Infliximab pharmacokinetics monitoring in inflammatory bowel disease

Česká verzia

Authors: Pavel Svoboda ^1,2; Tomáš Kupka ^1,2
Authors place of work: Interní klinika LF OU a FN Ostrava ¹; Katedra interních oborů LF OU Ostrava ²
Published in the journal: Vnitř Lék 2020; 66(8): 34-38
Category:

Summary

Therapeutic drug monitoring is a strategy utilized to optimize biological therapy. It consists in the drug level measurement before the next dose is due, when the drug concentration reaches the trough level, and includes the detection of potential antidrug antibodies. The monitoring makes it possible to adjust the therapy accordingly – to intensify or change the biologics applied to secure safe and highly effective therapeutics. Therapeutic optimization is based on the nature of therapy failure, which can be caused by pharmacokinetic or pharmacodynamic factors. Pharmacokinetic monitoring can be currently classified as reactive, measuring the drug level and antidrug antibodies during therapy failure, or adverse reactions to the drug applied, and proactive, monitoring patients in clinical remission to retain remission and prevents development of a secondary failure.

Keywords:

Crohn’s disease – IBD – infliximab – pharmacokinetics – TDM – Ulcerative colitis

Zdroje

1. Konečný M, Ehrmann J. Pokroky v diagnostice a léčbě nespecifických střevních zánětů. Vnitř Lék 2014; 60: 625–629.

2. Bortlík M. Konvenční a biologická terapie idiopatických střevních zánětů. Vnitř Lék 2018; 64: 642–653.

3. Colombel JF, Feagan B, Sandborn WJ, et al. Therapeutic drug monitoring for inflamatory bowel disease. Inflam Bowel Dis 2012; 18(2): 349–358.

4. Hrdlička L. Péče o IBD pacienty v terénní praxi. Vnitř Lék 2018; 64: 654–658.

5. Vande Casteele N, Feagan BG, Gils A, et al. Therapeutic drug monitoring in inflammatory bowel disease: current state and future perspectives. Curr Gastroenterol Rep 2014; 16: 378.

6. Vande Casteele N, Herfarth H, Katz J, et al. American Gastroenterological Association Institute technical review on the role of therapeutic drug monitoring in the management of inflammatory bowel diseases. Gastroenterology 2017; 153: 835–857.

7. Colombel JF, Feagan B, Sandborn WJ, et al. Therapeutic drug monitoring for inflamatory bowel disease. Inflam Bowel Dis 2016; XXX: XXX–XXX.

8. Vande Casteele N, Breynaert C, Vermeire S, et al., Incidence of acute severe infusion reactions to infliximab depends on definition used rather than assay. Aliment Pharmacol Ther 2011; 34: 401–403.

9. Ungar B, Yavzori M, Fudim E, et al. Addition of immunomodulators can reverse antibody formativ an loss response in patients treated with adalimimab. Gastroenterolgoy 2016; 150: S414.

10. Marits P, Landucci L, Sundin U, et al. Trough levels of infliximab and antibodies towards infliximab in kohort of 79 IBD patients with mainteinance infliximab treatment. J Crohns Colitis 2014; 8: 881–889.

11. Brandse JF, Strik AS, Mould D, et al. Insufficient infliximab exposure predisposes to imunogenicity and enhanced clearance of infliximab in IBD. DDW 2016, oral pre‑ sentation 695.

12. Gils A, Van Stappen T, Dreesen E, et al. Harmonization of infliximab and anti‑infliximab assai facilitates in clinical samples. Inflamm Bowel dis 2016; 22: 969–975.

13. Malíčková K, Ďuricová D. Bortlík M, et al. Serum infliximab trouhg levels: A comparation of free different immunoassays for monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease. Biologicals 2016; 44(1): 33–36.

14. Horin S, Vande Casteele N, Schreiber S, et al. Biosimilars in inflammatory bowel disease: facts and fears of extrapolation. Clin Gastro Hepatol 2016; 14: 1685–1696.

15. Melmed GY, Irving PM, Jones, et al. Appropriateness of testing for anti‑tumor necrosis factor agent and antibody concentrations ad interpretation of results. Clin Gastroenterol Hepatol 2016; 14: 1302–1309.

16. 16) Dotain I, Roy Y, Yanii H, et al. Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: a population pharmacokinetic study. Inflamm Bowel Dis 2014; 20(12): 2247–2259.

17. Yarur AJ, Jain A, Sussman DA, et al. The association of tissue anti TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study. Gut 2016; 65: 249–255.

18. 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.

19. Singh N, Rosenthal CJ, Melmed GY, et al. Early infliximab trough levels are associated with persistent remission in pediatric patients with inflammatory bowel disease. Inflamm Bowel Dis 2014; 20: 1708–1713.

20. Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha‑neutralizing agent. N Engl J Med 2001; 345: 1098–1104.

21. Yarur AJ, Kanagala V, Stein DJ et al. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn’s disease. Aliment Pharmacol Ther 2017; 45: 933–940.

22. Mitrev N, Karijawasam V, Leong RW. Infliximab trough cut‑off for perianal Crohn’s disease: another piece of the therapeutic drug monitoring‑guided infliximab dosing puzzle. Aliment Pharmacol Ther 2017; 45: 1279–1280.

23. Feuerstein JD, Nguyen GC, Kupfer SS, et al. American Gastroenterological Associati‑ on Institute Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease. Gastroenterology 2017; 153: 827–834.

24. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Eng J Med 2010; 362: 1383–1395.

25. Baert F, Norman M, Vermeire S, et al. Influence of immunogenicity on the long‑term efficacy of infliximab in Crohns disease. N Engl J Med 2003; 348: 601–608.

26. Feagan BG, McDonald JW, Panaccione R, et al. S1051 methotrexate for the prevention of antibodies to infliximab in patients with Crohn’s disease. Gastroenterology 2010; 138: S167–S168.

27. Farell RJ, Alsahli M, Jeen YT, et al. Interavenous hydrocortisone premedication reduces antibodies to infliximab in Crohns disease: a randomized controlled trial. Gastroenterology 2003; 124: 542–553.

28. Panaccione R, Ghosh S, Middleton S, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy with ether agent in ulcerative colitis. Gastroenterology 2014; 146: 392-400.

29. Roblin X, Rinaudo M, Del Tedesco E, et al. Development of an algorithm incorporating pharmacokinetics of adalimumab in inflammatory bowel diseases. Am J Gastroenterol 2014; 109: 1250–1256.

30. 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.

31. 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 2015; 13: 522–530.

32. Leclerc M, Marotte H, Paul S, et al. Persistence of antibodies to infliximab for more than two months strongly predicts loss of response to infliximab in inflammatory bowel diseases. Gastroenterol Hepatol (NY) 2014; 10: (7 Suppl. 4).

33. 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.

34. Feuerstein JD, Nguyen GC, Kupfer SS, et al. American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease. Gastroenterology 2017; 153: 827–834.

35. Afif W, Loftus jr. EV, 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.

36. Strik AS, Bots SJ, D’Haens G, et al. Optimization of antiTNF therapy in patients with inflammatory bowel disease. Expert Rev Clin Pharmacol 2016; 9: 429–439.

37. Ding NS, Hart A, de Cruz P Systematic review: predicting and optimising response to anti‑TNF therapy in Crohn’s disease – algorithm for practical management. Aliment Pharmacol Ther 2016; 43: 30–51.

38. Karmiris K, Paintaud G, Noman M, et al. Influence of trough serum levels and immu‑ nogenicity on long‑term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology 2009; 137: 1628–1640.

39. Minar P, Saeed SA, Afreen M, et al. Practical use of infliximab concentration monitoring in pediatric Crohn disease. J Pediatr Gastroenterol Nutr 2016; 62: 715–722.

40. Viola F, Civitelli F, Di Nardo G, et al. Efficacy of adalimumab in moderate‑to‑severe pediatric Crohn’s disease. Am J Gastroenterol 2009; 104: 2566–2571.

41. Papamichael K, van Stappen T, Vande Casteele N, et al. Infliximab concentration thre‑ sholds during induction therapy are associated with short‑term mucosal healing in pati‑ ents with ulcerative colitis. Clin Gastroenterol Hepatol 2016; 14: 543–549.

42. Singh N, Rosenthal CJ, Melmed GY, et al. Early infliximab trough levels are associated with persistent remission in pediatric patients with inflammatory bowel disease. Inflamm Bowel Dis 2014; 20: 1708–1713.

43. Ding NS, Hart A, de Cruz P. Systematic review: predicting and optimising response to anti‑TNF therapy in Crohn’s disease – algorithm for practical management. Aliment Pharmacol Ther 2016; 43: 30–51.

44. Cornillie F, Hanauer SB, Diamond RH, et al. Postinduction serum infliximab trough le‑ vel and decrease of C‑reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut 2014; 63: 1721–1727.

45. Amin A, Prosser C, Kroeker K, et al. Using infliximab trough levels and fecal calprotectin levels together to guide clinical decisions has the potential to improve outcomes in inflammatory bowel disease patients on maintenance infliximab therapy. Gastroenterology 2016; 150: S422.

46. 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: 1258–1264.

47. Steenholdt C, Frederiksen MT, Bendtzen K et al. Time course and clinical implications of development of antibodies against adalimumab in patients with inflammatory bowel disease. J Clin Gastroenterol 2015; 50: 483–489.

48. Papamichael K, Vande Csteele N., Billiet T, et al. Early therapeutic drug monitoring for prediction of short‑term muckal healing in pacients with ulcerative colitis treated with infliximab. Gastroenterology 2015; 148: S848.

49. Bortlík M, Ďuricová D, Malíčková K, et al. Infliximab trough levels may predict sustained response to infliximab in patients with Crohns disease. JCC 2013; 7: 736–743.

50. 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.

51. Papamichael K, Vande Casteele N, Ferrante M, et al. Therapeutic drug monitoring during induction of anti‑tumor necrosis factor therapy in inflammatory bowel disease: definic a therapeutic Windows. Inflamm Bowel Dis 2017; 23:, 1510–1515.

52. Pariente B, de Chambrun GP, Krzysiek R, et al. Trough levels and antibodies to infliximab may not predict response to intensification of infliximab therapy in patients with inflammatory bowel disease. Inflamm Bowel Dis 2011; 18: 1199–1206.

53. Roblin X, Williet N, Peyrin‑Biroulet L. Thiopurin metabolism in the area of combotherapy. Inflamm Bowel Dis 2016; 22: 1496–1501.

54. Del Tedesco E, Paul S, Marotte H. Azathioprine dose reduction in inflammatory bowel disease patients on combination therapy: A prospekte study. DDW 2016, oral presenation 693.

55. D’Haens G, Vermeire S, Lambrecht G, et al. OP029 Drug‑concentration versus symptom‑driven dose adaptation of Infliximab in patients with active Crohn’s disease: a prospective, randomised, multicentre trial (Tailorix). ECCO; 2016.

56. Papamichael K, Chachu KA, Vajravelu RK, et al. Improved long term outcomes of patients with inflammatory bowel disease receiving proactive compared with reactive monitoring of serum concentrations of infliximab. Clin Gastroenterol Hepatol 2017; 15: 1580–1588.

57. 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: 919–927.

58. Steenholdt C, Brynskov J, Thomsen OO, et al. Individualized therapy is a long‑term cost‑effective method compared to dose intensification in Crohn’s disease patients failing infliximab. Dig Dis Sci 2015; 60: 2762–2770.

59. Vande Casteele N, Khanna R, Levesque BG, et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn’s disease. Gut 2015; 64: 1539–1545.

60. Flamant M, Roblin X. Could therapeutic drug monitoring of antiTNF‑alpha be useful to consider a de‑escalation of treatment? Expert Opin Biol Ther 2015; 15: 1657–1660.

61. Louis E, Mary JY, Vernier‑Massouille G, et al. Maintenance of remission among patients with Crohn’s disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology 2012; 142: 63–70.

62. Papamichael K, Vande Casteele N, Gils A, et al. Long‑term outcome of patients with Crohn’s disease who discontinued infliximab therapy upon clinical remission. Clin Gastroenterol Hepatol 2015; 13: 1103–1110.

63. Ben‑Horin S, Waterman M, Kopylov U, 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: 444–447.

64. D’Haens G, Vermeire S, Lambrecht G, et al. GETAID. Increasing infliximab dose based on symptoms, biomarkers, and serum drug concentrations does not increase clinical, endoscopic, and corticosteroid‑free remission in patients with active luminal Crohn’s disease. Gastroenterology 2018; 154: 1343–1351.

65. Papamichael K, Vajravelu RK, Vaughn BP, et al. Proactive infliximab monitoring following reactive testing is associated with better clinical outcomes than reactive testing alone in patients with inflammatory bowel disease. J Crohns Colitis 2018; 12: 804–810.

66. Bortlík M, Ďuricová D, Machková N, et al. Impact of anti‑tumor necrosis factor alpha antibodies administered to pregnant woman with inflammatory bowel disease on long‑term outcome of exposé children. Inflamm Bowel Dis 2014; 20: 495–501.

67. Steenholdt C, Bendtzen K, Brynskov J, et al. Optimizing treatment with TNF inhibitors in inflammatory bowel disease by monitoring drug levels and antidrug antibodies. In‑ flamm Bowel Dis 2016; 22: 1999–2015.

68. Steenholdt C, Brynskov J, Thomsen OO, et al. Implications of infliximab treatment failure and influence of personalized treatment on patient‑reported health‑related quality of life and productivity outcomes in Crohn’s disease. J Crohns Colitis 2015; 9: 1032–1042.

69. Velayos FS, Kahn JG, Sandborn WJ, et al. 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: 654–666.

70. Negoescu DM, Enns EA, Swanhorst B, et al. Proactive vs reactive Therapeutic drug monitoring of infliximab in Crohns disease: A cost‑effectivness analysis in a simulated cohort. Inflamm Bowel Dis 2019; 50: 1–9.