Comparative study of the pharmacodynamic and pharmacologic effects of Betaseron® and AVONEX(TM)

Journal of Interferon and Cytokine Research

Volumn 18, Issue 11, 1998, Pages 967-975

  Williams, Gary J ^a   Witt, Patricia L ^b  

^a BAYER AG   (Germany)

^b MEDICAL COLLEGE OF WISCONSIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA 2 MICROGLOBULIN; BETA INTERFERON; BETA1A INTERFERON; IBUPROFEN; INTERFERON BETA SERINE; INTERLEUKIN 10; NEOPTERIN;

ADULT; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG EFFECT; FEVER; HUMAN; IMMUNOTHERAPY; INTRAMUSCULAR DRUG ADMINISTRATION; MULTIPLE SCLEROSIS; MYALGIA; NORMAL HUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; SUBCUTANEOUS DRUG ADMINISTRATION;

EID: 0031678450     PISSN: 10799907     EISSN: None     Source Type: Journal    
DOI: 10.1089/jir.1998.18.967     Document Type: Article

References (57)

1. LENGYEL, P. (1982). Biochemistry of interferons and their actions. Annu. Rev. Biochem. 51, 251-282.
2. THE IFNB MULTIPLE SCLEROSIS STUDY GROUP. (1993). Interferon beta-1b is effective in relapsing-remitting multiple sclerosis I: clinical results. Neurology 43, 655-661.
3. THE IFNB MULTIPLE SCLEROSIS STUDY GROUP AND THE UNIVERSITY OF BRITISH COLUMBIA MS/MRI ANALYSIS GROUP. (1995). Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. Neurology 45, 1277-1285.
4. LI, D.K.B., PATY, D.W., KOOPMANS, R.A., and ZHAO, G. (1996). The effects of interferon beta-1b in multiple sclerosis as assessed by MRI. Clin. Immunother. 5(Suppl. 1), 47-54.
5. PATY, D.W., LI, D.K.B., UBC MS/MRI STUDY GROUP; IFNB MULTIPLE SCLEROSIS STUDY GROUP. (1993). Interferon beta-lb is effective in relapsing-remitting multiple sclerosis II: MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43, 662-667.
6. 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., BROWN-SCHEIDLE, C.M., COATS, M.E., COHAN, S.L., DOUGHERTY, D.S., KINKEL, R.P., MASS, M.K., MUNSCHAUER, E.E., 3rd., PRIORE, R.L., PULLICINO, P.M., SCHEROKMAN, B.J., WHITHAM, R.H., et al. (1996). Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis. The Multiple Sclerosis Collaborative Research Group (MSCRG). Ann. Neurol. 39, 285-294.
7. NORONHA, A., TOSCAS, A., and JENSEN, M.A. (1993). Interferon beta decreases T cell activation and interferon gamma production in multiple sclerosis. J. Neuroimmunol. 46, 145-153.
8. DHIB-JALBUT, S., JIANG, H., XIA, Q., BLATT, L., JOHNSON, K.P., and HILT, D. (1996). Comparative effects of interferon-consensus 1, interferon-α2a, and interferon-β1b on HLA expression and lymphoproliferation: a preclinical model for treatment of multiple sclerosis. J. Interferon Cytokine Res. 16, 195-200.
9. WEINSTOCK-GUTTMAN, B., RANSOHOFF, R.M., KINKEL, P.R., and RUDICK, R.A. (1995). The interferons: biologic effects, mechanisms of action, and use in multiple sclerosis [Review]. Ann. Neurol. 37, 7-15.
10. ARNASON, B.G.W., DAYAL, A., QU, Z.X., JENSEN, M.A., GENC, K., and REDER, A.T. (1996). Mechanisms of action of interferon-beta in multiple sclerosis. Semin. Immunopathol. 18, 125-148.
11. HALL, G.L., COMPSTON, A., and SCOLDING, N.J. (1997). Beta-interferon and multiple sclerosis. Trends Neurosci. 20, 63-67.
12. CALABRESI, P.A., TRANQUILL, L.R., DAMBROSIA, J.M., STONE, L.A., MALONI, H., BASH, C.N., FRANK, J.A., and MCFARLAND, H.F. (1997). Increases in soluble VCAM-1 correlate with a decrease in MRI lesions in multiple sclerosis treated with interferon beta-1b. Ann. Neurol. 41, 669-674.
13. LING, P.D., WARREN, M.K., and VOGEL, S.N. (1985). Antagonistic effect of interferon-beta on the interferon-gamma-induced expression of Ia antigen in murine macrophages. J. Immunol. 135, 1857-1863.
14. RANSOHOFF, R.M., DEVAJYOTHI, C., ESTES, M.L., BABCOCK, G., RUDICK, R.A., FROHMAN, E.M., and BARNA, B.P. (1991). Interferon-beta specifically inhibits interferon-gamma-induced class II major histocompatibility complex gene transcription in a human astrocytoma cell line. J. Neuroimmunol. 33, 103-112.
15. RUDICK, R.A., CARPENTER, C.S., COOKFAIR, D.L., TUOHY, V.K., and RANSOHOFF, R.M. (1993). In vitro and in vivo inhibition of mitogen-driven T-cell activation by recombinant interferon beta. Neurology 43, 2080-2087.
16. (+) B cells in active multiple sclerosis and reversal by interferon beta-1b therapy. J. Clin. Invest. 99, 2664-2671.
17. DHIB-JALBUT, S., JIANG, H., and WILLIAMS, G.J. (1996). The effect of interferon β-1b on lymphocyte-endothelial cell adhesion. J. Neuroimmunol. 71, 215-222.
18. STÜVE, O., DOOLEY, N.P., UHM, J.H., ANTEL, J.P., FRANCIS, G.S., WILLIAMS, G.J., and WEE YONG, V. (1996). Interferon β-1b decreases the migration of T lymphocytes in vitro: effects on matrix metalloproteinase-9. Ann. Neurol. 40, 853-863.
19. STÜVE, O., CHABOT, S., JUNG, S.S., WILLIAMS, G., and YONG, V.W. (1997). Chemokine-enhanced migration of human peripheral blood mononuclear cells is antagonized by interferon beta-lb through an effect on matrix metalloproteinase-9. J. Neuroimmunol. 80, 38-46.
20. LEPPERT, D., WAUBANT, E., BURK, M.R., OKSENBERG, J.R., and HAUSER, S.L. (1996). 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. 40, 846-853.
21. KENNEDY, M.K., TORRANCE, D.S., PICHA, K.S., and MOHLER, K.M. (1992). Analysis of cytokine mRNA expression in the central nervous system of mice with experimental autoimmune encephalomyelitis reveals that IL-10 mRNA expression correlates with recovery. J. Immunol. 149, 2496-2505.
22. ROTT, O., FLEISCHER, B., and CASH, E. (1994). Interleukin-10 prevents experimental allergic encephalomyelitis in rats. Eur. J. Immunol. 24, 1434-1440.
23. SKIAS, D.D., and REDER, A.T. (1995). IL-10 inhibits EAE. Neurology 45(Suppl. 4), A349 (abstract).
24. SHAKIR, S., BYSKOSH, P.V., and REDER, A.T. (1994). Interferon-β induces interleukin-10 mRNA in mononuclear cells (MNC). Neurology 44(Suppl. 2), A211-A212 (abstract).
25. PORRINI, A.M.; GAMBI, D., and REDER, A.T. (1995). Interferon effects on interleukin-10 secretion. Mononuclear cell response to interleukin-10 is normal in multiple sclerosis patients. J. Neuroimmunol. 61, 27-34.
26. REP, M.H.G., HINTZEN, R.Q., POLMAN, C.H., and VANLIER, R.A.W. (1996). Recombinant interferon-beta blocks proliferation but enhances interleukin-10 secretion by activated human T-cells. J. Neuroimmunol. 67, 111-118.
27. RUDICK, R.A., RANSOHOFF, R.M., PEPPLER, R., MEDENDORP, S.V., LEHMANN, P., and ALAM, J. (1996). Interferon beta induces interleukin-10 expression: relevance to multiple sclerosis. Ann. Neurol. 40, 618-627.
28. NEILLEY, L.K., GOODIN, D.S., GOODKIN, D.E., and HAUSER, S.L. (1996). Side effect profile of interferon beta-1b in MS: results of an open label trial. Neurology 46, 552-554.
29. GOLDSTEIN, D., SIELAFF, K.M., STORER, B.E., BROWN, R.R., DATTA, S.P., WITT, P.L., TEITELBAUM, A.P., SMALLEY, R.V., and BORDEN, E.C. (1989). Human biologic response modification by interferon in the absence of measurable serum concentrations: a comparative trial of subcutaneous and intravenous interferon Betaserine. J. Natl. Cancer Inst. 81, 1061-1068.
30. JAKSCHIES, D., HOCHKEPPEL, H., HORISBERGER, M., DEICHER, H., and VON WUSSOW, P. (1990). Emergence and decay of the human Mx homolog in cancer patients during and after interferon-alpha therapy. J. Biol. Response Mod. 9, 305-312.
31. LIBERATI, A.M., GAROFANI, P., DEANGELIS, V., DICLEMENTE, F., HORISBERGER, M., CECCHINI, M., BETTI, A.R., PALMISANO, L., ASTOLFI, S., NASTARI, A., VILLA, A., and ARZANO, S. (1994). Double-blind randomized phase I study on the clinical tolerance and pharmacodynamics of natural and recombinant interferon-beta given intravenously. J. Interferon Res. 14, 61-69.
32. LIBERATI, A.M., FIZZOTTI, M., PROIETTI, M.G., DIMARZIO, R., SCHIPPA, M., BISCOTTINI, B., SENATORE, M., BERRUTO, P., CANALI, S., PERETTI, G., and ZANOLO, G. (1988). Biochemical host response to interferon-beta. J. Interferon Res. 8, 765-777.
33. LIBERATI, A.M., HORISBERGER, M.A., PALMISANO, L., ASTOLFI, S., NASTARI, A., MECHATI, S., VILLA, A., MANCINI, S., ARZANO, S., and GRIGNANI, F. (1992). Double-blind randomized phase I study on the clinical tolerance and biological effects of natural and recombinant interferon-β. J. Interferon Res. 12, 329-336.
34. ser in healthy volunteers and its effects on serum neopterin. Pharm. Res. 10, 567-572.
35. WITT, P.L., STORER, B.E., BRYAN, G.T., BROWN, R.R., FLASHNER, M., LAROCCA, A.T., COLBY, C.B., BORDEN, E.C. (1993). Pharmacodynamics of biological response in vivo after single and multiple doses of interferon-β. J. Immunother. 13, 191-200.
36. ALAM, J., GOELZ, S., RIOUX, P., SCARAMUCCI, J., JONES, W., MCALLISTER, A., CAMPION, M., and ROGGE, M. (1997). 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, 546-549.
37. ALAM, J., MCALLISTER, A., SCARAMUCCI, J., JONES, W., and ROGGE, M. (1997). Pharmacokinetics and pharmacodynamics of interferon beta-1a (IFNβ-1a) in healthy volunteers after intravenous, subcutaneous or intramuscular administration. Clin. Drug Invest. 14, 35-43.
38. TOWBIN, H., SCHMITZ, A., JAKSCHIES, D., VON WUSSOW, P., and HORISBERGER, M.A. (1992). A whole blood immunoassay for the interferon-inducible human Mx protein. J. Interferon Res. 12, 67-74.
39. OH, S.-K., LUHOWSKYJ, S., WITT, P., RITCH, P., REITSMA, D., TOWBIN, H., HORISBERGER, M., VON WUSSOW, P., and BLUESTEIN, B. (1994). Quantitation of interferon-induced Mx protein in whole blood lysates by an immunochemiluminescent assay: elimination of protease activity of cell lysates in toto. J. Immunol. Methods 176, 79-91.
40. HENDRIX, C.W., PETTY, B.G., WOODS, A., KUWAHARA, S.K., WITTER, F.R., SOO, W., GRIFFIN, D.E., and LEITMAN, P.S. (1995). Modulation of alpha-interferon's antiviral and clinical effects by aspirin, acetaminophen, and prednisone in healthy volunteers. Antiviral Res. 28, 121-131.
41. Product Information, Avonex™. (1998). In: Physician's Desk Reference. Montvale, NJ: Medical Economics Company, p. 697.
42. Product Information, Betaseron®. (1998). In: Physician 's Desk Reference. Montvale, NJ: Medical Economics Company, p. 697.
43. GOMI, K., MORIMOTO, M., INOUE, A., et al. (1984). Pharmacokinetics of human recombinant interferon-β in monkeys and rabbits. Gann 75, 292-300.
44. BOCCI, V. (1984). Evaluation of route of administration of interferon in cancer: a review and a proposal. Cancer Drug Deliv. 1, 337-351.
45. SATOH, Y.I., KASAMA, K., KAJITA, A., SHIMIZU, H., and IDA, N. (1984). Different pharmacokinetics between natural and recombinant human interferon beta in rabbits. J. Interferon Res. 4, 411-422.
46. BOCCI, V. (1985). Distribution, catabolism and pharmacokinetics of interferons. In: In Vivo and Clinical Studies. N.B. Finter and R.K. Oldham (eds) New York: Elsevier, pp. 47-72.
47. ser17 in African green monkeys. J. Interferon Res. 13, 111-120.
48. ALAM, J., GORMAN, B., STANNARD, M., DAWSON, A., LOYNDS, P., MANI, T., and FOX, L. (1991). Clinical pharmacology of recombinant beta interferon in humans. J. Interferon Res. 11(Suppl. 1), S246.
49. JACOBS, L., and MUNSCHAUER, F.E. (1992). Treatment of multiple sclerosis with interferons. In: Treatment of Multiple Sclerosis Trial Design, Results and Future Perspectives. R.A. Rudick and D.E. Goodkin (eds.) London: Springer, pp. 223-250.
50. SALMAGGI, A., DUFOUR, A., EOLI, M., CORSINI, E., LA MANTIA, L., MASSA, G., NESPOLO, A., and MILANESE, C. (1996). Low serum interleukin-10 levels in multiple sclerosis: further evidence for decreased systemic immunosuppression? J. Neurol. 243, 13-17.
51. MUSETTE, P., BENVENISTE, O., LIM, A., BEQUET, D., KOURILSKY, P., DORMONT, D., and GACHELIN, G. (1996). The pattern of production of cytokine mRNAs is markedly altered at the onset of multiple sclerosis. Res. Immunol. 147, 435-441.
52. REICKMANN, P., ALBRECHT, M., KITZE, B., et al. (1994). Cytokine mRNA levels in mononuclear blood cells from patients with multiple sclerosis. Neurology 44, 1523-1526.
53. MOSSMANN, T.R., and MOORE, K.W. (1991). The role of IL-10 in crossregulation of Th1 and Th2 responses. Immunol. Today 12, A49-A53.
54. WANG, P., WU, P., SIEGEL, M.I., EGAN, R.W., and BILLAH, M.M. (1994). IL-10 inhibits transcription of cytokine genes in human peripheral blood mononuclear cells. J. Immunol. 153, 811-816.
55. DRULOVIC, J., MOSTARICA-STOJKOVIC, M., LEVIC, Z., STOJSAVLJEVIC, N., PRAVICA, V., and MESAROS, S. (1997). Interleukin-12 and tumor necrosis factor-alpha levels in cerebrospinal fluid of multiple sclerosis patients. J. Neurol. Sci. 147, 145-150.
56. RUDICK, R.A., RANSOHOFF, R.M., LEE, J.-C., PEPPLER, R., YU, M., MATHISEN, P.M., and TUOHY, V.K. (1998). In vivo effects of interferon beta-1a on immunosuppressive cytokines and multiple sclerosis. Neurology 50, 1294-1300.
57. BYSKOSH, P.V., and REDER, A.T. (1996). Interferon beta-1b effects on cytokine mRNA in peripheral mononuclear cells in multiple sclerosis. Mult. Scler. 1, 262-269.