Randomized trial of oral teriflunomide for relapsing multiple sclerosis

Paul O'Connor, Jerry S. Wolinsky, Christian Confavreux, Giancarlo Comi, Ludwig Kappos, Tomas P. Olsson, Hadj Benzerdjeb, Philippe Truffinet, Lin Wang, Aaron Miller, Mark S. Freedman

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Abstract

BACKGROUND: Teriflunomide is a new oral disease-modifying therapy for relapsing forms of multiple sclerosis. METHODS: We concluded a randomized trial involving 1088 patients with multiple sclerosis, 18 to 55 years of age, with a score of 0 to 5.5 on the Expanded Disability Status Scale and at least one relapse in the previous year or at least two relapses in the previous 2 years. Patients were randomly assigned (in a 1:1:1 ratio) to placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide once daily for 108 weeks. The primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. RESULTS: Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teriflunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (P

Original languageEnglish
Pages (from-to)1293-1303
Number of pages11
JournalNew England Journal of Medicine
Volume365
Issue number14
DOIs
Publication statusPublished - Oct 6 2011

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

O'Connor, P., Wolinsky, J. S., Confavreux, C., Comi, G., Kappos, L., Olsson, T. P., Benzerdjeb, H., Truffinet, P., Wang, L., Miller, A., & Freedman, M. S. (2011). Randomized trial of oral teriflunomide for relapsing multiple sclerosis. New England Journal of Medicine, 365(14), 1293-1303. https://doi.org/10.1056/NEJMoa1014656