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.
OBJECTIVE
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.
De Stefano
Nicola
N
Department of Neurological and Behavioral Sciences, University of Siena, Italy. destefano@unisi.it
Filippi
Massimo
M
Hawkins
Clive
C
D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000473:pathology; D010455:Peptides / Q000627:therapeutic use*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D010455:Peptides; D000068717:Glatiramer Acetate; D008775:Methylprednisolone