NABs study
Posted: Mon Aug 21, 2006 8:03 am
First Patient Enrolled in Study to Evaluate Impact of Regular Neutralizing Antibody (NAb) Testing on Multiple Sclerosis Treatment Patterns
Largest Study of Its Kind Will Examine Changes in Treatment Management of Tested and Non-Tested Patients Receiving a High-Dose Interferon.
Teva Neuroscience, Inc., announced today the initiation of the first-ever study designed to examine how the implementation of regularly scheduled interferon beta (IFN-(beta) ) neutralizing antibody (NAb) tests in multiple sclerosis (MS) patients receiving high-dose IFN-(beta) therapy ultimately affects treatment patterns, versus the usual care of IFN-(beta) patients. The study, called the NAbs Count Study, began enrollment in approximately 130 centers across the United States with the first patient entering the trial on July 25, 2006.
Studies have shown that the presence of IFN-(beta) NAbs may negatively alter the therapeutic effectiveness of the commercially available IFN-(beta) class of disease modifying drugs commonly used to treat multiple sclerosis, which includes IFN-(beta)-1a SC (Rebif®), IFN-(beta)-1b SC (Betaseron®), and IFN-(beta)-1a IM (Avonex®), and that NAbs developed in five percent to 45 percent of all multiple sclerosis patients treated with these drugs (1, 2, 3). Despite the evidence that patients who develop NAbs are likely to become IFN-(beta) non-responders, and present an increased risk of relapses and disease progression, NAbs testing has not been a part of routine clinical practice (4).
"The initiation of the NAbs Count Study underscores Teva's long-standing commitment to the MS community," said Judy Abdalla, Senior Director Medical Affairs, Teva Neuroscience. "We are excited to be working with some of the top medical centers in the United States to gather information that could provide additional information on what guides multiple sclerosis treatment decisions."
The European Federation of Neurological Societies (EFNS) released guidelines recommending that IFN-(beta) NAbs testing be conducted in all IFN-(beta)-treated MS patients at 12 and 24 months of therapy. The EFNS guidelines also recommend that testing should be repeated in patients who test positive for NAbs and therapy with IFN-(beta) should be discontinued in patients with high titers of NAbs sustained at repeated measurements with 3- to 6-month intervals (5).
About the Study
The NAbs Count Study is a 12-month, randomised, controlled, open-label, parallel group study taking place in approximately 130 study sites in the United States. Patients 18 years of age and older with a diagnosis of MS who have been receiving high-dose IFN-(beta) therapy at approved doses - either Rebif® or Betaseron® - continuously for at least 12 months are eligible. The study is expected to enroll approximately 2,440 subjects.
Patients will be randomised to one of two study groups. One group of patients (Regularly Scheduled NAb Testing Arm) will be scheduled for multiple IFN-(beta) NAb tests (up to 3 NAb tests over a nine-month period) with a follow-up visit at 12 months. The other cohort of patients (Usual Care Arm) will be observed for 12 months under usual care conditions, which typically do not include regularly scheduled NAb tests. As the primary endpoint of the study, researchers will evaluate the differences between study arms in the proportion of subjects whose high-dose IFN-(beta) therapy was changed during a 12-month follow-up period. Patients and health care providers interested in learning more about the study can visit www.clinicaltrials.gov and enter the trial's identifier code of NCT00336557 for more information.
Please see enclosed additional important information.
(1)Avonex® Prescribing Information, www.avonex.com (2)Rebif® Prescribing Information, www.rebif.com (3)Betaseron ® Prescribing Information, www.betaseron.com (4)Giovannoni G, Goodman A. Neutralizing anti-IFN-{beta} antibodies: How much more evidence do we need to use them in practice? Neurology 2005; 65(1):6-8.
(5)P.S. Sorensen, et al. "Guidelines on use of anti-IFN-(beta) antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-(beta) antibodies in multiple sclerosis" European Journal of Neurology 2005, 12: 817-827
Source: Teva Neuroscience, Inc.
Largest Study of Its Kind Will Examine Changes in Treatment Management of Tested and Non-Tested Patients Receiving a High-Dose Interferon.
Teva Neuroscience, Inc., announced today the initiation of the first-ever study designed to examine how the implementation of regularly scheduled interferon beta (IFN-(beta) ) neutralizing antibody (NAb) tests in multiple sclerosis (MS) patients receiving high-dose IFN-(beta) therapy ultimately affects treatment patterns, versus the usual care of IFN-(beta) patients. The study, called the NAbs Count Study, began enrollment in approximately 130 centers across the United States with the first patient entering the trial on July 25, 2006.
Studies have shown that the presence of IFN-(beta) NAbs may negatively alter the therapeutic effectiveness of the commercially available IFN-(beta) class of disease modifying drugs commonly used to treat multiple sclerosis, which includes IFN-(beta)-1a SC (Rebif®), IFN-(beta)-1b SC (Betaseron®), and IFN-(beta)-1a IM (Avonex®), and that NAbs developed in five percent to 45 percent of all multiple sclerosis patients treated with these drugs (1, 2, 3). Despite the evidence that patients who develop NAbs are likely to become IFN-(beta) non-responders, and present an increased risk of relapses and disease progression, NAbs testing has not been a part of routine clinical practice (4).
"The initiation of the NAbs Count Study underscores Teva's long-standing commitment to the MS community," said Judy Abdalla, Senior Director Medical Affairs, Teva Neuroscience. "We are excited to be working with some of the top medical centers in the United States to gather information that could provide additional information on what guides multiple sclerosis treatment decisions."
The European Federation of Neurological Societies (EFNS) released guidelines recommending that IFN-(beta) NAbs testing be conducted in all IFN-(beta)-treated MS patients at 12 and 24 months of therapy. The EFNS guidelines also recommend that testing should be repeated in patients who test positive for NAbs and therapy with IFN-(beta) should be discontinued in patients with high titers of NAbs sustained at repeated measurements with 3- to 6-month intervals (5).
About the Study
The NAbs Count Study is a 12-month, randomised, controlled, open-label, parallel group study taking place in approximately 130 study sites in the United States. Patients 18 years of age and older with a diagnosis of MS who have been receiving high-dose IFN-(beta) therapy at approved doses - either Rebif® or Betaseron® - continuously for at least 12 months are eligible. The study is expected to enroll approximately 2,440 subjects.
Patients will be randomised to one of two study groups. One group of patients (Regularly Scheduled NAb Testing Arm) will be scheduled for multiple IFN-(beta) NAb tests (up to 3 NAb tests over a nine-month period) with a follow-up visit at 12 months. The other cohort of patients (Usual Care Arm) will be observed for 12 months under usual care conditions, which typically do not include regularly scheduled NAb tests. As the primary endpoint of the study, researchers will evaluate the differences between study arms in the proportion of subjects whose high-dose IFN-(beta) therapy was changed during a 12-month follow-up period. Patients and health care providers interested in learning more about the study can visit www.clinicaltrials.gov and enter the trial's identifier code of NCT00336557 for more information.
Please see enclosed additional important information.
(1)Avonex® Prescribing Information, www.avonex.com (2)Rebif® Prescribing Information, www.rebif.com (3)Betaseron ® Prescribing Information, www.betaseron.com (4)Giovannoni G, Goodman A. Neutralizing anti-IFN-{beta} antibodies: How much more evidence do we need to use them in practice? Neurology 2005; 65(1):6-8.
(5)P.S. Sorensen, et al. "Guidelines on use of anti-IFN-(beta) antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-(beta) antibodies in multiple sclerosis" European Journal of Neurology 2005, 12: 817-827
Source: Teva Neuroscience, Inc.