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   DIR Return to: AUBAGIO (teriflunomide)
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       #Post#: 1105--------------------------------------------------
       (Abst.) Long-term safety and efficacy of teriflunomide: 9-yr.
       followup of TEMSO study
   DIR By: agate
       Date: February 13, 2016, 12:21 pm
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       From PubMed, February 13, 2016:
       --- Quote ---
       > Neurology. 2016 Feb 10.
       >
       > Long-term safety and efficacy of teriflunomide: Nine-year
       follow-up of the randomized TEMSO study
       >
       > O'Connor P, Comi G, Freedman MS, Miller AE, Kappos L, Bouchard
       JP, Lebrun-Frenay C, Mares J, Benamor M, Thangavelu K, Liang J,
       Truffinet P, Lawson VJ, Wolinsky JS; Teriflunomide Multiple
       Sclerosis Oral (TEMSO) Trial Group and the MRI-AC in Houston,
       Texas; Teriflunomide Multiple Sclerosis Oral TEMSO Trial Group
       and the MRI-AC in Houston Texas.
       > Collaborators (149)
       >
       > 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.
       --- End Quote ---
       The abstract can be seen here
  HTML http://www.ncbi.nlm.nih.gov/pubmed/26865517.
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