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Betaseron “BENEFIT” Follow-Up Study Results Published


August 3, 2007

In a study just published, researchers have shown for the first time that early treatment can slow the rate at which disability progresses in individuals who have had a first event suggestive of multiple sclerosis but who have not yet been diagnosed with definite MS. The study is a follow-up to the completed, two-year BENEFIT study, in which treatment with Betaseron®(interferon beta-1b, Bayer HealthCare Pharmaceuticals) was shown to delay the onset of clinically definite MS in people at high-risk for the disease compared with people who did not receive treatment. In the three-year follow-up study, both groups are now receiving Betaseron, and the study is assessing the impact of early treatment versus delayed treatment on the progression of MS. The first years’ results of the ongoing follow-up study were reported by Drs. Ludwig Kappos (University Hospital, Basel, Switzerland), Mark Freedman (University of Ottawa, Ontario, Canada) in the August 4, 2007 issue ofThe Lancet(370; 389-397). The study is funded by Bayer Schering Pharma.

Details:

Of the original BENEFIT study group of 468 people, 418 are enrolled in the follow-up study, with 261 in the early treatment group, and 157 in the delayed treatment group. Of these, 392 completed the first year of follow-up.

After one year of follow-up, 37% of those who received early treatment with Betaseron developed definite MS, compared to 51% of those whose treatment was delayed, a reduction of the risk of developing definite MS of 41%. In addition, 16% of the early treatment group and 24% of the delayed treatment group showed confirmed progression by one or more points on the EDSS (a standard measure of MS disability), representing a reduced risk for disease progression of 40%.

The results from this well-designed follow-up study are important, according to Dr. John R. Richert, Executive vice President of Research and Clinical Programs at the National MS Society. “Previous studies showed that early immune-modulating treatment could delay the development of definite MS, but this is the first study to also show a delay in disability progression. This adds to growing evidence that early and ongoing treatment can forestall disease activity in the future,” stated Dr. Richert.

The BENEFIT follow-up study is continuing for two more years.

-- Research and Clinical Programs

Betaseron is a registered trademark of Bayer HealthCare Pharmaceuticals

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