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| Article Authors: | M S Freedman; A Bar-Or; J Oger; A Traboulsee; D Patry; C Young; T Olsson; D Li; H-P Hartung; M Krantz; L Ferenczi; T Verco; MAESTRO-01 Investigators |
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| Article Title: | A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS. |
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| Reference ID: | 1022657 |
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| Abstract: | OBJECTIVE: To evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS) who express human leukocyte antigen (HLA) haplotype DR2 or DR4 (DR2(+) or DR4(+)). METHODS: This multicenter randomized 2-year, double-blind, placebo-controlled study included 612 subjects with a diagnosis of SPMS and an Expanded Disability Status Scale (EDSS) score of 3.5-6.5, stratified according to baseline EDSS score (3.5-5.0, or 5.5-6.5) and HLA haplotype (DR2(+) or DR4(+), or DR2(-)/DR4(-)). Upon entry of 100 DR2(-)/DR4(-) subjects, further study enrollment was limited to DR2(+) or DR4(+) subjects. Subjects were randomly assigned to either 500 mg MBP8298 or placebo, given by IV injection once every 6 months for 2 years. The primary outcome measure was time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later. Secondary outcomes included mean change in EDSS, mean change in Multiple Sclerosis Functional Composite, MRI changes, annualized relapse rate, and quality of life. RESULTS: There were no significant differences between treatment groups in either the primary or secondary endpoints. MBP8298 was well tolerated in all treated subjects with no safety issues identified. CONCLUSION: In the population studied, treatment with MBP8298 did not provide a clinical benefit compared to placebo. Classification of evidence: This study provides Class 1 evidence that MBP8298 is not effective in patients with SPMS who are HLA DR2(+) or DR4(+). |
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| Affiliations: | University of Ottawa, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario, Canada. mfreedman@toh.on.ca |
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| Date: | 2011 |
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| Reference Type: | Literature |
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| PubMed ID: | 21975206 |
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| Journal: | Neurology |
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| Journal Volume: | 77 |
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| Article Pages: | 1551-60 |
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| Journal ISSN: | 1526-632X |
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| Article Chemical List: | MBP-8298;Myelin Basic Proteins;Peptide Fragments |
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| Article MeSH List: | Adult; Aged; Disability Evaluation; Disease Progression; Double-Blind Method; Female; Humans; Kaplan-Meier Estimate; Longitudinal Studies; Magnetic Resonance Imaging; Male; Middle Aged; Multiple Sclerosis(drug therapy; pathology; psychology); Myelin Basic Proteins(therapeutic use); Peptide Fragments(therapeutic use); Quality of Life; Severity of Illness Index; Time Factors; Treatment Outcome |
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| Curation Last Updated: | 2013-05-28 22:37:36 |
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