Bayer HealthCare reports positive five-year data from multiple sclerosis study

The results confirm a continued benefit of initiating treatment with Betaseron shortly after the first event. The study also demonstrated that early treatment with Betaseron had a beneficial effect on cognition that became even more pronounced over time.

At five years, patients with early treatment had better cognitive function (mean Pasat score) compared to patients with delayed treatment. Pasat, or the paced auditory serial addition test, is a widely accepted tool that measures intellectual function and cognition.

According to the company, the Betaseron in newly emerging multiple sclerosis for initial treatment (Benefit) study was the first to demonstrate a reduction in the risk of confirmed Expanded Disability Status Scale (EDSS) progression, as measured by the EDSS, with early versus delayed treatment. This effect first appeared at year three, with a significant risk reduction of 40% (p=0.022). Over five years, a nominal risk reduction of 24% was observed for early treatment compared to delayed treatment. This difference over five years was not statistically significant.

The key findings from the Benefit five-year study showed that: starting Betaseron after the first clinical event delayed the development of clinically definite multiple sclerosis (MS) 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%) 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.

Mark Freedman, investigator of the study, said: “The Benefit five-year results are the first and only prospectively planned data to confirm a continuous benefit over five years when treatment is initiated shortly after the earliest sign of MS. These results confirm that treatment with Betaseron after the first MS event or attack can reduce the risk of developing MS over five years compared to delayed treatment.”