[P06.096] Reductions in MRI Disease Activity and Relapse Rates Observed after Induction of Shortterm Immunosuppression with Mitoxantrone Followed by Longterm Glatiramer Acetate (GA) Are Maintained at 24 Months in Patients with Relapsing Remitting Multiple Sclerosis (RRMS)

Timothy Vollmer, Denise Campagnolo, Phoenix, AZ, Hillel Panitch, Burlington, VT, Amit Bar-Or, Douglas Arnold, Montreal, QC, Canada

OBJECTIVE: To determine whether the increased efficacy and the safety observed at 15 months with GA after brief mitoxantrone therapy is maintained with continued GA therapy at 24 months. BACKGROUND: GA therapy during recovery of the immune system from short-term immunosuppression therapy may lead to enhanced GA efficacy. A single-blind controlled study found that GA monotherapy after brief mitoxantrone therapy was safe and highly effective compared with GA alone for producing early and significant decreases in MRI activity and relapses in patients with RRMS at 15 months. We hereby report the results of a 24 month followup. DESIGN/METHODS: Original study included 40 RRMS patients with 1-15 Gd enhancing lesions and EDSS scores 0-6.5 at screening. Patients were randomized to receive 3 monthly IV infusions of mitoxantrone (36mg/m² total) followed by a 2-week washout then GA 20mg/d SC for 12.5 months (M-GA, n=21) or GA 20mg/d alone (GA, n=19) for 15 months. In the follow-up of continued GA therapy, primary outcomes were safety and tolerability. Secondary outcomes included changes from baseline to 24 months in Gd-enhanced lesions, relapses, and EDSS. RESULTS: Thirty patients entered the extension study. Analyses at 15 months indicated a 70% reduction in Gd-enhanced lesions in the M-GA group vs GA group (Risk ratio = 0.30, 95% CI [0.11-0.86], p = 0.0147). These effects appear to be sustained. Preliminary results from approximately half of the extension cohort at 24M follow-up showed a reduction of 90% (baseline to 24 months) in Gd lesions in the M-GA group, and 70% in the GA group. Final results on the full cohort will be presented. Both treatments remained safe. CONCLUSIONS/RELEVANCE: Long-term continuous GA after brief immunosuppression with mitoxantrone is safe and highly effective. Early decreases in MRI and disease activity are maintained for up to 24 months. Supported by: Research grant from Teva Neurosciences, Kansas City, MO.
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)

The embargo for all abstracts to be presented at the 59th Annual Meeting is in effect until the date and time of the presentation unless otherwise noted on the abstract and/or press release. If there are questions, please contact the AAN media and public relations team.