Bayer Schering Pharma AG, Germany, has announced new data, which show that immediate initiation of Betaferon (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) can significantly reduce the risk of permanent neurological impairment as measured by the Expanded Disability Status Scale (EDSS) by 40 per cent over three years compared to delayed treatment. These findings from the BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For initial Treatment) studies were presented 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 MS, which can lead to accumulated disability later in life. The BENEFIT results clearly show that immediate treatment with Betaferon 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 MS," said Dr Mark S Freedman, Professor of Neurology at the 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."
"Immediate treatment" refers to treatment initiated after the first clinical event; "delayed treatment" is initiated after the second clinical event or after 2 years, whatever comes first.
"We are delighted that the BENEFIT study continues to deliver ground-breaking results," said Darlene Jody, MD, president of Bayer HealthCare's Specialized Therapeutics Global Business Unit. "In the past year, Betaferon has received approval around the world for use in patients with the earliest signs of MS. We intend to submit this novel data for inclusion in our label. Regulatory approval would further differentiate Betaferon from other products in the market place and strengthen our position."
BENEFIT is a multi-centre trial conducted at 98 sites in 20 countries and included patients presenting with a single clinical episode suggestive of MS. A total of 468 patients with a first clinical demyelinating event suggestive of MS and typical MRI findings were randomised to receive either 250 micrograms of interferon beta-1b (Betaferon) every other day or placebo as a subcutaneous injection in a double blind fashion.