Good News: Oral Cladribine Effective
In the Phase III clinical trial of 1326 patients, the two oral cladribine tablet treatment groups using different dose regimens demonstrated a statistically less relapses compared to placebo. Patients from the lower dose group experienced 58% less replases a year compared to placebo (0.14 versus 0.33 for the placebo group; p<0.001). Patients from the higher dose group experienced a 55% reduction in relapses per year with respect to placebo (0.15 versus 0.33; p<0.001). Cladribine also reduced MRI activity and had benefits on preventing worsening disability.
Low white count occurred more frequently in the cladribine tablet treatment groups. Besides low white count, the most frequently reported adverse events in the three study groups were headaches and nasopharyngitis. Full safety data has not yet been reported.
The MS Center for Innovations in Care is a site for the ONWARD trial of adding oral cladribine to interferon. For more information on cladribine including participating in a trial, visit the clinical trials section.
BY: Barry Singer, MD DATE: January 23, 2009 TOPIC: MS Research News