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Five-Year Data Confirm That Early Treatment with Betaseron(R) at First Sign of Disease Can Delay Progression to MS

Sunday, September 21, 2008 General News J E 4
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MONTREAL, Sept. 20 Bayer HealthCare Pharmaceuticalsannounced today that new data from its BENEFIT (BEtaseron in Newly Emergingmultiple sclerosis For Initial Treatment) study confirm that early initiationof Betaseron(R) (interferon beta-1b) treatment in patients with a first eventsuggestive of multiple sclerosis (MS) significantly delayed the onset ofclinically-definite MS (CDMS) by 37 percent (p=0.003) and McDonald MS by 45percent (p<0.0001) over five years compared to delayed treatment. The resultsconfirm a continued benefit of initiating treatment with Betaseron shortlyafter the first event.(1) These five-year findings from the BENEFIT study werepresented today at the World Congress on Treatment and Research in MultipleSclerosis (WCTRIMS).

"The BENEFIT five-year results are the first and only prospectivelyplanned data to confirm a continuous benefit over five years when treatment isinitiated shortly after the earliest sign of MS," said Dr. Mark Freedman,Professor of Neurology at the University of Ottawa and investigator of thestudy. "These results confirm that treatment with Betaseron after the firstMS event or attack can reduce the risk of developing MS over five yearscompared to delayed treatment."

The study also demonstrated that early treatment with Betaseron had abeneficial effect on cognition that became even more pronounced over time. Atfive years, patients with early treatment had better cognitive function (meanPASAT score) compared to patients with delayed treatment (p= 0.0045).(1)PASAT, or the Paced Auditory Serial Addition Test, is a widely accepted toolthat measures intellectual function and cognition.

"Changes in cognitive function have important implications for a patient'squality of life. Changes in cognition, along with fatigue, can be a reasonfor early departure from the workforce. Patients treated early with Betaseronfared better in tests of cognitive function compared to those with delayedtreatment, which is good news for people with MS," Dr. Freedman said.

The BENEFIT study was the first to demonstrate a reduction in the risk ofconfirmed EDSS progression, as measured by the Expanded Disability StatusScale (EDSS), with early versus delayed treatment. This effect first appearedat 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 observedfor early treatment compared to delayed treatment. This difference over fiveyears 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 thedevelopment of CDMS by more than two years (750 days) in the 40th percentile.

-- Patients treated early with Betaseron had a greater reduction inrelapse rate over five years compared to patients with delayed treatment,(0.21 versus 0.27) despite the latter receiving at least three years oftreatment 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 thefirst two years.

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

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

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

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

About BENEFIT

BENEFIT is the first and only prospectively planned five-year MS study todemonstrate the long-lasting benefits of
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