WEDNESDAY, Jan. 20 (HealthDay News) -- Two new drugs -- both oral, rather than injected -- may soon be available to combat multiple sclerosis.
Three studies, all being published early online Jan. 20 in the New England Journal of Medicine, find that the new drugs -- fingolimod and cladribine -- reduce relapse rates in people with relapsing-remitting multiple sclerosis (MS). Both drugs work by altering the immune system response.
However, as is often the case with immune-suppressing medications, there are concerns about side effects, including an increased risk of serious infections and possibly, cancer.
"Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS," said Dr. John Richert, executive vice president of research and clinical programs for the National Multiple Sclerosis Society (NMSS). "The drugs appear to be quite effective, and at the moment, appear to have a reasonable risk-benefit ratio. However, it will be very important for people with MS and their physicians to remain vigilant and be on the lookout for side effects."
All three studies were funded by the drug's manufacturers -- Novartis for fingolimod and Merck Serono for cladribine. Both manufacturers are currently pursuing U.S. Food and Drug Administration approval for their medications.
Multiple sclerosis is a chronic, potentially disabling illness that's believed to be an autoimmune disorder. In MS, the body's natural defense system mistakenly attacks the fatty substance that protects the nerves (myelin). About 400,000 Americans have multiple sclerosis, according to the NMSS.
The current treatments for MS are all injectable medications, which Richert said is sometimes a barrier for people to start early treatment. He said that treatments may be more successful if they're started early in the course of the disease, so he's hoping that having oral medications will help people start treatment sooner.
Two of the new studies focused on the oral medication called fingolimod. Both were phase 3 studies. One study included more than 1,000 people with relapsing-remitting MS. The study participants were randomly selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or a placebo.
Annual relapse rates were less than 1 percent each year, but were 54 percent less for the lower dose of fingolimod and 60 percent for the higher dose. The study also found slower disease activity and progression.
In the second study on fingolimod, 1,153 people with relapsing-remitting MS were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg of fingolimod or a weekly dose of 30 micrograms of interferon beta-1a (Avonex) for one year. The annual relapse rate on either drug was less than 1 percent in this study as well. However, the people on fingolimod had up to a 52 percent lower relapse rate. This study found no significant differences in disease progression between the two treatments.
Both studies found that the lower dose of the drug was better tolerated. A small number of serious infections occurred, including two deaths from herpes infections in these studies. And, there appeared to be a higher incidence of cancer in people taking fingolimod.