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Alemtuzumab (Lemtrada) - encouraging clinical trial results published

Author: MS Trust

The results of phase III clinical trials of alemtuzumab (Lemtrada) have been published in the Lancet

Alemtuzumab is an experimental drug treatment for people with relapsing remitting multiple sclerosis that is currently going through the licensing process with the European Medicines Agency (EMA) and the Federal Drug Administration (FDA) in the US. If approved, it is expected to be marketed under the name Lemtrada.

The results of the CARE-MS I clinical trial published today showed that alemtuzumab was twice as effective as beta interferon in reducing relapses in people with relapsing remitting MS who had not received any treatment previously. However, more people in the alemtuzumab group experienced side effects, some of which were serious. In addition, the reduction in disability seen in previous trials was not observed here.

A second trial, called CARE-MS II, tested alemtuzumab in people with relapsing remitting MS who had experienced at least one relapse on treatment with beta interferon or glatiramer acetate. After two years, half of those on beta interferon had relapsed but only a third of those in the alemtuzumab group. 20% of people receiving interferon had accumulated further disability compared with 13% of the alemtuzumab group.

Alemtuzumab was originally licensed for use in B-cell chronic lymphocytic leukaemia, a type of cancer, and in organ transplantation under the name MabCampath. Following encouraging clinical trial results, some neurologists have been using alemtuzumab 'off-license' for people with aggressive MS. In August 2012, the manufacturer chose to surrender the license for alemtuzumab but has now applied for a new license for the drug to be used in MS. There has been some criticism of the manufacturer over this move as it is anticipated that they will reintroduce the drug at a higher price.

The results of these trials of alemtuzumab are encouraging for people with relapsing-remitting MS although it is important for individuals to balance the risks and benefits when choosing any disease modifying treatment and to talk through their options with their neurologist and MS specialist nurse.

It is vital that alemtuzumab makes swift progress through the regulatory process so that, if found to be safe and effective, it can then be considered by NICE.

If the drug is licensed, NICE will consider the cost effectiveness of alemtuzumab, amongst other factors, when deciding if it will become available on the NHS.

Amy Bowen, Director of Service Development at the MS Trust
Multiple sclerosis, drugs in development timline Multiple sclerosis, phase IIII drugs in development
Find out more about Licensing studies
Alemtuzumab (Lemtrada) in the A to Z of MS
Alemtuzumab (Lemtrada) factsheet
Disease modifying drug therapy
Publications in the Lancet
CARE-MS I clinical trial
CARE-MS II clinical trial