AAN 2013: more on the safety of oral cladribine

“The following is the safety profile of oral cladribine in the ORACLE or CIS study that was presented at the AAN.”

“The most important bit of information buried in this poster is the section on neoplasms.”

Neoplasms (malignant, benign, and unspecified) occurred in 1 patient (0.5%) in the cladribine 5.25 mg/kg group (uterine leiomyoma), 3 (1.5%) in the cladribine 3.5 mg/kg group (papillary thyroid cancer, skin papilloma, squamous cell carcinoma of skin), and 6 (2.9%) in the placebo group (thyroid neoplasm [n=3], uterine leiomyoma [n=2], benign tonsillar neoplasm [n=1]). As defined by the study protocol, all neoplasms were considered serious and related to the study treatment.

“In comparison to the CLARITY or RRMS study there is not signal in this study that cladribine causes cancer, at least in the short-term. The question is whether or not, considering the profile of cladribine, you would be prepared to take the yet to be defined risk of a possible increase in cancer risk for the convenience and efficacy of cladribine tablets?”

CoI: multiple

8 thoughts on “AAN 2013: more on the safety of oral cladribine”

  1. Yup, Don Giovannoni continues his crusade to infiltrate the NHS with toxic concoctions that remain unproven I terms of preventing MS progression.Don Giovannoni reminds me of the character Dr. Jonathan Banks in the new movie Side Effects in which a psychiatrist moves from Britain to America because he believes doctors over there have a more "positive" view of medicine. If you watch the film you'll see just how dangerous such thinking can be.Also, great to see how overjoyed some progressive MSers must be at being told their brains are being shredded. Trust, if the disease doesn't shred brains the perhaps DMTs will do the job for us.

    1. Dr Dre, where have you been? We thought the worst. You sound just like the average British neurologist; nihilistic to the end. What if you are wrong and Don Giovannoni is correct? I would take my chances with cladribine, better the devil you know than you don't.

    2. Dre Dre and his problem with useful pharmacology.If you guys can get the cladribine, take it.

  2. When I started Cladribine I was told there was a risk of cancer of 4% higher than the non-Cladribine population. Given the multitudes of cancer risks in modern society from poor food choices, diesel fumes, PET plastics etc I thought the risk vs benefits of Cladribine were worth it and happily took it and remain gutted that it was pulled from the market half way through my treatment programme. Having gone from back to back relapses in the 2 years prior to Cladribine to having plateaued since Cladribine to me it appears to have been successful beyond my wildest dreams. Just wish I could have finished the course.Please, please keep the pressure on to have Cladribine returned to the market. The powers that be seem to throwing away an excellent MS Treatment here for no equally excellent reason.

    1. I think I saw your reply on the MS Soc website, but I got the impression there was a 4% risk of cancer ie 4 in 100 got cancer, which is too big a risk, whereas if it's 4% higher than the norm, that to me is acceptable. I'd much prefer it to the russian roulette of nataluzimab and PML, and its monthly infusion regime. With alemtuzumab you are told you have a higher lifetime risk of lymphoma, and to check your moles regularly. Perhaps if Merck lose out with rebif once BG12 is available, they will look once more at oral cladribine.

  3. Perhaps if Merck lose out with rebif once BG12 is available, they will look once more at oral cladribine.Doubt it…..the patent life ticks away with each day of inactivity.

  4. The tumors are mostly present because of a human papilloma virus (HPV) but they are not contagious. The squamous papilloma is made up of mucous-producing tissues and they can be red or pink in color caused by too much production of keratin, and they have rounded or pointed ends.

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