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A to Z of MS Teriflunomide (Aubagio)

Product names

Aubagio


Teriflunomide is a disease modifying drug for relapsing remitting MS.

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.

Teriflunomide research

Three main studies have provided the evidence to support approval of teriflunomide for multiple sclerosis:

  • TEMSO
    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.
  • TENERE
    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
    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.

References

National Institute for Health and Care Excellence (NICE).
Teriflunomide for treating relapsing–remitting 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.
Read online

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.
Read online

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.
abstract

Patient Information Leaflet

Aubagio (EMC website)
Webcast on drug therapy
Neurologist Prof David Bates addresses some of the questions people ask about disease modifying drugs
Watch the webcast

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