Large Study Shows that Presence of Neutralizing Antibodies Do Not Predict Clinical Response to Betaferon® Treatment
Berlin – Bayer Schering Pharma AG, Germany, announced today the results of a retrospective study demonstrating that the presence of neutralizing antibodies (NAbs) that can develop in response to Betaferon® (interferon beta-1b) therapy did not predict clinical response in patients with multiple sclerosis (MS).(1) The study looked at data from over 6,600 patients across three continents. It is the largest dataset ever analyzed on the relevance of NAbs to interferon beta therapy. The results were published in the March issue of The Journal of International Medical Research.
“This study confirms that NAbs, which develop in response to Betaferon® therapy, tend to disappear over time and provides important evidence that the presence of NAbs in these patient populations was not associated with a poor clinical response to treatment.” said Dr. Douglas Goodin, lead author of the article and Professor of Neurology, University of California, San Francisco. “While it is unclear how these findings might apply to other beta interferon therapies, these data underscore the fact that decisions regarding Betaferon® treatment should be based on the clinical circumstances of the individual patient and not solely on the basis of their NAb status.”
NAbs are antibodies that may attach themselves to an injected protein drug, such as beta interferon therapy, thereby potentially inhibiting its biological activity. All immunomodulating therapies for MS may cause the development of NAbs in a varying portion of patients, but there is controversy in the medical community about the role NAbs may or may not play in a patient’s response to therapy.
“This study reinforces expert recommendations that treatment decisions should be based on a patient’s overall response to therapy and not on the actual or potential presence of neutralizing antibodies”, said Darlene Jody, M.D., Executive Vice President, Specialized Therapeutics, at Bayer Schering Pharma. “When treating MS, especially from the first event, the proven efficacy and safety of Betaferon® is what patients and prescribers can continue to rely on.”
The published study addressed the clinical impact of NAbs to Betaferon® 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). The study findings also confirm and reinforce previous clinical data showing that NAb status does not necessarily affect the efficacy of Betaferon® treatment, and that most patients who test positive for NAbs to Betaferon® revert to NAb-negative status over time (3,4). Since the development of NAbs is specific to each medication, it is unclear how these findings for Betaferon® might apply to other beta interferons.
About the Study
The study reviewed the NAb status of 6,698 Betaferon® 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 Betaferon®, was 37%. This finding was similar to the reported incidence seen in Betaferon® 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.
Repeat testing further demonstrated that NAbs to Betaferon® disappeared over time.
Among 2,387 patients tested a second time, only 34.1% (813 patients) had at least two consecutive titres ≥20 NU/ml:
Of these patients, 347 were tested further, of whom 25.4% (88) had reverted to NAb-negative status by the time of their last sample.
Among patients with a high titre of ≥400 NU/ml, 26.7% (24/90) of patients with two consecutive titres ≥400 NU/ml had reverted to NAb-negative status after repeated testing.
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® / Betaferon®
Betaseron®, which is marketed outside the U.S. and Canada under the trademark Betaferon®, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. Betaferon® is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaferon® has the broadest experience of any MS medication. In the U.S., Europe and Japan, the drug has been approved for all relapsing forms of MS. It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 percent. Sixteen years’ follow up of people treated with Betaferon® has shown that it is safe and well tolerated.
1. Goodin, DS, Hurwitz B, Noronha A. Neutralizing Antibodies to Interferon β-1b are Not Associated with Disease Worsening in Multiple Sclerosis. J Int Med Res. 2007; 35: 173-187.
2. Goodin DS et al. Neutralizing antibodies to interferon beta: Assessment of their clinical and radiographic impact: An evidence report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2007; 68: 977– 984.
3. Durelli L, Verdun E, Barbero P, et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002;359: 1453–60.
4. Sorensen P, Ross C, Clemmesen KM, et al. Clinical importance of neutralising antibodies against interferon beta in patients with relapsing-remitting multiple sclerosis. Lancet 2003;362: 1184–91.
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG, Germany.
Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.
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