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Neutralizing Antibodies Positivity Does Not Affect Clinical Outcome in Multiple Sclerosis Patients: Presented at ECTRIMS By Chris Berrie PRAGUE, CZECH REPUBLIC -- October 16, 2007 -- Neutralizing antibody (NAbs) positivity does not reduce the efficacy of interferon beta-1b (IFNbeta-1b) treatment, according to results of a substudy analysis of patients with a first event suggestive of multiple sclerosis (MS) in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Results of the Betaferon(R) in Newly Emerging Multiple Sclerosis For Initial Treatment (BENEFIT) were presented here on October 12 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Although the development of NAbs is seen with all current immunomodulatory therapies, there is little data to indicate their impact on treatment efficacy. Therefore, researchers conducted this study to analyze the effects of NAbs positivity in patients who were initially randomized to the early IFNbeta-1b treatment group of the BENEFIT study. For their analysis, Mark S. Freedman, MD, Steering Committee Member and Professor of Medicine (Neurology), University of Ottawa, and Director, Multiple Sclerosis Research Unit, Ottawa Hospital-General Campus, Ottawa, Ontario, Canada, and colleagues enrolled 468 patients who had shown a first neurological event suggestive of MS and had at least two clinically silent brain lesions on magnetic resonance imaging (MRI). The researchers identified 277 patients who received IFNbeta-1b 250 mcg SC every other day and for whom NAb titers were available. Over the 3 years of this subanalysis, 31.8% (n = 88) of these patients were found to have positive NAb titers. However, 46.6% of these 88 patients reverted to NAb-negative status by the end of the 3 years. The primary efficacy measure of the study was time to clinically definite MS, which was used in the BENEFIT study. The direct comparison between the NAb-positive patients and the rest of the IFNbeta-1b treatment group over the 3 years of this analysis shows similar risks of developing clinically definite MS. Furthermore, when analyzed according to NAb titer, the results show no significant difference between NAb-positive versus NAb-negative patients. Similarly, there were no significant effects for time to confirmed clinically definite MS progression. Therefore, this subgroup analysis demonstrates no evidence that NAb status (regardless of titer level) reduces the efficacy of IFNbeta-1b treatment. These findings suggest that NAb status is not a determining factor in treatment decisions for patients with a first neurological event suggestive of MS, the researchers concluded. Funding for this study was provided by Bayer Schering Pharma AG. [Presentation title: The Betaferon® in Newly Emerging Multiple Sclerosis For Initial Treatment (BENEFIT) Studies: Neutralising Antibodies Did Not Affect Clinical Outcomes After 3 Years. Abstract P185] E-mail this page to a friend or colleague! To print, use this version