New data confirm that early initiation of Betaferon (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) significantly delays the onset of clinically-definite MS (CDMS) by 37 per cent (p=0.003) and McDonald MS by 45 per cent (p<0.0001) over five years compared to delayed treatment. The results confirm a continued benefit of initiating treatment with Betaferon shortly after the first event. These five year findings from the BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study were presented at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS) in Montreal, Canada.

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

The study also demonstrated that early treatment with interferon beta 1-b has a beneficial effect on cognition that becomes 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 (p= 0.0045). PASAT, or the Paced Auditory Serial Addition Test, is a widely accepted tool that measures intellectual function and cognition.

"Changes in cognitive function have important implications for a patient's quality of life and, along with fatigue, can be a reason for early departure from the workforce. Patients treated early with Betaferon 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 disability, 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 per cent (p=0.022). Over five years, a nominal risk reduction of 24 per cent (p= 0.177) 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 interferon beta 1-b 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 interferon beta 1-b had a greater relapse rate reduction 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. It also showed 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 acceptance of interferon beta 1-b by patients with the earliest signs of MS. Two thirds of patients in the early treatment group continuously adhered to Betaferon 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 in line with the product labelling with no new safety signals detected. The total number of patients experiencing at least one serious adverse event was similar, and most serious AEs were not related to the study medication.

BENEFIT is first and only MS trial to prospectively demonstrate the continuous benefits of initiating interferon beta-1b (Betaferon) after the first clinical event suggestive of MS. Overall results from the trial show that early initiation of interferon beta 1-b treatment in patients with the earliest signs of the disease delays the development of CDMS and McDonald MS, slows cognitive decline, and reduces the risk of confirmed disability.

Betaferon, which is marketed in the US and Canada under the trademark Betaseron, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. In the US, Europe and Japan, Betaferon has been approved for all relapsing forms of MS. Sixteen years' follow-up of people treated with Betaferon has shown that it is safe and well tolerated.

Multiple Sclerosis is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS.