FRIDAY, April 19, 2002
Fri Apr 19,11:57 PM ET
By Robert Preidt
Researchers want to know if a drug commonly used to treat multiple sclerosis
(MS) will work better if they double the dose.
They believe the higher regimen will work, but they'll soon find out for sure. A two-year, international trial to test high-dose treatment of the drug interferon beta-1b begins later this year. The trial, the largest ever for an MS drug, will include about 2,000 people at 200 hospitals and MS centers in North and South America, Europe and Australia.
The trial is being conducted by German drug firm Schering AG and its American subsidiary, Berlex Laboratories. Interferon beta-1b is sold in the United States under the brand name Betaseron and in Europe under the brand name Betaferon.
Interferon beta-1b is already used to treat people with relapsing-remitting MS. The current approved dose is 250 micrograms (mcg) by injection every other day. This randomized, blinded study will compare the current dose to a higher dose of 500 mcg every other day.
"The philosophy of the new study is really to see if the drug can offer more benefits to the patients by going to the higher dose," says Dr. Ayad Abdulahad, vice president of clinical development for central nervous system at Berlex, which is in Montville, N.J.
He says previous research and studies indicate the higher dose is more effective than the current approved dose. They'll attempt to confirm that with this large-scale trial, which is being done in response to the needs of people with MS and at the urging of MS specialists, Abdulahad says.
While the current 250-mcg dose is effective, "we expect the 500-microgram dose to deliver more benefit to the patient," he says.
Relapsing-remitting MS is the most common form of the disease. It's characterized by partial or total recovery after attacks that may include vision problems or movement disorders. About 70 percent of people with MS initially have the relapsing-remitting form.
MS is a chronic disease that involves inflammation and the breakdown of the protective insulation, called a myelin sheath, that surrounds the nerve fibers of the central nervous system, says the National Multiple Sclerosis Society.
The disorder affects more than 300,000 Americans. Symptoms vary in severity and duration, and include blurred vision, loss of balance and poor coordination, slurred speech, tremors, extreme fatigue, and even paralysis and blindness. There is no cure.
Interferon beta-1b helps reduce inflammation that MS causes in the central nervous system, Abdulahad says.
It's too soon to comment on the importance or potential impact of this trial, says Arney Rosenblat, public affairs director for the National Multiple Sclerosis Society.
"But any study of this size will surely add to the overall body of knowledge about treating MS and that should be encouraged," she says.
She says there are several different drugs available to treat MS symptoms.
"But all of the products do basically the same thing -- they reduce the number of attacks and the severity of the attacks by about a third. And indications are that they slow disease progression," Rosenblat says.
She says some people respond better to one drug than to another.
If this trial into a higher dose of interferon beta-1b is successful, it will give people with MS another option for managing their disease, Rosenblat says.
What To Do: For more information about MS, go to the National Multiple
Sclerosis Society or the National Institute of Neurological Disorders and
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