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Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis
Date:4/29/2009

of the study, both dose regimens of Cladribine Tablets demonstrated a statistically significant reduction of at least 70% in the mean number of active T1 gadolinium-enhanced lesions per subject per scan, the mean number of active T2 lesions per subject per scan, as well as the mean number of combined unique lesions per subject per scan, compared to placebo (reductions ranging from 73% to 88% depending on MRI measure and dose group; p<0.001 for each of these MRI measures and for both dose regimens).

Overall, the frequencies of adverse events by MedDRA System Organ Class in both cladribine treatment groups were comparable to those observed in the placebo group. The most commonly reported adverse events were headaches, nasopharyngitis, upper respiratory tract infections and nausea. Lymphopenia, an expected event based on the presumed mechanism of action of cladribine, occurred more frequently in the Cladribine Tablets treatment groups (low-dose regimen: 22%; high-dose regimen: 31%; placebo: 2%).

The overall rate and incidence of infections in patients treated with Cladribine Tablets and placebo were similar. Herpes zoster infections were reported in 2.3% of patients treated with Cladribine Tablets. These herpes infections were localized to the skin and responded appropriately to treatment.

In patients treated with Cladribine Tablets, four malignancies were reported during the study (cervical stage 0, melanoma, ovarian and pancreatic), and a case of choriocarcinoma was reported at week 14 of gestation in a cladribine-treated patient who became pregnant 6 months after completion of the study. Observed malignancies were isolated cases across different organ systems. The current ongoing clinical studies with Cladribine Tablets will provide data on a larger patient population and a longer duration of treatment to collect more conclusive information on this safety aspect.

Merck Serono plans to submit Cla
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SOURCE Merck Serono
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