Schering AG has announced that the proven benefits of interferon beta-1b (Betaferon) treatment for people living with multiple sclerosis (MS) was underlined by a long-term follow-up study (8 years), which shows the benefits of early treatment with interferon beta-1b, compared to placebo, continue many years beyond the completion of the clinical study, presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Vienna. In addition, the study design of a 16-year long-term follow-up study was also presented.

"Studies with interferon beta-1b in MS have shown that we can significantly reduce the number of relapses, slow the progression of the disease and improve patients' quality of life in both relapsing-remitting MS and secondary progressive disease. Emerging evidence from long-term observations in well-defined cohorts of patients, although not as rigorous as randomized trials, may help to increase our confidence in the sustainability of these effects. In addition, these studies may help in defining profiles of responders to therapy," said prof. Ludwig Kappos, Dept. of Neurology, University Hospital in Basel, Switzerland.

The results of the long-term follow-up of the European Study of interferon beta-1b in secondary progressive MS (EUSPMS) demonstrated a sustained advantage for those patients initially randomized to active treatment, and support early treatment with interferon beta-1b in SPMS. Of 137 patients with follow up to month 96 (8 years) or longer, patients randomized to receive interferon beta-1b in the initial double-blind phase of the trial had significantly lower disease progression in Expanded Disability Status Score (EDSS) than those randomized to placebo. Patients included in the long-term follow-up study represented 69 per cent of the patients who originally entered the double-blind study in these participating centres, release from Schering AG said.

The long-term follow-up study also revealed that there was a significant positive correlation between a longer length of time on treatment and a reduction of disability in the patients' EDSS score. In other words the longer patients continued to receive treatment, the less severe the progression of their disease, or the greater their improvement.

Experience of patients involved in the original North American interferon beta-1b pivotal trial during the 16 years following their enrolment has already provided a critical demonstration of the individual long-term benefits of Betaferon in RRMS. The protocol for a 16-year follow-up study was presented at ECTRIMS. The study will use a novel approach to explore the long-term safety and effectiveness of interferon beta-1b systematically by evaluating patients who were treated in the pivotal trial, the release says.

"This study will constitute the longest follow-up evaluation of any MS treatment," professor George Ebers, head of the University Department of Clinical Neurology, Oxford, UK said adding, "Our methodology for studying patients employing cross-sectional data collection and comparison with matched controls will provide information on the 16-year effectiveness and safety of interferon beta-1b in patients with RRMS."