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Interferon Beta-1b Improvements in Multiple-Sclerosis Patients Maintained Over the Long Term: Presented at AAN By Jill Stein SAN DIEGO, C.A. -- April 5, 2006 -- The early efficacy, safety, and tolerability profile of interferon beta-1b (Betaseron) in multiple sclerosis (MS) patients remains consistent after 16 years of treatment, researchers reported here at the 58th Annual Meeting of the American Academy of Neurology (AAN). These results are from the Betaseron 16-Year Long-Term Follow-up (16-Year LTF) Study, which constitutes the longest follow-up study for any disease-modifying therapy in MS. Importantly, the data also document a sustained reduction in the annual relapse rate of up to 40%. The investigators used data from patients who had participated in the original pivotal trial to assess the long-term safety and efficacy of interferon beta-1b in patients with relapsing-remitting MS, said George Ebers, MD, professor of medicine, Oxford University, Oxford, United Kingdom. In the original trial, said Dr. Ebers, patients were randomised to 1 of 3 treatment arms: interferon beta-1b 50 mcg, interferon beta-1b 250 mcg, or placebo, administered subcutaneously every other day. This was followed by a median 45-month observation period. Original analysis after 2 years showed that significantly more patients in the active treatment arm were relapse-free, those relapses were less frequent, and MS-related hospitalisations were halved. These improvements were maintained at 5 years. Of the original 372 patients enrolled in the pivotal trial, which led to the first approved immunomodulatory therapy in MS, 328 (88.2%) have been identified. The 16-year analysis showed that patients remaining on long-term treatment had a slower disease progression compared with patients who did not continue on long-term treatment. Among the patients who reached Expanded Disability Status Scale (EDSS) level 6.0 (meaning they needed a cane for walking), those on long-term interferon beta-1b treatment reached EDSS 6.0 after a median of 13 years compared with 7 years for patients on short-term treatment. Long-term treatment was defined as use of interferon beta-1b for more than 80% of the time since the start of the pivotal trial (about 12 years or longer), while short-term treatment was defined as use for less than 10% of the time (about 1.6 years or less). "The results suggest that early and continuous long-term treatment may have an advantage," Dr. Ebers said. Dr. Ebers noted that additional analyses are ongoing, and will also compare these results to expected outcomes using different natural history databases. This study was supported by Schering AG and Berlex. [Presentation title: The Interferon Beta-1b 16-Year Long-Term Follow-Up Study: The Final Results. Abstract P01.079] E-mail this page to a friend or colleague! To print, use this version