Short-term combination of glatiramer acetate with IV steroid treatment preceding treatment with GA alone assessed by MRI-disease activity in patients with relapsing-remitting multiple sclerosis

Nicola De Stefano, Massimo Filippi, Clive Hawkins

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objectives: To assess if short-term combination of glatiramer acetate (GA) and IV steroid in patients with relapsing-remitting multiple sclerosis (RRMS) is safe and sustains the effect of GA treatment on MRI-disease activity. Methods: RRMS patients with ≥ 2 gadolinium (Gd)-enhancing lesions on screening MRI and EDSS score ≤ 4.0 received GA injection (20 mg subcutaneously once daily) and monthly 1 g IV Methylprednisolone (IVMP) for 6 months. Afterwards, all subjects received GA injections daily alone for additional 6 months. Neurological evaluations were performed at screening, baseline and every 3 months. Laboratory tests for safety were performed at screening, baseline, months 1, 6 and 12. Brain MRIs were performed at screening, baseline, months 5, 6, 11, and 12 to assess the change in the number of Gd-enhancing lesions i) from baseline to month 6, and ii) from baseline to month 12 compared with the change from baseline to month 6. Results: 89 subjects were eligible for the study. In this group, GA in combination with IVMP resulted in 65% (95% CI = 0.25-0.49, p <0.0001) reduction in the number of Gd-enhancing lesions. This reduction was sustained for additional 6 months when patients received GA alone. The analysis for change achieved in the second 6 month period showed no difference from the change achieved in the first six months (ratio 0.75, 90% CI = 0.468-1.197). Overall, treatment was well tolerated and adverse events reported were similar to the known safety profile of GA. Conclusions: Short-term combination of GA with 1 g monthly IVMP, preceding treatment with GA alone, is safe. MRI data suggest that this combination therapy may result in an early and sustained reduction of disease activity in RRMS patients.

Original languageEnglish
Pages (from-to)44-50
Number of pages7
JournalJournal of the Neurological Sciences
Volume266
Issue number1-2
DOIs
Publication statusPublished - Mar 15 2008

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Relapsing-Remitting Multiple Sclerosis
Steroids
Methylprednisolone
Gadolinium
Therapeutics
Safety
Glatiramer Acetate
Injections

Keywords

  • Glatiramer acetate
  • Methylprednisolone
  • MRI
  • Multiple sclerosis

ASJC Scopus subject areas

  • Ageing
  • Clinical Neurology
  • Surgery
  • Neuroscience(all)
  • Developmental Neuroscience
  • Neurology

Cite this

@article{ac18b559d3f14aa4bf5d99dff1be635e,
title = "Short-term combination of glatiramer acetate with IV steroid treatment preceding treatment with GA alone assessed by MRI-disease activity in patients with relapsing-remitting multiple sclerosis",
abstract = "Objectives: To assess if short-term combination of glatiramer acetate (GA) and IV steroid in patients with relapsing-remitting multiple sclerosis (RRMS) is safe and sustains the effect of GA treatment on MRI-disease activity. Methods: RRMS patients with ≥ 2 gadolinium (Gd)-enhancing lesions on screening MRI and EDSS score ≤ 4.0 received GA injection (20 mg subcutaneously once daily) and monthly 1 g IV Methylprednisolone (IVMP) for 6 months. Afterwards, all subjects received GA injections daily alone for additional 6 months. Neurological evaluations were performed at screening, baseline and every 3 months. Laboratory tests for safety were performed at screening, baseline, months 1, 6 and 12. Brain MRIs were performed at screening, baseline, months 5, 6, 11, and 12 to assess the change in the number of Gd-enhancing lesions i) from baseline to month 6, and ii) from baseline to month 12 compared with the change from baseline to month 6. Results: 89 subjects were eligible for the study. In this group, GA in combination with IVMP resulted in 65{\%} (95{\%} CI = 0.25-0.49, p <0.0001) reduction in the number of Gd-enhancing lesions. This reduction was sustained for additional 6 months when patients received GA alone. The analysis for change achieved in the second 6 month period showed no difference from the change achieved in the first six months (ratio 0.75, 90{\%} CI = 0.468-1.197). Overall, treatment was well tolerated and adverse events reported were similar to the known safety profile of GA. Conclusions: Short-term combination of GA with 1 g monthly IVMP, preceding treatment with GA alone, is safe. MRI data suggest that this combination therapy may result in an early and sustained reduction of disease activity in RRMS patients.",
keywords = "Glatiramer acetate, Methylprednisolone, MRI, Multiple sclerosis",
author = "{De Stefano}, Nicola and Massimo Filippi and Clive Hawkins",
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doi = "10.1016/j.jns.2007.08.036",
language = "English",
volume = "266",
pages = "44--50",
journal = "Journal of the Neurological Sciences",
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T1 - Short-term combination of glatiramer acetate with IV steroid treatment preceding treatment with GA alone assessed by MRI-disease activity in patients with relapsing-remitting multiple sclerosis

AU - De Stefano, Nicola

AU - Filippi, Massimo

AU - Hawkins, Clive

PY - 2008/3/15

Y1 - 2008/3/15

N2 - Objectives: To assess if short-term combination of glatiramer acetate (GA) and IV steroid in patients with relapsing-remitting multiple sclerosis (RRMS) is safe and sustains the effect of GA treatment on MRI-disease activity. Methods: RRMS patients with ≥ 2 gadolinium (Gd)-enhancing lesions on screening MRI and EDSS score ≤ 4.0 received GA injection (20 mg subcutaneously once daily) and monthly 1 g IV Methylprednisolone (IVMP) for 6 months. Afterwards, all subjects received GA injections daily alone for additional 6 months. Neurological evaluations were performed at screening, baseline and every 3 months. Laboratory tests for safety were performed at screening, baseline, months 1, 6 and 12. Brain MRIs were performed at screening, baseline, months 5, 6, 11, and 12 to assess the change in the number of Gd-enhancing lesions i) from baseline to month 6, and ii) from baseline to month 12 compared with the change from baseline to month 6. Results: 89 subjects were eligible for the study. In this group, GA in combination with IVMP resulted in 65% (95% CI = 0.25-0.49, p <0.0001) reduction in the number of Gd-enhancing lesions. This reduction was sustained for additional 6 months when patients received GA alone. The analysis for change achieved in the second 6 month period showed no difference from the change achieved in the first six months (ratio 0.75, 90% CI = 0.468-1.197). Overall, treatment was well tolerated and adverse events reported were similar to the known safety profile of GA. Conclusions: Short-term combination of GA with 1 g monthly IVMP, preceding treatment with GA alone, is safe. MRI data suggest that this combination therapy may result in an early and sustained reduction of disease activity in RRMS patients.

AB - Objectives: To assess if short-term combination of glatiramer acetate (GA) and IV steroid in patients with relapsing-remitting multiple sclerosis (RRMS) is safe and sustains the effect of GA treatment on MRI-disease activity. Methods: RRMS patients with ≥ 2 gadolinium (Gd)-enhancing lesions on screening MRI and EDSS score ≤ 4.0 received GA injection (20 mg subcutaneously once daily) and monthly 1 g IV Methylprednisolone (IVMP) for 6 months. Afterwards, all subjects received GA injections daily alone for additional 6 months. Neurological evaluations were performed at screening, baseline and every 3 months. Laboratory tests for safety were performed at screening, baseline, months 1, 6 and 12. Brain MRIs were performed at screening, baseline, months 5, 6, 11, and 12 to assess the change in the number of Gd-enhancing lesions i) from baseline to month 6, and ii) from baseline to month 12 compared with the change from baseline to month 6. Results: 89 subjects were eligible for the study. In this group, GA in combination with IVMP resulted in 65% (95% CI = 0.25-0.49, p <0.0001) reduction in the number of Gd-enhancing lesions. This reduction was sustained for additional 6 months when patients received GA alone. The analysis for change achieved in the second 6 month period showed no difference from the change achieved in the first six months (ratio 0.75, 90% CI = 0.468-1.197). Overall, treatment was well tolerated and adverse events reported were similar to the known safety profile of GA. Conclusions: Short-term combination of GA with 1 g monthly IVMP, preceding treatment with GA alone, is safe. MRI data suggest that this combination therapy may result in an early and sustained reduction of disease activity in RRMS patients.

KW - Glatiramer acetate

KW - Methylprednisolone

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KW - Multiple sclerosis

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