A to Z of MS Alemtuzumab (Lemtrada)

Product name

Lemtrada - previously known as Campath

Alemtuzumab is an experimental drug treatment for people with relapsing remitting multiple sclerosis. Alemtuzumab is already licensed for use in B-cell chronic lymphocytic leukaemia, a type of cancer.

Results of a trial involving 334 people with relapsing remitting MS that compared alemtuzumab with beta interferon 1a were published in 2008. At the end of the three year trial, 77% of people on a lower low-dose of alemtuzumab and 84% of those on a higher-dose had experienced no relapses, compared with 52% of people receiving beta interferon 1a. The results also showed that compared with beta interferon 1a, alemtuzumab reduced the risk of sustained disability by 71%.

Four year follow-up data from this study were presented at the American Academy of Neurology (AAN) meeting in April 2010. This showed that more people on alemtuzumab remained free of relapses and showed no worsening of disability than the group on beta interferon 1a. The data was updated at the 2011 AAN meeting where it was announced that 65% of those receiving alemtuzumab remained free of clinically active disease up to four years after their last course of treatment, compared to 27% of people receiving beta interferon 1a. However, people on either drug whose MS had got worse in the first few years were excluded from the follow-up studies.

Results of two larger phase III studies were announced in 2011.

CARE-MS I

CARE-MS I was a two year trial that compared alemtuzumab and interferon beta 1a in 581 people in the first few years after diagnosis with relapsing remitting MS.

Initial results from the CARE-MS I were first announced in July 2011 and presented at the ECTRIMS meeting in October 2011. These showed that alemtuzumab reduced relapses by 55% compared to interferon beta 1a over the two years of the trial. The effect on disease progression was similar, with 8% of the alemtuzumab group and 11% of interferon beta group showing a worsening in their EDSS score.

CARE-MS II

CARE-MS II was a two year trial that looked at 840 people who had continued to have relapses despite treatment with beta interferon.

Results annonced in a company press release, the relapse rate of those on alemtuzumab was reduced by 49% compared to those on beta interferon 1a (Rebif). The risk of disease progression was also reduced by 42% compared to beta interferon.

Side effects of alemtuzumab included autoimmune thyroid-related problems, which affected about 16% of participants, and ITP (idiopathic thrombocytopenic purpura) a bleeding disorder, which affected about 1%.

Progressive MS
A seven year study of 25 people with secondary progressive multiple sclerosis showed reduced activity on MRI scans but the people continued to accrue disability.

How alemtuzumab works

Alemtuzumab is a type of drug called monoclonal antibodies. Alemtuzumab acts by killing T-cells which form part of the immune system and which in MS mistakenly attack myelin and cause the inflammation seen on MRI scans. It is thought that the T-cells regenerated following treatment with alemtuzumab will not include those that destroy myelin.

How is alemtuzumab given?

In trials alemtuzumab is given by a course of infusions over three to five days once a year.

Side effects and contraindications

The use of alemtuzumab in this clinical trial was voluntarily suspended in September 2004 following one fatal case of immune thrombocytopenic purpura (ITP), a blood clotting disorder. Other cases of ITP were identified and treated. ITP is not fatal if caught early enough, however, it remains a significant risk.

Almost a quarter of participants developed thyroid-related side effects. These are treatable but can mean lifelong thyroid medication.

Flu-like symptoms after infusion were reported. As alemtuzumab works by suppressing the immune system, anyone on treatment will be more vulnerable to infections such as colds and viruses for some time after the infusion.

References

Coles AJ, et al.
The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy.
Journal of Neurology 2006;253(1):98-108.
abstract

Coles AJ, et al.
Alemtuzumab vs interferon beta-1a in early multiple sclerosis.
New England Journal of Medicine 2008;359:1786-1801.
abstract

Experimental MS drug outperforms standard treatment
News report from AAN
WebMD - 15 April 2010
read online

Twyman C.
More alemtuzumab relapsing-remitting multiple sclerosis patients are free of clinical disease activity at five years.
Poster presented at the 63rd AAN Annual Meeting, Hawaii, 2011
abstract

Alemtuzumab reduces relapses vs interferon in MS.
Medscape news item 24 October 2011.
read online

Positive results announced from second phase III study of alemtuzumab in MS.
National MS Society (USA) news item 15 November 2011.
read online

Paolillo A, et al.
Quantitative MRI in patients with secondary progressive MS treated with monoclonal antibody Campath 1H.
Neurology 1999;53(4):751-757.
abstract

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