AMSTERDAM—Data from TEMSO, the first pivotal phase III trial of teriflunomide, were reported by Paul O’Connor, FRCPC, MSc, at a satellite symposium at the ECTRIMS/ACTRIMS 5th Joint Triennial Congress. The two-year, double-blind study found a significant reduction in annualized relapse rates with both the 7-mg and 14-mg doses of teriflunomide compared with placebo as well as a significant reduction in the risk of sustained disability progression in the higher dose group. Both doses showed good safety and tolerability in patients with relapsing-remitting MS. Both doses were superior to placebo on a range of MRI end points in a dose-dependent fashion.
A long-term extension of TEMSO showed that teriflunomide was well tolerated with a favorable safety profile up to six years following randomization, with no unexpected adverse events related to long-term treatment.
Dr. O’Connor, Professor of Medicine at the University of Toronto and Director of the MS Clinic at St. Michael’s Hospital in Toronto, also discussed results from an extension of the phase II study of teriflunomide, which has provided information on up to nine years of teriflunomide treatment. Clinical and MRI disease activity remained low over the course of this extension and treatment-related adverse events were similar to those in the initial 36-week double-blind trial.
Both the extension of the Phase II trial and an extension of the TEMSO trial reported minimal clinical and MRI activity. A trend towards greater benefit on both clinical and MRI parameters was seen in patients who were continually treated with teriflunomide compared with placebo-treated patients who were switched to active treatment.