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

Research output: Contribution to journalArticle

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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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Multiple Sclerosis
Recurrence
Mouth Diseases
Placebos
Risk Reduction Behavior
teriflunomide
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

O'Connor, P., Wolinsky, J. S., Confavreux, C., Comi, G., Kappos, L., Olsson, T. P., ... 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

Randomized trial of oral teriflunomide for relapsing multiple sclerosis. / O'Connor, Paul; Wolinsky, Jerry S.; Confavreux, Christian; Comi, Giancarlo; Kappos, Ludwig; Olsson, Tomas P.; Benzerdjeb, Hadj; Truffinet, Philippe; Wang, Lin; Miller, Aaron; Freedman, Mark S.

In: New England Journal of Medicine, Vol. 365, No. 14, 06.10.2011, p. 1293-1303.

Research output: Contribution to journalArticle

O'Connor, P, Wolinsky, JS, Confavreux, C, Comi, G, Kappos, L, Olsson, TP, Benzerdjeb, H, Truffinet, P, Wang, L, Miller, A & Freedman, MS 2011, 'Randomized trial of oral teriflunomide for relapsing multiple sclerosis', New England Journal of Medicine, vol. 365, no. 14, pp. 1293-1303. https://doi.org/10.1056/NEJMoa1014656
O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. New England Journal of Medicine. 2011 Oct 6;365(14):1293-1303. https://doi.org/10.1056/NEJMoa1014656
O'Connor, Paul ; Wolinsky, Jerry S. ; Confavreux, Christian ; Comi, Giancarlo ; Kappos, Ludwig ; Olsson, Tomas P. ; Benzerdjeb, Hadj ; Truffinet, Philippe ; Wang, Lin ; Miller, Aaron ; Freedman, Mark S. / Randomized trial of oral teriflunomide for relapsing multiple sclerosis. In: New England Journal of Medicine. 2011 ; Vol. 365, No. 14. pp. 1293-1303.
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