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Glatiramer acetate after induction therapy with mitoxantrone in relapsing multiple sclerosis

¹ Barrow Neurological Institute, Phoenix, AZ, USA
² University of Vermont, Burlington, VT, USA
³ Montreal Neurological Institute, Montreal, Canada
⁴ Evergreen Neuroscience Institute, Kirkland, WA, USA
⁵ University of Ottawa, Ottawa, ON, Canada
⁶ Integra Research Clinic, San Antonio, TX, USA
⁷ Teva Pharmaceutical Industries Ltd., Netanya, Israel
⁸ Montreal Neurological Institute, Montreal, Canada; NeuroRx Research, Montreal, Canada

^* To whom correspondence should be addressed.

	Abstract

Forty relapsing multiple sclerosis patients with 1–15 gadolinium (Gd)-enhancing lesions on screening brain magnetic resonance imaging (MRI) and Expanded Disability Status Scale (EDSS) scores 0–6.5 were randomized to receive short-term induction therapy with mitoxantrone (three monthly 12 mg/m² infusions) followed by 12 months of daily glatiramer acetate (GA) therapy 20 mg/day subcutaneously for a total of 15 months (M-GA, n = 21) or daily GA 20 mg/day for 15 months (GA, n = 19). MRI scans were performed at months 6, 9, 12 and 15. The primary measure of outcome was the incidence of adverse events; secondary measures included number of Gd-enhanced lesions, confirmed relapses and EDSS changes. Except age, baseline demographic characteristics were well matched in both treatment arms. Both treatments were safe and well tolerated. M-GA induction produced an 89% greater reduction (relative risk (RR) = 0.11, 95% confidence interval (CI): 0.04–0.36, p  Gd-enhancing lesions at months 6 and 9 and a 70% reduction (RR = 0.30, 95% CI: 0.11–0.86, p  relapse rates were 0.16 and 0.32 in the M-GA and GA groups, respectively. Short-term immunosuppression with mitoxantrone followed by daily GA for up to 15 months was found to be safe and effective, with an early and sustained decrease in MRI disease activity.

Key Words: multiple sclerosis, immunology, de-myelinating disease, combination therapy, mitoxantrone, glatiramer acetate, induction therapy

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