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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Main Authors:	Arnold, Douglas L., Narayanan, Sridar, Antel, Samson
Format:	Online
Language:	English
Published:	Springer Berlin Heidelberg 2013
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3705142/

id	pubmed-3705142
recordtype	oai_dc
spelling	pubmed-37051422013-07-11 Neuroprotection with glatiramer acetate: evidence from the PreCISe trial Arnold, Douglas L. Narayanan, Sridar Antel, Samson Original Communication 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. Springer Berlin Heidelberg 2013-04-16 2013-07 /pmc/articles/PMC3705142/ /pubmed/23589190 http://dx.doi.org/10.1007/s00415-013-6903-5 Text en © The Author(s) 2013 Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Arnold, Douglas L. Narayanan, Sridar Antel, Samson
spellingShingle	Arnold, Douglas L. Narayanan, Sridar Antel, Samson Neuroprotection with glatiramer acetate: evidence from the PreCISe trial
author_facet	Arnold, Douglas L. Narayanan, Sridar Antel, Samson
author_sort	Arnold, Douglas L.
title	Neuroprotection with glatiramer acetate: evidence from the PreCISe trial
title_short	Neuroprotection with glatiramer acetate: evidence from the PreCISe trial
title_full	Neuroprotection with glatiramer acetate: evidence from the PreCISe trial
title_fullStr	Neuroprotection with glatiramer acetate: evidence from the PreCISe trial
title_full_unstemmed	Neuroprotection with glatiramer acetate: evidence from the PreCISe trial
title_sort	neuroprotection with glatiramer acetate: evidence from the precise trial
description	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.
publisher	Springer Berlin Heidelberg
publishDate	2013
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3705142/
_version_	1611993014278815744

Neuroprotection with glatiramer acetate: evidence from the PreCISe trial

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