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

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