ARTICLE | Clinical News

Cladribine tablets: Additional Phase III data

January 25, 2010 8:00 AM UTC

Additional data from the double-blind, international Phase III CLARITY trial in 1,326 patients with relapsing-remitting MS showed that 3.5 and 5.25 mg/kg oral cladribine significantly increased relapse-free rates vs. placebo (79.7% and 78.9% vs. 60.9%, p<0.001 for both), lowered the risk of 3-month sustained progression of disability vs. placebo (p=0.02 and p=0.03, respectively) and reduced brain lesion count as measured by MRI vs. placebo (p<0.001 for both). Lymphocytopenia was observed in 21.6% and 31.5% of patients in the low- and high-dose cladribine arms, respectively, vs. 1.8% of patients in the placebo arm. Data were published in the New England Journal of Medicine. ...