Aubagio® (teriflunomide)

FDA-Approved Medications: New Data

Company: Genzyme

  • Oral; 7-mg or 14-mg once daily
  • Approved in 2012 for RMS

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The exact mechanism by which teriflunomide exerts a therapeutic effect in relapsing forms of MS is unknown, but may involve reducing the number of activated lymphocytes – immune-system cells – in the central nervous system. The agent has anti-inflammatory properties and has been shown to inhibit the synthesis of pyrimidine, an organic compound involved with various cells and processes throughout the body.32

Aubagio won FDA approval for use in relapsing forms of MS following positive results from four randomized, controlled, double-blind clinical trials. In the first study, 1,088 participants were randomized in a 1:1:1 ratio to receive Aubagio 7 mg, Aubagio 14 mg, or placebo, and followed for up to 26 months. Participants receiving Aubagio had a statistically significant reduction in the annual relapse rate (ARR) – the study’s primary endpoint – compared to individuals receiving placebo. The second study followed 1,165 patients for up to 40 months, also randomizing them in a 1:1:1 ratio to receive Aubagio 7 mg, Aubagio 14 mg, or placebo, and specifying ARR as the primary end point. Both doses of Aubagio again showed statistically significant advantages over placebo in terms of a lower relapse rate and on other measures of efficacy.

The third study followed a similar design, but focused on participants who had experienced a first clinical event consistent with acute demyelination (CIS) occurring within 90 days of randomization. After following them for up to 108 weeks, the study found that significantly higher proportions of Aubagio-treated patients remained free of relapse relative to individuals receiving placebo.

The fourth study examined MRI characteristics of 179 patients with RMS. The mean number of unique active lesions per brain MRI scan during the 36-week treatment period was lower in patients treated with Aubagio as compared to placebo.32

More recently, researchers examined the long-term impact of Aubagio on the performance status of people with relapsing MS. A study presented at the ECTRIMS-ACTRIMS Meeting in 2017 reported on 172 individuals who had received either 7 mg or 14 mg of Aubagio for up to 14 years, including time spent in an earlier trial of the medication. Researchers found consistently low EDSS scores in individuals who received Aubagio 14 mg throughout the initial and extension phases of the original study (2.28), at Year 5 (2.33) and at Year 10 (2.26). After Year 10, EDSS scores remained stable, but the number of participants had become small.33

Another study presented at the 2017 ECTRIMS-ACTRIMS Meeting examined the long-term disability outcomes of various subgroups of patients who had participated in earlier trials of Aubagio. Analysis of data on more than 1,300 patients found that the risk of confirmed disability worsening (CDW) five years after initiating treatment with 14 mg of Aubagio was broadly similar across subgroups stratified by sex, age, and EDSS score, among other factors.34

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