What has the TEMSO trial demonstrated on the use of teriflunomide (Aubagio) to treat relapsing-remitting multiple sclerosis (MS) (RRMS)?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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Answer

Approval was based on a randomized trial (TEMSO) of 1088 patients with a minimum of 1 relapse in the previous year or 2 relapses in the last 2 years. Teriflunomide was shown to significantly reduce annualized relapse rates (31% relative risk reduction compared with placebo [P< .001]). It was also shown in the TEMSO trial to reduce disability progression at doses of 14 mg/day. [102] However, the FDA has not approved the use of teriflunomide to slow disability progression.

Phase III of the TEMSO study found that teriflunomide significantly slowed brain volume loss compared with placebo over 2 years in patients with relapsing MS. Data obtained from MRI were used to assess patients treated with 14 mg or 7 mg of the drug, or placebo. By month 12, median percent reduction from baseline in brain volume was 0.39, 0.40, and 0.61 for teriflunomide 14 mg, 7 mg, and placebo, respectively. [103]


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