A to Z of MS
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A to Z of MS Teriflunomide (Aubagio)
The drug can be prescribed for adults with active relapsing remitting MS (normally defined as two clinically significant relapses in the previous two years), providing they do not have highly active or rapidly evolving severe relapsing remitting multiple sclerosis.
Studies have shown that teriflunomide reduces the number of relapses by around one third and slows down progression.
Three main studies have provided the evidence to support approval of teriflunomide for multiple sclerosis:
TEMSO was a two year, double-blind study of 1088 people with relapsing remitting MS, comparing two doses of teriflunomide with placebo. Those people taking teriflunomide had one third fewer relapses than those taking placebo. The higher dose (14mg daily) also reduced disability progression by about one third compared to placebo.
This study compared two different doses of teriflunomide with interferon beta 1a (Rebif) in 324 people over two years and measured how long it took till participants had a relapse; this was the same for both doses of teriflunomide and interferon beta 1a.
TOWER tested two different doses of teriflunomide or placebo for at least 48 weeks in 1169 people with relapsing remitting MS. The higher dose reduced relapse rates by about one third compared to placebo and reduced disability progression by about one third.
How teriflunomide works
Teriflunomide stops certain immune cells from multiplying. This results in lower numbers of both B-cells and T-cells, two types of white blood cell involved in the damage associated with MS. In addition, it appears to have other immunomodulatory and anti-inflammatory actions.
Teriflunomide is closely related to leflunomide which is used to treat rheumatoid arthritis, an autoimmune condition.
How is teriflunomide taken?
Teriflunomide is taken as a tablet, once daily.
Side effects and contraindications
A common side effect of treatment includes increased liver enzyme levels, indicating liver damage. In addition, nausea, diarrhoea, and hair thinning can occur during the first few months of treatment but generally improve in the following months of treatment.
Contraception and pregnancy
Based on data in animal studies, there is an increased risk of having a baby with birth defects if teriflunomide is taken during pregnancy. Teriflunomide remains in the blood for a long time after stopping treatment, so this risk may continue for up to two years.
Women of childbearing age must use an effective method of contraception during treatment and for two years after stopping teriflunomide.
Women who suspect that they are pregnant while taking teriflunomide, or in the two years after stopping treatment, should contact their GP immediately for a pregnancy test. If the test confirms pregnancy, the blood level of teriflunomide can be reduced rapidly to safe levels by taking certain medicines (cholestyramine or activated charcoal).
Women who wish to become pregnant should stop taking teriflunomide. The removal of teriflunomide can be speeded up using the medicines described above. A blood test can confirm that levels of teriflunomide are low enough that it is safe to attempt to become pregnant.
National Institute for Health and Care Excellence (NICE).
Teriflunomide for treating relapsingremitting multiple sclerosis.
NICE technology appraisal guidance 303.
Available from NICE website
Scottish Medicines Consortium (SMC).
Advice: teriflunomide (Aubagio) - 10 March 2014.
Available from SMC website
O'Connor P, et al.
Randomized trial of oral teriflunomide for relapsing multiple sclerosis.
New England Journal Medicine 2011;365(14):1293-303.
Vermersch P, et al.
Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
Multiple Sclerosis Journal 2014;20:706-17.
Confavreux C, et al.
Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.
Lancet Neurology 2014;13(3):247-256.
Miller AE, et al.
Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial.
Lancet Neurology 2014 Sep 2. [Epub ahead of print]
Patient Information Leaflet
- Aubagio (EMC website)
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