From the Ectrims site:

http://www.akm.ch/ectrims2006/

Short-term combination of glatiramer acetate with IV steroid treatment preceding treatment with GA alone offers early and persistent effects on MRI-disease activity in patients with RRMS

C. Hawkins, M. Filippi, N. De Stefano and the 9011 Study Group

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Background: Data on short-term use of IV steroids in combination with immunomodulatory therapy in multiple sclerosis (MS) are scarce. Also limited are safety data on the continuous use of IV steroids together with immunomodulatory drugs in this disease.

We hypothesized that short-term combination of steroids with glatiramer acetate (GA) may result in depleting the autoaggressive T-cell population and enhance the induction of regulatory GA-specific T-cells. This would possibly increase the efficacy of GA treatment alone.

Objectives: To ascertain whether short-term combination of GA and IV steroids in patients with relapsing-remitting (RR) MS is safe, accelerates and maintains the effects of GA treatment on MRI-disease activity.
Methods: A group of RRMS patients (age range 18-45 years) with at least two T1-weighted gadolinium (T1-W Gd) enhancing lesions on screening MRI and EDSS score <=4.0 received Copaxone (GA injection) 20 mg subcutaneously (sc) once daily, and monthly 1g IV Methylprednisolone (IVMP) for 6 months.

Afterwards, all subjects received GA sc injections daily alone for additional 6 months. Brain MRIs were performed at screening, baseline, and at month 5, 6, 11, and 12, and neurological evaluations at screening, baseline, month 3 and then every three months. Suspected on-trial relapses were confirmed at an unscheduled visit. Safety laboratory tests at screening, baseline, month 1, 6 and termination.

The primary outcome measures of the study were: 1) The change from baseline to month 6 in the total number of T1-W Gd-enhancing lesions, and 2) The change in the total number of T1-W Gd-enhancing lesions, from baseline to month 12 compared with the change from baseline observed at month 6 (non-inferiority test, using 20% threshold).

Results: Of 171 subjects screened 89 (60.7% females) were eligible. Pooled baseline characteristics (mean±SD) were age (31.5±6.6 years), disease duration (2.3±3.5 years), EDSS (1.8±1.1), pre-study annual relapse rate (1.65±0.74), and number of T1-W Gd-enhancing lesions (5.4±6.8) at baseline. GA, when used in combination with monthly 1g IVMP, produced a 65% (95% CI 0.25, 0.49, p <0.0001) reduction in the number of T1-W Gd-enhancing lesions.

This reduction was sustained for an additional 6 month period when patients received GA alone. The non-inferiority analyses for the change achieved in the second 6 month period showed no difference from the change achieved in first six months (ratio 0.75, 90% CI 0.468, 1.197). Overall, adverse events reported throughout the 12 months were similar to the safety profile of Copaxone. In addition, compared to pre-study annual relapse rate, mean annualized relapse rate was reduced to 0.55 and 0.45 during the first and the second study periods, respectively. Mean converted EDSS change from baseline reached significance for patients completing 12 months treatment ( -0.15, 95% CI -0.29, -0.13, p = 0.0323).

Conclusions: Short-term combination of GA with 1g monthly IVMP, preceding treatment with GA alone, is safe and offers early and persistent effects on MRI¨Cdisease activity in RRMS patients.