May 2001

From Wake Forest University Baptist Medical Center

Double-drug therapy may benefit some multiple sclerosis patients

WINST0N-SALEM, N.C. - People with the most common types of multiple sclerosis who don't respond to traditional therapy may benefit from a combination drug therapy, a Wake Forest University Baptist Medical Center (WFUBMC) researcher reported today at the annual meeting of the American Academy of Neurology in Philadelphia, Penn.

In a pilot study, patients with aggressive relapsing-remitting or secondary progressive multiple sclerosis (MS) whose disease wasn't controlled with interferon beta-1B, a commonly used treatment, showed a reduction in disease progression when mitoxantrone was added.

"Our study, which was the first to test the safety and effectiveness of this combination of drugs, showed that it may be an effective therapy for a significant number of patients," said Douglas Jeffery, M.D., assistant professor of neurology at WFUBMC and the study's principal investigator.

Jeffery said that 35 percent to 50 percent of MS patients don't have an optimal response when taking interferon beta-1B and might benefit from the combination therapy.

The study enrolled 10 patients who continued to have attacks, or relapses, during at least six months of treatment with interferon beta-1b (sold under the brand name Betaseron). In addition, magnetic resonance imaging (MRI) showed that these patients, while on monotherapy, continued to develop brain plaques or scarring from MS. These lesions are from damage to myelin, the sheath that protects nerve fibers. The patients developed a mean of three new lesions a month.

Mitoxantrone (sold under the brand name Novantrone) was then added to the patients' therapy for six months. This medication, originally used to treat cancer, was approved for MS treatment last fall. During this treatment period, relapses and new lesions were reduced by 50 percent.

"This is significant because patients in the study had aggressive MS that wasn't responsive to standard treatment," said Jeffery. "The combination therapy shows excellent promise for patients who aren't successfully controlled on monotherapy. It was safe and showed no toxicity."

MS is a disease of the central nervous system that affects the brain and spinal cord. It strikes an estimated 250,000 people in the United States and is the major acquired neurologic disease in young adults. Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction.

Relapsing-remitting MS, the most common form of the disease, is characterized by attacks interspersed with stable periods. About 75 percent of people are originally diagnosed with this form of the disease. Secondary progressive MS is the second stage of MS for nearly half the patients initially diagnosed as relapsing-remitting. In this stage, there are periods of intermittent attacks and remissions before the disease begins a course of steady progression.

Other less common forms include primary-progressive MS, in which the symptoms generally do not remit, and progressive-relapsing MS, which is characterized by obvious acute attacks.

WFUBMC cares for more than 2,000 patients with MS. It operates a multi-disciplinary clinic that enables patients to see an array of MS specialists during each visit. The treatment team includes specialists in neurology; nursing; clinical nutrition; physical, occupational, speech, recreational and respiratory therapies; social work; clinical psychology; assistive technology and pastoral care.












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