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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
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Article Figures & Data

Figures

  • Figure 1
    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.

  • Figure 2
    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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  • Data Supplement

    One appendix, three tables, and two figures; three PDF files.

    Neurology® data supplements are not copyedited before publication. Published editorials and translations have been copyedited.
    © 2016 American Academy of Neurology.

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  • Coinvestigators

    Neurology® data supplements are not copyedited before publication. Published editorials and translations have been copyedited.
    © 2016 American Academy of Neurology.

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