Neuroprotection with glatiramer acetate: evidence from the PreCISe trial

The phase III, multicenter, randomized, placebo-controlled PreCISe trial assessed glatiramer acetate (GA) effects in patients with clinically isolated syndromes (CIS) suggestive of multiple sclerosis (MS). To assess the neuroprotective effect of GA in a subset of patients in the PreCISe trial, we us...

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Bibliographic Details
Published in:Journal of neurology 2013-07, Vol.260 (7), p.1901-1906
Main Authors: Arnold, Douglas L., Narayanan, Sridar, Antel, Samson
Format: Article
Language:English
Subjects:
Adult
Axons - drug effects
Axons - pathology
Brain
Brain - drug effects
Brain - pathology
Demyelinating Diseases - drug therapy
Demyelinating Diseases - pathology
Double-Blind Method
Female
Glatiramer Acetate
Humans
Magnetic resonance imaging
Male
Medicine
Medicine & Public Health
Metabolism
Middle Aged
Multiple sclerosis
Neurology
Neuroprotective Agents - pharmacology
Neuroprotective Agents - therapeutic use
Neuroradiology
Neurosciences
Original Communication
Peptides - pharmacology
Peptides - therapeutic use
Review boards
Spectrum analysis
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Summary:The phase III, multicenter, randomized, placebo-controlled PreCISe trial assessed glatiramer acetate (GA) effects in patients with clinically isolated syndromes (CIS) suggestive of multiple sclerosis (MS). To assess the neuroprotective effect of GA in a subset of patients in the PreCISe trial, we used proton magnetic resonance spectroscopy (MRS) to measure N-acetylaspartate (NAA), a marker of neuronal integrity, in a large central volume of brain. Thirty-four CIS patients randomized to GA 20 mg/day ( n  = 19) SC or placebo ( n  = 15) were included. Patients who relapsed (developed clinically definite MS [CDMS]) were removed from the substudy. NAA/creatine (NAA/Cr) ratios were compared between GA-treated and placebo-treated patients. Twenty patients with CIS had not converted to CDMS and were still in the double-blind phase of the trial at 12 months of follow-up. Paired changes in NAA/Cr differed significantly in patients treated with GA (+0.14, n  = 11) compared with patients receiving placebo (−0.33, n  = 9, p  = 0.03) at 12 months, consistent with a neuroprotective effect of GA in vivo. Patients with CIS who received GA showed improvement in brain neuroaxonal integrity, as indicated by increased NAA/Cr, relative to comparable patients treated with placebo, who showed a decline in NAA/Cr consistent with findings from natural history studies.
ISSN:0340-5354
1432-1459
DOI:10.1007/s00415-013-6903-5