Lemtrada has been granted a license by the EMA, and in April 2014 NICE recommended that it should be available on the NHS for people in England and Wales.
Current phase of trial: completed phase 3
Type of MS: relapsing remitting MS
- How does Lemtrada work?
- How is Lemtrada taken?
- Latest research
- Earlier research
- What are the side effects of Lemtrada?
- How does Lemtrada compare with current therapies?
- When is Lemtrada likely to become available in the UK?
Lemtrada was originally developed to treat certain types of leukaemia and lymphoma (cancers of the immune system).
It is taken as an intravenous infusion for 3-5 days annually.
The most recent data from phase 3 trials has shown 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 DMD 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 previoulsy 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.
In October 2008 researchers in Cambridge announced results of a phase 2 clinical trial involving 334 people with early stage, active relapsing remitting MS. The trial was conducted over a three-year-period and compared annual infusions of Lemtrada with the drug beta-interferon.
Of the people taking Lemtrada over a three-year-period there was a 71 per cent reduction in disability progression and a 74 per cent reduction in the relapse rate per year compared with people taking beta-interferon.
On average participants taking Lemtrada experienced an improvement in disability at 6 months that was sustained for the 3 years (measured on the Expanded Disability Status Scale). In comparison, participants taking beta-interferon showed a progression in disability.
Results of a further five year follow-up study showed that participants who received Lemtrada were three times less likely to have a relapse over the course of a year compared with those receiving interferon beta-1a. Nearly 90 per cent of Lemtrada-treated participants were free of accumulated disability, compared with 75 per cent of participants taking interferon beta-1a.
Lemtrada is generally well tolerated. The most common side effects are:
- infusion-associated reactions, such as headache, rash, nausea, hives, fever, itching, insomnia, and fatigue
- infection, such as upper respiratory and urinary tract infections, sinusitis and herpes simplex infections, which were mostly mild to moderate in severity.
Less common side effects also included autoimmune thyroid problems in around 16 per cent of people, and immune thrombocytopenia (ITP - an autoimmune condition associated with a lowered platelet count) in around 1 per cent of people.
Some of these side effects are potentially serious but all were discovered early and given prompt treatment.
Lemtrada was more successful at reducing the relapse rate and accumulation of disability compared with Rebif and appeared to be a more effective treatment. However, Lemtrada was associated with a number of side effects that beta-interferon was not associated with.
Lemtrada has been licensed by the European Medicines Agency (EMA) as a first-line treatment for people with active relapsing remitting MS.
In April 2014, NICE confirmed that Lemtrada should be made available to anyone with relapsing remitting MS who may be deemed eligible. The NICE recommendation is subject to appeal, but if there are no hold ups it could be available on the NHS within the next few months.
A decision will be made for people in Scotland and Northern Ireland over the coming months and we will continue to update our information as and when we know more.