VCU part of breakthrough research for multiple sclerosis

By Michael Ford
University News Services

RICHMOND, Va. – A Virginia Commonwealth University researcher is part of a breakthrough study that shows treatments with interferon beta 1a, sold prescriptively as Avonex, may slow the progress of multiple sclerosis or even prevent the disease from developing in high-risk patients.

The study, published in the Sept. 28 issue of the New England Journal of Medicine involved 383 patients and 50 medical centers in the United States and Canada, including VCU�s Medical College of Virginia Hospitals. The Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study, known as CHAMPS, began in April 1996 and ended in March 2000.

Affecting about 1 million people worldwide and more than 350,000 Americans, multiple sclerosis is a chronic inflammatory disease of the central nervous system. The symptoms include numbness, loss of balance, vision problems, weakness, difficulty walking and paralysis. The disease usually affects women between the ages of 20 and 40.

Warren L. Felton III, M.D., chairman of VCU�s Neuro-Ophthalmology Division, is one of the study's principal investigators. He enrolled the first clinical subject in the CHAMPS trial. Nine people participated in the trial at the VCU site.

Researchers say the results show initiating therapy with Avonex at the first sign a patient may develop MS can significantly delay development of the disease. Felton said this finding will have a significant influence on the way doctors – particularly neurologists – treat patients with multiple sclerosis.

A person traditionally is diagnosed with clinically definite multiple sclerosis after at least two episodes of symptoms. MS causes the destruction of myelin, the insulation around nerve fibers in the brain and spinal cord. Researchers used magnetic resonance imaging to identify lesions on the brain consistent with the occurrence of demyelination, a marker for those at risk for a second attack or clinically definite MS.

"In the past, if a patient presented with a demyelinating event – that could be optic neuritis, a brain-stem event causing double vision or balancing trouble or a myelitis causing paralysis or sensory loss in the legs – the patient would be followed, anticipating another event," Felton said. "It would be after the second event that the drug would be started. This study indicates that by beginning this treatment right after the first attack, there is an improved chance of delaying the onset of that second attack, and therefore the disease itself. The CHAMPS results will change the way that we administer this immunomodulating drug for patients who have MS."

In the CHAMPS trial, half of the participants received interferon beta 1a. The other half received a placebo. After observing participants for three years, about a third of Avonex patients had developed definitive MS, compared to half of the placebo group.

"Next will be an extension of the CHAMPS trial, called the CHAMPIONS study," Felton said. "We need to continue to monitor these patients to determine if giving the drug this early will reduce or delay the development of disability."

The study's lead author is Lawrence Jacobs, M.D., professor of neurology at the State University of New York at Buffalo. The study was funded by Biogen Inc. of Cambridge Mass., the manufacturer of Avonex.