Changes in serum trough levels of infliximab during treatment intensification but not in antiinfliximab antibody detection are associated with clinical outcomes after therapeutic failure in Crohn's disease

Journal of Crohn's and Colitis

Volumn 9, Issue 3, 2015, Pages 238-245

  Steenholdt, Casper ^a   Bendtzen, Klaus ^b   Brynskov, Jørn ^a   Thomsen, Ole Ø ^a   Munck, Lars K ^c   Christensen, Lisbet A ^d   Pedersen, Gitte ^e   Kjeldsen, Jens ^f   Ainsworth, Mark A ^a  

^a GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^b Rigshospitalet   (Denmark)

^c KØGE HOSPITAL   (Denmark)

^d AARHUS UNIVERSITY HOSPITAL   (Denmark)

^e HVIDOVRE HOSPITAL   (Denmark)

^f ODENSE UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Antibodies against IFX; Dose intensification; Dose optimization; IBD; Infliximab; Loss of response; Therapeutic drug monitoring

Indexed keywords

INFLIXIMAB; ANTIBODY; GASTROINTESTINAL AGENT;

ADULT; ANTIBODY DETECTION; ARTICLE; CLINICAL ARTICLE; CLINICAL OUTCOME; COHORT ANALYSIS; CONTROLLED STUDY; CROHN DISEASE; DIAGNOSTIC TEST ACCURACY STUDY; DRUG DOSE INTENSIFICATION; DRUG RESPONSE; DRUG TREATMENT FAILURE; FEMALE; HUMAN; MALE; POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECEIVER OPERATING CHARACTERISTIC; SENSITIVITY AND SPECIFICITY; ADOLESCENT; BLOOD; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG MONITORING; IMMUNOLOGY; MULTICENTER STUDY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; STATISTICAL MODEL; TREATMENT FAILURE; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES; CROHN DISEASE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INFLIXIMAB; LINEAR MODELS; MALE; PROSPECTIVE STUDIES; ROC CURVE; TREATMENT FAILURE; YOUNG ADULT;

EID: 84929917123     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1093/ecco-jcc/jjv004     Document Type: Article

References (37)

1. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009;104:760-7
2. Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2011;106:644-59
3. D'Haens GR, Panaccione R, Higgins PD, et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organization: when to start, when to stop, which drug to choose, and how to predict response? Am J Gastroenterol 2011;106:199-212
4. Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut 2011;60:571-607
5. Dignass A, Van AG, Lindsay JO, et al. The second European evidencebased Consensus on the diagnosis and management of Crohn's disease: Current management. J Crohns Colitis 2010;4:28-62
6. Kopylov U, Mantzaris GJ, Katsanos KH, et al. The efficacy of shortening the dosing interval to once every six weeks in Crohn's patients losing response to maintenance dose of infliximab. Aliment Pharmacol Ther 2011;33:349-57
7. Katz L, Gisbert JP, Manoogian B, et al. Doubling the infliximab dose versus halving the infusion intervals in Crohn's disease patients with loss of response. Inflamm Bowel Dis 2012;18:2026-33
8. Bendtzen K, Ainsworth M, Steenholdt C, Thomsen OO, Brynskov J. Individual medicine in inflammatory bowel disease: Monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factoralpha antibodies. Scand J Gastroenterol 2009;44:774-81
9. Leal RF, Planell N, Kajekar R, et al. Identification of inflammatory mediators in patients with Crohn's disease unresponsive to anti-TNFa therapy. Gut 2014;Apr 3 [Epub ahead of print]:doi:10.1136/ gutjnl-2013-306518
10. Khanna R, Sattin BD, Afif W, et al. Review article: a clinician's guide for therapeutic drug monitoring of infliximab in inflammatory bowel disease. Aliment Pharmacol Ther 2013;38:447-59
11. 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;108:40-7
12. Chaparro M, Guerra I, Munoz-Linares P, Gisbert JP. Systematic review: antibodies and anti-TNF-alpha levels in inflammatory bowel disease. Aliment Pharmacol Ther 2012;35:971-86
13. Steenholdt C, Brynskov J, Thomsen OO, et al. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut 2014;63:919-27
14. Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol 2013;11:654-66
15. Ordas I, Mould DR, Feagan BG, Sandborn WJ. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther 2012;91:635-46
16. Hibi T, Sakuraba A, Watanabe M, et al. Retrieval of serum infliximab level by shortening the maintenance infusion interval is correlated with clinical efficacy in Crohn's disease. Inflamm Bowel Dis 2012;18:1480-7
17. Wang SL, Ohrmund L, Hauenstein S, et al. Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum. J Immunol Methods 2012;382:177-88
18. Lallemand C, Kavrochorianou N, Steenholdt C, et al. Reporter gene assay for the quantification of the activity and neutralizing antibody response to TNFalpha antagonists. J Immunol Methods 2011;373:229-39
19. Bendtzen K. Personalized medicine: theranostics (therapeutics diagnostics) essential for rational use of tumor necrosis factor-alpha antagonists. Discov Med 2013;15:201-11
20. Lin KK, Velayos F, Fisher E, Terdiman JP. Durability of infliximab dose intensification in Crohn's disease. Dig Dis Sci 2012;57:1013-9
21. Chaparro M, Martinez-Montiel P, Van Domselaar M, et al. Intensification of infliximab therapy in Crohn's disease: efficacy and safety. J Crohns Colitis 2012;6:62-7
22. Roblin X, Rinaudo M, Del TE, et al. Development of an algorithm incorporating pharmacokinetics of adalimumab in inflammatory bowel diseases. Am J Gastroenterol 2014;109:1250-6
23. Vande CN, Gils A, Singh S, et al. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol 2013;108:962-71
24. Paul S, Del TE, Marotte H, et al. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis 2013;19:2568-76
25. Steenholdt C, Ainsworth MA, Tovey M, et al. Comparison of techniques for monitoring infliximab and antibodies against infliximab in Crohn's disease. Ther Drug Monit 2013;35:530-8
26. Steenholdt C, Bendtzen K, Brynskov J, Thomsen OE, Ainsworth MA. Clinical implications of measuring drug and anti-drug antibodies by different assays when optimizing infliximab treatment failure in Crohn's disease: post hoc analysis of a randomized controlled trial. Am J Gastroenterol 2014;109:1055-64
27. St Clair EW, Wagner CL, Fasanmade AA, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebocontrolled trial. Arthritis Rheum 2002;46:1451-9
28. Arijs I, Quintens R, Van LL, et al. Predictive value of epithelial gene expression profiles for response to infliximab in Crohn's disease. Inflamm Bowel Dis 2010;16:2090-8
29. Derer S, Till A, Haesler R, et al. mTNF reverse signalling induced by TNFalpha antagonists involves a GDF-1 dependent pathway: implications for Crohn's disease. Gut 2013;62:376-86
30. Vande Casteele N, Buurman DJ, Sturkenboom MG, et al. Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays. Aliment Pharmacol Ther 2012;36:765-71
31. Lee LY, Sanderson JD, Irving PM. Anti-infliximab antibodies in inflammatory bowel disease: prevalence, infusion reactions, immunosuppression and response, a meta-analysis. Eur J Gastroenterol Hepatol 2012;24:1078-85
32. Steenholdt C, Svenson M, Bendtzen K, Thomsen OO, Brynskov J, Ainsworth MA. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2011;34:51-8
33. 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;105:1133-9
34. Yanai H, Lichtenstein L, Assa A, et al. Levels of drug and antidrug antibodies are associated with outcome of interventions after loss of response to infliximab or adalimumab. Clin Gastroenterol Hepatol 2014;Jul 25. pii: S1542-3565(14)01074-X. doi: 10.1016/j.cgh.2014.07.029. [Epub ahead of print]
35. Steenholdt C, Al-Khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis 2012;18:2209-17
36. Ungar B, Chowers Y, Yavzori M, et al. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2014;63:1258-64
37. Lahiff C, Safaie P, Awais A, et al. The Crohn's disease activity index (CDAI) is similarly elevated in patients with Crohn's disease and in patients with irritable bowel syndrome. Aliment Pharmacol Ther 2013;37:786-94