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Short-term combination of glatiramer acetate with i.v. steroid treatment preceding treatment with GA alone assessed by MRI-disease activity in patients with relapsing-remitting multiple sclerosis.
J Neurol Sci 2008; 266(1-2):44-50JN

Abstract

OBJECTIVES

To assess if short-term combination of glatiramer acetate (GA) and i.v. 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 >or=2 gadolinium (Gd)-enhancing lesions on screening MRI and EDSS score <or=4.0 received GA injection (20 mg subcutaneously once daily) and monthly 1 g i.v. 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.

Authors+Show Affiliations

Department of Neurological and Behavioral Sciences, University of Siena, Italy. destefano@unisi.itNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

17897678

Citation

De Stefano, Nicola, et al. "Short-term Combination of Glatiramer Acetate With I.v. Steroid Treatment Preceding Treatment With GA Alone Assessed By MRI-disease Activity in Patients With Relapsing-remitting Multiple Sclerosis." Journal of the Neurological Sciences, vol. 266, no. 1-2, 2008, pp. 44-50.
De Stefano N, Filippi M, Hawkins C, et al. Short-term combination of glatiramer acetate with i.v. steroid treatment preceding treatment with GA alone assessed by MRI-disease activity in patients with relapsing-remitting multiple sclerosis. J Neurol Sci. 2008;266(1-2):44-50.
De Stefano, N., Filippi, M., & Hawkins, C. (2008). Short-term combination of glatiramer acetate with i.v. steroid treatment preceding treatment with GA alone assessed by MRI-disease activity in patients with relapsing-remitting multiple sclerosis. Journal of the Neurological Sciences, 266(1-2), pp. 44-50.
De Stefano N, et al. Short-term Combination of Glatiramer Acetate With I.v. Steroid Treatment Preceding Treatment With GA Alone Assessed By MRI-disease Activity in Patients With Relapsing-remitting Multiple Sclerosis. J Neurol Sci. 2008 Mar 15;266(1-2):44-50. PubMed PMID: 17897678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-term combination of glatiramer acetate with i.v. 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, AU - ,, Y1 - 2007/09/25/ PY - 2007/06/12/received PY - 2007/08/22/revised PY - 2007/08/27/accepted PY - 2007/9/28/pubmed PY - 2008/4/29/medline PY - 2007/9/28/entrez SP - 44 EP - 50 JF - Journal of the neurological sciences JO - J. Neurol. Sci. VL - 266 IS - 1-2 N2 - OBJECTIVES: To assess if short-term combination of glatiramer acetate (GA) and i.v. 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 >or=2 gadolinium (Gd)-enhancing lesions on screening MRI and EDSS score <or=4.0 received GA injection (20 mg subcutaneously once daily) and monthly 1 g i.v. 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. SN - 0022-510X UR - https://www.unboundmedicine.com/medline/citation/17897678/Short_term_combination_of_glatiramer_acetate_with_i_v__steroid_treatment_preceding_treatment_with_GA_alone_assessed_by_MRI_disease_activity_in_patients_with_relapsing_remitting_multiple_sclerosis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-510X(07)00616-8 DB - PRIME DP - Unbound Medicine ER -