Antibodies to infliximab and risk of infusion reactions in patients with inflammatory bowel disease: A systematic review and meta-analysis

Inflammatory Bowel Diseases

Volumn 20, Issue 1, 2014, Pages 1-6

  O'Meara, Sorcha ^a   Nanda, Kavinderjit S ^a   Moss, Alan C ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Antibodies; Immunogenicity; Infliximab; Infusion reactions

Indexed keywords

IMMUNOMODULATING AGENT; INFLIXIMAB; MERCAPTOPURINE;

DELAYED HYPERSENSITIVITY; EFFECT SIZE; HUMAN; IMMUNOGENICITY; INFLAMMATORY BOWEL DISEASE; META ANALYSIS; OBSERVATIONAL STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUBLISHING; QUALITY CONTROL; REVIEW; RISK REDUCTION; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS AS TOPIC; DRUG HYPERSENSITIVITY; HUMANS; INFLAMMATORY BOWEL DISEASES; INFUSIONS, INTRAVENOUS; META-ANALYSIS AS TOPIC; PROGNOSIS; RISK FACTORS;

EID: 84893700580     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1097/01.MIB.0000436951.80898.6d     Document Type: Review

References (38)

1. Clark M, Colombel JF, Feagan BC, et al. American gastroenterological association consensus development conference on the use of biologics in the treatment of inflammatory bowel disease, June 21-23, 2006. Gastroenterology. 2007;133:312-339.
2. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997;337:1029-1035.
3. Cohen RD, Tsang JF, Hanauer SB. Infliximab in Crohn's disease: first anniversary clinical experience. Am J Gastroenterol. 2000;95:3469-3477.
4. Farrell RJ, Shah SA, Lodhavia PJ, et al. Clinical experience with infliximab therapy in 100 patients with Crohn's disease. Am J Gastroenterol. 2000;95:3490-3497.
5. Moss AC, Fernandez-Becker N, Jo KK, et al. The impact of infliximab infusion reactions on long-term outcomes in patients with Crohn's disease. Aliment Pharmacol Ther. 2008;28:221-227.
6. Cheifetz A, Smedley M, Martin S, et al. The incidence and management of infusion reactions to infliximab: a large center experience. Am J Gastroenterol. 2003;98:1315-1324.
7. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003; 348:601-608.
8. Farrell RJ, Alsahli M, Jeen YT, et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology. 2003;124:917-924.
9. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462-2476.
10. Ben Horin S, Mazor Y, Yanai H, et al. The decline of anti-drug antibody titres after discontinuation of anti-TNFs: implications for predicting re-induction outcome in IBD. Aliment Pharmacol Ther. 2012;35:714-722.
11. Steenholdt C, Al Khalaf M, Brynskov J, et al. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012;18:2209-2217.
12. Vermeire S, Noman M, Van Assche G, et al. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut. 2007;56:1226-1231.
13. Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013;108:40-47.
14. Aarden L, Ruuls SR, Wolbink G. Immunogenicity of anti-tumor necrosis factor antibodies-toward improved methods of anti-antibody measurement. Curr Opin Immunol. 2008;20:431-435.
15. Vande CN, Gils A, Singh S, et al. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol. 2013; 108:962-971.
16. Chirmule N, Jawa V, Meibohm B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. AAPS J. 2012;14:296-302.
17. Afif W, Loftus EV Jr, Faubion WA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010;105:1133-1139.
18. Siegel CA, Finlayson SR, Sands BE, et al. Adverse events do not outweigh benefits of combination therapy for Crohn's disease in a decision analytic model. Clin Gastroenterol Hepatol. 2012;10:46-51.
19. Hanauer SB, Wagner CL, Bala M, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol. 2004;2: 542-553.
20. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64:401-406.
21. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence-study limitations (risk of bias). J Clin Epidemiol. 2011;64:407-415.
22. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000; 283:2008-2012.
23. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539-1558.
24. Egger M, Davey SG, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629-634.
25. Cates CJ. Simpson's paradox and calculation of number needed to treat from meta-analysis. BMC Med Res Methodol. 2002;2:1.
26. Candon S, Mosca A, Ruemmele F, et al. Clinical and biological consequences of immunization to infliximab in pediatric Crohn's disease. Clin Immunol. 2006;118:11-19.
27. Maser EA, Villela R, Silverberg MS, et al. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006;4:1248-1254.
28. Miele E, Markowitz JE, Mamula P, et al. Human antichimeric antibody in children and young adults with inflammatory bowel disease receiving infliximab. J Pediatr Gastroenterol Nutr. 2004;38:502-508.
29. Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004;350: 876-885.
30. Ordas I, Feagan BG, Sandborn WJ. Therapeutic drug monitoring of tumor necrosis factor antagonists in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2012;10:1079-1087.
31. Sadowski DC, Bernstein CN, Bitton A, et al. Canadian Association of Gastroenterology Clinical Practice Guidelines: the use of tumour necrosis factor-alpha antagonist therapy in Crohn's disease. Can J Gastroenterol. 2009;23:185-202.
32. Augustsson J, Eksborg S, Ernestam S, et al. Low-dose glucocorticoid therapy decreases risk for treatment-limiting infusion reaction to infliximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2007;66: 1462-1466.
33. Centocor, Inc. Malvern PA. Remicade™ (infliximab) prescribing information. 1998.
34. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359: 1541-1549.
35. Parikh A, Leach T, Wyant T, et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis. 2012;18:1470-1479.
36. Targan SR, Feagan BG, Fedorak RN, et al. Natalizumab for the treatment of active Crohn's disease: results of the ENCORE Trial. Gastroenterology. 2007;132:1672-1683.
37. Ben Horin S, Yavzori M, Katz L, et al. The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut. 2011;60:41-48.
38. Hart MH, de Vrieze H, Wouters D, et al. Differential effect of drug interference in immunogenicity assays. J Immunol Methods. 2011;372: 196-203.