Both authors equally contributed to review planning, data collection, and drafting of article, and have approved the final draft submitted.
Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: A critical systematic review†
Article first published online: 23 FEB 2009
Copyright © 2009 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 15, Issue 8, pages 1264–1275, August 2009
How to Cite
Cassinotti, A. and Travis, S. (2009), Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: A critical systematic review. Inflamm Bowel Dis, 15: 1264–1275. doi: 10.1002/ibd.20899
- Issue published online: 15 JUL 2009
- Article first published online: 23 FEB 2009
- Manuscript Accepted: 21 JAN 2009
- Manuscript Received: 20 JAN 2009
- Schering Plough
- UCB Pharma
- Crohn's disease;
Background: Infliximab (IFX) is a chimeric (mouse/human) anti-TNF-alpha monoclonal antibody approved for the treatment of refractory luminal and fistulizing Crohn's disease (CD). It is a source of potential immunogenicity for humans, with the occurrence of anti-infliximab antibodies (ATIs), which are thought to interfere with the pharmacodynamics and/or pharmacokinetics of the compound. It remains unclear whether ATIs have any clinical importance for drug efficacy or safety. We review studies specifically evaluating the incidence of ATIs in CD and their impact on the efficacy and safety of IFX.
Methods: A systematic review was undertaken by electronic searches of the PubMed and SCOPUS databases from earliest records to October 2008, as well as reference lists of all relevant articles and relevant abstracts from meetings.
Results: The biological and clinical mechanisms of ATI development are poorly understood. The incidence of ATIs in vivo depends on multiple analytical and clinical factors, both patient- and treatment-related. The presence of ATIs is weakly and variably associated with clinical response or infusion reactions, but not with reactions relevant to clinical decision-making. Enormous variation in the methods of reporting ATIs and immunogenicity of IFX make almost any interpretation possible from different studies, but few have clinical relevance.
Conclusions: There is no clear evidence that ATIs have an impact on efficacy or safety, nor a need to measure or prevent them in clinical practice. Circulating drug concentration may be a more relevant measure of immunogenicity.
(Inflamm Bowel Dis 2009)