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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

emonstrated a statistically significant reduction in the annualized rate of relapses compared to placebo (primary endpoint). Patients treated with the low-dose regimen of Cladribine Tablets experienced a 58% relative reduction in annualized relapse rates with respect to placebo (0.14 versus 0.33 for the placebo group; p<0.001). Patients in the high-dose regimen group experienced a 55% relative reduction in annualized relapse rates with respect to placebo (0.15 versus 0.33; p<0.001).

The proportion of patients who remained relapse-free (one secondary endpoint of the trial) was significantly higher in the Cladribine Tablets treatment groups than in the placebo group. Over the two-year period of the study, 80% of the patients treated with the low dose regimen of Cladribine Tablets and 79% of the patients treated with the high-dose regimen experienced no clinical relapse, compared with 61% of the patients from the placebo group (p<0.001 for both dose regimens). Therefore, the relative risk to relapse in patients treated with Cladribine Tablets was approximately half of that seen in patients on placebo.

Treatment with Cladribine Tablets led to a more than 30% reduction in the risk of disability progression (another secondary endpoint) relative to placebo over the two-year period of the study (low-dose regimen: hazard ratio=0.67; p=0.018 - high-dose regimen: hazard ratio=0.69; p=0.026). Progression of disability was measured by a 1-point or greater increase in the Expanded Disability Status Scale (EDSS) sustained for at least three months (or at least a 1.5 point increase if baseline EDSS was 0; or 0.5 point increase if baseline EDSS was 5.0 and above).

Sustained and statistically significant reductions in different types of brain lesions as measured by each of the pre-specified key magnetic resonance imaging (MRI) secondary endpoints were shown and were consistent with clinical outcomes. Over the two year period
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SOURCE Merck Serono
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