Abstract •This report describes the first use of recombinant-DNA-produced human interferon in patients with multiple sclerosis (MS). Ninety-eight patients who were clinically definite for MS with two or more documented exacerbations during the preceding two years were admitted to this placebo-controlled double-blind randomized trial. Although both groups were similar, placebo patients had later MS onset. Patients injected themselves with 2 X 106 lU of α-2interferon or placebo three times each week for up to 52 weeks. This dose of interferon was well tolerated in that side effects were minimal. During the trial, the exacerbation rate was sharply reduced in both groups. In the three-month follow-up period after stopping treatment, more patients who were receiving interferon than placebo became worse neurologically. More patients who were receiving interferon than placebo changed from exacerbating MS to progressive MS during the trial. Thus, no clear therapeutic benefit of α-2 interferon for MS was detected. References 1. Charcot JM: Lectures on the Diseases of the Nervous System: Delivered at La Salpetriere , Sigerson G (trans). London, New Sydenham Society, 1877-1889. 2. Aronson SM, Bauer HJ, Brown JR, et al: Therapeutic Claims in Multiple Sclerosis . New York, National Multiple Sclerosis Society, 1982. 3. Scheinberg L, Raine CS (eds): Multiple sclerosis: Experimental and clinical aspects . Ann NY Acad Sci 1984;436:1-518.Crossref 4. Matthews WB: Treatment , in Matthews WB, Acheson ED, Batchelor JR (eds): McAlpine's Multiple Sclerosis . New York, Churchill Livingstone Inc, 1985, chap 10, pp 233-278. 5. Isaacs A, Lindeman J: Virus interference: I. The interferon . Proc R Soc Lond 1957;147:258-267.Crossref 6. Gresser I, Burke D, Cantell K, et al: Interferon 6 1985 . Orlando, Fla, Academic Press, 1985. 7. Cantell K, Hirvonen S: Large-scale production of human leukocyte interferon containing 108 units per milliliter. J Gen Virol 1978;39:541-543.Crossref 8. Fantes KH, Finter NB: Large-scale preparation of interferon-αfor clinical use , in Zoon KC, Noguchi PD, Liu TY (eds): Interferon: Research, Clinical Application, and Regulatory Consideration . New York, Elsevier Science Publishing Co Inc, 1984. 9. Neighbor PA, Bloom BR: Absence of virusinduced lymphocyte suppression and interferon production in multiple sclerosis . Proc Natl Acad Sci USA 1979;76:476-480.Crossref 10. Neighbor PA, Miller AE, Bloom BR: Interferon responses of leukocytes in multiple sclerosis . Neurology 1981;31:561-566.Crossref 11. Neighbor PA, Grayzel AI, Miller AE: Endogenous and interferon-augmented natural killer cell activity of human peripheral blood mononuclear cells in vitro: Study of patients with multiple sclerosis, systemic lupus erythematosus, or rheumatoid arthritis . Clin Exp Immunol 1982;49:11-21. 12. Johnson KP: Systemic interferon therapy for multiple sclerosis: Design of a trial . Arch Neurol 1983;40:681-682.Crossref 13. Panitch HS, Knobler RL, Francis GS, et al: A trial of natural a-interferon in the treatment of multiple sclerosis: II. Clinical results . Neurology 1984;34( (suppl 1) ):111.Crossref 14. Kamin-Lewis RM, Panitch HS, Merigan TC, et al: Decreased interferon synthesis and responsiveness to interferon by leukocytes from multiple sclerosis patients given natural α-interferon . J Interferon Res 1984;4:423-432.Crossref 15. Jacobs L, O'Malley J, Freeman A, et al: Intrathecal interferon reduces exacerbations of multiple sclerosis . Science 1981;214:1026-1028.Crossref 16. Ruutiainen J, Panelius M: Toxic effects of interferon administered intrathecally . Br Med J 1983;286:940.Crossref 17. Billiau A, Heremans H, Ververken D, et al: Tissue distribution of human interferons after exogenous administration in rabbits, monkeys, and mice . Arch Virol 1981;68:19-25.Crossref 18. Habif DV, Lipton R, Cantell K: Interferon crosses blood-cerebrospinal fluid barrier in monkeys . Proc Soc Exp Biol Med 1975;149:287-289.Crossref 19. Poser CM, Paty DW, Scheinberg L, et al: New diagnostic criteria for multiple sclerosis: Guidelines for research protocols . Ann Neurol 1983;13:227-231.Crossref 20. International Federation of Multiple Sclerosis Societies: Minimal Record of Disability, 1983 . Acta Neurol Scand 1984;70(suppl 101):169-190. 21. Lundberg GD, Iverson C, Radulescu G: Now read this: The SI units are here, editorial . Arch Neurol 1986;43:547-557.Crossref 22. Knobler RL, Panitch HS, Braheny SL, et al: Systemic α-interferontherapy of multiple sclerosis . Neurology 1984;34:1273-1279.Crossref 23. Mickey MR, Ellison GW, Myers LW: An illness severity score for multiple sclerosis . Neurology 1984;34:1343-1347.Crossref 24. Hirsch RL, Johnson KP: Natural killer cell activity in multiple sclerosis patients treated with recombinant interferon α-2 . Clin Immunol Immunopathol 1985;37:236-244.Crossref 25. Hirsch RL, Johnson KP: The effect of recombinant alpha-2 interferon on defective natural killer cell activity in multiple sclerosis . Neurology 1985;35:597-599.Crossref 26. Hirsch RL, Johnson KP: Placebo-induced enhancement of natural killer cell activity in a double-blind trial of recombinant α-2interferon in multiple sclerosis patients , in Spector NH (ed): Neuroimmunomodulation: Proceedings of the First International Workshop on Neuroimmuno modulation . Bethesda, Md, International Working Group on Neuroimmunomodulation, 1985. 27. Sibley WA, Bamford CR, Clark K: Clinical viral infections and multiple sclerosis . Lancet 1985;1:1313-1315.Crossref
Archives of Neurology – American Medical Association
Published: Dec 1, 1986
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