News Review From Harvard Medical School -- Studies: New Drug Effective against MS
A new medicine appears effective against multiple sclerosis (MS), 2 new studies find. Unlike most MS drugs, it is given as a pill. The studies focused on BG-12, developed by Biogen Idec. The drug is a version of the chemical fumarate. It works by protecting nerves against injury. One study included about 1,200 people. They had the relapsing and remitting form of MS. Symptoms for this type of MS come and go. People were randomly assigned to receive either of 2 doses of BG-12, or placebo (fake) pills. After 2 years, relapse rates were reduced by half in the 2 groups that received BG-12, compared with the placebo group. The other study included about 1,400 people. The design and results were similar. But this study also included a group that received glatiramer (Copaxone). This is an injection drug already used to treat MS. Relapse rates were slightly lower with BG-12 than with glatiramer. But the study was not designed to show differences between the two drugs. The New England Journal of Medicine published the studies. The New York Times wrote about them September 20.
By Robert H. Shmerling, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
Multiple sclerosis (MS) is a mysterious disease.
Without warning, people who were healthy suddenly develop problems with nerve function that often are severe. Symptoms may include:
- Poor coordination or unsteady gait
- Vision problems, such as double or blurred vision
- Problems with speech
- Pain or numbness in the face
- Urinary problems, such as losing bladder control or being unable to completely empty the bladder
- Numbness, tingling or weakness in the arms or legs
Sometimes multiple sclerosis gets better at times and worse at other times. This is called the relapsing and remitting type. For other people, it gets relentlessly worse over time. Symptoms may come at unpredictable times. That can be one of the most frustrating features of the disease.
Although there are many treatments for multiple sclerosis, they don't always work well. And side effects are common.
That's why a new drug that helps people with multiple sclerosis is a big deal. The current edition of the New England Journal of Medicine includes 2 studies about MS. They report positive results with a drug called BG-12.
It's not actually a new drug. It's a form of fumarate, a chemical with many uses. For example, it helps to protect furniture from moisture and fungus. However, researchers discovered another use. They found that it could also suppress the immune system and keep nerves healthy. These effects could be helpful for a disease like multiple sclerosis, in which the immune system seems to attack the nervous system.
The first study included more than 1,200 people. All of them had relapsing and remitting multiple sclerosis. Researchers compared 2 doses of BG-12 with a placebo pill. The other study was similar, except that there was also another group. People in this group received injections of glatiramer (Copaxone), a drug already approved to treat MS. Both studies lasted 2 years.
In the first study, people who received BG-12 had:
- Fewer relapses of symptoms -- About 27% had relapses, compared with 46% in the placebo group.
- Less disability -- The rate was 16% to 18%, compared with 27% in the placebo group.
- Fewer new or worsening abnormal areas shown on a brain MRI
In the second study, improvement for people receiving BG-12 was similar, though less dramatic. BG-12 also appeared to be somewhat more effective than glatiramer, though the study was not designed to prove this.
Side effects of BG-12 were generally mild. They included flushing, diarrhea, nausea and stomach pain.
This treatment did not cure anyone's disease. But it was effective and at least as good as (maybe better than) a currently approved drug, glatiramer.
There's more good news: BG-12 is a pill. Glatiramer is given by injection. So are some of the other commonly prescribed drugs for multiple sclerosis.
Last week, the U.S. Food and Drug Administration approved another new MS drug, Aubagio (teriflunomide). This approval, and these studies on BG-12, provide new reasons for optimism among people with MS. The news is especially good for those who have not done well with other treatments.
What Changes Can I Make Now?
Unfortunately, there is no known way to prevent multiple sclerosis. If you have already been diagnosed with the disease, you have several treatment options. Each has its own risks and benefits to consider.
Some drugs treat the disease itself by suppressing or changing the immune system. These include:
Some other medicines don't treat the disease itself. But they can help reduce symptoms and other problems that often occur along with MS.
- Muscle relaxants may help with spasms and tightness in the muscles.
- Antidepressants can improve mood.
- Anti-seizure medicines can prevent or reduce seizures (which may complicate multiple sclerosis).
- Urinary tract infections and overactive bladder contractions may occur along with MS. Antibiotics help treat the infections. Bladder relaxing medicines, such as Oxybutynin, can help with contractions.
Do you have symptoms, such as those above, that could be caused by multiple sclerosis? Are they lasting symptoms, with no other clear cause? See your doctor for evaluation.
What Can I Expect Looking to the Future?
You can expect to hear much more about new treatments for MS, including BG-12. Considering the results of these studies, BG-12 could be approved soon. However, it will take more research to know whether this drug is safe and effective for the many years that people with MS require treatment.
I hope that our understanding of multiple sclerosis will improve in the future. And that could lead to something even better than new treatments that reduce symptoms. It could lead to a cure.