You take Aubagio as a pill once a day to reduce the number and severity of relapses. It reduces the number of relapses by about one third (30%), compared to taking placebo.
Common side effects include feeling sick, diarrhoea and hair thinning.
What is Aubagio used for in MS?
Aubagio is moderately effective (category 1.1) DMD; in clinical trials people taking Aubagio had about 30% fewer relapses than people taking placebo. In clinical trials, MRI scans showed people taking Aubagio had fewer, smaller or no new areas of active MS (lesions). Aubagio may also slow down the build-up of disability associated with MS.
Who can take Aubagio?
Aubagio can be prescribed for adults with active relapsing remitting MS.
Aubagio has been approved for use on the NHS since 2014. It can only be prescribed by a neurologist.
It's important that you tell your MS team if you have any health problems or are taking other medicines. Aubagio may not be appropriate if you have existing medical conditions including: severe liver problems, serious problems affecting the immune system (eg AIDS) and significant problems affecting bone marrow or reduced blood cell counts (eg anaemia, leucopenia, neutropenia or thrombocytopenia).
Conception and Pregnancy
You must not become pregnant while taking Aubagio. Studies in animals suggest that there is an increased risk of having a baby with birth defects if Aubagio is taken during pregnancy. Aubagio remains in the blood for a long time after stopping treatment, so this risk may continue for up to two years.
Women of child bearing age should use an effective method of contraception during treatment and for two years after stopping Aubagio. A small recent study showed that in four out of ten couples where the man was taking Aubagio, Aubagio was detected at low levels in the woman too. This suggests that Aubagio can be transferred in semen. Men taking Aubagio treatment should use barrier methods of contraception during treatment and for two years after stopping.
If you suspect you are pregnant while you are taking Aubagio, or in the two years after stopping treatment, you should contact your GP immediately for a pregnancy test. If the test confirms your pregnancy, you can take medication (cholestyramine or activated charcoal) that rapidly eliminates traces of Aubagio from your body. If you wish to become pregnant, this same method can be used by women and men to reduce Aubagio to safe levels before attempting to conceive.
Do not stop your Aubagio treatment without discussing it with your MS team first.
How do I take Aubagio?
You take Aubagio as a pill, once daily.
What side effects could I get with Aubagio?
Common side effects of treatment include feeling sick, diarrhoea and hair thinning which can occur during the first few months of treatment but generally improve in following months. Increased blood levels of liver enzymes can also occur.
Common side effects (affecting more than 1 person in 100)
- increased levels of liver enzymes
- nausea and diarrhoea
- hair thinning and loss
- pins and needles
- infections: including influenza, urinary, nose and throat
- decrease in white blood cells (neutropenia)
- mild allergic reactions
- nerve pain
- decrease in red blood cells (anaemia)
- increase in blood pressure
- musculoskeletal pain
Less common side effects (affecting less than 1 person in 100)
- decrease in blood platelets (thrombocytopenia)
- peripheral neuropathy
A full list of side effects is included in the manufacturer's Patient Information Leaflet.
Assessment before treatment
Before starting Aubagio, you should have blood tests to measure blood cell counts and check your liver function. Your blood pressure will also be checked.
As Aubagio must not be taken during pregnancy, women of child-bearing age may be offered a pregnancy test.
Assessment during treatment
Once you've started treatment you'll have blood tests to monitor liver function, generally every 2 weeks for the first 6 months and every 8 weeks thereafter. Depending on local practice, the tests may be carried out at a local GP surgery or it may be necessary to attend a hospital clinic. Blood pressure and blood cell counts will also be monitored periodically during treatment.
During the coronavirus outbreak, you may find that your regular blood tests happen less frequently, may take place in a different location or may temporarily stop. The Association of British Neurologists has assessed the risks and benefits of blood monitoring for people taking DMDs, and has recommended a safe minimum schedule during this period. The recommendation for Aubagio is that your blood tests can take place every month for the first 6 months, and every 4 months after that. If you notice any new or worsening MS symptoms, you should contact your MS team.
How does Aubagio work?
Three main studies have provided the evidence to support approval of Aubagio for multiple sclerosis:
- TEMSO - Aubagio compared to placebo (2011)
TEMSO was a two year, double-blind study of 1088 people with relapsing remitting MS, comparing two doses of Aubagio with placebo. Compared to placebo, the drug reduced the number of relapses in one year by 31%. The higher dose also reduced disability progression by 29.8% compared to placebo.
- TOWER - Aubagio compared to placebo (2014)
TOWER tested two different doses of Aubagio or placebo for at least 48 weeks in 1169 people with relapsing remitting MS. Compared to placebo, the higher dose reduced the number of relapses in one year by 36%. The higher dose of Aubagio reduced the risk of disability progression by 31.5%.
- TENERE - Aubagio compared to Rebif (2014)
This study compared two doses of Aubagio with Rebif (interferon beta 1a) in 324 people over two years. The main measure of the study was the time to first relapse or stopping treatment for any reason. There was no difference in this measure between either dose of Aubagio or Rebif. The number of relapses in one year was approximately the same for Rebif and the higher dose of Aubagio.
- NICE Technology Appraisal Guidance 303 Full guideline Teriflunomide for treating relapsing-remitting multiple sclerosis
- Full guideline Advice: teriflunomide (Aubagio) - 10 March 2014
- New England Journal Medicine 2011;365(14):1293-303. Summary Randomized trial of oral teriflunomide for relapsing multiple sclerosis.
- Multiple Sclerosis Journal 2014;20:706-17. Summary Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.
- Lancet Neurology 2014;13:247-256. Summary Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.
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