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Development of neutralizing antibodies to intramuscular interferon beta-1a (Avonex ®)Biogen Idec, Inc., USA, Susan.goelz{at}biogenidec.com
Biogen Idec Canada Inc., Canada
The most frequent treatment for relapsing-remitting multiple sclerosis (RRMS) is interferon beta (IFNß). Development of neutralizing antibodies (NAbs) to IFN therapy is a well-documented phenomenon. Patients who have persistent NAbs of sufficient titer no longer receive clinical benefit from these therapies. In the case of intramuscular (IM) IFNß-1a (Avonex®), approximately 22% of patients in the pivotal trial (conducted from 1990 to 1994) developed NAbs. However, improvements in the processes for the production of IFNß-1a-Avonex resulted in a commercial product (first released in 1996) that was significantly less immunogenic; approximately 2% of patients developed NAbs with titers
Multiple Sclerosis, Vol. 13, No. 1 suppl,
14-20 (2007) |
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20 neutralizing units (NU)/mL. In a large three-year Phase IV clinical trial using IFNß-1a-Avonex, it was shown that NAb-positive patients had significantly greater annual relapse rates, greater increases in disability (compared with baseline), and more lesions detected by MRI compared with NAb-negative patients, indicating that the development of NAbs has serious consequences for patients with MS treated with IFNß. Therefore, maintaining the low immunogenicity of IFNß-1a-Avonex in the context of improving formulations and delivery options, has been a critical objective for Biogen Idec in the development of this important therapy for patients with MS. Multiple Sclerosis 2007; 13: S14—S20 http://msj.sagepub.com