[S02.003] Glatiramer Acetate Combined with Minocycline Reduces the Number of T1 Gd-Enhancing and New T2 Lesions Compared to Glatiramer Actetate Alone
Luanne Metz, David Li, Anthony Traboulsee, Vancouver, BC, Canada, Mary Myles, Edmonton, AB, Canada, Pierre Duquette, Jean Godin, Montreal, QC, Canada, Michel Constantin, Montreal, PQ, Canada, V. Wee Yong, Calgary, AB, Canada
OBJECTIVE: To evaluate the add-on effect of minocycline in subjects initiating treatment with GA. BACKGROUND: Glatiramer acetate (GA) reduces clinical and MRI activity in relapsing-remitting multiple sclerosis (RRMS). Recently minocycline was shown to reduce enhancing MRI activity in a pilot trial. Animal studies support an increased benefit from the combination. DESIGN/METHODS: RRMS patients (n=44) with one or more T1-enhancing lesions on their screening MRI were randomized to either GA 20 mg daily + minocycline 100 mg twice daily or GA + placebo. Subjects were assessed clinically and by MRI at screening and months 1, 3, 8 and 9. The primary outcome was the total number of T1 enhancing lesions at months 8 and 9. RESULTS: Forty subjects completed the study. Two subjects from each group discontinued study drug. Groups were balanced clinically at baseline except for greater T1-enhancing lesion number in the GA/minocycline group (median 3 versus 2; mean 7.62 versus 2.43 (p=0.07)). Despite this imbalance treatment favoured the GA/minocycline group. At months 8 and 9, the number of T1-enhancing lesions was reduced by 63% (mean 1.47 versus 2.95; p=0.08) and the number of new T2 lesions was reduced by 65% (mean 1.84 versus 5.14; p=0.06), compared to GA/placebo. Relapse risk was reduced by 42% in the GA/minocycline group (0.19 versus 0.41; p=NS). Treatment was safe and well tolerated. CONCLUSIONS/RELEVANCE: A trend to significance on both primary and secondary end-points, despite imbalance at baseline, reflects a consistent pattern of benefit favoring the combination of GA and minocycline. As minocycline is a safe, well-tolerated and inexpensive therapy a further study of this combination in RRMS is warranted. Supported by: Teva Neuroscience Canada. Category - MS and Related Diseases SubCategory - Clinical Science
Tuesday, May 1, 2007 2:30 PM
Scientific Sessions: Multiple Sclerosis: Clinical Trials I (2:00 PM-3:30 PM) 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.
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