First oral drug could benefit many with the autoimmune disease, researchers sayThe first pill designed to reduce the number of attacks in people with multiple sclerosis appears to be effective in early tests, Italian researchers report.
1. The pill was effective in preventing relapses in more than 60 percent of patients who took the pill for three years, according to research that was expected to be presented April 15 the American Academy of Neurology annual meeting, in Chicago.
"All of the current treatments for MS must be injected, so having a pill you can swallow with a glass of water would be a welcome improvement for many people," lead researcher Dr. Giancarlo Comi, from Vita-Salute San Raffaele University in Milan, said in a prepared statement.
In the study, Comi's team treated 281 people with relapsing MS with FTY720 (fingolimod) or a placebo. After six months, two-thirds of the patients who received FTY720 had more than 50 percent fewer relapses, compared with those receiving placebo.
During the three years of the trial, more than 67 percent of the 173 people receiving FTY720 were free of relapses. In addition, 89 percent of the patients were free of disease activity and 75 percent did not develop new lesions or see their lesions enlarge. This was confirmed by MRI scans, the researchers stated.
"The first-line treatments for MS, beta interferon and glatiramer acetate, reduce the relapse rate by only about 30 percent, so this is a significant development for people with MS," Comi said in a statement.
The most commonly reported side effects of FTY720 were headache, flu and cold symptoms.
The drug works by binding to receptors on immune cells, isolating them in the lymph nodes, thereby reducing their ability to cause the damage associated with MS symptoms.
The study was paid for by Novartis Pharma AG, maker of FTY720.
One expert thinks this preliminary data is encouraging, but a lot more needs to be done to prove the drug's effectiveness.
"This is a new drug that has a very strong scientific rationale why it could work," said Dr. John Richert, executive vice president of the National Multiple Sclerosis Society. "Certainly, everything we've seen so far continues to keep us optimistic."
Richert noted that over three years, 77 patients receiving the drug dropped out of the study. "You're left wondering if a more severe adverse event led to the dropouts," he said.
The six-month data where the drug was tested against placebo looks promising, Richert said. "If this turns out to be a safe oral drug that has substantial benefit, that will be very important for many people with MS," he added.