Therapeutic drug monitoring in inflammatory bowel disease: Current state and future perspectives

Current Gastroenterology Reports

Volumn 16, Issue 4, 2014, Pages

  Vande Casteele, Niels ^a,b,c   Feagan, Brian G ^c   Gils, Ann ^b   Vermeire, Séverine ^d   Khanna, Reena ^c   Sandborn, William J ^a,c   Levesque, Barrett G ^a,c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b DEPARTMENT OF PHARMACEUTICAL AND PHARMACOLOGICAL SCIENCES   (Belgium)

^c ROBARTS RESEARCH INSTITUTE   (Canada)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

Author keywords

Adalimumab; Anti drug antibodies; Anti TNF; Biologics; Crohn's disease; Immunogenicity; Infliximab; Trough concentrations; Ulcerative colitis

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; DIGOXIN; INFLIXIMAB; MERCAPTOPURINE; TUMOR NECROSIS FACTOR INHIBITOR; ANTIBODY; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT; TUMOR NECROSIS FACTOR ALPHA;

ARTHRALGIA; CLINICAL EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; CROHN DISEASE; DOSE RESPONSE; DRUG COST; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG MONITORING; HUMAN; INFLAMMATORY BOWEL DISEASE; OUTCOME ASSESSMENT; PERSONALIZED MEDICINE; REVIEW; SKIN DEFECT; TREATMENT RESPONSE; ULCERATIVE COLITIS; BLOOD; DRUG ANTAGONISM; IMMUNOLOGY; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; METABOLISM; METHODOLOGY; PRACTICE GUIDELINE;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; DRUG MONITORING; HUMANS; INDUCTION CHEMOTHERAPY; INFLAMMATORY BOWEL DISEASES; MAINTENANCE CHEMOTHERAPY; PRACTICE GUIDELINES AS TOPIC; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84894640694     PISSN: 15228037     EISSN: 1534312X     Source Type: Journal    
DOI: 10.1007/s11894-014-0378-0     Document Type: Review

References (49)

1. Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007;132(1):52-65.
2. 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(9317):1541-9.
3. Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353(23):2462-76.
4. Sandborn WJ, van Assche G, Reinisch W, Colombel JF, D'Haens G, Wolf DC, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142(2):257-65.
5. Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, et al. Subcutaneous golimumab induces clinical response and remission in patients with Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2014;146(1):85-95.
6. Allez M, Karmiris K, Louis E, Van Assche G, Ben-Horin S, Klein A, et al. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: definitions, frequency and pharmacological aspects. J Crohns Colitis. 2010;4(4):355-66.
7. D'Haens GR, Panaccione R, Higgins PDR, Vermeire S, Gassull M, Chowers Y, 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[quest]. Am J Gastroenterol. 2011;106(2):199-212.
8. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009;104(3):760-7.
9. Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn's disease: a systematic review. Am J Gastroenterol. 2011;106(4):674-84.
10. Schnitzler F, Fidder H, Ferrante M, Noman M, Arijs I, Van Assche G, et al. Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: results from a single-centre cohort. Gut. 2009;58(4):492-500.
11. • 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(4):635-46. Review of pharmacological aspects associated with the use of anti-TNF monoclonal antibodies in IBD.
12. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-68.
13. Nestorov I. Clinical pharmacokinetics of tumor necrosis factor antagonists. J Rheumatol Suppl. 2005;74:13-8.
14. Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum Infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006;4(10):1248-54.
15. Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010;59(1):49-54.
16. Van Moerkercke W, Compernolle G, Ackaert C, Gils A, Vermeire S, Jürgens M, et al. S31 Mucosal healing in Crohn's disease is associated with high infliximab trough levels. J Crohn's Colitis Suppl. 2010;4(1):30-1.
17. Karmiris K, Paintaud G, Noman M, Magdelaine-Beuzelin C, Ferrante M, Degenne D, et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009;137(5):1628-40.
18. • Steenholdt C, Ainsworth MA, Tovey M, Klausen TW, Thomsen OO, Brynskov J, et al. Comparison of techniques for monitoring infliximab and antibodies against infliximab in Crohn's disease. Ther Drug Monit. 2013;35(4):530-8. Comparative study of different assays used for therapeutic drug monitoring.
19. • Vande Casteele N, Buurman DJ, Sturkenboom MGG, Kleibeuker JH, Vermeire S, Rispens T, et al. Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays. Aliment Pharmacol Ther. 2012;36(8):765-71. Comparative study of different assays used for therapeutic drug monitoring.
20. Wang SL, Ohrmund L, Hauenstein S, Salbato J, Reddy R, Monk P, 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(1-2):177-88.
21. Imaeda H, Andoh A, Fujiyama Y. Development of a new immunoassay for the accurate determination of anti-infliximab antibodies in inflammatory bowel disease. J Gastroenterol. 2012;47(2):136-43.
22. •• Reinisch W, Feagan BG, Rutgeerts PJ, Adedokun OJ, Cornillie FJ, Diamond R, et al. 566 Infliximab concentration and clinical outcome in patients with ulcerative colitis. Gastroenterology. 2012;142(5, Supplement 1):S-114. Abstract of post hoc analysis of ACT 1 and ACT 2 trials investigating the correlation between infliximab trough concentrations and clinical outcomes.
23. Murthy S, Kevans D, Seow CH, Newman A, Steinhart AH, Silverberg MS, et al. Sa2047 Association of serum infliximab and antibodies to Infliximab to long-term clinical outcome in acute ulcerative colitis. Gastroenterology. 2012;142(5, Supplement 1):S-388.
24. Feagan BG, Singh S, Lockton S, Hauenstein S, Ohrmund L, Croner LJ, et al. 565 Novel Infliximab (IFX) and Antibody-to-Infliximab (ATI) Assays are Predictive of Disease Activity in Patients With Crohn's Disease (CD). Gastroenterology. 2012;142(5):S-114.
25. Bortlik M, Duricova D, Malickova K, Machkova N, Bouzkova E, Hrdlicka L, et al. Infliximab trough levels may predict sustained response to infliximab in patients with Crohn's disease. J Crohns Colitis. 2013;7(9):736-43.
26. •• Chiu YL, Rubin DT, Vermeire S, Louis E, Robinson AM, Lomax KG, et al. Serum adalimumab concentration and clinical remission in patients with Crohn's disease. Inflamm Bowel Dis. 2013;19(6):1112-22. Post hoc analysis of CLASSIC 1 and CLASSIC 2 trials investigating the correlation between adalimumab trough concentration and clinical remission.
27. •• Mostafa NM, Eckert D, Pradhan RS, Mensing S, Robinson AM, Sandborn WJ, et al. P333 Exposure-efficacy relationship (ER) for adalimumab during induction phase of treatment of adult patients with moderate to severe ulcerative colitis (UC). U Eur Gastroenterol J. 2013;1(1 suppl):A221-2. Abstract of post hoc analysis of ULTRA 2 trial investigating the exposure-response relationship for adalimumab.
28. Velayos FS, Sheibani S, Lockton S, Hauenstein S, Singh S, Terdiman JP, et al. 490 Prevalence of Antibodies to Adalimumab (ATA) and correlation between ata and low serum drug concentration on CRP and clinical symptoms in a prospective sample of IBD Patients. Gastroenterology. 2013;144(5):S-91.
29. Yarur AJ, Deshpande AR, Sussman DA, Hauenstein S, Lockton S, Barkin JS, et al. Tu1147 Serum adalimumab levels and antibodies correlate with endoscopic intestinal inflammation and inflammatory markers in patients with inflammatory bowel disease. Gastroenterology. 2013;144(5):S-774-5.
30. Imaeda H, Takahashi K, Fujimoto T, Bamba S, Tsujikawa T, Sasaki M, et al. Clinical utility of newly developed immunoassays for serum concentrations of adalimumab and anti-adalimumab antibodies in patients with Crohn's disease. J Gastroenterol. 2014;49(1):100-9.
31. Roblin X, Marotte H, Rinaudo M, Del Tedesco E, Moreau A, Phelip JM, et al. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014;12(1):80-4.
32. • 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(6):654-66. Simulated model evaluating the cost-effectiveness of a TDM based approach for the treatment of secondary loss of response.
33. •• Steenholdt C, Brynskov J, Thomsen OO, Munck LK, Fallingborg J, Christensen LA, 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. 2013 Jul 22. [Epub ahead of print]. First randomized controlled trial evaluating a TDM based approach for the treatment of secondary loss of response.
34. • Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, et al. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013;19(12):2568-76. Prospective observational study investigating the correlation between mucosal healing and serum adalimumab concentration before and after dose escalation at time of loss of response.
35. Vermeire S, Gils A. Value of drug level testing and antibody assays in optimising biological therapy. Front Gastroenterol. 2012;4(1):41-3.
36. Cleynen I, Vermeire S. Paradoxical inflammation induced by anti-TNF agents in patients with IBD. Nat Rev Gastroenterol Hepatol. 2012;9(9):496-503.
37. Krieckaert C, Nair SC, Nurmohamed MT, van Dongen CJ, Lems WF, Lafeber FP, et al. Evaluating the cost-effectiveness of personalized treatment with adalimumab using serum drug level and anti-adalimumab antibodies in rheumatoid arthritis patients. Ann Rheum Dis. 2012;71(Suppl3):104.
38. Vande Casteele N, Compernolle G, Ballet V, Van Assche G, Gils A, Vermeire S, et al. 1159 Results on the optimisation phase of the prospective controlled Trough Level Adapted Infliximab Treatment (TAXIT) Trial. Gastroenterology. 2012;142(5):S-211-2.
39. •• Vande Casteele N, Gils A, Ballet V, Compernolle G, Peeters M, Van Steen K, et al. OP001 Randomised controlled trial of drug level versus clinically based dosing of infliximab maintenance therapy in IBD: final results of the TAXIT study. U Eur Gastroenterol J. 2013;1(1 suppl):A1. Abstract of final results of TAXIT trial.
40. Vande Casteele N, Ballet V, Van Assche G, Rutgeerts P, Vermeire S, Gils A. Early serial trough and antidrug antibody level measurements predict clinical outcome of infliximab and adalimumab treatment. Gut. 2012;61(2):321.
41. •• Cornillie F, Hanauer S, Diamond R, Wang J, Zelinger D, Xu Z, et al. Early serum infliximab trough level, clinical disease activity and CRP as markers of sustained benefit of infliximab treatment in Crohn's disease: a post-hoc analysis of the ACCENT1 trial. Am J Gastroenterol. 2011;106:S462-3. Abstract of post hoc analysis of ACCENT 1 trial investigating serum infliximab trough concentration as a marker of sustained benefit.
42. • Baert FJ, Drobne D, Ballet V, Gils A, Vande Casteele N, Hauenstein S, et al. 492 Trough levels and antidrug antibodies predict safety and success of restarting Infliximab after a long drug holiday. Gastroenterology. 2013;144(5, Supplement 1):S-91-2. Retrospective cohort study evaluating the use of TDM when restarting infliximab after a drug holiday.
43. •• 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(1):40-7. Meta-analysis of the impact of antibodies to infliximab on serum infliximab concentrations and clinical outcomes.
44. • Vande Casteele N, Gils A, Singh S, Ohrmund L, Hauenstein S, Rutgeerts P, et al. Antibody response to Infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol. 2013;108(6):962-71. Transient versus sustained antibodies to infliximab and their impact on infliximab pharmarcokinetics and clinical outcomes.
45. Ungar B, Chowers Y, Yavzori M, Picard O, Fudim E, Har-Noy O, et al. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut. 2013 Sep 16. [Epub ahead of print]
46. • Ben-Horin S, Waterman M, Kopylov U, Yavzori M, Picard O, Fudim E, et al. Addition of an immunomodulator to infliximab therapy eliminates antidrug antibodies in serum and restores clinical response of patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11(4):444-7. Preliminary results suggesting that adding an immunosuppressant can eliminate anti-drug antibodies.
47. Smith M, Blaker P, Patel C, Marinaki A, Arenas M, Escuredo E, et al. The impact of introducing thioguanine nucleotide monitoring into an inflammatory bowel disease clinic. Int J Clin Pract. 2013;67(2):161-9.
48. Vermeire S, Ferrante M, Rutgeerts P. Recent advances: personalised use of current Crohn's disease therapeutic options. Gut. 2013;62(10):1511-5.
49. Fasanmade AA, Adedokun OJ, Olson A, Strauss R, Davis HM. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther. 2010;48(5):297-308.