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Five-Year Data Confirm That Early Treatment with Betaseron(R) at First Sign of Disease Can Delay Progression to MS
Date:9/20/2008

ENEFIT is the first and only prospectively planned five-year MS study to demonstrate the long-lasting benefits of initiating Betaseron (interferon beta-1b) after the first clinical event suggestive of MS. Overall, results from the trial showed that early initiation of Betaseron treatment in patients with the earliest signs of the disease delayed the progression to CDMS and McDonald MS, and improved cognitive function as measured by PASAT.

The multi-center trial was 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 randomized to receive either 250 micrograms of Betaseron every other day or placebo as a subcutaneous injection in a double blind fashion for a maximum of two years. The study was designed to encompass a representative population of patients with the earliest signs of MS, including patients with mono- or multifocal lesions.

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 early versus delayed treatment with Betaseron on the long-term course of the disease for a total observation time of five years.

"Early treatment" refers to treatment initiated after the first clinical event; "delayed treatment" refers to treatment initiated after the second clinical event or after two years, whichever occurs first.

About Betaseron

Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multi
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
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