Terapeutické monitorovanie hladín biologickej liečby chronických črevných zápalov – odporúčania do praxe
Laura Gombošová1, Zuzana Zelinková2, Barbora Kadlečková2, Peter Lietava3, Miloš Greguš4, Erika Barlová Orcid.org 5, Lucia Novotná Orcid.org 5
+ Affiliation
To read this article in full, please register for free on this website.
Benefits for subscribers
Benefits for logged users
Literature
1. Strik AS, Berends SE, Löwenberg M. Therapeutic drug monitoring-based dosing of TNF inhibitors in inflammatory bowel disease: the way forward? Exp Rev Clin Pharm 2019; 12(9): 885–891. doi: 10.1080/17512433.2019.1642745.
2. Fine S, Papamichael K, Cheifetz AS. Etiology and Management of Lack or Loss of Response to Anti–Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease. Gastroenterol Hepatol 2019; 15(12): 656–665.
3. Papamichael K, Rakowsky S, Rivera C et al. Association between serum infliximab trough concentrations during maintenance therapy and biochemical, endoscopic, and histologic remission in Crohn’s disease. Inflamm Bowel Dis 2018; 24(10): 2266–2271. doi: 10.1093/ibd/izy132.
4. Brandse JF, van den Brink GR, Wildenberg ME et al. Loss of infliximab into feces is associated with lack of response to therapy in patients with severe ulcerative colitis. Gastroenterology 2015; 149(2): 350–355.e2. doi: 10.1053/j.gastro.2015.04.016.
5. Ungar B, Chowers Y, Yavzori M et al; ABIRISK consortium. The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 2014; 63(8): 1258–1264. doi: 10.1136/gutjnl-2013-305259.
6. Mitrev N, van de Casteele N, Seow CH et al. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther 2017; 46(11–12): 1037–1053. doi: 10.1111/apt.14368.
7. Feuerstein JD, Nguyen GC, Kupfer SS et al. American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease. Gastroenterology 2017; 153(3): 827–834. doi: 10.1053/j.gastro.2017.07.032.
8. Torres J,Chaparro M, Julsgaard M et al. European Crohn’s and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. J Crohns Colitis 2023; 17(1): 1–27. doi: 10.1093/ecco-jcc /jjac115.
9. Lamb CA, Kennedy NA, Raine T et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019; 68(3): s1–s106. doi: 10.1136/gutjnl-2019-318484.
10. Torres J, Bonovas S, Doherty G et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment. J Crohns Colitis 2020; 4–22. doi: 10.1093/ecco-jcc/jjz180.
11. Raine T, Bonovas S, Burisch J et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis 2022; 16(1): 2–17. doi: 10.1093/ecco-jcc/jjab178.
12. Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 2006; 11(1–2): 81–88. doi: 10.1016/S1359-6446(05)03638-X.
13. 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(7): 542–553. doi: 10.1016/s1542-3565(04)00238-1.
14. Guidi L, Pugliese D, Tonucci TP et al. Therapeutic drug monitoring is more cost effective than a clinically based approach in the management of loss of response to infliximab in inflammatory bowel disease: an observational multicentre study. J Crohns Colitis 2018; 12(9): 1079–1088. doi: 10.1093/ecco-jcc/jjy076.
15. Martins CA, Moss CA, Sobrado CW et al. Practical aspects of proactive TDM for anti-TNF agents in IBD: defining time points and thresholds to target. J Crohn’s Colitis 2019; 1(3) 360–363. doi: 10.1093/crocol/otz049.
16. Papamichael K, Chachu KA, Vajravelu RK et al. Improved longterm outcomes of patients with inflammatory bowel disease receiving proactive compared with reactive monitoring of serum concentrations of infliximab. Clin Gastroenterol Hepatol 2017; (10): 1580–1588. doi: 10.1016/j.cgh.2017.03.031.
17.Sethi S, Dias S, Kumar A et al. Meta-analysis: The efficacy of therapeutic drug monitoring of anti-TNF-therapy in inflammatory bowel disease. Aliment Pharmacol Ther 2023; 57(12): 1362–1374. doi: 10.1111/apt.17313.
18. Zelinková Z. Intenzifikácia anti-TNF liečby účinnosť, bezpečnosť, náklady [špecializačná práca]. Bratislava: Slovenska zdravotnicka univerzita v Bratislave. Fakulta verejneho zdravotnictva 2022.
19. Colombel JF, Adedokun OJ, Gasink C et al. Combination therapy with infliximab and azathioprine improves infliximab pharmacokinetic features and efficacy-a post-hoc analysis. Clin Gastroenterol Hepatol 2019; 17(8): 1525–1532.1. doi: 10.1016/j.cgh.2018.09.033.
20. Dressen E, Bossyut P, Mulleman D et al. Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases. Clin Pharmacol 2017; 9: 101–111. doi: 10.2147/CPAA.S138414.
21. Van Stappen T et al. Validation of a sample pretreatment protocol to convert a drug-sensitive into a drug-tolerant antiinfliximab antibody immunoassay. Drug Test Anal 2017; 9(2): 243–247. doi: 10.1002/dta.1968.
22. Clarke WT, Papamichael K, Vande Casteele N et al. Infliximab and Adalimumab Concentrations May Vary Between the Enzyme-Linked Immunosorbent Assay and the Homogeneous Mobility Shift Assay in Patients With Inflammatory Bowel Disease: A Prospective Cross-Sectional Observational Study. Inflamm Bowel Dis 2019; 25(11): e143–e145. doi: 10.1093/ibd/izz202.
23. Atiqi S, Hooijberg F, Loeff FC et al. Immunogenicity of TNF-Inhibitors. Front Immunol 2020; 11: 312. doi: 10.3389/fimmu.2020.00312.
24. Vermeire S, Dreesen E, Papamichael K et al. How, When, and for Whom Should We Perform Therapeutic Drug Monitoring? Clin Gastroenterol Hepatol 2020; 18(6): 1291–1299. doi: 10.1016/j.cgh.2019.09.041.
25. Lim MH, Aluzaite K, Schultz M et al. Infliximab trough levels: A comparison between the Quantum Blue Infliximab assay and the established ELISA. J Gastroenterol Hepatol 2020; 35(8): 1302–1306. doi: 10.1111/jgh.14964.
26. Cherry M, Dutzer D, Nasser Y et al. Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab. J Clin Med 202; 9(9): 2739. doi: 10.3390/jcm9092739.
27. Amiot A, Bouguen G, Bonnaud et al. French National Consensus Clinical guidelines for the management of IBD study group. Clinical guidelines for the management of inflammatory bowel disease: Update of a French national consensus. Dig Liver Dis 2021; 53(1): 35–43. doi: 10.1016/j.dld.2020.10.018.
28. Liefferinckx C, Minsart Ch, Toubeau JF et al. Infliximab trough levels at induction to predict treatment failure during maintenance. Inflamm Bowel Dis 2017; 23(8): 1371–1381. doi: 10.1097/MIB.0000000000001120.
29. Frederiksen MT, Bendtzen K, Ainsworth MA et al. Time course and clinical implications of development of antibodies against adalimumab in patients with inflammatory bowel disease. J Clin Gastroenterol 2015; 50(6): 483–489. doi: 10.1097/MCG.0000000000000375.
30. Vande Casteele N, Compernolle G, Ballet V et al. Results on the optimisation phase of the prospective controlled trough level adapted infliximab treatment (TAXIT) trial. Gastroenterol 2012; 142(5): S-211-S-212.
31. Strik AS, Löwenberg M, Buskens CHJ et al. Higher anti-TNF serum levels are associated with perianal fistula closure in Crohn’s disease patients. Scand J Gastroenterol 2019; 54(4): 453–458. doi: 10.1080/00365521.2019.1600014.
32. Drobne D, Kurent T, Golob S et al. Success and safety of high infliximab trough levels in inflammatory bowel disease. Scand J Gastroenterol 2018; 53(8): 940–946. doi: 10.1080/00365521.2018.1486882.
33. Fernandes SR, Bernardo S, Simoes C et al. Proactive infliximab drug monitoring is superior to conventional management in inflammatory bowel disease. Inflamm Bowel Dis 2020; 26(2): 263–270. doi: 10.1093/ibd/izz131.
34. Castelle NV, Ferrante M, Van Assche G et al. Through concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 2015; 148(7): 1320–1329.e3. doi: 10.1053/j.gastro.2015.02.031.
35. 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(7): 804–810. doi: 10.1093/ecco-jcc/jjy039.
36. Vaughn BP, Martinez-Vazquez M, Patwardhan VR et al. Proactive therapeutic concentration monitoring of infliximab may improve outcomes for patients with inflammatory bowel disease: results from a pilot observational study. Inflamm Bowel Dis 2014; 20(11): 1996–2003. doi: 10.1097/MIB.0000000000000156.
37. Papamichael K, Juncadella A, Wong D et al. Proactive therapeutic drug monitoring of adalimumab is associated with better long-term outcomes compared with standard of care in patients with inflammatory bowel disease. J Crohns Colitis 2019; 13(8): 976–981. doi: 10.1093/ecco-jcc/jjz018.
38. Shmais M, Regueiro M, Hashash JG. Proactive versus reactive therapeutic drug monitoring: why, when, and how? Inflamm Intest Dis 2022; 7(1): 50–58. doi: 10.1159/000518755.
39. Nguyen NH, Solitano V, Vuyyuru SK et al. Proactive therapeutic drug monitoring vs. conventional management for inflammatory bowel diseases: a systematic review and meta-analysis. Gastroenterology 2022; 163(4): 937–949. doi: 10.1053/j.gastro.2022.06.052.
40. Little RD, Ward MG, Wright E et al. Therapeutic Drug Monitoring of Subcutaneous Infliximab in Inflammatory Bowel Disease – Understanding Pharmacokinetics and Exposure Response Relationships in a New Era of Subcutaneous Biologic. J Clin Med 2022; 11(20): 6173. doi: 10.3390/jcm11206173.
41. Paul S, Williet N, Nancey S et al. No Difference of Adalimumab Pharmacokinetics When Dosed at 40 mg Every Week or 80 mg Every Other Week in IBD Patients in Clinical Remission After Adalimumab Dose Intensification. Dig Dis Sci 2021; 66(8): 2744–2749. doi: 10.1007/s10620-020-06567-x.
42. Huguet JM, García-Lorenzo V, Martí L et al. Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study. Biomedicines 2022; 10(9): 2130. doi: 10.3390/biomedicines10092130.
43. Roblin X, Veyrard P, Bastide L et al. Subcutaneous injection of infliximab CT-P13 results in stable drug levels within 14-day treatment cycle in Crohn‘s disease. Aliment Pharmacol Ther 2022; 56(1): 77–83. doi: 10.1111/apt.16852.
44. Atreya R, Neurath MF. IL-23 Blockade in Anti-TNF Refractory IBD: From Mechanisms to Clinical Reality. J Crohns Colitis 2022; 16(2): ii54–ii63. doi: 10.1093/ecco-jcc/jjac007.
45. Villareal EM, Yarur AJ. Better Late than Never: Adding Thiopurines After Loss of Response to Infliximab Monotherapy. Dig Dis Sci 2021; 66(9): 2851–2852. doi: 10.1007/s10620-020-06681-w.
46. Polakovicova V, Kadleckova B, Lucenicova J et al. Positive pharmacokinetic effect of azathioprine co-medication on infliximab trough levels is dose-dependent. Dig Liv Dis 2019; 51(8): 1112–1116. doi: 10.1016/j.dld.2019.05.001.
47. Ben-Horin S, Chowers Y, Ungar B et al. Undetectable anti-TNF drug levels in patients with long-term remission predict successful drug withdrawal. Aliment Pharmacol Ther 2015; 42(3): 356–364. doi: 10.1111/apt.13268.
48. Papamichael K, Vande Casteele N, Billiet T et al. Early therapeutic drug monitoring for prediction of short-term mucosal healing in pacients with ulcerative colitis treated with infliximab. J Crohns Colitis 2015; 9(1): 45–46. doi: 10.1093/ecco-jcc/jju027.067.
49. Baert F, Drobne D, Gils A et al. Early trough levels and antibodies to infliximab predict safety and success of reinitiation of infliximab therapy. Clin Gastroenterol Hepatol 2014; 12(9): 1474–1481. doi: 10.1016/j.cgh.2014.01.033.
50. Julsgaard M, Christensen LA, Gibson PR et al. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology 2016; 151(1): 110–119. doi: 10.1053/j.gastro.2016.04.002.
51. Mahadevan U, Wolf DC, Dubinsky M et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013; 11(3): 286–292. doi: 10.1016/j.cgh.2012.11.011.
52. Mahadevan U, Robinson C, Bernasko N et al. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Inflamm Bowel Dis 2019; 25(4): 627–641. doi: 10.1093/ibd/izz037.
53. Kanis SL, Lima-Karagiannis A, van der Ent C et al. Anti-TNF Levels in Cord Blood at Birth are Associated with Anti-TNF Type. 2018; 12(8): 939–947. doi: 10.1093/ecco-jcc/jjy058.
54. Restellini S, Biedermann L, Hruz P et al. Update on the Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding. Digestion 2020; 101(1): 27–42. doi: 10.1159/000502886.
55. Lichtenstein GR, Feagan BG, Mahadevan U et al. Pregnancy Outcomes Reported During the 13-Year TREAT Registry: A Descriptive Report. Am J Gastroenterol 2018; 113(11): 1678–1688. doi: 10.1038/s41395-018-0202-9.
56. Luu M, Benzenine E, Doret M et al. Continuous Anti-TNFa Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus. A Retrospective Cohort on the French National Health Insurance Database (EVASION). Am J Gastroenterol 2018; 113(11): 1669–1677. doi: 10.1038/s41395-018-0176-7.
57. Pouillon L, Vermeire S, Bossuyt P. Vedolizumab trough level monitoring in inflammatory bowel disease: a state-of-the art overview. BMC Med 2019; 17(1): 89. doi: 10.1186/s129 16-019-1323-8.
58. Hanžel J, Sever N, Ferkolj I et al. Early vedolizumab trough levels predict combined endoscopic and clinical remission in inflammatory bowel disease. United Eur Gastroenterol J 2019; 7(6): 741–749.
59. Guidi L, Pugliese D, Panici Tonucci T et al. Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease. United European Gastroenterol J 2019; 7(9): 1189–1197. doi: 10.1177/20506 40619873784.
60. Yacoub W, Williet N, Pouillon L et al. Early vedolizumab trough levels predict mucosal healing in inflammatory bowel disease: a multicentre prospective observational study. Aliment Pharmacol Ther 2018; 47(7): 906–912. doi: 10.1111/apt.14548.
61. Singh S, Dulai PS, Vande Casteele N et al. Systematic review with meta-analysis: association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases. Aliment Pharmacol Ther 2019; 50(8): 848–857. doi: 10.1111/apt.15484.
62. lsoud D, Vermeire S, Verstockt B. Monitoring vedolizumab and ustekinumab drug levels in patients with inflammatory bowel disease: hype or hope? Curr Opin Pharmacol 2020; 55: 17–30. doi: 10.1016/j.coph.2020.09.002.
63. Thoman AK, Schulte LA, Globig AM et al. Ustekinumab serum concentrations are associated with clinical outcomes in Crohn‘s disease – a regional multi-center pilot study. Z Gastroenterol 2020; 58(5): 439–444. doi: 10.1055/a-1088-1461.
64. Hanžel J, Zdovc J, Kurent T et al. Peak Concentrations of Ustekinumab After Intravenous Induction Therapy Identify Patients With Crohn‘s Disease Likely to Achieve Endoscopic and Biochemical Remission. Clin Gastroenterol Hepatol 2021; 19(1): 111–118. doi: 10.1016/j.cgh.2020.02.033.
65. Painchart C, Brabant S, Duveau N et al. Ustekinumab Serum Trough Levels May Identify Suboptimal Responders to Ustekinumab in Crohn‘s Disease. Dig Dis Sci 2020; 65(5): 1445–1452. doi: 10.1007/s10620-019-05865-3.
66. Adedokun OJ, Xu Z, Gasink C et al. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn‘s Disease. Gastroenterology 2018; 154(6): 1660–1671. doi: 10.1053/j.gastro.2018.01.043.
67. Heron V, Afif W. Update on Therapeutic Drug Monitoring in Crohn‘s Disease. Gastroenterol Clin North Am 2017; 46(3): 645–659. doi: 10.1016/j.gtc.2017.05.014.