Cut-off levels and diagnostic accuracy of infliximab trough levels and anti-infliximab antibodies in Crohn's disease

Scandinavian Journal of Gastroenterology

Volumn 46, Issue 3, 2011, Pages 310-318

  Steenholdt, Casper ^a   Bendtzen, Klaus ^b,c   Brynskov, Jørn ^a   Thomsen, Ole Østergaard ^a   Ainsworth, Mark Andrew ^a  

^a GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^b Rigshospitalet   (Denmark)

^c Biomonitor A/S   (Denmark)

Author keywords

Crohn's disease; inflammatory bowel disease; infliximab; TNF; ulcerative colitis

Indexed keywords

INFLIXIMAB;

ADULT; ARTICLE; CROHN DISEASE; DIAGNOSTIC ACCURACY; FEMALE; HUMAN; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RADIOIMMUNOASSAY; SENSITIVITY AND SPECIFICITY; TREATMENT RESPONSE; ULCERATIVE COLITIS;

ADULT; ANTI-INFLAMMATORY AGENTS; ANTIBODIES; ANTIBODIES, MONOCLONAL; COLITIS, ULCERATIVE; CROHN DISEASE; FEMALE; HUMANS; MALE; MIDDLE AGED; RADIOIMMUNOASSAY; RETROSPECTIVE STUDIES; ROC CURVE; SENSITIVITY AND SPECIFICITY; TREATMENT FAILURE;

EID: 79751477764     PISSN: 00365521     EISSN: 15027708     Source Type: Journal    
DOI: 10.3109/00365521.2010.536254     Document Type: Article

References (38)

1. Rutgeerts P, Vermeire S, Van Assche G. Biological therapies for inflammatory bowel diseases. Gastroenterology 2009; 136:1182-97.
2. Behm BW, Bickston SJ. Tumor necrosis factor-alpha anti-body for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev 2008:CD006893.
3. Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcer-ative colitis. Cochrane Database Syst Rev 2006:CD005112.
4. European Medicines Agency (EMEA). European Public Assessment Report (EPAR) for Remicade. Available at: www.emeaeuropa.eu/humandocs/PDFs/EPAR/ Remicade/H-240-PI-en pdf.
5. Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002;359:1541-9. (Pubitemid 34621118)
6. Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology 2006;130:323-33.
7. Sandborn WJ, Hanauer SB, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh DG, et al. Adalimumab for mainte-nance treatment of Crohn's disease: results of the CLASSIC II trial. Gut 2007;56:1232-9. (Pubitemid 47300424)
8. Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for mainte-nance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132:52-65. (Pubitemid 46108762)
9. Clark M, Colombel JF, Feagan BC, Fedorak RN, Hanauer SB, Kamm MA, 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;133:312-39. (Pubitemid 47031141)
10. Bendtzen K, Ainsworth M, Steenholdt C, Thomsen OO, Brynskov J. Individual medicine in inflammatory bowel dis-ease: monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha anti-bodies. Scand J Gastroenterol 2009;44:774-81.
11. Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003;348:601-8. (Pubitemid 36204954)
12. Farrell RJ, Alsahli M, Jeen YT, Falchuk KR, Peppercorn MA, Michetti P. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology 2003;124:917-24. (Pubitemid 36389794)
13. Ternant D, Aubourg A, Magdelaine-Beuzelin C, Degenne D, Watier H, Picon L, et al. Infliximab pharma-cokinetics in inflammatory bowel disease patients. Ther Drug Monit 2008;30:523-9.
14. Candon S, Mosca A, Ruemmele F, Goulet O, Chatenoud L, Cezard JP. Clinical and biological consequences of immu-nization to infliximab in pediatric Crohn's disease. Clin Immunol 2006;118:11-19. (Pubitemid 43012041)
15. Maser EA, Villela R, Silverberg MS, Greenberg GR. Asso-ciation of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol 2006;4:1248-54. (Pubitemid 44512213)
16. Van AG, Magdelaine-Beuzelin C, D'Haens G, Baert F, Noman M, Vermeire S, et al. Withdrawal of immunosup-pression in Crohn's disease treated with scheduled infliximab maintenance: a randomized trial. Gastroenterology 2008; 134:1861-8. (Pubitemid 351790744)
17. Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treat-ment in acute ulcerative colitis. Gut 2010;59:49-54.
18. Cornillie F, Shealy D, D'Haens G, Geboes K, Van Assche G, Ceuppens J, et al. Infliximab induces potent anti-inflammatory and local immunomodulatory activity but no systemic immune suppression in patients with Crohn's disease. Aliment Pharmacol Ther 2001;15:463-73. (Pubitemid 32242771)
19. Afif W, Loftus EV Jr, Faubion WA, Kane SV, Bruining DH, Hanson KA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 2010;105(5):1140-1.
20. Munkholm P, Langholz E, Nielsen OH, Kreiner S, Binder V. Incidence and prevalence of Crohn's disease in the county of Copenhagen, 1962-87: a sixfold increase in incidence. Scand J Gastroenterol 1992;27:609-14.
21. Langholz E, Munkholm P, Davidsen M, Binder V. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology 1994;107:3-11. (Pubitemid 24195339)
22. Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassays as predictors of clinical efficacy of infliximab in Crohn's disease. Am J Gastroenterol 2008;103:944-8 (Pubitemid 351501078)
23. Biomonitor A/S, Copenhagen, Denmark. Available at: www. biomonitor.dk.
24. Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum 2006;54:3782-9. (Pubitemid 44955878)
25. Svenson M, Geborek P, Saxne T, Bendtzen K. Monitoring patients treated with anti-TNF-alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology 2007;46:1828-34. (Pubitemid 350168300)
26. Arnese M, Salustri A, Fioretti PM, Cornel JH, Boersma E, Reijs AE, et al. Quantitative angiographic measurements of isolated left anterior descending coronary artery stenosis. Correlation with exercise echocardiography and technetium-99 m 2-methoxy isobutyl isonitrile single-photon emission computed tomography. J Am Coll Cardiol 1995;25:1486-91.
27. Available at: https://faculty.vassar.edu/lowry/clin1.html. 2010.
28. Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004;350:876-85. (Pubitemid 38252535)
29. Hanauer SB, Wagner CL, Bala M, Mayer L, Travers S, Diamond RH, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treat-ment in Crohn's disease. Clin Gastroenterol Hepatol 2004;2: 542-53. (Pubitemid 38834038)
30. Vermeire S, Noman M, Van Assche G, Baert F, D'Haens G, Rutgeerts P. Effectiveness of concomitant immunosuppres-sive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 2007;56:1226-31. (Pubitemid 47300423)
31. Rutgeerts P, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. Gastroenterology 2004;126:402-13. (Pubitemid 38182297)
32. Bendtzen K, Steenholdt C, Ainsworth M, Thomsen OO, Brynskov J. Monitoring of bioavailability, pharmacokinetics and immunogenicity of tumour necrosis factor-alpha inhibi-tors. Ugeskr Laeger 2010;172:44-7.
33. Hennig C, Rink L, Fagin U, Jabs WJ, Kirchner H. The influence of naturally occurring heterophilic anti-immunoglobulin anti-bodies on direct measurement of serum proteins using sand-wich ELISAs. J Immunol Methods 2000;235:71-80. (Pubitemid 30089785)
34. Bendtzen K. Anti-IFN BAb and NAb antibodies: a minireview. Neurology 2003;61(9 Suppl 5):S6-10.
35. Cassinotti A, Travis S. Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: a critical systematic review. Inflamm Bowel Dis 2009;15:1264-75.
36. Bendtzen K, Steenholdt C, Ainsworth M, Thomsen OO, Brynskov J. Comment on 'Predicting the response to inflix-imab from trough serum levels'. Gut 2010;59:1298-9.
37. Aarden L, Ruuls SR, Wolbink G. Immunogenicity of anti-tumor necrosis factor antibodies-toward improved methods of anti-antibody measurement. Curr Opin Immunol 2008; 20:431-5.
38. Radstake TR, Svenson M, Eijsbouts AM, van den Hoogen FH, Enevold C, van Riel PL, et al. Formation of antibodies against infliximab and adalimumab strongly cor-relates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2009;68:1739-45.