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dc.contributor.authorO'Connor, Paul
dc.contributor.authorComi, Giancarlo
dc.contributor.authorFreedman, Mark S.
dc.contributor.authorMiller, Aaron E.
dc.contributor.authorKappos, Ludwig
dc.contributor.authorBouchard, Jean-Pierre
dc.contributor.authorLebrun-Frenay, Christine
dc.contributor.authorMares, Jan
dc.contributor.authorBenamor, Myriam
dc.contributor.authorThangavelu, Karthinathan
dc.contributor.authorLiang, Jinjun
dc.contributor.authorTruffinet, Philippe
dc.contributor.authorLawson, Victoria J.
dc.contributor.authorWolinsky, Jerry S.
dc.contributor.authorTeriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston, Texas
dc.contributor.authorZajicek, John Peter
dc.date.accessioned2016-08-31T15:30:09Z
dc.date.available2016-08-31T15:30:09Z
dc.date.issued2016-03-08
dc.identifier.citationO'Connor , P , Comi , G , Freedman , M S , Miller , A E , Kappos , L , Bouchard , J-P , Lebrun-Frenay , C , Mares , J , Benamor , M , Thangavelu , K , Liang , J , Truffinet , P , Lawson , V J , Wolinsky , J S , Teriflunomide Multiple Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston, Texas & Zajicek , J P 2016 , ' Long-term safety and efficacy of teriflunomide : nine-year follow-up of the randomized TEMSO study ' , Neurology , vol. 86 , no. 10 , pp. 920-930 . https://doi.org/10.1212/WNL.0000000000002441en
dc.identifier.issn0028-3878
dc.identifier.otherPURE: 243286144
dc.identifier.otherPURE UUID: 263193e9-aea2-4c1d-b72c-89f5ac22ed9a
dc.identifier.otherPubMed: 26865517
dc.identifier.otherScopus: 84960471895
dc.identifier.otherORCID: /0000-0003-3481-825X/work/64034731
dc.identifier.urihttp://hdl.handle.net/10023/9408
dc.descriptionThis study was funded by Sanofi Genzyme.en
dc.description.abstractOBJECTIVE: 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.
dc.format.extent11
dc.language.isoeng
dc.relation.ispartofNeurologyen
dc.rights© 2016 American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.en
dc.subjectRC0321 Neuroscience. Biological psychiatry. Neuropsychiatryen
dc.subjectNDASen
dc.subject.lccRC0321en
dc.titleLong-term safety and efficacy of teriflunomide : nine-year follow-up of the randomized TEMSO studyen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.identifier.doihttps://doi.org/10.1212/WNL.0000000000002441
dc.description.statusPeer revieweden


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