Bayer HealthCare announced recently that researchers have presented data from two international long-term follow-up studies in multiple sclerosis: the BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment (BENEFIT) eight-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 in Amsterdam, The Netherlands.
Data from the BENEFIT eight-year study confirm that early first-line use of betaferon (interferon beta-1b) stabilised 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 eight-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 per cent) 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.
“Data from the BENEFIT eight-year study confirm that in the majority of patients, early first-line use of betaferon adequately stabilized disease activity and reduced the need to switch to any escalation therapy over the eight year period,” said Professor Niall Tubridy, consultant neurologist, St Vincent’s Private Hospital, Dublin, Ireland.
In the BENEFIT eight-year extension study, the frequency of adverse events (AEs) was within the well-established safety and tolerability profile of betaferon, Bayer said. 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 per cent relative reduced risk in mortality compared with patients receiving placebo for up to the first five years of treatment. Further, the study analysed cause-of-death data for the majority of deceased patients and found that 78.3 per cent 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 favourable 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. n
