Cladribine Tablets Reduce Risk of MS Progression and Relapse, Clinical Trial Shows

Cladribine Tablets Reduce Risk of MS Progression and Relapse, Clinical Trial Shows

Cladribine tablets reduce the risk of disability progression and relapse in patients with relapsing multiple sclerosis (MS), the CLARITY clinical trial indicates.

The treatment was also well-tolerated and had a good safety profile, according to a presentation at the Annual Meeting of the American Academy of Neurology (AAN) in Boston, April 22-28.

Cladribine is an oral small molecule developed by Merck developed that selectively targets immune lymphocytes. The white blood cells are believed to play a central role in mechanisms underlying MS.

The Phase 3 CLARITY trial (NCT00213135) investigated the safety and effectiveness of cladribine in 1,326 relapsing-remitting MS (RRMS) patients. The study’s primary measuring stick was the change in the annual rate of relapse (ARR) at 96 weeks. Researchers also wanted to see if the treatment could increase the number of relapse-free patients and could impact the progression of disability.

Cladribine significantly decreased the risk of disease progression and relapse in a subset of 289 patients with high disease activity, trial showed. The risk over six months decreased substantially in 82 percent of those patients, versus 47 percent in the CLARITY population overall, when compared with a placebo, researchers said.

 

The tablets also reduced the relative risk of ARR in 67 percent of patients with high disease activity, compared with 58 percent in the overall CLARITY population.

“We know that a proportion of patients with MS have a higher risk of relapse and disability progression than the broader population,” Gavin Giovannoni, the trial’s principal researcher, said in a press release. “These data are important since they indicate that patients in the high disease activity subgroup treated with Cladribine Tablets showed a greater response than that seen in the overall CLARITY trial population.”

The analysis included patients who had never received treatment or had been exposed to disease modifying drugs before the trial. Researchers also found that relapse, treatment history and brain scan characteristics can help identify patients who are at higher risk of experiencing relapses or disease progression.

Taking cladribine for 20 days over a two-year period initially led to a decrease in the number of patients’ white blood cells, the CLARITY and the CLARITY Extension study (NCT00641537) indicated. But by the end of treatment year 1 and 2, the numbers had recovered to within a normal range. Lymphopenia, or a drop in white blood cells, was the most common side effect reported in patients taking cladribine.

“Cladribine Tablets is thought to selectively target the adaptive immune response in MS, and may be able to address a medical need in those patients already at higher risk of disability progression or relapses,” Luciano Rossetti, Merck’s head of Global R&D, concluded.

 

5 comments

  1. Judith Hague says:

    My neurologist says she will be ordering this new drug when it is available in drug stores. I will be anxious to use it. However I am concerned about its twice yearly schedule ? Will it really last in its coverage for that long? I have tried a few other MS drugs with no real effects, but I am willing to try this one, too! I have had MS for 29 years, and I now use a wheel chair. I am most anxious to turn back my disability !!

    • Tim Bossie says:

      We are not aware of that right now Gary. However, if we do get news about this we will do an updated article.

  2. Sharon Allum says:

    I’m interested in this new treatment but have already failed on Tecfidera due to very low lymphocytes. I have now been now on Aubagio for 9 months, but I have just finished a 5 day oral steroid treatment for a sensory relapse in my hand/wrist, but I now have new symptoms not related to my previous one (trigeminal neuralgia, facial numbness and lack of tastebuds! I’m waiting for my neurologist/MS nurse to call me back as I only started the carbamazipine yesterday!

  3. Gary Brogden says:

    I have been on Rebif 44 for about 12 years but after a recent MRI scan was told that the Rebif is no longer working well in controlling my MS progression so I have been offered Cladribine but reading the literature and the possible side effects I am hesitant. I have since joined a Mavenclad (Cladribine) forum and most of the participants taking Cladribine have been positive about taking this drug so I might give it a go!

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