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March 08, 2016; 86 (10) ArticleOpen Access

Long-term safety and efficacy of teriflunomide

Nine-year follow-up of the randomized TEMSO study

Paul O'Connor, Giancarlo Comi, Mark S. Freedman, Aaron E. Miller, Ludwig Kappos, Jean-Pierre Bouchard, Christine Lebrun-Frenay, Jan Mares, Myriam Benamor, Karthinathan Thangavelu, Jinjun Liang, Philippe Truffinet, Victoria J. Lawson, Jerry S. Wolinsky, For the Teriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston, Texas
First published February 10, 2016, DOI: https://doi.org/10.1212/WNL.0000000000002441
Paul O'Connor
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Giancarlo Comi
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Mark S. Freedman
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Aaron E. Miller
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Ludwig Kappos
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Jean-Pierre Bouchard
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Christine Lebrun-Frenay
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Jan Mares
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Myriam Benamor
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Karthinathan Thangavelu
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Jinjun Liang
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Philippe Truffinet
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Victoria J. Lawson
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Jerry S. Wolinsky
From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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From the University of Toronto (P.O.), Ontario, Canada; University Vita-Salute San Raffaele (G.C.), Milan, Italy; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ontario, Canada; Icahn School of Medicine at Mount Sinai (A.E.M.), New York, NY; University Hospital Basel (L.K.), Switzerland; Laval University, Centre Hospitalier Universitaire de Québec (J.-P.B.), Québec, Canada; Hôpital Pasteur (C.L.-F.), Nice, France; Fakultni Nemocnice Olomouc (J.M.), Olomouc, Czech Republic; Sanofi Genzyme (M.B., P.T.), Chilly-Mazarin, France; Sanofi Genzyme (K.T.), Cambridge, MA; Sanofi (J.L.), Bridgewater, NJ; Fishawack Communications Ltd. (V.J.L.), Abingdon, UK; and University of Texas Health Science Center at Houston (J.S.W.).
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Long-term safety and efficacy of teriflunomide
Nine-year follow-up of the randomized TEMSO study
Paul O'Connor, Giancarlo Comi, Mark S. Freedman, Aaron E. Miller, Ludwig Kappos, Jean-Pierre Bouchard, Christine Lebrun-Frenay, Jan Mares, Myriam Benamor, Karthinathan Thangavelu, Jinjun Liang, Philippe Truffinet, Victoria J. Lawson, Jerry S. Wolinsky, For the Teriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston, Texas
Neurology Mar 2016, 86 (10) 920-930; DOI: 10.1212/WNL.0000000000002441

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This article has a correction. Please see:

  • Long-term safety and efficacy of teriflunomide: Nine-year follow-up of the randomized TEMSO study - October 04, 2016
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    Figure 1 Patient disposition in Teriflunomide Multiple Sclerosis Oral (TEMSO) and the TEMSO extension study

    a The major reason for screening failure was failure to meet inclusion criteria (n = 155 [62.0%]); b 2 patients (1 each in the 14-mg and 7-mg teriflunomide groups) were not exposed to study medication because of protocol violation; c did not give consent to continue in extension study; d 2 patients in the 14-mg/14-mg group were randomized but not treated: 1 did not wish to continue and the other 1 prematurely discontinued study treatment and did not take any double-blind medication in the extension.

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    Figure 2 Efficacy outcomes in the core Teriflunomide Multiple Sclerosis Oral (TEMSO) and extension studies (modified intent-to-treat population)

    (A) Annualized relapse rate. (B) Mean EDSS score. (C) Number of Gd-enhancing T1 lesions. a Patients receiving placebo in the core study are shown as one group for this analysis. Week refers to time since start of core study. Week 108 is end of core study/start of extension study. Total number of Gd-enhancing T1 lesions defined as all lesions enhanced on T1 scan. *p < 0.005 compared with pooled placebo group; **p < 0.05 compared with placebo/7-mg group. CI = confidence interval; EDSS = Expanded Disability Status Scale; Gd = gadolinium.

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