Patients treated with Betaferon? (interferon beta-1b) shortly after their first clinical MS event or ?attack? showed a 40 percent lower risk of developing confirmed disability when compared to patients in whom treatment was delayed. The results ? which were fast-tracked and published in The Lancet today ? provide the first controlled evidence that delaying Betaferon? treatment has an effect on later accumulation of disability. No other MS therapy has demonstrated this effect in this early patient population.
The BENEFIT study (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment), sponsored by Bayer Schering Pharma AG, compared Betaferon? treatment initiated after a first clinical event with delayed treatment. The study was conducted at 98 sites in 20 countries and included a total of 468 patients.
In the study, investigators measured MS progression of patient disability using a validated, well-established scale called EDSS (Expanded Disability Status Scale).(1) Disability progression was defined as an increase in a patient?s EDSS score by at least one point that was confirmed after six months. A confirmed increase by one point in the EDSS scale can be an important and robust predictor of permanent and severe disability later in the disease.(2)
?This research has important implications for the way we treat MS, because for the first time, we have controlled data that irrefutably demonstrates the value of early intervention with effective treatment for patients,” said Dr. Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland, and lead investigator of the BENEFIT study. ?These findings support the decision to actively treat patients at the first clinical sign of MS to delay the accumulation of disability.?
“The data from BENEFIT not only reinforces the evidence that treatment with Betaferon? after the first clinical attack reduces the risk of subsequent MS attacks, but is also the first to demonstrate an impact on disability progression.” said David Bates, Professor of Clinical Neurology at the University of Newcastle upon Tyne, UK.
Other highlights from the study include:
? Sensitivity analyses confirmed the robustness of the main findings.
? Development of neutralizing antibodies did not have an impact on disability-related or relapse-related outcomes in the trial. This confirms other published, peer ?reviewed research.(3)
? Betaferon? was safe and well-tolerated, with the reporting of adverse events (AEs) similar to those previously reported for the drug.(4)
? 90 percent of the patients who entered the follow-up study elected to receive Betaferon? treatment, indicating high patient acceptance of treatment. In the study, methods that may have helped patients stay on therapy included the implementation of dose titration at the start of treatment, the use of an auto-injector to give the injections and co-medication with an analgesic in the first weeks of treatment.
“Bayer HealthCare revolutionized the treatment of MS when we introduced Betaferon? as the first disease modifying treatment,” said Darlene Jody, M.D., Senior Vice President and President of Bayer HealthCare?s Specialized Therapeutics Global Business Unit. “The BENEFIT results have the potential to again transform the MS treatment paradigm as they provide convincing evidence that treating patients with Betaferon? shortly after the first clinical event suggestive of MS can delay disability progression.”
Around the world, Betaferon? is approved for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations, as well as for use in patients after the first attack of MS.