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Trial Shows Risk of Developing Multiple Sclerosis Significantly Reduced with Interferon Beta-1b Early Treatment

OTTAWA, CANADA -- August 17, 2006 -- Researchers have found that treatment of patients with interferon beta-1b after a first attack suggestive of multiple sclerosis (MS) cuts their risk of developing the disease in half over the next two years, according to results from the BENEFIT (BEtaferon(R)/BEtaseron(R) in Newly Emerging Multiple Sclerosis for Initial Treatment) clinical trial.

The findings were published for the first time in an expedited manner in this week's online issue of Neurology.

One of the primary investigators of the BENEFIT study was Mark S. Freedman, MSc MD FAAN FRCPC, of The Ottawa Hospital and the University of Ottawa in Ottawa, Canada. Ottawa was one of 93 test sites in 20 countries where this 487 patient, double-blinded, phase III study was conducted.

"Our study provides a strong rationale for the early use of early interferon beta-1b therapy after the first episode suggestive of MS," said Dr. Freedman. "It is well established that neurological damage, including damage of the nerve fibers or axons, can occur even before MS is diagnosed. The current thinking is that by limiting the amount of axonal damage through early and effective therapy, we can postpone a person's disability. The prime concern of people with MS is that they will become disabled in the next 10 to 20 years."

Dr. Freedman continued, "It is important for people who are experiencing symptoms of MS to see a neurologist for diagnosis and treatment. The findings of the BENEFIT study show that early treatment with interferon beta-1b helps to reduce the risk of developing MS."

MS is a chronic, somewhat unpredictable disease of the central nervous system, and symptoms can include fatigue, vision problems, weakness, numbness, tingling, stiffness, dizziness, loss of bladder control and slurred speech.

The two-year data published in Neurology show that treatment with interferon beta-1b, at really the earliest clinically identifiable time point in the evolution phase of the disease, reduced the risk of developing clinically definite MS by 50 percent, compared with patients who received a placebo drug. BENEFIT is the only early two-year MS trial that utilized a high dose, high frequency interferon-beta therapy, which has already been shown to be superior to low dose/frequency regimens in patients with established relapsing-remitting disease. In the BENEFIT study, over 85 percent of those patients who did not receive the therapy but were on a placebo-drug, went on to meet current diagnostic criteria for MS by either developing new MRI lesions or experiencing another clinical attack within two years of having their first clinical event. In contrast, patients who received the interferon beta-1b therapy were two times better protected against developing MS.

The BENEFIT study was supported by funding from Schering AG, Germany, marketers of BEtaferon BEtaseron (R)/ (R).


SOURCE: The Ottawa Hospital

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