Immediate Treatment Of Early Multiple Sclerosis Patients Significantly Delayed Permanent Disability

Multiple Sclerosis Treatment

Bayer HealthCare Pharmaceuticals announced new data, which show that immediate initiation of Betaseron treatment in patients with a first event suggestive of multiple sclerosis can significantly reduce the risk of permanent neurological impairment as measured by the Expanded Disability Status Scale by 40 percent over three years compared to delayed treatment.

These findings from the BENEFIT (BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment) studies were presented today at the American Academy of Neurology's 59th Annual Meeting in Boston, Massachusetts.

"Some patients have already developed significant neurological damage when they first present with signs of multiple sclerosis, which can lead to accumulated disability later in life. The BENEFIT results clearly show that immediate treatment with Betaseron initiated after the first clinical event can significantly reduce that damage, which could translate into a greater delay in the time it takes for patients to suffer from the debilitating consequences of multiple sclerosis," said Dr. Mark S. Freedman, Professor of Neurology atthe University of Ottawa and investigator of the study. "This is a truly novel finding that has not yet been demonstrated for any other immunomodulatory MS treatment, and underscores the urgent need to treat patients early, rather than waiting for further signs of MS to develop. Physicians and patients should consider these unprecedented findings when making treatment decisions."

"We are delighted that the BENEFIT study continues to deliver groundbreaking results," said Darlene Jody, M.D., Senior Vice President and President, of Bayer Healthcare's Specialized Therapeutics Global Business Unit. "In the past year, Betaseron has received approval around the world for use in patients after the first event suggestive of MS. We intend to submit this novel data for inclusion in our label. Regulatory approval would further differentiate Betaseron from other products in the market place and strengthen our position."

BENEFIT is a multi-center trial conducted at 98 sites in 20 countries and included patients presenting with a single clinical episode suggestive of multiple sclerosis. A total of 468 patients with a first clinical demyelinating event suggestive of MS and typical MRI findings were randomized to receive either 250 micrograms of interferon beta-1b (Betaseron) every other day or placebo as a subcutaneous injection in a double blind fashion. The placebo-controlled treatment period lasted up to 24 months or up to the time when patients were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaseron to prospectively assess the impact of such immediate versus delayed treatment with Betaseron on the long-term course of the disease for a total observation time of five years.

Results from a prospectively planned analysis of patients three years after the first event suggestive of MS showed that:

-- Immediate treatment with Betaseron after the first event suggestive of multiple sclerosis reduced the risk for confirmed EDSS progression by 40 percent over three years compared to delayed treatment.

-- At three years, patients who initiated Betaseron treatment immediately were 41 percent(5) less likely to progress to clinically definite multiple sclerosis versus patients who began treatment later. These results confirm the findings of the placebo-controlled BENEFIT study.

At the end of three years, 73 percent of patients were on Betaseron treatment after the first event suggestive of multiple sclerosis.