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Contact: Genzyme

Currently Enrolling Trials

General Information

Aubagio (teriflunomide) is an immunomodulatory agent with anti-inflammatory properties.

Aubagio is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Aubagio is supplied as a tablet for oral administration. The recommended dose is 7 mg or 14 mg orally once daily, taken with or without food.

Mechanism of Action

Aubagio inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

Side Effects

Adverse effects associated with the use of Aubagio may include, but are not limited to, the following:

ALT increased
Alopecia
Diarrhea
Influenza
Nausea
Paresthesia

Clinical Trial Results

The FDA approval of Aubagio was based on two studies.

Study One: This double-blind, placebo-controlled study enrolled 1,088 subjects with relapsing forms of multiple sclerosis (RMS). The subjects received once-daily doses of teriflunomide 7 mg, 14 mg or placebo over 108 weeks. The primary endpoint was the annualized relapse rate (ARR). The ARR was significantly reduced in both Aubagio dose groups compared to placebo: Aubagio 14 mg: 0.369 (p = 0.0005); Aubagio 7 mg: 0.370 (p = 0.0002); placebo: 0.539; the relative risk reduction was 31% for both Aubagio arms. The percentage of subjects remaining relapse-free at week 108 was 56.5% in the 14 mg arm, 53.7% in the 7 mg arm and 45.6% in the placebo arm. The percent disability progression at week 108 was 20.2% and 21.7% in the Aubagio 14 mg and 7 mg arms, respectively, versus 27.3% in the placebo arm. The time-to-disability progression sustained for 12 weeks was statistically significantly reduced only in the Aubagio 14 mg group compared to placebo. In addition, the change in total lesion volume from baseline was significantly lower in both the Aubagio arms than in the placebo arm and both Aubagio groups had significantly fewer gadolinium-enhancing lesions per T1-weighted scan than the placebo group.

Study Two: This randomized, double-blind, placebo-controlled study enrolled 179 MS subjects with relapse. The subjects were treated with twice the usual dose of Aubagio for the first week and then received 7 mg or 14 mg of Aubagio or placebo for the remainder of the 36-week treatment period. The primary endpoint was the average number of unique active lesions/MRI scan during treatment. MRI was performed at baseline, six weeks, 12 weeks, 18 weeks, 24 weeks, 30 weeks and 36 weeks. Baseline demographics were consistent across treatment groups. The mean number of unique active lesions per brain MRI scan during the 36-week treatment period was lower in subjects treated with Aubagio 14 mg (0.98) and 7 mg (1.06) as compared to placebo (2.69), the difference being statistically significant for both (p=0.0052 and p=0.0234, respectively).