Who can take fingolimod?
Whether you can have fingolimod differs a little depending on where you live.
In England and Northern Ireland
- People who have the same or an increased number of relapses despite treatment with beta interferons (Avonex, Rebif, Betaferon, Extavia or Plegridy) or glatiramer acetate (Copaxone)
In Scotland and Wales
- People with highly active relapsing MS and another DMT hasn't worked for you
- People who have had two or more disabling relapses in one year, and an MRI scan shows you're getting more lesions
Across the UK
If you're taking natalizumab (Tysabri) and you're at high risk of the brain infection PML you can be switched to fingolimod. The most recent Association of British Neurologist (ABN) guidance (2015) suggests that fingolimod can also be used as your first DMT if you have highly active relapsing MS.
An assessment by a European regulatory agency was carried out in March 2016 to look at the benefits of treating people with highly active relapsing remitting MS with fingolimod, after they have failed to respond to treatment with at least one other DMT. They didn't find any added benefit of treating someone with fingolimod compared with similar drugs that could be used for these people.
How does fingolimod work?
Special types of cells in your immune system, called T and B cells, are thought to cause a lot of the damage in MS. They normally kill viruses and bacteria that get into your body but in MS they damage your nerves. Fingolimod stops them leaving your lymph nodes where they're made. This means fewer of them get into your brain and spinal cord where they would attack the covering (myelin) around your nerves.
Fingolimod is a tablet you take once a day.
How well does fingolimod work?
MS drugs can be put into three groups based on how well they control it. The effectiveness of fingolimod is classed as 'good'. This puts it between the DMTs classed as 'high' effectiveness and those classed as 'moderate'. This is based on how much it reduces relapses and slows down how fast people's disability gets worse.
Relapses dropped by: 54%
This means that in a trial, on average, people saw a 54% drop in the number of relapses they had. This was compared to people who took a placebo, a dummy treatment with no drug in it.
Disability getting worse was slowed down by: 30%
This means that in a trial, on average, people saw a 30% drop in the risk of their disability getting worse. This was compared to people who took a placebo.
What are the side effects of fingolimod?
Compared to other DMTs the risk of side effects, especially serious ones, is somewhere in the middle.
More than one in 10 people get diarhoea, back pain, headache, cough, tiredness, or have more chance of getting infections like flu.
When you take your first dose of fingolimod it can cause your heart to slow down or its beat becomes irregular. Because of this you're given your first dose of fingolimod in hospital and monitored for at least six hours after taking it to check for any problems. Your heart soon goes back to normal.
PML: a very rare side effect
Fingolimod is used by people who are switched from another drug, natalizumab, because they're at risk of getting a rare viral brain infection called PML (progressive multifocal leukoencephalopathy). There's also an extremely small risk of PML when you take fingolimod because it makes your immune system work less well. PML can be fatal or leave you seriously disabled but the risk of getting it while on fingolimod is extremely small. As of July 2016, 13 cases of PML have been seen in over 213,000 people across the world taking fingolimod.
There's a virus that makes your risk of getting PML higher. Your specialist can tell from a blood test if you have this virus. If you do, your MS team will talk to you about PML and what you can do about it.