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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

early departure from the workforce. Patients treated early with Betaseron fared better in tests of cognitive function compared to those with delayed treatment, which is good news for people with MS," Dr. Freedman said.

The BENEFIT study was the first to demonstrate a reduction in the risk of confirmed EDSS progression, as measured by the Expanded Disability Status Scale (EDSS), with early versus delayed treatment. This effect first appeared at year three, with a significant risk reduction of 40 percent (p=0.022).(2) Over five years, a nominal risk reduction of 24 percent (p=0.177) was observed for early treatment compared to delayed treatment. This difference over five years was not statistically significant.(1)

The key findings from the BENEFIT five-year study showed that:(1)

-- Starting Betaseron after the first clinical event delayed the development of CDMS by more than two years (750 days) in the 40th percentile.

-- Patients treated early with Betaseron had a greater reduction in relapse rate over five years compared to patients with delayed treatment, (0.21 versus 0.27) despite the latter receiving at least three years of treatment after the second attack or after two years (p=0.014; Poisson model). This effect was mainly due to the differences between the groups during the first two years.

-- Early treatment significantly reduced the development of newly active brain lesions (new or enlarging T2 lesions, Gd-enhancing lesions) compared to delayed treatment (p=0.0062).

-- In the BENEFIT study there was a high level of study completion of Betaseron by patients with the earliest signs of MS. Two-thirds of patients (67 percent) in the early treatment group continued on Betaseron for five years.

-- Patients consistently reported a high Health-Related Quality of Life over the five-year study period.

Adverse events (AEs) reported at five years were consistent with the product label.

About BENEFIT

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SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
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