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16-Year Follow-Up Data for Interferon Beta-1b Show Positive Impact on Course of Multiple Sclerosis and Mortality: Presented at ECTRIMS By Bruce Sylvester MADRID, SPAIN -- October 2, 2006 -- Results from a 16-year study of subcutaneous interferon beta-1b (Betaferon) show that continuous long-term treatment has a positive impact on the course of relapsing multiple sclerosis and might affect mortality. The findings were presented here on September 29th at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on behalf of the Betaseron/Betaferon LTF Study Group. "This is the longest follow-up of the interferon studies, including 88% of the subjects from the pivotal IFNB-1b trial," said lead investigator George Ebers, MD, professor of neurology, University of Oxford, Oxford, United Kingdom. "We see signals here that treatment does impact long-term survival." The study evaluated outcomes in patients who were enrolled in the original IFN-1b pivotal trial which began in 1988. The researchers collected data on survival, disease status, relapse rate, Expanded Disability Status Scale score, adverse events, magnetic resonance imaging parameters and other data. The results were divided and analysed according to original treatment group in the pivotal trial: placebo, 50 mcg IFNB-1b or 250 mcg IFNB-1b every other day. The investigators divided the 16-year results into several categories based on IFNB-1b usage: · "never" equals IFNB-1b less than or equal to 10% of the time, · "ever" equals IFNB-1b greater than 10–80% of the time and · "always" equals IFNB-1b greater than 80% of the time. Of the original 372 subjects, 328 (88.2%) have been identified, with 293 still living and 35 deceased. Data from 260 subjects showed that 30% of 260 patients are currently taking IFNB-1b, with almost 10 years (3345 days) of median exposure to the study drug. Wheelchair use was required by 44.2% of "never" subjects and 29.4% of "always" subjects. Also, median time to a score of 6 on the Expanded Disability Status Scale was 6 years later for "always" subjects than for "never" subjects. "Annualised relapse rates were lower in the 'always' group, compared with the 'never' group. Adverse events were uncommon" the researchers wrote in their poster. This study is the longest and most complete follow-up of any disease modifying MS, the authors noted. Based on this evidence, the long-term safety of IFNB-1b is excellent, they concluded. They also noted that they observed a greater number of deaths in the placebo group versus the treatment groups. "This suggests that early treatment and continuous long-term treatment with IFNB-1B may have an advantage in reducing the mortality associated with MS. Every effort is being made to identify the causes of mortality." The study was supported by Schering AG, Berlin, Germany. [Presentation title: Final Results From the Interferon Beta-1b 16-Year Long-Term Follow-Up Study. Abstract P666] E-mail this page to a friend or colleague! To print, use this version