Good News For Patients With Relapsing-Remitting Multiple Sclerosis

Promising preliminary results of a recently completed pilot phase II trial on the biological effects of oral interferon (IFN-alpha) in relapsing-remitting multiple sclerosis (RRMS) patients were presented at the Multiple Sclerosis Update, sponsored by The University of Texas-Houston, on October 22.

"Drugs to treat multiple sclerosis are available, however a small percentage of MS patients take them because they are only available via injection and they have side effects," says Dr. Staley A. Brod, associate professor of neurology at The University of Texas-Houston Medical School, who led the study. "Our study reveals that an oral interferon-alpha has a modulating effect on inflammation on brain MRI in relapsing-remitting multiple sclerosis patients. This is the first time an ingested protein has demonstrated an affect on any disease process."

Dr. Brod's research study questioned if 10,000 or 30,000 units ingested IFN-alpha on alternate days would reduce the number of enhancing lesions on MRI brain scans in patients with early RRMS. The NIH-supported research was a double-blind, randomized, placebo-controlled study.

Additional criteria for the study included early diagnosis of RRMS, and MRI results that demonstrated at least one area of baseline gadolinium-enhanced T1 lesion (areas of inflammation in the brain) on MRI while not on immunosuppressive therapy.

Thirty patients, selected from a pool of 79, were randomized into three treatment groups. One group was treated with 10,000 units of IFN-alpha, another with 30,000 units of IFN-alpha and a third group was treated with a placebo. Each group was treated for nine months and received monthly MRI scans.

The result: Dr. Brod showed that the low dose oral IFN-alpha group performed better than the placebo group. There were no side effects.

"For patients with MS, this may be of major importance," says Dr. Brod. "Activity on MRI scans can indicate the ability to decrease attacks of MS and perhaps stop the progression of disease that often results in the use of a cane, walker and ultimately a wheelchair. Additional clinical studies with primary clinical outcomes will need to evaluate the usefulness of ingested IFN-alpha in larger clinical trials.

"Our discovery may revolutionize the treatment of MS and other autoimmune diseases," Dr. Brod concludes.

Multiple sclerosis is an inflammatory disease of the nervous system. It is unpredictable and often crippling. It disrupts communication between the brain and other parts of the body leaving some people unable to speak, walk or write.

- SANDRA HENRY

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©2006 Texas Medical Center

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