Double-drug Therapy Shows Promise for Some Multiple Sclerosis Patients

April 16, 2002

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 researcher reported today at the annual meeting of the American Academy of Neurology in Denver, Colo.

In a follow-up to results reported at last year’s meeting, Douglas Jeffery, M.D., Ph.D., associate professor of neurology, said that 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.

During an average treatment period of six months with the combination therapy, relapses were reduced by 64 percent and new lesions were reduced by 88 percent in the 10 patients being evaluated. Only two out of 10 patients had evidence of disease activity on magnetic resonance imaging (MRI) scans by the end of the study.

“Our study, which is the first to test the safety and effectiveness of this combination of drugs, suggests that the combination therapy is effective in patients who haven’t been stable on monotherapy,” said Jeffery, the study’s principal investigator.

Jeffery said that about 50 percent of MS patients don’t have an optimal response when taking interferon beta-1B alone 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 to four new lesions a month on Betaseron alone. It should be noted that Jeffery sought to enroll patients with aggressive MS in the study.

Mitoxantrone (sold under the brand name Novantrone) was then added to the patients’ therapy. This medication, originally used to treat cancer, was approved for MS treatment in 2000.

“These results are significant because patients in the study had aggressive MS that wasn’t responsive to standard treatment,” said Jeffery. “The combination therapy shows excellent promise. It was safe and showed no significant 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 a 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 85 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.

Wake Forest cares for more than 2,000 patients with MS. It operates a multidisciplinary 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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