Patients Treated with Betaferon After First MS Attack Experienced Significant Delay in Disability Progession
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.
BENEFIT is a multi-center trial conducted at 98 sites in 20 countries and included patients presenting with a first clinical episode suggestive of MS and typical MRI findings. The primary outcome measures were time to diagnosis of CDMS (Clinically Definite MS), time to confirmed EDSS (Expanded Disability Status Scale) progression and patient reported Quality of Life outcomes (FAMS-TOI). A total of 468 patients were randomized to receive either 250 micrograms of interferon beta-1b (Betaferon®) every other day or placebo as a subcutaneous injection in a double-blind fashion. The placebo-controlled treatment period lasted up to 24 months or up to the time when patients experienced a second attack and were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaferon® to prospectively assess the impact of such early versus delayed treatment with Betaferon® on the long-term course of the disease for a total observation time of five years. The results reported in the Lancet are from a pre-planned analysis at three years.
Previous published studies in this patient population have been criticised as less scientifically rigorous, because of their retrospective nature, unblinded assessments and the high number of patients lost to follow-up. The BENEFIT study was the first study in early MS patients designed to overcome these shortcomings.
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.
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.
1. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444–52.
2. Rio J, Nos C, Tintore M, Tellez N, Galan I, Pelayo R, Comabella M, Montalban X. Defining the response to interferon-beta in relapsing-remitting multiple sclerosis patients. Ann Neurol 2006; 59: 344-52.
3. Goodin DS, Hurwitz B, Noronha A.. Neutralizing Antibodies to Interferon beta-1b are Not Associated with Disease Worsening in Multiple Sclerosis. J Int Med Res. 2007; 35: 173-187.
4. AEs were within the established range as reported in the SPC/PI.
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Posted: August 2007