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®
Betaferon®, which is marketed in the U.S. and Canada under the trademark Betaseron®, was the first disease-modifying drug for MS to be introduced and is well-established as a treatment around the world. Betaferon has been approved for all relapsing forms of MS in the U.S., Europe and Japan. In China for patients with relapsing-remitting MS.
About Multiple Sclerosis
MS is a chronic, progressive disease of the central nervous system. The likelihood of disability increases the longer a person has MS. The symptoms vary from person to person and can be unpredictable. They can include the following: fatigue or tiredness, dimness of vision in one or both eyes, weakness in one or more extremities, numbness and tingling in the face, arms, legs and trunk, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.