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Address correspondence and reprint requests to Dr Sibley, University Hospital, Tucson, AZ 85724.
our previously reported multicenter, blinded, randomized, controlled study of two doses of interferon beta-lb (IFNB) in 372 patients demonstrated a reduction in relapse frequency and severity and in MRI activity. We now report the results of the continuation of that study. The median time on study was 46.0 months for the placebo arm, 45.0 months for 1.6 million international units (MIU), and 48.0 months for 8 MIU. IFNB had a persistent beneficial effect on exacerbation rate and MRI burden of disease and was relatively free of long-term side effects. There was a one-third reduction in exacerbation rate in the 8-MIU treatment arm, compared with placebo, in each of 5 years. Serial annual MRI was done in all patients, and 217 of the patients had either a fourth- or fifth-year scan. There was no significant progression of lesion burden in the 8-MIU arm in each successive year compared with baseline (at 4 years, p = 0.917), whereas a highly significant increase in lesion area occurred in the placebo arm (p = 0.0001). Among the 154 noncompleters, there was no systematic bias recognized that favored either treatment arm for the outcome measures of exacerbation rate, disability, or MRI activity. Dropouts in the placebo group had higher exacerbation rates and accumulation of MRI lesion burden than did dropouts in the other treatment arms, which probably reduced the power of the study to demonstrate treatment effects on these measures in the later years of the trial. Neutralizing antibodies to IFNB were detectable in 38% of patients by the third year and were associated with a significant attenuation of treatment effect on exacerbation rate. However, the reduction in exacerbation rate approached 50% in the antibody-negative 8-MIU group. For all patients, both baseline and end point lesion burden significantly correlated with disability. Increase in MRI lesion area was also significantly correlated with increase in disability over the course of the study, validating serial MRI as an outcome measure with clinical relevance. Since the 8-MIU treatment arm had significantly less lesion accumulation by MRI, a reasonable expectation is that IFNB will limit progression of disability. Confirmed disease progression occurred in fewer patients in the high-dose treatment arm (35%) than in the placebo arm (46%) (p = 0.096). These results support but do not establish an effect of IFNB in limiting progression of disability. This study was not originally powered to demonstrate a treatment effect on disease progression. At these levels of disability, more patients or longer follow-up, or both, would be required. Accordingly, additional clinical trials will be necessary to evaluate the role of IFNB in preventing disability.
*See page 1285 for the IFNB Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group participants.
Received December 7, 1994. Accepted in final form December 20, 1994.
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G. Giovannoni Strategies to treat and prevent the development of neutralizing anti-interferon-{beta} antibodies Neurology, November 11, 2003; 61(90095): S13 - 17. [Abstract] [Full Text]
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M. Kremenchutzky Long-term evolution of anti-INF{beta} antibodies in IFN{beta}-treated MS patients: The London, Canada, MS Clinic experience Neurology, November 11, 2003; 61(90095): S29 - 30. [Full Text]
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R. A. Rudick Biologic impact of interferon antibodies, and complexities in assessing their clinical significance Neurology, November 11, 2003; 61(90095): S31 - 34. [Abstract] [Full Text]
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A. J. Petkau Statistical approaches to assessing the effects of neutralizing antibodies: IFN{beta}-1b in the pivotal trial of relapsing-remitting multiple sclerosis Neurology, November 11, 2003; 61(90095): S35 - 37. [Abstract] [Full Text]
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M. Rovaris, F. Agosta, M. P. Sormani, M. Inglese, V. Martinelli, G. Comi, and M. Filippi Conventional and magnetization transfer MRI predictors of clinical multiple sclerosis evolution: a medium-term follow-up study Brain, October 1, 2003; 126(10): 2323 - 2332. [Abstract] [Full Text] [PDF]
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F. M. Boneschi, M. Rovaris, K. P Johnson, A. Miller, J. S Wolinsky, D. Ladkani, G. Shifroni, G. Comi, and M. Filippi Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trials Multiple Sclerosis, August 1, 2003; 9(4): 349 - 355. [Abstract] [PDF]
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D Pelletier, S J Nelson, J Oh, J P Antel, M Kita, S S Zamvil, and D E Goodkin MRI lesion volume heterogeneity in primary progressive MS in relation with axonal damage and brain atrophy J. Neurol. Neurosurg. Psychiatry, July 1, 2003; 74(7): 950 - 952. [Abstract] [Full Text] [PDF]
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L. A Prosser, K. M Kuntz, A. Bar-Or, and M. C Weinstein Patient and community preferences for treatments and health states in multiple sclerosis Multiple Sclerosis, June 1, 2003; 9(3): 311 - 319. [Abstract] [PDF]
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S. Sturzebecher, K. P. Wandinger, A. Rosenwald, M. Sathyamoorthy, A. Tzou, P. Mattar, J. A. Frank, L. Staudt, R. Martin, and H. F. McFarland Expression profiling identifies responder and non-responder phenotypes to interferon-{beta} in multiple sclerosis Brain, June 1, 2003; 126(6): 1419 - 1429. [Abstract] [Full Text] [PDF]
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 B. Santarlasci and A. Messori Clinical Trial Response and Dropout Rates with Olanzapine Versus Risperidone Ann. Pharmacother., April 1, 2003; 37(4): 556 - 563. [Abstract] [Full Text] [PDF]
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M. Inglese, J.H.T.M. van Waesberghe, M. Rovaris, K. Beckmann, F. Barkhof, D. Hahn, L. Kappos, D.H. Miller, C. Polman, C. Pozzilli, et al. The effect of interferon {beta}-1b on quantities derived from MT MRI in secondary progressive MS Neurology, March 11, 2003; 60(5): 853 - 860. [Abstract] [Full Text] [PDF]
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A. Bertolotto, F. Gilli, A. Sala, M. Capobianco, S. Malucchi, E. Milano, F. Melis, F. Marnetto, R. L.P. Lindberg, R. Bottero, et al. Persistent neutralizing antibodies abolish the interferon {beta} bioavailability in MS patients Neurology, February 25, 2003; 60(4): 634 - 639. [Abstract] [Full Text] [PDF]
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 C. L M Sudlow and C. E Counsell Problems with UK government's risk sharing scheme for assessing drugs for multiple sclerosis BMJ, February 15, 2003; 326(7385): 388 - 392. [Full Text] [PDF]
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H F Petereit, H Lindemann, and S Schoppe Effect of immunomodulatory drugs on in vitro production of brain-derived neurotrophic factor Multiple Sclerosis, February 1, 2003; 9(1): 16 - 20. [Abstract] [PDF]
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C. Polman, L. Kappos, R. White, F. Dahlke, K. Beckmann, C. Pozzilli, A. Thompson, J. Petkau, and D. Miller Neutralizing antibodies during treatment of secondary progressive MS with interferon {beta}-1b Neurology, January 14, 2003; 60(1): 37 - 43. [Abstract] [Full Text] [PDF]
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D. H. Miller, O. A. Khan, W. A. Sheremata, L. D. Blumhardt, G. P.A. Rice, M. A. Libonati, A. J. Willmer-Hulme, C. M. Dalton, K. A. Miszkiel, P. W. O'Connor, et al. A Controlled Trial of Natalizumab for Relapsing Multiple Sclerosis N. Engl. J. Med., January 2, 2003; 348(1): 15 - 23. [Abstract] [Full Text] [PDF]
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H F Petereit, S Nolden, S Schoppe, S Bamborschke, R Pukrop, and W D Heiss Low interferon gamma producers are better treatment responders: a two-year follow-up of interferon beta-treated multiple sclerosis patients Multiple Sclerosis, December 1, 2002; 8(6): 492 - 494. [Abstract] [PDF]
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 L. A. Prosser, K. M. Kuntz, A. Bar-Or, and M. C. Weinstein The Relationship between Risk Attitude and Treatment Choice in Patients with Relapsing-Remitting Multiple Sclerosis Med Decis Making, December 1, 2002; 22(6): 506 - 513. [Abstract] [PDF]
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 J. S. Burks, B. G. Arnason, P. K. Coyle, C. C. Ford, A. Noronha, and K. W. Rammohan Issues and Practices in Multiple Sclerosis Neurorehabil Neural Repair, December 1, 2002; 16(4): 307 - 320. [Abstract] [PDF]
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 S. A. Brod Ingested Type I Interferon: State of the Art as Treatment for Autoimmunity Experimental Biology and Medicine, December 1, 2002; 227(11): 981 - 988. [Abstract] [Full Text]
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H. Panitch, D.S. Goodin, G. Francis, P. Chang, P.K. Coyle, P. O'Connor, E. Monaghan, D. Li, and B. Weinshenker Randomized, comparative study of interferon {beta}-1a treatment regimens in MS: The EVIDENCE Trial Neurology, November 26, 2002; 59(10): 1496 - 1506. [Abstract] [Full Text] [PDF]
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M. Clanet, E.W. Radue, L. Kappos, H.P. Hartung, R. Hohlfeld, M. Sandberg-Wollheim, M.F. Kooijmans-Coutinho, E.C. Tsao, and A.W. Sandrock A randomized, double-blind, dose-comparison study of weekly interferon {beta}-1a in relapsing MS Neurology, November 26, 2002; 59(10): 1507 - 1517. [Abstract] [Full Text] [PDF]
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G Giovannoni, F E Munschauer 3rd, and F Deisenhammer Neutralising antibodies to interferon beta during the treatment of multiple sclerosis J. Neurol. Neurosurg. Psychiatry, November 1, 2002; 73(5): 465 - 469. [Full Text] [PDF]
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