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Spotlight on Interferon-β-1b in Relapsing-Remitting and Secondary Progressive Multiple Sclerosis

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Abstract

Interferon-β-1b (Betaseron®, Betaferon®) is a non-glycosylated recombinant human interferon-β approved for high-frequency, subcutaneous (SC) administration in the treatment of multiple sclerosis (MS). Its mechanism of action is unknown, but may involve modulation of the autoimmune pathogenic processes of MS.

In a randomized, double-blind trial in patients with relapsing-remitting MS (RRMS), SC interferon-β-1b 250μg (8 million International Units [MIU]) every other day reduced the annual relapse rate and increased the proportion of relapse-free patients compared with placebo. It also reduced relapse severity, hospitalizations, and disease activity assessed by magnetic resonance imaging (MRI), and increased the time to first relapse. Progression of disability showed a trend towards reduction relative to placebo and baseline, but did not reach statistical significance.

SC interferon-β-1b 250μg every other day was shown in a randomized trial to be superior to intramuscular (IM) interferon-β-1a 30μg (6 MIU) once weekly with respect to reductions in relapse-related parameters, disability progression and MRI-assessed disease activity.

In patients with secondary progressive MS (SPMS), SC interferon-β-1b 250μg every other day slowed progression of the disease relative to placebo in one randomized, double-blind trial, but not in another. In both studies, interferon-β-1b 250μg recipients had fewer relapses and less MRI-assessed disease activity than placebo recipients. The difference in primary outcome may reflect differences in patient entry criteria.

Interferon-β-1b is generally well tolerated and the common adverse events (e.g. injection site reactions, asthenia and an influenza-like symptom complex) are clinically manageable. In a randomized trial, the tolerability of SC interferon-β-1b 250μg every other day was generally similar to that of IM interferon-β-1a 30μg once weekly, except for higher incidences of injection site reactions and neutralizing anti-interferon-β antibodies with SC interferon-β-1b.

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Acknowledgments

The full text article in CNS Drugs 2004; 18 (8): 521–546 was reviewed by: G. Comi, Department of Neurology, Ospedale San Raffaele, Milan, Italy; F. Deisenhammer, Department of Neurology, University of Innsbruck, Innsbruck, Austria; O. Fernández, Institute of Neurosciences, Hospital Regional Universitario Carlos Haya, Malaga, Spain; M. Filippi, Scientific Institute and University San Raffaele, Milan, Italy; R.B. Forbes, Department of Neurology, Royal Victoria Hospital, Belfast, Northern Ireland; M.J. Nuijten, MEDTAP International, Amsterdam, The Netherlands; T. Traboulsee, University of British Columbia, Vancouver, British Columbia, Canada.

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  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, PA, 19067, USA

    Paul L. McCormack & Lesley J. Scott

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  1. Paul L. McCormack
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  2. Lesley J. Scott
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Correspondence to Paul L. McCormack.

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This Spotlight is derived from abstract and summary text of an Adis Drug Evaluation originally published in full in CNS Drugs 2004; 18 (8): 521–546. Reviewers of the original full text article are listed in the Acknowledgments section

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McCormack, P.L., Scott, L.J. Spotlight on Interferon-β-1b in Relapsing-Remitting and Secondary Progressive Multiple Sclerosis. BioDrugs 18, 343–347 (2004). https://doi.org/10.2165/00063030-200418050-00006

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