNS. A 10-year follow-up. Brain 1998;121:495-503.
8. Williams GJ, Witt PL. Comparative study of the pharmacodynamic and pharmacologic effects of Betaseron and Avonex. J Interferon Cytokine Res 1998;18:967-975.
9. Stürzebecher S, Maibauer R, Heuner A, Beckmann K, Aufdembrinke B. Pharmacodynamic comparison of single doses of IFN-β1a and IFN-β1b in healthy volunteers. J Interferon Cytokine Res 1999;19:1257-1264.
10. Rothuizen LE, Buclin T, Spertini F, et al. Influence of interferon β-1a dose frequency of PBMC cytokine secretion and biological effect markers. J Neuroimmunol 1999;99:131-141.
11. The IFNβ 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.
12. IFNB Multiple Sclerosis Study Group, 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.
13. PRISMS Study Group. Randomized double-blind placebo-controlled study of interferon-β1a in relapsing/remitting multiple sclerosis. Lancet 1998;352:1498-1504.
14. PRISMS Study Group, University of British Columbia MS/ MRI Analysis Group. PRISMS-4: Long-term efficacy of interferon-β-1a in relapsing MS. Neurology 2001;56:1628-1636.
15. Clanet M, Kappos L, Radue EW, et al. Results of the European interferon beta-1a (Avonex) dose-comparison study. J Neurol 2001;248:II/63. Abstract.
16. Poser CM, Paty DW, Scheinberg L, et al. New diagnostic criteria for multiple sclerosis: Guidelines for research protocols. Ann Neurol 1983;13:227-231.
17. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 1983;33:1444-1452.
18. Abdul-Ahad A, Galazka AR, Revel M, Biffoni M, Borden EC. Incidence of antibodies to interferon-β in patients treated with recombinant human interferon-β1a from mammalian cells. Cytokines Mol Ther 1997;3:27-32.
19. Li DKB, Zhao GJ, Paty DW, University of British Columbia MS/MRI Analysis Research Group, SPECTRIMS Study Group. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology 2001;56: 1505-1513.
20. Once Weekly Interferon for MS Study Group. Evidence of interferon β-1a dose response in relapsing-remitting MS. Neurology 1999;53:679-686.
21. Koch GG, Tangen CM, Jung JW, Amara IA. Issues for covariance analysis of dichotomous and ordered categorical data from randomized clinical trials and non-parametric strategies for addressing them. Stat Med 1998;17:1863-1892.
22. Alam J, McAllister A, Scaramucci J, Jones W, Rogge M. Pharmacokinetics and pharmacodynamics of interferon beta-1a (IFNβ-1a) in healthy volunteers after intravenous, subcutaneous or intramuscular administration. Clin Drug Invest 1997; 14:35-43.
23. Munafo A, Trinchard-Lugan I, Nguyen TXQ, Buraglio M. Comparative pharmacokinetics and pharmacodynamics of recombinant human interferon beta-1a after intramuscular and subcutaneous administration. Eur J Neurol 1998;5:187-193.
24. Rice G, Incorvais B, Munari L, et al. A Cochrane review of recombinant interferons trials in relapsing remitting multiple sclerosis. J Neurol 2001;248(suppl 2):II/62.
25. Goodin DS, Frohman EM, Garmany GP, 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;58:169-178.
26. Lublin FD, Reingold SC. Placebo-controlled clinical trials in multiple sclerosis: Ethical considerations. Ann Neurol 2001;49: 677-681.
27. Jacobs LD, Cookfair DL, Rudick RA, et al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. Ann Neurol 1996;39:285-294.
28. Witt PL, Storer BE, Bryan GT, et al. Pharmacodynamics of biological response in vivo after single and multiple doses of interferon-β. J Immunother 1993;13:191-200.
29. Panitch HS, Hirsch RL, Haley AS, Johnson KP. Exacerbations of multiple sclerosis in patients treated with gamma interferon. Lancet 1987;1:893-895.
30. Noronha A, Toscas A, Jensen MA. IFN-beta decreases T. cell activation and IFN-gamma production in multiple sclerosis. J Neuroimmunol 1993;46:145-154.
31. Miller A, Lanir N, Shapiro S, et al. Immunoregulatory effects of interferon-β and interacting cytokines on human vascular endothelial cells. Implications for multiple sclerosis and other autoimmune diseases. J Neuroimmunol 1996;64:151-161.
32. Leppert D, Waubant E, Burk MR, Oksenberg 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.
33. Boutros T, Croze E, Yong VW. Interferon-β is a potent promoter of nerve growth factor production by astrocytes. J Neurochem 1997;69:939-946.
34. Rudick RA, Ransohoff RM, Peppler R, van der Brug M, Lehmann P, Alam J. Inferferon beta induces interleukin-10 expression: Relevance to multiple sclerosis. Ann Neurol 1996;40: 618-627.
35. 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.
36. Hua LL, Liu JS, Brosnan CF, Lee SC. Selective inhibition of human glial inducible nitric oxide synthase by interferon-beta: Implications for multiple sclerosis. Ann Neurol 1998;43: 384-387.
37. Giovannoni G, Miller DH, Losseff NA, et al. Serum inflammatory markers and clinical/MRI markers of disease progression in multiple sclerosis. J Neurol 2001;248:487-495.
38. Jacobs LD, Beck RW, Simon JH, et al, for the CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelination event in multiple sclerosis. N Engl J Med 2000;343:898-904.
39. Weinshenker BG, Bass B, Rice GPA, et al. The natural history of multiple sclerosis: A geographically based study. 2. Predictive value of the early clinical course. Brain 1989;112:1419-1428.
40. Goodkin DE, North ASG. Interferon beta-1b in secondary progressive MS: Clinical and MRI results of a 3-year randomized controlled trial. Neurology 2000;54:2352. Abstract.
41. Lublin FD, Cutter GR. Exacerbation recovery and the progression of multiple sclerosis. Neurology 2000;54(suppl 3): A216-A217. Abstract.
42. Johnson KP, Brooks BR, Ford CC, et al. Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Mult Scler 2000;6:255-266.
43. Confavreux C, Vukusic S, Moreau T, Adeleine P. Relapses and progression of disability in multiple sclerosis. N Engl J Med 2000;343:1430-1438.
44. SPECTRIMS Study Group, Hughes RAC. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: Clinical results. Neurology 2001;56:1496-1504.
45. Brex PA, Ciccarelli O, O'Riordan JI, Sailer M, Thompson AJ, Miller DH. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med 2002;3:158-164.
46. Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: Results of a 2-year prospective randomized multicentre study (INCOMIN). Lancet 2002;359:1453-1460.