Multiple Sclerosis Centers of Excellence
Teriflunomide (Aubagio®) is a once daily oral agent approved for treatment of adult patients with relapsing forms of multiple sclerosis (RRMS). It is thought teriflunomide’s mode of action reduces the number of activated lymphocytes in the central nervous system (CNS). In addition, it appears to have other immunomodulatory and anti-inflammatory actions. Teriflunomide is the principal active metabolite of leflunomide which is used to treat rheumatoid arthritis, an autoimmune condition. The recommended dose of teriflunomide is 7 mg or 14 mg orally once daily. In clinical trials it has demonstrated significantly lower annualized relapse rates (ARR), development of fewer lesions seen on MRI and confirmed disability progression for the 14 mg daily dose, in comparison to placebo. An active comparator trial with IFNB1a (Rebif) demonstrated no statistical superiority between the treatment arms for the risk of treatment failure, the primary composite endpoint of the study. Additionally, the treatment arms were not distinguishable on the endpoint of estimated annual relapse rate. There are trials currently underway which are investigating the safety and efficacy of adjunct therapy with teriflunomide in addition to IFNB1a and glatiramer. The most common adverse events include increased liver function tests (ALT), alopecia (hair loss), diarrhea, influenza, nausea and paresthesia. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide. Teriflunomide is a metabolite of leflunomide and as such, has the same precautions as leflunomide regarding hepatic impairment and use. Teriflunomide can be used without dose adjustment in patients with mild to moderate hepatic impairment. It is contraindicated in patients with severe hepatic impairment. Patients with preexisting liver disease may be at an increased risk of developing elevated serum transaminases when taking teriflunomide. It may take 8 months up to 2 years for teriflunomide to be cleared from the body upon discontinuation of therapy. If a patient needs to discontinue teriflunomide therapy due to serious adverse reaction (e.g., drug-induced liver injury, serious skin reactions), potential/ confirmed pregnancy or intolerance to therapy an accelerated elimination procedure. Although teriflunomide carries a pregnancy category X rating, a pregnancy registry has not demonstrated an increase in neonatal deficits as a result of teriflunomide exposure. Individuals who have questions about Teriflunomide (Aubagio) should contact their healthcare provider.
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Updated: September 2015