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Alemtuzumab

Other names: Campath
In development for: Relapsing/remitting MS
Status: Phase III
Last updated: April 2008

How does it work?

This monoclonal antibody is currently licensed to treat a type of leukaemia. Alemtuzumab binds to an antigen called CD52 which is found on the surface of certain T-cells, a type of lymphocyte involved in the MS immune response.

How is it given?

Alemtuzumab is given by iv infusion. In recent clinical trials, alemtuzumab was given by a course of infusions once a year; for five consecutive days at start of treatment, once every day for three days after one year of treatment, and for some people, once every day for three days after two years of treatment.

Clinical studies

Results from a Phase II trial were presented in 2007 at two international conferences. This study enrolled 334 people with active, early relapsing/remitting MS, and compared two doses of alemtuzumab with a high dose of beta interferon 1a, which is one of the currently licensed treatments for this type of MS. People were randomised to receive either high-dose alemtuzumab, or low-dose alemtuzumab, or beta interferon 1a.

Alemtuzumab was given by a course of infusions once a year; for five consecutive days at start of treatment, once every day for three days after one year of treatment, and for some people, once every day for three days after two years of treatment. Beta interferon 1a is an under-the-skin injection that is self-administered three times a week. Everyone on the trial received intravenous steroids (methyprednisolone) for three days every twelve months.

The results showed that after two years of the trial, people receiving both doses of alemtuzumab performed significantly better comparing the number of relapses at the end of the trial. At two years, 85% of low-dose alemtuzumab and 91% of high-dose alemtuzumab receivers had experienced no relapses, compared with 61% of people receiving beta interferon 1a.

A Phase III trial (CAMMS323) comparing the lower dose of alemtuzumab used in the Phase II study with beta interferon 1a over a two year period started in the UK and the USA in 2007. The UK trial centre is in Cambridge. The study will continue for three to four years.

Side effects and contraindications

Two significant side effects have occurred during alemtuzumab treatment:

  • idiopathic thrombocytopenic purpura (ITP), a disorder that prevents blood from clotting, was fatal in one case
  • overactive thyroid gland (Graves disease) or abnormal thyroid function

Additional safety measures are being taken to allow early diagnosis and treatment of these side effects.

References

Coles AJ

Alemtuzumab improved multiple sclerosis functional composite scores and delayed time to first relapse at 2-year interim analysis compared to subcutaneous interferon beta-1a. P 557
Multiple Sclerosis 2007; 13: S166

Coles AJ

Efficacy of alemtuzumab in treatment-naïve relapsing-remitting multiple sclerosis: analysis after two years of study CAMMS 223
Academy of American Neurologists 2007; 59th AAN Annual Meeting April 28-5 May 2007; presentation S12.004

Further information about CAMMS323

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