Epitopes described in "A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS."

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
Article Title:A phase III study evaluating the efficacy and safety of MBP8298 in secondary progressive MS.
Reference Detail
Reference ID:1022657
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(+).
Reference Type:Literature
PubMed ID:21975206
Journal Volume:77
Article Pages:1551-60
Journal ISSN:1526-632X
Article Chemical List:MBP-8298;Myelin Basic Protein;Peptide Fragments
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 Protein(therapeutic use); Peptide Fragments(therapeutic use); Quality of Life; Severity of Illness Index; Time Factors; Treatment Outcome
Curation Last Updated:2014-10-14 18:30:52