Thousands of Americans who suffer from multiple sclerosis (MS) might one day be able to take advantage of a drug that new research suggests is both safe and effective.
Multiple sclerosis is a chronic and often disabling disease that affects nearly 400,000 people in the United States. It attacks the protective substance called myelin that covers the nerve fibers of the brain and spinal cord.
Myelin is similar to the insulation of a wire and ensures proper nerve function. Once the myelin is damaged, the disease can also damage the nerve fibers themselves, leading to scars in these delicate tissues.
This damage leads to symptoms as mild as tingling in your feet and fingers, or as severe as paralysis or blindness. Eighty-five percent of MS patients are diagnosed with what is called relapsing-remitting MS, which means they experience flare-ups of symptoms, followed by partial or complete recovery.
A team of researchers looked at nearly 1,500 patients in 28 countries taking the experimental oral drug, known for now by the name BG-12, to see whether such flare-ups decreased, as well as whether they experienced any side effects from the treatment. The patients were studied for two years.
The results were encouraging. Overall, the patients receiving the experimental drug did better than the placebo group. Those who took the drug twice daily cut their chances of experiencing a flare-up by 44 percent, while those taking it three times a day reduced their chances by 51 percent. By comparison, the researchers wrote, a drug currently used for MS only cuts flare-up rates by 29 percent. Additionally, an MRI scan revealed that patients taking BG-12 had fewer scars on their nerves and brain.
If it is more widely used, the drug might offer hope to a large number of patients like Bill Yoho of Little Hocking, Ohio, who remembers the day he was diagnosed with MS.
"I felt numbness and tingling in my feet and hands, and my eyeballs did not track, oh, and dizzy spells," Yoho, 55, recalled. "That's how it was diagnosed. I thought it would be nothing, but my wife dragged me to the doctor and they did an MRI."
The scan, along with blood tests and his symptoms, led Yoho's doctor to the diagnosis. Shortly afterward, he heard of the clinical trial for BG-12.
"I heard about a clinical trial; I had no idea what that meant," he said. "And we started talking about it. You know, when I can go to work; it's a good day. If I can spend time with my family; it's a good day. So I participated."
Yoho received the drug itself rather than the placebo. And while he said that he still experiences some symptoms of MS, they have been fewer and less severe. He said he has experienced no new symptoms while taking the drug.
If approved by the U.S. Food and Drug Administration, BG-12 would join two other oral medications on the market for MS.
"There is a great need for effective oral agents with acceptable safety profiles for MS patients with mild disease," said Dr. Lawrence Samkoff, associate professor of neurology at the University of Rochester in Rochester, N.Y., who was not involved with the study. "These newer oral medications will inaugurate a new era in the treatment of relapsing MS, giving patients and their physicians more choices."
Samkoff added that while BG-12 has some mild side effects, including flushing and an upset stomach, such symptoms tended to decreased within one month of taking BG-12.
Still, more research might be needed before BG-12 becomes more widely available, even after this two-year study.
"[Two years] is the standard these days, but the question is: is it adequate?" said Dr. John Corboy, professor and director of the department of neurology at the University of Colorado. "[It] is quite long in general, but very short when you consider the typical duration someone has MS."
Dr. Timothy Coetzee, chief research officer of the National MS Society, agreed. "As with any new therapy, it's important to do follow-up studies to understand the impact of the treatment over the long term," he said. "This will help us gain more specific knowledge of the long-term impact of this treatment on the immune system as well as the nervous system."
Today, Yoho's past participation allows him to continue taking the drug, and he said he hopes that his participation in the research will one day help others to benefit from the research.
"The coolest part about the study, I get to help finding a medication that really helps," Yoho said. "That's really cool."
- Pharmaceuticals & Drug Trials