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| Significant Survival Advantage with Betaferon Treatment |
New findings from the longest assessment of any MS-specific treatment show that patients treated earlier with Betaferon® (interferon beta-1b) had a 39.3% relative reduced risk in mortality for the time since randomization in the study (P=0.027), compared with patients receiving placebo for up to the first five years of treatment. The magnitude of the effect of Betaferon on survival observed in this study can be illustrated by the number needed to treat: Eight patients needed to receive early Betaferon treatment in the trial (number needed to treat) in order to avoid one death as compared to placebo.
The data, presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), reaffirm Betaferon's favorable benefit to risk profile for up to two decades of use.
In general, people with MS have a shorter life expectancy (about 7 to 14 years less) compared with the general population. This reduction in life expectancy significantly affects people beginning in their late 40s or early 50s, a time when they are typically in their prime years. "These groundbreaking results provide us with the first strong survival evidence in MS, and demonstrate a large and clinically important survival benefit for patients treated initially with Betaferon in this cohort of patients," said Dr. Anthony Reder, Director, University of Chicago MS Clinic and Professor, University of Chicago Department of Neurology. "By initiating Betaferon early in the disease course, we may be able to prevent one death for every eight patients treated as observed over this trial period of 21 years. MS is a chronic disease that requires life-long treatment, so physicians and their patients need long-term evidence so they can appropriately evaluate the true benefit to risk profile of their medication." "The Betaferon 21-Year Long-term Follow-up Study constitutes the longest follow-up study for any disease-modifying therapy in MS and is part of our ongoing commitment to improving the care of people with this disease," said Andreas Fibig, Chairman of the Board of Management of Bayer Schering Pharma AG. "With its established benefit/risk profile and proven long-term efficacy, Betaferon represents a trusted first-choice, first-line treatment for MS patients." The 21-Year Long-term Follow-up Study is a cross-sectional assessment of the randomized controlled multicenter pivotal trial study population. It assesses the vital status and clinical data from patients who participated in the pivotal North American Betaferon trials, sponsored by Bayer HealthCare Pharmaceuticals. The randomized treatment phase of the pivotal North American Betaferon trial patients was up to five years. The treatment duration during the randomized phase of the pivotal trials was a median of 3.8 years. Vital status information from 366 out of originally 372 patients randomized was obtained (more than 98 percent of the original participants) at 21 years after the start of the pivotal trial and analyzed to investigate the relationship timing of drug initiation and exposure and long-term outcomes. The study's 98.4 percent ascertainment of the vital status (dead or alive) for patients is a level that is unprecedented and unsurpassed in MS studies to date, and a key strength of the trial.
About Betaferon® / Betaseron®
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About Bayer Schering Pharma |




New findings from the longest assessment of any MS-specific treatment show that patients treated earlier with Betaferon® (interferon beta-1b) had a 39.3% relative reduced risk in mortality for the time since randomization in the study (P=0.027), compared with patients receiving placebo for up to the first five years of treatment. The magnitude of the effect of Betaferon on survival observed in this study can be illustrated by the number needed to treat: Eight patients needed to receive early Betaferon treatment in the trial (number needed to treat) in order to avoid one death as compared to placebo.
The data, presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), reaffirm Betaferon's favorable benefit to risk profile for up to two decades of use.
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