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Treatment with Copaxone Plus Minocycline Showed Substantial,Reduction of Disease Activity in Patients with Active,Relapsing-Remitting Multiple Sclerosis

served after Induction of Short-term Immunosuppression with Mitoxantrone Followed by Long-term Glatiramer Acetate (GA) Are Maintained at 24 Months in Patients with Relapsing Remitting Multiple Sclerosis (RRMS), determined that the increased efficacy and the safety observed at 15 months with COPAXONE(r) after brief mitoxantrone therapy was maintained with continued COPAXONE(r) at 24 months. The original study included RRMS patients (n=40), ages 18-55, who had at least one Gd-enhancing lesion at the time of the screening MRI and an Expanded Disability Status Scale (EDSS) score of ˜ 6.5. Brain MRIs were performed at screening and months six, nine, 12 and 15.

The abstract is accessible online at: http://www.abstracts2view.com/aan2007boston/view.php?nu=AAN07L_P06.096&terms <http://www.abstracts2view.com/aan2007boston/view.php?nu=AAN07L_P06.096&terms> .

Patients were randomized to receive 3 monthly intravenous (IV) infusions of mitoxantrone (36 mg/m2 total) followed by a 2-week washout, then COPAXONE(r) 20 mg/d for 12.5 months (n=21) or COPAXONE(r) 20 mg/d alone (n=19) for 15 months.

In the 24-month follow-up of continued COPAXONE(r) therapy, primary outcomes were safety and tolerability. Secondary outcomes included changes from baseline to 24 months in Gd-enhancing lesions, relapses and EDSS.

Thirty patients entered the extension study. Analyses at 15 months indicated a 70 percent reduction in Gd-enhancing lesions in the mitoxantrone-COPAXONE(r) group vs COPAXONE(r) group (risk ratio=0.30, 95 percent CI [0.11-0.86], p=0.0147). These effects appeared to be sustained.

The analysis, Reductions in Gd Enhancing Lesions Observed with Glatiramer Acetate Following a Brief and Low Dose Course of Mitoxantrone in
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