A late-stage trial of the drug Gilenya (fingolimod) has brought good news for patients with relapsing-remitting multiple sclerosis (RRMS), a disease for which treatments have become more effective and common over the past decade.
Multiple sclerosis (MS) is a progressive autoimmune disease that affects the central nervous system, causing neurological symptoms such as muscle weakness, numbness, tremors, and difficulty walking. Relapsing-remitting MS is a particularly difficult disease to live with: Patients have relapses, during which they experience a barrage of symptoms that get better after a short period of time, although their functioning never completely returns to normal levels. Therefore, each time a patient experiences an attack, their health declines further. As ACSH's Dr. Gilbert Ross explains, If you can reduce the frequency of these attacks, you can help the patient to maintain function for longer, and reduce overall degradation of the nervous system.
Thus the results of the randomized control trial of Gilenya, an oral drug produced by Novartis, provide some good news. In this two-year study of over 2,000 patients with RRMS, patients who received a daily dose of Gilenya had a 48 percent reduction in their annual rate of relapse compared to those who received a placebo. Furthermore, at the end of the two years, the Gilenya-treated patients had lost a smaller amount of brain volume.
Gilenya was approved for the treatment of RRMS last year in the U.S. Dr. Ross notes that, although this two-year study is promising, it will still be important to track the drug s side effects over a longer period of time. With another MS treatment, he says, longer-term analyses found that certain serious side effects were not quite as rare as researchers had initially thought. It will be important to watch out for this with Gilenya as well.