Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Clinical review report. Teriflunomide (Aubagio — Genzyme Canada) indication: relapsing-remitting multiple sclerosis. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Clinical Review Report; SR0350. 2014 Authors' conclusions 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. Indexing Status Subject indexing assigned by CRD MeSH Administration, Oral; Aspartate Aminotransferases; Canada; Crotonates; Drug Evaluation; Immunologic Factors; Middle Aged; Multiple Sclerosis, Relapsing-Remittings; Toluidines; Treatment Outcome Language Published English Country of organisation Canada English summary An English language summary is available. Address for correspondence Canadian Agency for Drugs and Technologies in Health (CADTH), 865 Carling Avenue, Suite 600, Ottawa, Ontario Canada, K1S 5S8 Email: requests@cadth.ca AccessionNumber 32015000169 Date abstract record published 03/03/2015 |