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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Long-term safety and efficacy of teriflunomide
Neurology, Volume 86, No. 10, Year 2016
Notification
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Description
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. © 2016 American Academy of Neurology.
Authors & Co-Authors
O'Connor, Paul W.
Canada, Toronto
University of Toronto
Comi, Giancarlo C.
Italy, Milan
Università Vita-salute San Raffaele
Freedman, Mark Steven
Canada, Ottawa
University of Ottawa
KAPPOS, L. D.
Switzerland, Basel
Universitätsspital Basel
Bouchard, Jean Pierre
Canada, Quebec
Université Laval
Lebrun-Frénay, Christine
France, Nice
Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
Statistics
Citations: 100
Authors: 6
Affiliations: 11
Identifiers
Doi:
10.1212/WNL.0000000000002441
ISSN:
00283878
Research Areas
Disability
Health System And Policy