Journal
MULTIPLE SCLEROSIS JOURNAL
Volume 18, Issue 8, Pages 1125-1134Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458511433304
Keywords
clinical trials observational study; multiple sclerosis; MRI; voxel-wise MTR
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Funding
- Biogen Idec., (Weston, MA, USA) [IRB NEU2011107E]
- Biogen Idec
- Bracco
- EMD Serono
- Genzyme
- Questcor Pharmaceuticals
- Teva
- Aspreva
- Acorda
- National Multiple Sclerosis Society
- National Institutes of Health
- ITN
- Cognition
- Teva Neuroscience
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Objective: To determine the effects of intravenous natalizumab and intramuscular interferon beta-1a (IFN beta-1a) on the volume of white-matter (WM) lesions and normal appearing brain tissue (NABT) undergoing voxel-wise (VW) increases in magnetization transfer ratio (MTR) suggestive of remyelination in patients with relapsing multiple sclerosis. Methods: This prospective, open-label, single-blinded study enrolled patients with relapsing-remitting multiple sclerosis (RRMS) and relapsing secondary progressive multiple sclerosis (RSPMS) as well as a group of age/sex-matched healthy controls (n=22). Patients with multiple sclerosis were assigned to receive natalizumab monotherapy (n=77; RRMS/RSPMS) or intramuscular IFN beta-1a (n=26) as either monotherapy (RRMS) or combined with pulsed i.v. methylprednisolone, as needed (RSPMS). The primary endpoint was the two-year change in volume of NABT VWMTR, by quantifying the number of voxels that increased (suggesting remyelination) or decreased (suggesting demyelination) in their MTR value. Results: The volume of tissue undergoing increases in VWMTR was significantly larger in natalizumab compared with IFN beta-1a-treated patients (year 1: p=0.001 in NABT and p<0.006 in WM lesions; year 2: p=0.008 in NABT) and compared with healthy control subjects (year 1: p=0.05 and year 2: p=0.007 in NABT). The larger volume within NABT undergoing decreases in VWMTR was detected in multiple sclerosis patients compared with healthy controls (p<0.001), and in the IFN beta-1a group compared with the natalizumab group (year 1: p=0.05; year 2: p=0.002). One patient on natalizumab died from progressive multifocal leukoencephalopathy eight months after completing the study. Conclusion: Natalizumab may promote remyelination and stabilize demyelination in lesions and NABT in relapsing multiple sclerosis, compared with intramuscular IFN beta-1a.
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