Results of the 96-week, placebo-controlled Phase III CLARITY trial show that oral cladribine therapy reduced the rate of clinical relapses, disability progression, and brain lesions in patients with MS. According to data released at the AAN Annual Meeting last month by drug developer Merck KGaA, cladribine-treated patients had a statistically significant decrease in annualized rate of relapses compared to controls. In the high-dose group, 79 percent of patients experienced no relapse, similar to the 80 percent of patients that were relapse-free in the lower dose group. In the control group, 61 percent of patients did not have relapses. Treatment reduced the risk of disability by more than 30 percent over two years. Cladibrine is administered in either two or four four- to five-day courses per year.
Another agent also shows promise for relapsing-remitting MS, according to data released at the annual meeting and reported by Novartis AG. In a Phase III trial comparing fingolimod to interferon beta-1a, 80 to 83 percent of patients treated with fingolimod were relapse-free for one year compared to 69 percent of those receiving interferon. The company also reported results of an open-label Phase II extension study showing continued low relapse rates after four years of fingolimod therapy.