A to Z of MS Cladribine

Product name

Leustat

Cladribine is an anti cancer drug used in the treatment of leukaemia that has been studied as a potential oral treatment for relapsing remitting multiple sclerosis.

The results of a two year phase III study (called CLARITY) involving more than 1300 people with relapsing remitting MS were published in January 2010. This study compared two doses of cladribine and placebo and showed a reduction in the relapse rate compared to placebo of 58% with the lower dose and 55% with the higher dose.

The manufacturers, Merck Serono, submitted the drug to the European Medicines Agency (EMA) for licensing in July 2009. The National Institute for Health and Clinical Excellence (NICE) intends to appraise cladribine through its Single Technology Appraisal (STA) process and has drawn up a draft scope for the appraisal.

In June 2010, the manufacturers resubmitted a New Drug Application for cladribine to the US Food and Drug Administration (FDA), after they received a 'refuse to file' letter following their initial licence application in November 2009. The FDA usually issues such a response when it finds applications to be incomplete.

How cladribine works

As with other chemotherapy drugs used in treating people with MS, cladribine is used to kill off cells in the immune system. In MS, the immune system is thought to attack the myelin sheath around nerves. The theory is that cladribine will slow down this attack.

How cladribine is given

In trials as a treatment for MS cladribine has been given orally as a tablet.

Side effects and contraindications

Side effects have included infections due to the reduction in white blood cells. Other common side effects in the trials have been headaches and symptoms of the common cold.

Reference

Giovannoni G, et al.
A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.
New England Journal of Medicine 2010;362(5):416-426.
abstract

Hartung HP, et al.
Development of oral cladribine for the treatment of multiple sclerosis.
Journal of Neurology 2010;257(2):163-170.
abstract

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