Interferon beta-1-b in Secondary Progressive MS. Results from a 3-year controlled study. The North American Study Group on Interferon beta-1-b in Secondary Progressive MS

University of Vermont, College of Medicine, Burlington 05401, USA.
Neurology (Impact Factor: 8.29). 11/2004; 63(10):1788-95. DOI: 10.1212/01.WNL.0000146958.77317.3E
Source: PubMed


To evaluate the efficacy and safety of interferon beta-1b (IFNbeta-1b) in subjects with secondary progressive multiple sclerosis (SPMS).
This 3-year, multicenter, double-blind, placebo-controlled, randomized trial of IFNbeta-1b included 939 subjects from the United States and Canada with SPMS and Expanded Disability Status Scale (EDSS) scores ranging from 3.0 to 6.5. Subjects were randomly assigned to receive either placebo or IFNbeta-1b (250 microg or 160 microg/m2 body surface area), administered subcutaneously every other day. The primary outcome was time to progression by > or =1.0 EDSS point (0.5 point if EDSS score was 6.0 to 6.5 at entry) confirmed at 6 months. Secondary outcomes included mean change in EDSS score from baseline, relapse-related measures, MRI activity, and a standardized neuropsychological function test.
There was no significant difference in time to confirmed progression of EDSS scores between placebo-treated patients and either of the IFNbeta-1b treatment groups. However, IFNbeta-1b treatment resulted in improvement on secondary outcome measures involving clinical relapses, newly active MRI lesions, and accumulated burden of disease on T2-weighted MRI. Effects were similar for both IFNbeta-1b treatment groups. Neutralizing antibodies to IFNbeta-1b were detected in 23% of 250-microg and 32% of 160-microg/m2 recipients, but their presence did not consistently affect clinical or MRI outcomes. IFNbeta-1b was also well tolerated at both doses.
Although no treatment benefit was seen on the time to confirmed progression of disability, relapse- and MRI-related outcomes showed significant benefit with both dosing regimens tested, a result consistent with the outcomes of earlier clinical trials.

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    • "The primary endpoint in both studies was time to disability progression over 3 years. Although this was prolonged by more than 200 days in both studies among patients receiving IFN beta-1b compared with placebo, the difference was only significant in the European study (P < 0.001) [8, 36–39]. In both studies, compared with placebo, IFN beta-1b reduced ARR over 3 years and prolonged time to first relapse by more than 200 days (P ≤ 0.01, all comparisons) [8, 36]. "
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    Advances in Therapy 09/2014; 31(9). DOI:10.1007/s12325-014-0149-1 · 2.27 Impact Factor
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    • "All target the CNS inflammation that results in demyelination and axonal damage, and are most effective when used in the earlier phases of the disease process [43] [44]. Treatment is less effective in secondary-progressive MS (SPMS) [45] [46] [47], when neurodegenerative processes become more important determinants of disability progression than inflammation. Second-generation therapies used to treat relapsing MS include natalizumab, administered by intravenous infusion, and the oral agents fingolimod and teriflunomide; none has been studied in SPMS. "
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    • "The progressive phase of MS, either secondary or primary, reflects a poorly understood insidious widespread axonal degeneration that is age-related and independent of relapses [2-4]. Currently available disease-modifying treatments, which act by modifying the inflammatory response, reduce the frequency of relapses, but are not effective in progressive MS [5-7]. "
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