Immunogenicity of bone morphogenetic proteins.
Publication/Presentation Date
5-1-2009
Abstract
OBJECT: The object of this paper is to review the immunogenicity of bone morphogenetic proteins (BMPs) and to compare the results of the immunogenicity characterization and clinical consequences between recombinant human (rh)BMP-2 and recombinant human osteogenic protein-1 (rhOP-1/BMP-7).
METHODS: The immunogenicity of therapeutic proteins and its clinical effects were reviewed. The characteristics of BMPs were also described in terms of immunogenicity. The methods and results of antibody detection in various clinical trials of rhBMP-2 and rhOP-1 were compared, including the most recent studies using a systematic characterization strategy with both a binding assay and bioassay.
RESULTS: Similar to all recombinant human proteins, rhBMPs induce immune responses in a select subgroup of patients. Adverse effects from this response in these patients, however, have not been reported with antibody formation to either rhBMP-2 or rhOP-1. Overall, the incidence of antibody formation was slightly higher in rhOP-1 trials than in rhBMP-2 trials.
CONCLUSIONS: Although they occur in a subgroup of patients, the immune responses against rhBMPs have no correlation with any clinical outcome or safety parameter. Clinicians, however, must be aware of the potential complications caused by the immunogenicity of BMPs until more studies clearly elucidate their safety.
Volume
10
Issue
5
First Page
443
Last Page
451
ISSN
1547-5654
Published In/Presented At
Hwang, C. J., Vaccaro, A. R., Lawrence, J. P., Hong, J., Schellekens, H., Alaoui-Ismaili, M. H., & Falb, D. (2009). Immunogenicity of bone morphogenetic proteins. Journal of neurosurgery. Spine, 10(5), 443–451. https://doi.org/10.3171/2009.1.SPINE08473
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
19442006
Department(s)
Administration and Leadership
Document Type
Article