- Who is eligible for Lemtrada?
- How does it work?
- How is it taken?
- How effective is it?
- What are the side effects?
Both the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) have issued their final guidance on Lemtrada. They have recommended that Lemtrada be prescribed on the NHS in England, Wales and Scotland for adults with active relapsing remitting MS. ‘Active’ is usually defined as two relapses in the previous two years.
From September 2014, hospitals and NHS Trusts in England and Wales will have to prescribe Lemtrada to all people who are eligible for it and who choose to take it. While in Scotland the NHS does not have the same legal obligation, there is a clear expectation on Health Boards to make SMC-recommended treatments available.
Decisions about whether Lemtrada will be available in Northern Ireland are expected later in 2014.
Lemtrada was originally developed to treat certain types of leukaemia and lymphoma (cancers of the immune system). It binds to and kills white blood cells (immune cells) thereby stopping the immune cells from entering the brain and attacking myelin (which is the cause of damage in MS).
It is taken as an intravenous infusion on five consecutive days, with a second course administered on three consecutive days, 12 months later. For the majority of patients who took part in clinical trials, no further treatment was required 12 months after the second course (results for further years are yet to be published).
Two phase 3 trials showed that Lemtrada can significantly reduce relapse rates and the worsening of disability compared to a standard MS therapy.
The CARE-MS 1 trial compared Lemtrada with Rebif in people with relapsing remitting MS who had previously not taken any disease modifying drug for their MS. People taking Lemtrada were around 55 per cent less likely to experience a relapse over the course of two years.
The CARE-MS 2 trial compared Lemtrada with Rebif in people with relapsing remitting MS who had experienced at least one relapse whilst previously taking beta-interferon or Copaxone. People taking Lemtrada were around 50 per cent less likely to experience a relapse and 42 per cent less likely to experience disability progression over the course of two years.
Results from a long-term follow up study of people taking Lemtrada have shown that the majority of people on the treatment experienced an overall improvement or stabilisation in disability over seven years. This study is the first to report longer term results of the drug.
You can read more about the study in our news story
Some of the more common side effects are headaches, rash, feeling sick, hives, fever, itching, not being able to sleep and fatigue. Other side effects include chest infections, urinary tract infections, cold sores and sinusitis.
There have been more serious side effects reported with Lemtrada, such as developing an overactive or underactive thyroid. These problems are treatable but require lifelong medication.
There is also a very small risk of developing a blood clotting disorder known as ITP (immune thrombocytopenia). It’s potentially very serious but treatable if it’s caught early.
Everyone taking Lemtrada will be monitored for problems relating to the thyroid and ITP. Your health care team should also tell you what to look out for and what to do if you notice any signs or symptoms of either problem.