Me, My MS and I

Cladribine Turned Down In Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use has today (21st January 2011) rejected Merk KGaA’s oral medication for relapsing-remitting MS, Cladribine. Despite currently available research data stating the effectiveness of Cladribine in treating RRMS, it was felt that the risks of the drug outweigh the benefits. As reported on Multiple Sclerosis Blog on, ” In trial, 2% of participants on the drug developed shingles and 4 people developed cancer, while neither of these things were seen in the placebo group.” Whilst it was also reported on the MS Trust Cladribine Factsheet that, “Although the trials so far have shown cladribine to be well tolerated, lymphopenia – an abnormally low level of lymphocytes (white blood cells that fight off disease) occurred more frequently in the cladribine treatment groups. With the exception of lymphopenia, headaches and nasopharyngitis (inflammation of the nasal passages and upper part of the throat) were the most frequently reported adverse events in the three treatment groups. An increased number of people with cancer have also been observed in clinical trials of cladribine which could point to an increased risk of cancer over time and with increasing doses of the drug.”

I can understand a desire for oral medications for MS for those whose bodies won’t tolerate injectible medications, for those who really don’t like self injecting, or for those who don’t meet the criteria for Tysabri etc and can’t tolerate the CRAB drugs. Apart from these reasons, is there really a need for MS oral medications to be developed so quickly? Are they any more effective than the treatments available now? Are the potentially serious side effects outweighed by then benefits of Cladribine? Merk officials plan to rebsubmit a new application for Cladribine in Europe in 2012 with more clinical evidence. I’m assuming that this would have to contain more positive clinical evidence in order to be approved!

It should be noted however that a, “58% relative reduction in yearly relapse rate was seen in the low dose treatment group and a 55% reduction in the high dose treatment group. A reduction in the number of MS lesions as seen on MRI was also observed in the cladribine treatment groups and there was a higher proportion of people who remained relapse free over the study period.”(1) So Cladribine clearly is effective in the treatment of RRMS, but at what potential cost?

Cladribine has been approved for use in Russia and Australia already, and the FDA in America is due to rule on Cladribine by roughly the end of February this year. Although on the whole Cladribine did seem to be well tolerated in trials,I often wonder, as MSers are we expected to put up with worse than usual medication side effects due to having a serious illness, as the side effects are equal to or less than the symptoms we live with, or is it that stronger medications with more serious side effects are needed to control our MS? It’s a fine balancing act either way, and although more treatment options such as oral medications for MS would be very welcome as additional choices other than the main CRAB drugs – the CRAB drugs are available now (along with other treatment possibilities such as Tysabri and Fingolimod [Gilenya]) – a more well rounded oral medication which has been refined for longer strikes me as a better option than one with a list of some rather offputting possible side effects. It depends what we’re willing to put up with when fighting our MS, I suppose. I’m all for throwing every I can at my MS, (possibly even the kitchen sink!), but if I then had to deal with another health complication as the result of a medication used to treat my MS, I’d then be in a worse position!

Some Cladribine Studies

  • Giovannoni G, Comi G, Cook S, et al. (1)
  • A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.

    New England Journal of Medicine 2010;362(5):416-426.


  • Current Controlled Trials website.Clarity extension study.[updated 17 Dec 2009. Cited 09 Nov 2010]
  • Current Controlled Trials website.Oral cladribine in early multiple sclerosis (MS).[updated 27 May 2010. Cited 09 Nov 2010]
  • Current Controlled Trials website.Phase II cladribine add-on to inteferon-beta (IFN-b) therapy in MS subjects with active disease.[updated 20 July 2010. Cited 09 Nov 2010]
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