Skip to content

Research at St Andrews

Long-term safety and efficacy of teriflunomide: nine-year follow-up of the randomized TEMSO study

Research output: Contribution to journalArticle


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, Teriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston, Texas, John Peter Zajicek

School/Research organisations


OBJECTIVE: To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563).

METHODS: A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to teriflunomide 14 mg or 7 mg.

RESULTS: By June 2013, median (maximum) teriflunomide exposure exceeded 190 (325) weeks per patient; 468 patients (63%) remained on treatment. Teriflunomide was well-tolerated with continued exposure. The most common adverse events (AEs) matched those in the core study. In extension year 1, first AEs of transient liver enzyme increases or reversible hair thinning were generally attributable to patients switching from placebo to teriflunomide. Approximately 11% of patients discontinued treatment owing to AEs. Twenty percent of patients experienced serious AEs. There were 3 deaths unrelated to teriflunomide. Soon after the extension started, annualized relapse rates and gadolinium-enhancing T1 lesion counts fell in patients switching from placebo to teriflunomide, remaining low thereafter. Disability remained stable in all treatment groups (median Expanded Disability Status Scale score ≤2.5; probability of 12-week disability progression ≤0.48).

CONCLUSIONS: In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving teriflunomide for up to 9 years. Disease activity decreased in patients switching from placebo and remained low in patients continuing on teriflunomide.

CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that long-term treatment with teriflunomide is well-tolerated and efficacy of teriflunomide is maintained long-term.



Original languageEnglish
Pages (from-to)920-930
Number of pages11
Issue number10
Early online date10 Feb 2016
Publication statusPublished - 8 Mar 2016

Discover related content
Find related publications, people, projects and more using interactive charts.

View graph of relations

Related by author

  1. Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis

    Freeman, J. A., Hendrie, W., Jarrett, L., Hawton, A., Barton, A., Dennett, R., Jones, B., Zajicek, J. P. & Creanor, S., 1 Aug 2019, In : Lancet Neurology. 18, 8, p. 736-747

    Research output: Contribution to journalArticle

  2. Machine-learning based identification of undiagnosed dementia in primary care: a feasibility study

    Jammeh, E. A., Carroll, C. B., Pearson, S. W., Escudero, J., Anastasiou, A., Zhao, P., Chenore, T., Zajicek, J. & Ifeachor, E., 12 Jun 2018, In : BJGP Open. 2, 2, 13 p., bjgpopen18X101589.

    Research output: Contribution to journalArticle

  3. Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III

    Newman, C. G. J., Bevins, A. D., Zajicek, J. P., Hodges, J. R., Vuillermoz, E., Dickenson, J. M., Kelly, D. S., Brown, S. & Noad, R. F., 2018, In : Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring. 10, p. 182-187 6 p.

    Research output: Contribution to journalArticle

  4. Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial

    Gunn, H., Andrade, J., Paul, L., Miller, L., Creanor, S., Green, C., Marsden, J., Ewings, P., Berrow, M., Vickery, J., Barton, A., Marshall, B., Zajicek, J. & Freeman, J. A., 27 Jul 2017, In : Pilot and Feasibility Studies. 4, 12 p., 26.

    Research output: Contribution to journalArticle

  5. Time-and region-specific season of birth effects in multiple sclerosis in the United Kingdom

    Cruz, P. M. R., Matthews, L., Boggild, M., Cavey, A., Constantinescu, C. S., Evangelou, N., Giovannoni, G., Gray, O., Hawkins, S., Nicholas, R., Oppenheimer, M., Robertson, N., Zajicek, J., Rothwell, P. M. & Palace, J., 1 Aug 2016, In : JAMA Neurology. 73, 8, p. 954-960 7 p.

    Research output: Contribution to journalArticle

Related by journal

  1. Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort

    Cossburn, M., Pace, A. A., Jones, J., Ali, R., Ingram, G., Baker, K., Hirst, C., Zajicek, J., Scolding, N., Boggild, M., Pickersgill, T., Ben-Shlomo, Y., Coles, A. & Robertson, N. P., 9 Aug 2011, In : Neurology. 77, 6, p. 573-9 7 p.

    Research output: Contribution to journalArticle

  2. Cannabis for dyskinesia in Parkinson disease: a randomized double-blind crossover study

    Carroll, C. B., Bain, P. G., Teare, L., Liu, X., Joint, C., Wroath, C., Parkin, S. G., Fox, P., Wright, D., Hobart, J. & Zajicek, J. P., 12 Oct 2004, In : Neurology. 63, 7, p. 1245-50 6 p.

    Research output: Contribution to journalArticle

  3. The effect of cannabis on tremor in patients with multiple sclerosis

    Fox, P., Bain, P. G., Glickman, S., Carroll, C. & Zajicek, J., 13 Apr 2004, In : Neurology. 62, 7, p. 1105-9 5 p.

    Research output: Contribution to journalArticle

  4. Familial parkinsonism with synuclein pathology: Clinical and PET studies of A30P mutation carriers

    Krueger, R., Kuhn, W., Leenders, KL., Sprengelmeyer, R. H., Mueller, T., Woitalla, D., Portman, AT., Maguire, RP., Veenma, L., Schroeder, U., Schoels, L., Epplen, JT., Riess, O. & Przuntek, H., 22 May 2001, In : Neurology. 56, 10, p. 1355-1362 8 p.

    Research output: Contribution to journalArticle

ID: 243286144