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  • Title: 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.
    Author: De Stefano N, Filippi M, Hawkins C, 9011 study group.
    Journal: J Neurol Sci; 2008 Mar 15; 266(1-2):44-50. PubMed ID: 17897678.
    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.
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