Journal
NEUROLOGY
Volume 77, Issue 16, Pages 1551-1560Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e318233b240
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Funding
- BioMS Medical Corp.
- Merck Serono
- Novartis
- sanofi-aventis
- Bayer Schering Pharma
- Genzyme Corporation
- EMD Serono, Inc.
- BioMS Medical
- Bayhill Therapeutics
- Biogen Idec
- Genentech, Inc.
- Teva Pharmaceutical Industries Ltd.
- Bayer Schering Pharma/Berlex
- Christopher Foundation
- MS Society of Canada
- CIHR
- Lotte Hecht Foundation
- Vancouver Hospital Foundation
- Bristol-Myers Squibb
- Lundbeck Inc.
- Elan Corporation
- Motor Neurone Disease Association
- British Polio Fellowship
- Swedish Research Council
- EU FP6
- Soderbergs Foundation
- Bibbi and Nils Jensens Foundation
- Montel Williams Foundation
- Swedish Brain foundation
- MRC [G0501747] Funding Source: UKRI
- Medical Research Council [G0501747] Funding Source: researchfish
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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(+). Neurology (R) 2011;77:1551-1560
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