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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe TEMSO and TOWER trials demonstrate that both doses of teriflunomide (7 mg and 14 mg) each significantly reduce the annualized relapse rates in patients with relapsing multiple sclerosis. Post hoc analyses of both trials indicate that only teriflunomide 14 mg significantly reduces the rate of all 5 markers of severe relapse in both studies.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Emultiple sclerosis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eteriflunomide\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Erelapse\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETOWER\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETEMSO\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eneurology clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edemyelinating diseases\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003ETeriflunomide is a once-daily oral immunomodulating drug approved in the United States for the treatment of relapsing multiple sclerosis (RMS). Teriflunomide was tested in 2 phase 3 trials\u2014TOWER [Confavreux C et al. \u003Cem\u003ELancet Neurol\u003C\/em\u003E. 2014] and TEMSO [O\u2019Connor P et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2011]. Results from these 2 trials indicate that among people with RMS, teriflunomide 7 mg and 14 mg are both associated with significant reductions in the annualized relapse rate (ARR) compared with placebo.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EBecause severe MS relapses are associated with disability progression and substantial economic cost, an agent capable of reducing this type of relapse could reduce health care costs and improve patient outcomes. Richard Macdonell, MD, Austin Health, Victoria, Australia, highlighted data from post hoc analyses of TOWER and TEMSO regarding the effect of teriflunomide on severe relapses in a poster presentation.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EAs there is no universal definition of what constitutes a severe relapse, these analyses examined the effect of teriflunomide on 5 surrogate markers: (1) relapses with sequelae defined by increase in Expanded Disability Status Scale score\/Functional System score 30 days postrelapse; (2) relapses with investigator-defined sequelae; (3) severe relapses by the Panitch definition, which is based on specified increases in Expanded Disability Status Scale and Functional System score used in the EVIDENCE trial in 2002; (4) relapses leading to hospitalization; and (5) relapses associated with increased use of health care resources, including those requiring intravenous corticosteroid treatment. All analyses were performed on the modified intent-to-treat population enrolled in each study (TEMSO, n\u2005=\u20051086; TOWER, n\u2005=\u20051165).\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003ECompared with placebo, teriflunomide 14 mg significantly reduced annualized rates of all 5 indicators of severe relapse in both TEMSO and TOWER. Teriflunomide 7 mg significantly reduced the annualized relapse rates for several different indicators of relapse in both studies. The effects of teriflunomide 7 mg, 14 mg, and placebo on severe relapses in TEMSO and TOWER are shown in \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/17.1\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Effects of Teriflunomide on Severe Relapses in TEMSO and TOWEREDSS, Expanded Disability Status Scale; FS, Functional System; IV, intravenous.Sources: O\u0026#x2019;Connor PW et al. J Neurol. 2013 and Miller AE et al. J Neurol. 2014.Reproduced with permission from R Macdonell, MD.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-767176128\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Effects of Teriflunomide on Severe Relapses in TEMSO and TOWEREDSS, Expanded Disability Status Scale; FS, Functional System; IV, intravenous.Sources: O\u0026#x2019;Connor PW et al. \u0026amp;lt;em\u0026amp;gt;J Neurol\u0026amp;lt;\/em\u0026amp;gt;. 2013 and Miller AE et al. \u0026amp;lt;em\u0026amp;gt;J Neurol\u0026amp;lt;\/em\u0026amp;gt;. 2014.Reproduced with permission from R Macdonell, MD.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/17.1\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/17.1\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/9\/17.1\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16569\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EEffects of Teriflunomide on Severe Relapses in TEMSO and TOWER\u003C\/p\u003E\n               \u003Cp id=\u0022p-7\u0022\u003EEDSS, Expanded Disability Status Scale; FS, Functional System; IV, intravenous.\u003C\/p\u003E\n               \u003Cp id=\u0022p-8\u0022\u003ESources: O\u2019Connor PW et al. \u003Cem\u003EJ Neurol\u003C\/em\u003E. 2013 and Miller AE et al. \u003Cem\u003EJ Neurol\u003C\/em\u003E. 2014.\u003C\/p\u003E\n               \u003Cp id=\u0022p-9\u0022\u003EReproduced with permission from R Macdonell, MD.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EBoth teriflunomide doses showed similar and manageable safety profiles across the 2 studies. Adverse events emerging more often with teriflunomide than with placebo included elevations in alanine aminotransferase, as well as headache and diarrhea.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EIn summary, teriflunomide has shown consistent and significant efficacy on annualized relapse rates in both TEMSO and TOWER. Teriflunomide also reduced the rate of severe relapses, which may help reduce health care costs related to episodes of relapse, as well as improve patients\u2019 quality of life.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/9\/17.1.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzlo8q\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlo8q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}