Over the last few years various biologicals (therapeutic proteins) have been brought on the market, including the monoclonals targeting TNFα (infliximab, adalimumab, etanercept) and CD20 (rituximab).
With the 2008 EMEA- and FDA-guidelines now in effect, assessment of antibody responses against biologicals has become a matter of great interest. For many years Sanquin and the Jan van Breemen Institute have been studying the clinical relevance of those antibody responses. It appears that biologicals elicit an antibody response in a substantial number of patients, resulting in the loss of efficacy of treatment.
For quite some time, Sanquin has been carrying out immunogenicity tests for rheumatologists, dermatologists and gastroenterologists on a routine basis, using a standard assay format. By closely monitoring drug levels and antibody formation, it has now become possible to adjust treatment to each individual patient.
- brochure (pdf)
- information for patients
- information for medical professionals and investigators
- information for commercial parties