Aubagio (teriflunomide) is a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). The Aubagio 14 mg dose has been shown to reduce relapses by 31.5% in the TEMSO trial and 36% in the TOWER trial. Both trials demonstrated a benefit in reducing the likelihood of disability progression. In the TEMSO trial, new active MRI lesions with contrast were reduced by 80% with treatment with 14 mg of Aubagio. The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair thinning.
Leflunomide, a treatment for rheumatoid arthritis, is converted in the body to teriflunomide. Globally since the launch of leflunomide, 2.1 million years of patient exposure has occurred. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide. Aubagio contains a Boxed Warning to alert prescribers and patients to the risk of liver problems and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and then at least monthly for 6 months. In addition, a baseline white blood count and tuberculosis TB test should be performed. Based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.