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Copaxone Treatment over Two Years after Short Term Induction with,Mitoxantrone Provided Sustained Benefits to Active,Relapsing-Remitting Multiple Sclerosis Patients

he 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 Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Are Paralleled by Favorable Effects on MRI Markers of Disease Burden and Black Hole Evolution, evaluated whether effects on MRI markers of disease burden and tissue damage corroborate the beneficial effects on disease activity observed 15 months after initiating COPAXONE(R) therapy with a brief, low dose induction with mitoxantrone.

The abstract is accessible online at: http://www.abstracts2view.com/aan2007boston/view.php?nu=AAN07L_P06.104 &terms. (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

This analysis compared patients who were randomized to receive either three months of induction treatment with mitoxantrone followed by COPAXONE(R) for 12 months (n=21) or COPAXONE(R) alone (n=19) for 15 months.

The further MRI analyses showed that the reductions in Gd-enhancing lesions and relapse activity seen at 15 months were accompanied by significant differences favoring the mitoxantrone-COPAXONE(R) group in the change from baseline in the volume of T2-weighted lesions (p=0.0139), the volume of T1-weighted lesions (p=0.0303) and the proportion of Gd-enhancing lesions that evolved into chronic black holes at month 15 (p=0.0023).

The analysis, "Tracking In Vivo
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