New Pill May Reduce Relapses in MS Patients
Study Shows Teriflunomide Could Become a New Alternative to Injections
Oct. 5, 2011 -- People with multiple sclerosis (MS) may soon have a second needle-free option to control their disease.
Last year, the FDA approved the first disease-modifying pill, a drug called Gilenya, to treat MS.
Now a new study shows that a different drug, a once-daily pill called teriflunomide, may also slow the progression of the neurological disease and its disabling attacks better than a placebo.
Currently, most of the disease-modifying drugs that treat MS are given by injection or intravenous infusion.
"Some patients have been sitting on the sidelines waiting for effective and safe oral medications," says researcher Jerry S. Wolinsky, MD, a professor of neurology at the University of Texas Health Science Center in Houston. Others with MS have been giving themselves regular injections for more than a decade.
"Their skin is just not holding up well. It's harder and harder for me to convince them to keep doing this because of the difficulties they have with these long-term injections," Wolinsky tells WebMD. For those reasons, he says, pills that work as effectively as the shots are "very important" options.
And drugmakers are racing to bring them to market.
In addition to teriflunomide, three other oral medications have been granted fast-track reviews by the FDA.
Testing a New Pill to Control MS
The new study, which is published in the New England Journal of Medicine, enrolled nearly 1,100 patients in 21 countries.
Ninety percent had the relapsing remitting form of MS -- an early stage of the disease. In this stage there are occasional flare-ups typically followed by partial or complete recovery of function.
The patients enrolled had at least two relapses in the previous two years, but no relapses in the two months before the study. Nearly 800 patients completed the two-year study.
The study found that teriflunomide reduced relapses in MS patients by 31% compared to a placebo. At the highest dose, the drug significantly reduced the number of treated patients who experienced worsening disability. It also reduced areas of active inflammation in the brain compared to placebo.
"People on the drug had fewer attacks," says researcher Paul O'Connor, MD, professor of neurology at the University of Toronto. "So what it meant to a patient is that if you were destined to have three attacks in one year, you would actually only have two."
"It slowed relapse and reduced the risk of disability progression by about 30%," O'Connor says.
The drug works by preventing fast-growing immune system cells from activating, multiplying, and responding to the body's own proteins, causing inflammation.
The most common side effects experienced by patients were diarrhea, nausea, hair thinning, and elevated levels of liver enzymes.
Rates of serious infections, a common risk of drugs that subdue an overactive immune system, were similar between the placebo and treatment groups. Serious infections affected 2.2% of those taking the placebo, 1.6% of those on the lower dose of teriflunomide, and 2.5% on the higher dose.