Five Year Data Confirm That Early Treatment With Betaferon® At First Sign Of Disease Can Delay Progression To MS

Main Category: Multiple Sclerosis
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 26 Sep 2008 - 0:00 PDT

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New data confirm that early initiation of Betaferon® (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) significantly delays the onset of clinically-definite MS (CDMS) by 37 percent (p=0.003) and McDonald MS by 45 percent (p<0.0001) over five years compared to delayed treatment. The results confirm a continued benefit of initiating treatment with Betaferon shortly after the first event. These five year findings from the BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study were presented at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS) in Montreal, Canada.

"The BENEFIT five-year results are the first and only prospective data to confirm a continuous benefit over five years when treatment is initiated shortly after the earliest sign of MS," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and investigator of the study. "These results confirm that treatment with Betaferon after the first MS event or attack can reduce the risk of developing MS over five years compared to delayed treatment."

The study also demonstrated that early treatment with interferon beta 1-b has a beneficial effect on cognition that becomes even more pronounced over time. At five years, patients with early treatment had better cognitive function (mean PASAT score) compared to patients with delayed treatment (p= 0.0045). PASAT, or the Paced Auditory Serial Addition Test, is a widely accepted tool that measures intellectual function and cognition.

"Changes in cognitive function have important implications for a patient's quality of life and, along with fatigue, can be a reason for early departure from the workforce. Patients treated early with Betaferon fared better in tests of cognitive function compared to those with delayed treatment, which is good news for people with MS," Dr. Freedman said.

The BENEFIT study was the first to demonstrate a reduction in the risk of confirmed disability, as measured by the Expanded Disability Status Scale (EDSS), with early versus delayed treatment. This effect first appeared at year three, with a significant risk reduction of 40 percent (p=0.022). Over five years, a nominal risk reduction of 24 percent (p= 0.177) was observed for early treatment compared to delayed treatment. This difference over five years was not statistically significant.

The key findings from the BENEFIT five year study showed that:

-- Starting interferon beta 1-b after the first clinical event delayed the development of CDMS by more than two years (750 days) in the 40th percentile.

-- Patients treated early with interferon beta 1-b had a greater relapse rate reduction over five years compared to patients with delayed treatment, (0.21 versus 0.27) despite the latter receiving at least three years of treatment after the second attack or after two years (p= 0.014; Poisson model). This effect was mainly due to the differences between the groups during the first two years.

-- Early treatment significantly reduced the development of newly active brain lesions (new or enlarging T2 lesions, Gd-enhancing lesions) compared to delayed treatment (p= 0.0062).

-- In the BENEFIT study there was a high level of acceptance of interferon beta 1-b by patients with the earliest signs of MS. Two thirds of patients in the early treatment group continuously adhered to Betaferon for five years.

-- Patients consistently reported a high Health-Related Quality of Life over the five-year study period.

Adverse events (AEs) reported at five years were in line with the product labeling with no new safety signals detected. The total number of patients experiencing at least one serious adverse event was similar, and most serious AEs were not related to the study medication.

About BENEFIT

BENEFIT is first and only MS trial to prospectively demonstrate the continuous benefits of initiating interferon beta-1b (Betaferon®) after the first clinical event suggestive of MS. Overall results from the trial show that early initiation of interferon beta 1-b treatment in patients with the earliest signs of the disease delays the development of CDMS and McDonald MS, slows cognitive decline, and reduces the risk of confirmed disability.

The multi-center trial was 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 1-b every other day or placebo as a subcutaneous injection in a double blind fashion for a maximum of two years. The study was designed to encompass a representative population of patients with the earliest signs of MS, including patients with mono- or multifocal lesions.

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 interferon beta 1-b to prospectively assess the impact of such early versus delayed treatment with interferon beta 1-b on the long-term course of the disease for a total observation time of five years.

"Early treatment" refers to treatment initiated after the first clinical event; "delayed treatment" is initiated after the second clinical event or after two years, whatever comes first.

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. 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 in one or more extremities, 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.

About Bayer Healthcare

The Bayer Group is a global enterprise with core competencies in the fields of health care, 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, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

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, 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 http://www.bayerscheringpharma.de

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