TY - JOUR
T1 - Randomized trial of oral teriflunomide for relapsing multiple sclerosis
AU - O'Connor, Paul
AU - Wolinsky, Jerry S.
AU - Confavreux, Christian
AU - Comi, Giancarlo
AU - Kappos, Ludwig
AU - Olsson, Tomas P.
AU - Benzerdjeb, Hadj
AU - Truffinet, Philippe
AU - Wang, Lin
AU - Miller, Aaron
AU - Freedman, Mark S.
PY - 2011/10/6
Y1 - 2011/10/6
N2 - 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
AB - 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
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U2 - 10.1056/NEJMoa1014656
DO - 10.1056/NEJMoa1014656
M3 - Article
C2 - 21991951
AN - SCOPUS:80053533877
VL - 365
SP - 1293
EP - 1303
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 14
ER -