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Large Study Shows that Presence of Neutralizing Antibodies Did Not,Predict Clinical Response to Betaseron Treatment

rlene Jody, M.D., Executive Vice President, Specialized Therapeutics, Bayer Schering Pharma AG, Germany. "When treating MS, especially from the first event, patients and prescribers can continue to rely on the proven efficacy and safety of Betaseron."

The published study addressed the clinical impact of NAbs to Betaseron therapy in an office-based or "real world" setting. These results are in line with the clinical practice guidelines recently published by the American Academy of Neurology.(2) Since the development of NAbs is specific to each medication, it is unclear how these findings for Betaseron might apply to other beta interferons.

About the Study

The study reviewed the NAb status of 6,698 Betaseron patients from North America (n=2010), Europe (n=2417) and Australia (n=2271) using the myxovirus protein A assay (MxA). The prevalence of persistently high neutralizing antibodies in the Australian cohort, which included patients regardless of clinical response to Betaseron, was 37%. This finding was similar to the reported incidence seen in Betaseron clinical trials. The incidence of persistently high NAbs in the European and North American groups, however, was only 28% and 21% respectively even those these patients were pre-classified as having a "poor clinical response" to therapy. Since the patients known to be poor responders were more often NAb negative than the general population, the study concluded that persistent, high NAb status was not a key predictor of clinical response to therapy.

Data for the study were collected during a six-year period (1996-2002). Most of the NAb testing (73%) was performed within the first three years of treatment, when patients are thought to be at the greatest risk of developing NAbs. Patients in the study had MS for an average seven to 10 years at the time of testing.

About Betaseron

Betaseron (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosi
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