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.

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
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.