{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T23:15:19Z","timestamp":1777936519624,"version":"3.51.4"},"reference-count":12,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2012,6,21]],"date-time":"2012-06-21T00:00:00Z","timestamp":1340236800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2012,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The Teriflunomide Multiple Sclerosis Oral (TEMSO) trial, a randomized, double-blind, placebo-controlled phase III study, demonstrated that teriflunomide significantly reduced annualized relapse rate (ARR), disease progression and magnetic resonance imaging (MRI) activity, with a favorable safety profile in relapsing multiple sclerosis (RMS) patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The purpose of this study was to report the effects of teriflunomide on ARR and disability progression in pre-specified subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      RMS patients (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =1088) were randomized to placebo or teriflunomide, 7 mg or 14 mg, once daily, for 108 weeks. Subgroup analyses were performed for ARR and disability progression by baseline demographics (gender, race, age), disease characteristics (Expanded Disability Status Scale (EDSS) strata, relapse history, multiple sclerosis (MS) subtype), MRI parameters (gadolinium-enhancing lesions, total lesion volume) and prior use of MS drugs. A generalized estimating equation method and Cox regression model were used to assess consistency of the treatment effect across subgroups, utilizing a treatment-by-subgroup interaction test for each factor separately.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Reductions in ARR and disability progression were consistent across subgroups in favor of teriflunomide, with no treatment-by-subgroup interaction test reaching statistical significance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The positive effects of teriflunomide were demonstrated consistently across subgroups in TEMSO.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1352458512450354","type":"journal-article","created":{"date-parts":[[2012,6,22]],"date-time":"2012-06-22T12:13:55Z","timestamp":1340367235000},"page":"1625-1632","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":83,"title":["Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis"],"prefix":"10.1177","volume":"18","author":[{"given":"Aaron E","family":"Miller","sequence":"first","affiliation":[{"name":"Mount Sinai School of Medicine, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"O\u2019Connor","sequence":"additional","affiliation":[{"name":"University of Toronto, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry S","family":"Wolinsky","sequence":"additional","affiliation":[{"name":"University of Texas Health Science Center, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Confavreux","sequence":"additional","affiliation":[{"name":"University Claude Bernard Lyon 1, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ludwig","family":"Kappos","sequence":"additional","affiliation":[{"name":"University Hospital Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomas P","family":"Olsson","sequence":"additional","affiliation":[{"name":"Karolinska Institute, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Truffinet","sequence":"additional","affiliation":[{"name":"sanofi-aventis, Chilly-Mazarin, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin","family":"Wang","sequence":"additional","affiliation":[{"name":"sanofi-aventis, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"D\u2019Castro","sequence":"additional","affiliation":[{"name":"Fishawack Communications Ltd, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giancarlo","family":"Comi","sequence":"additional","affiliation":[{"name":"University Vita-Salute San Raffaele, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark S","family":"Freedman","sequence":"additional","affiliation":[{"name":"University of Ottawa, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the Teriflunomide Multiple Sclerosis Trial Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2012,6,21]]},"reference":[{"key":"e_1_3_2_2_2","first-page":"333","article-title":"Review of teriflunomide and its potential in the treatment of multiple sclerosis","volume":"5","author":"Warnke C","year":"2009","unstructured":"Warnke C, Meyer zu, Horste G, Hartung HP, . Review of teriflunomide and its potential in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat 2009; 5: 333\u2013340.","journal-title":"Neuropsychiatr Dis Treat"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1014656"},{"key":"e_1_3_2_4_2","first-page":"S23","article-title":"A placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis: clinical efficacy and safety outcomes","volume":"16","author":"O\u2019Connor P","year":"2010","unstructured":"O\u2019Connor P, Wolinsky J, Confavreux C, . A placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis: clinical efficacy and safety outcomes. Mult Scler 2010; 16: S23. 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Mult Scler 2010; 16: S347.(Abstract P982).","journal-title":"Mult Scler"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.22366"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.33.11.1444"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.55.5.689"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa011341"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/135245850100700105"},{"key":"e_1_3_2_11_2","volume-title":"Presented at the 63rd Annual Meeting of the American Academy of Neurology","author":"Devonshire V","unstructured":"Devonshire V, Havrdova E, O\u2019Connor P, . Fingolimod (FTY720) reduces the risk of 3-month confirmed disability progression: sub-group analysis from the 24-month FREEDOMS study in relapsing MS. Presented at the 63rd Annual Meeting of the American Academy of Neurology. 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