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Alemtuzumab (Campath)

Alemtuzumab (Campath) is an experimental new drug treatment for people with relapsing remitting multiple sclerosis (MS).

Other names: Campath
In development for: Relapsing remitting multiple sclerosis (MS)
Status: Phase III
Last updated: June 2009

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, and kills the T-cell.

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

The early clinical trials of alemtuzumab were run in both relapsing and progressive types of MS.

In people with relapsing remitting MS, alemtuzumab reduced the numbers of relapses that people experienced and improving their disability levels immediately. Improvement in disability continued for up to three years after treatment.

However, more mixed results were seen in a study of 25 people with secondary progressive MS. MRI scans over seven years showed no new lesions forming in the brains and spinal cords of those participants who had been treated with alemtuzumab, but the people on this trial continued to accrue disability. This led researchers to the idea that something other than inflammation of myelin is at work in progressive MS [1]. Consequently, they have looked at whether alemtuzumab works best if used early in relapsing remitting forms of MS.

Results from a Phase II trial (CAMMS 223) were published in the New England Journal of Medicine in October 2008 [2]. 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.

The results showed that people receiving both doses of alemtuzumab performed significantly better comparing the number of relapses at the end of the trial. At three years, 77% of low-dose alemtuzumab and 84% of high-dose alemtuzumab receivers had experienced no relapses, compared with 52% of people receiving beta interferon 1a. The results also show that compared with beta interferon 1a, alemtuzumab reduced the risk of sustained disability by 71% [2].

Further clincal trials

  • Comparison of alemtuzumab and Rebif efficacy in multiple sclerosis, study one (CARE-MS I) - CAMMS 323

    • This phase III trial comparing the lower dose of alemtuzumab used in the phase II study with beta interferon 1a (Rebif) in 525 people over a two year period started in the UK and the USA in 2007. The study is expected to report in 2012. Further details of this study.

  • Comparison of alemtuzumab and Rebif efficacy in multiple sclerosis, study two (CARE-MS II) - CAMMS 324

    • This second phase III trial is comparing two doses of alemtuzumab with beta interferon 1a (Rebif) for two years in 700 people who have continued to have relapses whilst on one of the licensed disease modifying therapies. Further details of this study.

  • Comparison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS)

    • A subset of the participants in CAMMS 324 will receive further testing designed to investigate how well alemtuzumab and Rebif work in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking). Further details of this study.

  • Extension studies

    • Three year extension studies of the phase II and III studies will examine long-term safety and efficacy of alemtuzumab and determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. Further details of this study.

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

  1. Coles AJ, Cox A, LePage E et al.
    The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy.
    Journal of Neurology 2006; 253(1): 98-108.
  2. Coles AJ, et al.
    Alemtuzumab vs interferon beta-1a in early multiple sclerosis.
    New England Journal of Medicine 2008;359:1786-1801.

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