Lemtrada (formerly alemtuzumab or CAMPATH-1H)
Type of MS: relapsing remitting MS
Research into: preventing damage caused by MS
How is it taken? Intravenous infusion once a year
- How does it work?
- Latest research
- Earlier research
- How does it compare to current therapies?
- When will it become available in the UK?
Lemtrada was developed to treat certain types of leukaemia and lymphoma (cancers of the immune system).
The most recent data from phase III trials has shown Lemtrada can significantly reduce relapse rates and the worsening of disability compared to a standard MS therapy.
The phase III results, released in November 2012, are made up of two trials called CARE-MS I and CARE-MS II.
CARE-MS I 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% less likely to experience a relapse over the course of two years (40% of people taking Rebif and 22% of people taking Lemtrada had relapses during the trial).
People taking Lemtrada were:
- Around 50% less likely to experience a relapse over the course of two years (51% of people taking Rebif and 35% of people taking Lemtrada had relapses during the trial).
- Around 42% less likely to experience disability progression over the course of two years (20% of people taking Rebif and 13% of people taking Lemtrada had worsening in disability during the trial).
Lemtrada was generally well tolerated. The most common side effects were:
- 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.
Side effects also included autoimmune thyroid problems in around 16% of people, and immune thrombocytopenia (ITP - an autoimmune condition associated with a lowered platelet count) in around 1%.
Some of these side effects are potentially serious but all were discovered early and given prompt treatment.
In October 2008 researchers in Cambridge announced results of a phase II 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% reduction in disability progression compared with people taking beta-interferon
- There was a 74% reduction in the relapse rate per year compared with people taking beta-interferon.
- The researchers measured the ten point Expanded Disability Status Scale (EDSS) score before and after treatment. On average participants taking Lemtrada experienced an improvement in disability at 6 months that was sustained for the 3 years. In comparison, participants taking beta-interferon showed a progression in disability.
Results of a further five year follow-up study show that:
- Participants who received Lemtrada were three times less likely to have a relapse over the course of a year compared with those receiving beta-interferon-1a.
- Nearly 90 percent of Lemtrada-treated participants were free of accumulated disability, compared with 75 percent of participants taking interferon beta-1a.
Overall, side effects experienced by participants taking Lemtrada were more severe than those taking beta-interferon. The five year follow-up data showed that:
- About 30% of participants taking Lemtrada suffered from thyroid disorders (treatable conditions where immune cells attack the thyroid gland and cause an hormonal imbalance).
- 6 participants on the trial (five taking Lemtrada and one taking beta-interferon-1a) developed a condition called immune thrombocytopenic purpura (ITP - a failure of the blood to clot). One of these participants died after ITP was not detected early. The others were treated without problems.
- 66% of participants taking Lemtrada experienced infections (compared with 47% of participants taking beta-interferon).
- One participant receiving Lemtrada was diagnosed with an autoimmune kidney disease. Following detection the participant was treated successfully and is in remission. Other side effects included infusion reactions.
The design of phase III trials involving Lemtrada changed to monitor people for these side effects more frequently and to detect and treat complications as early as possible.
Lemtrada was more successful at reducing the relapse rate and accumulation of disability compared with Rebif and appeared to be a more effective treatment.
Despite this, Lemtrada was associated with a number of side effects that beta-interferon was not associated with.
Lemtrada has just been licensed by the European Medicines Agency (EMA) as a first-line treatment for people with active relapsing remitting MS.
Before Lemtrada is made available on the NHS it will need to be evaluated for cost effectiveness by the National Institute for Health and Care Excellence (NICE). NICE are due to hear evidence and give an initial indication of their decision in the autumn. We will continue to update our information as and when we know more.