[P06.104] 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

Douglas L. Arnold, Montreal, Canada, Amit Bar-Or, Montreal, QC, Canada, Mark Freedman, Ottawa, ON, Canada, Suzanne Gazda, San Antonio, Hillel Panitch, Burlington, VT, Timothy Vollmer, Phoenix, AZ

OBJECTIVE: To determine whether effects on MRI markers of disease burden and tissue damage corroborate the beneficial effects on disease activity observed 15 months after initiating Glatiramer acetate (GA) therapy with a brief, low dose induction with mitoxantrone. BACKGROUND: Glatiramer acetate (GA) alone following a brief, low dose induction with mitoxantrone was found safe and more effective than GA alone in suppressing disease activity in a 15-month, randomized, single-blind study of patients with RRMS. DESIGN/METHODS: 40 RRMS patients, age 18 to 55 years, with 1-15 Gd-enhancing lesions on screening MRI and EDSS score 0-6.0 were randomized to receive either GA (20 mg/d sc, starting two weeks after the last of 3 monthly infusions of mitoxantrone (36mg/m2 total; n=21) or GA alone 20 mg/d sc, for a total period of 15 months (n = 19). MRI was obtained at baseline, 6,9,12 and 15 months. RESULTS: Baseline age (mean SD) (37.2 9.7 years), disease duration (3.5 4.8 years), EDSS (2.3 1.1), and number of Gd-enhancing lesions (3.75 3.95) were well-matched in the two arms. Reductions in Gd-enhancing lesions (Relative Risk Ratio = 0.30, 95% CI [0.11 0.86], p = 0.0147) and relapse activity at 15 months were accompanied by significant differences favoring the Mitoxantrone-GA group in the change from baseline in: the volume of T2w lesions (p=0.0139), the volume of T1w lesions (p=0.0303), and the proportion of Gd-enhancing lesions that evolved into chronic black holes at month 15 (p=0.0023). CONCLUSIONS/RELEVANCE: Long-term continuous therapy with GA after a brief, low dose induction with mitoxantrone is safe and highly effective. Decreases in disease activity, as assessed clinically and by MRI, were accompanied by favourable effects on the accumulation of T2w and T1w lesion load, and on the evolution of Gd-enhancing lesions into chronic black holes. Supported by: Teva Neuroscience.
Category - MS and Related Diseases
SubCategory - Clinical Science

Thursday, May 3, 2007 7:00 AM

Poster Sessions: Multiple Sclerosis and Related Diseases: Therapeutics (7:00 AM-10:00 AM)

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