Authors' recommendations: Based on the results of two phase 3 double-blind randomized controlled trials, teriflunomide 14 mg may reduce the annualized relapse rate (ARR) by approximately 30% to 35% compared with no treatment (placebo) over one to three years of treatment. However, the benefits of teriflunomide compared with no treatment in terms of reducing disability are less certain, given that disability sustained for 24 weeks was not statistically significantly different between teriflunomide and placebo in either trial. There were no differences in health-related quality of life or fatigue between teriflunomide and placebo. Direct head-to-head evidence for teriflunomide 14 mg, limited to one investigator-blinded randomized controlled trial, reported no statistically significant difference in ARR or time to failure (primary outcome) between teriflunomide 14 mg and interferon beta-1a 44 mcg; however, the trial was not designed to test equivalence or non-inferiority of teriflunomide, and thus this cannot be inferred.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.cadth.ca/media/cdr/clinical/SR0350_Aubagio_CL_Report_e.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Canadian Agency for Drugs and Technologies in Health

Contact Address: 600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553; Fax: +1 613 226 5392;

Contact Name: requests@cadth.ca

Contact Email: requests@cadth.ca

Copyright: Canadian Agency for Drugs and Technologies in Health (CADTH)