Betaferon Long-term Study Shows That Early Disability in MS Patients Predicts Later Cognitive Decline
In the study, MS patients with higher baseline levels of disability based on a validated, well-established scale called EDSS (Expanded Disability Status Scale) (1) and/or disease burden as measured by magnetic imaging resonance (MRI) had greater levels of cognitive decline 16 years later.
“These are the first data to demonstrate a significant correlation between baseline levels of disability and a later decline in cognitive abilities over 16 years,” said Dawn Langdon, Ph.D., senior lecturer at Royal Holloway, University of London. “This suggests that slowing the development of disability through initiation of early treatment might be critical to preserving a patient’s cognitive function later in life.”
Previously presented and published results of landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study(2) demonstrated that early Betaferon® treatment of patients with a first MS attack significantly slowed the development of disability over three years. No other MS therapy has demonstrated this effect in this early patient population.
The data presented today show that clinical disability and MRI findings in the early stages of the disease determine cognitive performance of patients 16 years later.
In particular, baseline EDSS(3)scores (-0.336, p<0.001) and MRI T2 burden of disease (BOD) (-0.454, p<0.001) are highly correlated with patients’ cognitive ability as measured by a cognitive performance index.
About the 16-Year Long-Term Follow-up Study:
The 16-Year Long-Term Follow-up study was a multicenter observational study that collected data from patients with relapsing-remitting MS who participated in the pivotal North American trials for Betaferon®. Of the original 372 patients involved in the pivotal trial, a total of 179 patients with a mean age of 51.4 years and a median EDSS score of 4.5 on a 10-point scale completed cognitive assessment. These patients were evenly derived from the original three arms (Betaferon® 50mcg, Betaferon® 250mcg, or placebo) of the pivotal study. Scores on five separate tests were combined to produce a Cognitive Performance Index (CPI). The investigators then compared the current CPI data with the prospectively collected EDSS and MRI data collected during the pivotal trial 16 years earlier.
About Betaferon® / Betaseron®
Betaferon®, which is marketed in the U.S. 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 U.S., Europe and Japan, Betaferon® has been approved for all relapsing forms of MS. It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 percent. Sixteen years’ follow-up of people treated with Betaferon® has shown that it is safe and well tolerated.
About Multiple Sclerosis
MS is a chronic, progressive disease of the central nervous system and the likelihood of disability increases the longer someone has MS. Symptoms of MS vary from person to person and can be unpredictable. They may include: Fatigue or tiredness, dimness of vision in one or both eyes, weakness of one or both legs, numbness and tingling in the face, arms, legs and trunk of the body, spasticity (muscle stiffness), dizziness, double vision, slurred speech and loss of bladder control.
References
(1) D.W. Langdon et al. Cognition in the later stages of multiple sclerosis: cognitive results from the Betaferon 16-Year Long-Term Follow-up Study, 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis, 2007
(2) Kappos L et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 2007 Aug 4; 370(9585): 389-97
(3) Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444–52.
About Bayer HealthCare
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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, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics 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.
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Posted: October 2007
