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From the University of Toronto (P.W.O.), Ontario; University of British Columbia and MS/MRI Research Group (D.L., D.W.P.), Vancouver, British Columbia; Ottawa Hospital (M.S.F.), Ontario; McGill University (A.B.-O.), Montreal, Quebec; London Health Sciences Centre (G.P.A.R.), Ontario; sanofi-aventis (J.A.S.), Laval, Quebec; Hôpital Neurologique (C.C.), Lyon, France; and sanofi-aventis (R.S.), Bridgewater, NJ.
Address correspondence and reprint requests to Dr O’Connor, St. Michael’s Hospital, 30 Bond St., Suite 3-007, Shuter Wing, Toronto, Ontario, Canada M5B 1W8; e-mail: oconnorp{at}smh.toronto.on.ca
Background: Teriflunomide, a dihydro-orotate dehydrogenase inhibitor, has immunomodulatory effects, including the ability to suppress experimental allergic encephalomyelitis. In this randomized, double-blind, placebo-controlled Phase II study, the authors examined the safety and efficacy of oral teriflunomide in multiple sclerosis (MS) with relapses.
Methods: Patients (n = 179) with relapsing–remitting MS (n = 157) or secondary progressive MS with relapses (n = 22) were randomized to receive placebo, teriflunomide 7 mg/day, or teriflunomide 14 mg/day for 36 weeks. MRI brain scans were performed every 6 weeks. The primary endpoint was the number of combined unique active lesions per MRI scan. Secondary endpoints included MRI-defined disease burden, relapse frequency, and disability increase.
Results: The median number of combined unique active lesions per scan was 0.5, 0.2, and 0.3 in the placebo, teriflunomide 7 mg/day (p < 0.03 vs placebo), and teriflunomide 14 mg/day (p < 0.01 vs placebo) groups during the 36-week double-blind treatment phase. Teriflunomide-treated patients also had significantly fewer T1 enhancing lesions per scan, new or enlarging T2 lesions per scan, and new T2 lesions. Patients receiving teriflunomide 14 mg/day had significantly reduced T2 disease burden. Teriflunomide treatment resulted in trends toward a lower annualized relapse rate and fewer relapsing patients (14 mg/day only) vs placebo. Significantly fewer patients receiving teriflunomide 14 mg/day vs placebo demonstrated disability increase. Treatment was well tolerated; numbers of adverse events and serious adverse events were similar in all treatment groups.
Conclusion: Oral teriflunomide was effective in reducing MRI lesions and was well tolerated in patients with relapsing multiple sclerosis.
*See the Appendix for a list of participating investigators.
The authors acknowledge the contribution of Donald Paty as a study investigator. Dr. Paty died before this manuscript was completed.
Disclosure: Sponsored by sanofi-aventis.
Received February 26, 2005. Accepted in final form November 17, 2005.
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