Teriflunomide is a new oral disease modifier for RMS that blocks de novo pyrimidine synthesis thus reducing T- and B-cells proliferation with no cytotoxicity. A comprehensive clinical development program for teriflunomide has been launched in monotherapy. First Phase II study results of the safety and efficacy of teriflunomide monotherapy in MS were published in Neurology in 2006. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in RMS. A Phase III study, TOPIC, is also underway in early MS or Clinically Isolated Syndrome (CIS). Teriflunomide has also been evaluated as an adjunct therapy to either interferon 1-beta or glatiramer acetate in two Phase II studies. Results of these studies were presented earlier this year during the American Committee for Treatment and Research in Multiple Sclerosis meeting (ACTRIMS) congress, and the American Academy of Neurology (AAN) meeting respectively. Phase II studies with teriflunomide (7mg and 14mg) in adjunct with interferon 1-beta demonstrated an improvement in outcomes, with a consistent safety profile in patients treated with the adjunct treatment compared with patients treated with IFN-beta and receiving placebo. In the other Phase II study, teriflunomide in adjunct to glatiramer acetate (GA) was well-tolerated compared to patients receiving GA and placebo. Although there was a numerical trend for the reduction in number and volume of gadolinium enhancing T-1 brain MRI lesions in the adjunct arm compared to placebo with GA, the relative effect was not as robust as that observed for teriflunomide with IFN-beta.
About TEMSO Study
TEMSO is a 2-year randomized, double-blind, placebo controlled study
including 1088 RMS patients worldwide, aged 18-55 years, with an Expanded
Disability Status Scale (EDSS) <= 5.5 and at least one relapse over the
previous year or at least 2 relapses over the preceding 2 years. Patients
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