Bayer HealthCare announced that researchers have presented data from two international long-term follow-up studies in multiple sclerosis: the BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) 8-Year Extension Study and the Betaferon® 21-Year Long-term Follow-up (LTF) Study. The abstracts were presented at the Fifth Triennial Meeting of the European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS – ACTRIMS) in Amsterdam, The Netherlands. Data from the BENEFIT 8-Year study confirm that early first line use of Betaferon (interferon beta-1b) stabilized disease in the majority of patients, as measured by both relapse rate and disability progression using the Expanded Disability Status Scale (EDSS). Importantly, the BENEFIT 8-Year study demonstrates that first line use of Betaferon prevented the need to switch to an escalation therapy in the majority of patients over the eight year period. Of the 468 patients who were treated with Betaferon, only 31 patients (6.6%) received treatments generally considered second or third line escalation therapies. Such treatments are, due to their risk to benefit profile or lack of long-term data, generally reserved for patients whose disease is not adequately controlled with first line disease-modifying therapies or have highly active disease.
“The BENEFIT 8-Year study data confirm that in the majority of patients who start Betaferon early, disease was adequately controlled over eight years preventing the need to switch to treatments that can be considered escalation therapies,” said Dr. Xavier Montalban, Director of the Neurology Research and Clinical Neuroimmunology Multiple Sclerosis Unit, The Department of Neurology, Vall d’Hebron University Hospital, Barcelona, Spain.
In the BENEFIT 8-Year Extension Study, the frequency of adverse events (AEs) was within the well-established safety and tolerability profile of Betaferon. The total number of patients experiencing serious adverse events (SAE) was similar in each group and almost all were unrelated to IFNB-1b, as assessed by the investigator.
Data from the 21-Year Long Term Follow-Up Study (LTF) – the longest assessment of any MS treatment – showed that patients treated earlier with Betaferon had a 46.8% relative reduced risk in mortality (p=0.0173) compared with patients receiving placebo for up to the first five years of treatment. Further, the study analyzed cause-of-death data for the majority of deceased patients and found that 78.3% of deaths were related to MS. The average age at death was low at only 52 years. These data confirm that the reduction in life expectancy often affects MS patients in their prime years.
“The 21-Year LTF study with Betaferon provides the first strong survival evidence for MS treatment, and further supports the importance of starting patients as soon as possible on an effective disease-modifying therapy with a favorable safety profile in the long-term”, said Dr. Anthony Reder, Director of the University of Chicago MS Clinic and University of Chicago Associate Professor, Department of Neurology.
About the BENEFIT Study
BENEFIT is an important milestone 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 and slows cognitive decline. Despite these differences between early and delayed treatment, overall Expanded Disability Status Scale (EDSS) values changed little over 8 years – in both treatment groups, the median EDSS remained 1.5 from baseline to 8 years.
The original BENEFIT 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 eight years.
The BENEFIT Extension was an international, multicenter, prospective, observational, non-interventional study. All patients randomized into the placebo phase of the BENEFIT study and treated at least once were eligible to enter the extension study. Patients were treated exclusively at the discretion of physician and patient and according to locally applicable standards. Evaluations were performed at baseline and every 6 months until December 2010, with a maximum follow-up of 8.7 years. The 284 patients enrolled in the extension study were recruited from 72 centers in 17 countries.
“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 the 21-Year LTF Study
The 21-Year LTF Study is a cross-sectional assessment of the randomized, controlled, multicenter pivotal North American Betaferon trial. The randomized treatment phase was up to five years; the median time on randomized treatment, either 250ug, 50ug or placebo, was 3.8 years. In the long-term analysis, investigators collected health information from patients who originally participated in this trial. At 21 years after the start of the pivotal trial, this vital status information was available for more than 98% of the original participants (366 of the 372), an ascertainment level that is unsurpassed in MS studies to date, and a key strength of the study. Researchers looked at the available health information to analyze the relationship between when patients started treatment, their total exposure to treatment, as well as their long-term outcomes.
For the cause of death analysis, an independent cause of death assessment committee used all available sources of information including the U.S. National Death Index, which provides coded death certificate data, other death certificates, each patient’s clinical file entries, pivotal study/16Y LTF study EDSS scores and secondary progressive MS data. Deaths were considered MS-related if they met one of the following criteria: Brainstem or upper spinal cord dysfunction due to MS; Aspiration pneumonia due to MS; Respiratory insufficiency due to MS; Sepsis due to MS; Death related to trauma due to MS; Pulmonary embolism secondary to lower extremity paralysis; Death related to side effects of treatment; Suicide; If otherwise insufficient data and MS was the first listed cause of death; EDSS greater than or equal to 7/no better explanation.
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 subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), 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, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.