First of Its Kind Data Show: Immediate Treatment of Early MS Patients with Betaseron Significantly Delayed Permanent DisabilityRisk to confirmed EDSS progression reduced by 40 percent compared to delayed treatment
BOSTON, May 01, 2007 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today new data, which show that immediate initiation(1) of Betaseron(R) (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) can significantly reduce the risk of permanent neurological impairment as measured by the Expanded Disability Status Scale (EDSS) by 40 percent(2) over three years compared to delayed treatment(3). These findings from the BENEFIT (BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment) studies(4) were presented today at the American Academy of Neurology's 59th Annual Meeting in Boston, Massachusetts.
"Some patients have already developed significant neurological damage when they first present with signs of MS, which can lead to accumulated disability later in life. The BENEFIT results clearly show that immediate treatment with Betaseron initiated after the first clinical event can significantly reduce that damage, which could translate into a greater delay in the time it takes for patients to suffer from the debilitating consequences of MS," said Dr. Mark S. Freedman, Professor of Neurology at the University of Ottawa and investigator of the study. "This is a truly novel finding that has not yet been demonstrated for any other immunomodulatory MS treatment, and underscores the urgent need to treat patients early, rather than waiting for further signs of MS to develop. Physicians and patients should consider these unprecedented findings when making treatment decisions."
"We are delighted that the BENEFIT study continues to deliver groundbreaking results," said Darlene Jody, M.D., Senior Vice President and President, of Bayer Healthcare's Specialized Therapeutics Global Business Unit. "In the past year, Betaseron has received approval around the world for use in patients after the first event suggestive of MS. We intend to submit this novel data for inclusion in our label. Regulatory approval would further differentiate Betaseron from other products in the market place and strengthen our position."
BENEFIT is a multi-center trial conducted at 98 sites in 20 countries and included patients presenting with a single clinical episode suggestive of MS. A total of 468 patients with a first clinical demyelinating event suggestive of MS and typical MRI findings were randomized to receive either 250 micrograms of interferon beta-1b (Betaseron) 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 were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaseron to prospectively assess the impact of such immediate versus delayed treatment with Betaseron on the long-term course of the disease for a total observation time of five years.
Results from a prospectively planned analysis of patients three years after the first event suggestive of MS showed that:
-- Immediate treatment with Betaseron after the first event suggestive of MS reduced the risk for confirmed EDSS progression by 40 percent over \ three years compared to delayed treatment. -- At three years, patients who initiated Betaseron treatment immediately were 41 percent(5) less likely to progress to clinically definite MS versus patients who began treatment later. These results confirm the findings of the placebo-controlled BENEFIT study.
At the end of three years, 73 percent of patients were on Betaseron treatment after the first event suggestive of MS.
Betaseron (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
The most commonly reported adverse reactions are lymphopenia, injection- site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Betaseron should be used with caution in patients with depression. Injection-site necrosis has been reported in 4 percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information.
About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) "Immediate initiation" or "immediate treatment" is treatment initiated after the first clinical event.
(2) By proportional hazards regression, adjusted for T2-lesion volume at screening.
(3) "Delayed treatment" is treatment initiated after the second clinical event or after 2 years, whichever is first.
(4) Mark S. Freedman, et al: Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT): Effects of Immediate vs. Early Onset of Interferon Beta-1b Treatment, American Academy of Neurology, 59th Annual Meeting.
(5) By proportional hazards regression, adjusted for a standard set of covariates.
Posted: May 2007