Guidelines for the administration of biological therapy in patients with inflammatory bowel diseases: third, updated edition
Authors:
M. Bortlík 1,2; D. Ďuricová
; M. Konečný; J. Koželuhová; A. Novotný; T. Douda; J. Stehlík; O. Shonová; K. Mareš; Luděk Hrdlička; P. Matějková; Z. Šerclová; L. Nedbalová; M. Tomanová
; M. Liberda; J. Bronský; K. Mitrová
; P. Drastich
; O. Ryska; Přemysl Falt
; J. Březina; T. Vaňásek; J. Kalvach; M. Kolář
; M. Lukáš
Authors place of work:
Klinické a výzkumné centrum pro střevní záněty ISCARE I. V. F. a. s., Praha
1; Interní klinika 1. LF UK a ÚVN Praha
Pracoviště spoluautorů jsou uvedena na webové stránce časopisu www. csgh. info.
2
Published in the journal:
Gastroent Hepatol 2016; 70(1): 11-26
Category:
IBD: Guidelines
doi:
https://doi.org/10.14735/amgh201611
Summary
The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.
The Editorial Board declares that the manuscript met the ICMJE „uniform requirements“ for biomedical papers.
Submitted:
22. 1. 2016
Accepted:
8. 2. 2016
Zdroje
1. Holdam AS, Bager P, Dahlerup JF. Biological therapy increases the health‑related quality of life in patients with inflammatory bowel disease in a clinical setting. Scand J Gastroenterol 2016; 51(6): 706– 711. doi: 10.3109/00365521.2015.1136352.
2. Armuzzi A, Pugliese D, Danese S et al. Infliximab in steroid‑ dependent ulcerative colitis: effectiveness and predictors of clinical and endoscopic remission. Inflamm Bowel Dis 2013; 19(5): 1065– 1072. doi: 10.1097/ MIB.0b013e3182802909.
3. Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359(9317): 1541– 1549.
4. Rungoe C, Langholz E, Andersson M et al.Changes in medical treatment and surgery rates in inflammatory bowel disease: a nationwide cohort study 1979– 2011. Gut 2014; 63(10): 1607– 1616. doi: 10.1136/ gutjnl‑ 2013‑ 305607.
5. Frolkis AD, Dykeman J, Negrón ME et al.Risk of surgery for inflammatory bowel diseases has decreased over time: a systematic review and meta‑analysis of population‑based studies. Gastroenterology 2013; 145(5): 996– 1006. doi: 10.1053/ j.gastro.2013.07.041.
6. Lichtenstein GR, Yan S, Bala M et al. Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease. Gastroenterology 2005; 128(4): 862– 869.
7. Bortlík M, Ďuricová D, Kohout P et al. Doporučení pro podávání biologické terapie u idiopatických střevních zánětů: 2. vydání. Gastroent Hepatol 2012; 66(1): 12– 22.
8. Bortlík M. Vývoj léčby idiopatických střevních zánětů v posledních 20 letech. Gastroent Hepatol 2015; 69(4): 341– 350.
9. Lukáš M. Obecné principy biologické léčby u IBD. In: Pavelka K et al (eds). Biologická léčba zánětlivých autoimunitních onemocnění. Praha: Grada 2014: 253– 264.
10. Lukáš M, Ďuricová D, Bortlík M. Doporučení pro podávání biologické terapie u idiopatických střevních zánětů. Čes a Slov Gastroent a Hepatol 2008; 62(5): 285– 291.
11. OCEMB Levels of Evidence Working Group. The Oxford 2011 Levels of Evidence: Oxford Centre for Evidence‑ Based Medicine. [online]. Available from www.cemb.net/ index.aspx?o=5653, 2011.
12. 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(2): 199– 212; quiz 213. doi: 10.1038/ ajg.2010.392.
13. Dignass A, Van Assche G, Lindsay JO et al. The second European evidence‑based Consensus on the diagnosis and management of Crohn's disease: current management. J Crohns Colitis 2010; 4(1): 28– 62. doi: 10.1016/ j.crohns.2009.12.002.
14. Mowat C, Cole A, Windsor A et al. Guide-lines for the management of inflammatory bowel disease in adults. Gut 2011; 60(5): 571– 607. doi: 10.1136/ gut.2010.224154.
15. Hanauer SB, Sandborn WJ, Rutgeerts P et al. Human anti‑tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC‑ I trial. Gastroenterology 2006; 130(2): 323– 333; quiz 591.
16. Colombel JF, Sandborn WJ, Rutgeerts P 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.
17. Sandborn WJ, Feagan BG, Rutgeerts P et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2013; 369(8): 711– 721. doi: 10.1056/ NEJMoa1215739.
18. Sands BE, Feagan BG, Rutgeerts P et al. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology 2014; 147(3): 618– 627. doi: 10.1053/ j.gastro.2014.05.008.
19. Šerclová Z, Ryska O, Bortlík M et al. Doporučené postupy chirurgické léčby pacientů s nespecifickými střevními záněty – 2. část: Crohnova nemoc. Gastroent Hepatol 2015; 69(3): 223– 238. doi: 10.14735/ amgh2015223.
20. Yassin NA, Askari A, Warusavitarne J et al. Systematic review: the combined surgical and medical treatment of fistulising perianal Crohn's disease. Aliment Pharmacol Ther 2014; 40(7): 741– 749. doi: 10.1111/ apt.12906.
21. Gecse KB, Bemelman W, Kamm MA et al. A global consensus on the classification, diagnosis and multidisciplinary treatment of perianal fistulising Crohn's disease. Gut 2014; 63(9): 1381– 1392. doi: 10.1136/ gutjnl‑ 2013‑ 306709.
22. Bortlík M. Současný pohled na léčbu perianálních píštělí u nemocných s Crohnovou chorobou. Gastroent Hepatol 2013; 67(1): 25– 29.
23. Sands BE, Blank MA, Patel K et al. Long‑term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol 2004; 2(10): 912– 920.
24. Colombel JF, Schwartz DA, Sandborn WJet al. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut 2009; 58(7): 940– 948. doi: 10.1136/ gut.2008.159251.
25. Van Assche G, Dignass A, Reinisch Wet al. The second European evidence‑-based Consensus on the diagnosis and management of Crohn's disease: Special situations. J Crohns Colitis 2010; 4: 63– 101. doi: 10.1016/ j.crohns.2009.09.009.
26. Lukáš M. Perspektivy biologické léčby u idiopatických střevních zánětů. Gastroent Hepatol 2014; 68(3): 225– 229.
27. Lakatos L, Kiss LS, David G et al. Incidence, disease phenotype at diagnosis, and early disease course in inflammatory bowel diseases in Western Hungary, 2002– 2006. Inflamm Bowel Dis 2011; 17(12): 2558– 2565. doi: 10.1002/ ibd.21607.
28. Peyrin‑Biroulet L, Harmsen WS, Tremaine WJ et al. Surgery in a population‑-based cohort of Crohn's disease from Olmsted County, Minnesota (1970– 2004). Am J Gastroenterol 2012; 107(11): 1693– 1701. doi: 10.1038/ ajg.2012.298.
29. Galandiuk S, Kimberling J, Al‑ Mishlab TGet al. Perianal Crohn disease: predictors of need for permanent diversion. Ann Surg 2005; 241(5): 796– 801; discussion 801– 802.
30. Danese S, Colombel JF, Reinisch Wet al. Review article: infliximab for Crohn's disease treatment‑ shifting therapeutic strategies after 10 years of clinical experience. Aliment Pharmacol Ther 2011; 33(8): 857– 869. doi: 10.1111/ j.1365‑ 2036.2011.04598.x.
31. Regueiro M, Schraut W, Baidoo L et al. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology 2009; 136(2): 441– 450.e1; quiz 716. doi: 10.1053/ j.gastro.2008.10.051.
32. Govani SM, Stidham RW, Higgins PD. How early to take arms against a sea of troubles? The case for aggressive early therapy in Crohn's disease to prevent fibrotic intestinal strictures. J Crohns Colitis 2013; 7(11): 923– 927. doi: 10.1016/ j.crohns.2013.06.011.
33. De Cruz P, Kamm MA, Hamilton AL et al. Crohn's disease management after intestinal resection: a randomised trial. Lancet 2015; 385(9976): 1406– 1417. doi: 10.1016/ S0140‑ 6736(14)61908‑ 5.
34. Herfarth HH. Anti‑tumor necrosis factor therapy to prevent Crohn's disease recurrence after surgery. Clin Gastroenterol Hepatol 2014; 12(9): 1503– 1506. doi: 10.1016/ j.cgh.2014.02.014.
35. Barrie A, Regueiro M. Biologic therapy in the management of extraintestinal manifestations of inflammatory bowel dis-ease. Inflamm Bowel Dis 2007; 13(11): 1424– 1429.
36. Brooklyn TN, Dunnill MG, Shetty A et al. Infliximab for the treatment of pyoderma gangrenosum: a randomised, double blind, placebo controlled trial. Gut 2006; 55(4): 505– 509.
37. Fries W, Giofré MR, Catanoso M et al. Treatment of acute uveitis associated with Crohn's disease and sacroileitis with infliximab. Am J Gastroenterol 2002; 97(2): 499– 500.
38. Herfarth H, Obermeier F, Andus T et al.Improvement of arthritis and arthralgia after treatment with infliximab (Remicade) in a German prospective, open‑ label, multicenter trial in refractory Crohn's disease. Am J Gastroenterol 2002; 97(10): 2688– 2690.
39. Löfberg R, Louis EV, Reinisch W et al. Adalimumab produces clinical remission and reduces extraintestinal manifestations in Crohn's disease: results from CARE. Inflamm Bowel Dis 2012; 18(1): 1– 9. doi: 10.1002/ ibd.21663.
40. Braun J, Brandt J, Listing J et al. Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet 2002; 359(9313): 1187– 1193.
41. Dignass A, Lindsay JO, Sturm A et al. Second European evidence‑based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis 2012; 6(10): 991– 1030. doi: 10.1016/ j.crohns.2012.09.002.
42. Rutgeerts P, Sandborn WJ, Feagan BG et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353(23): 2462– 2476.
43. Lukáš M. Biologická léčba u nemocných s ulcerózní kolitidou. Postgrad Med 2011; 13: 993– 997.
44. Reinisch W, Sandborn WJ, Panaccione Ret al. 52‑week efficacy of adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/ or immunosuppressants. Inflamm Bowel Dis 2013; 19(8): 1700– 1709. doi: 10.1097/ MIB.0b013e318281f2b7.
45. Sandborn WJ, Colombel JF, D'Haens G et al. One‑year maintenance outcomes among patients with moderately‑ to‑ se-verely active ulcerative colitis who respond-ed to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther 2013; 37(2): 204– 2413. doi: 10.1111/ apt.12145.
46. Sandborn WJ, van Assche G, Reinisch W et al. Adalimumab induces and maintains clinical remission in patients with moderate‑ to‑ severe ulcerative colitis. Gastroenterology 2012; 142(2): 257– 265.e1– e3. doi: 10.1053/ j.gastro.2011.10.032.
47. Sandborn WJ, Feagan BG, Marano C et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate‑ to‑ severe ulcerative colitis. Gastroenterology 2014; 146(1): 85– 95; quiz e14– e15. doi: 10.1053/ j.gastro.2013.05.048.
48. Sandborn WJ, Feagan BG, Marano C et al. Subcutaneous golimumab maintains clinical response in patients with moderate‑ to‑ severe ulcerative colitis. Gastroenterology 2014; 146(1): 96– 109.e1. doi: 10.1053/ j.gastro.2013.06.010.
49. Feagan BG, Rutgeerts P, Sands BE et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013; 369(8): 699– 710. doi: 10.1056/ NEJMoa1215734.
50. Lukáš M. Vedolizumab v léčbě ulcerózní kolitidy. Gastroent Hepatol 2015; 69(1): 29– 32.
51. Järnerot G, Hertervig E, Friis‑ Liby I et al. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo‑ controlled study. Gastroenterology 2005; 128(7): 1805– 1811.
52. Monterubbianesi R, Aratari A, Armuzzi Aet al. Infliximab three‑dose induction regimen in severe corticosteroid‑ refractory ulcerative colitis: early and late outcome and predictors of colectomy. J Crohns Colitis 2014; 8(8): 852– 858. doi: 10.1016/ j.crohns.2014.01.006.
53. Laharie D, Bourreille A, Branche J et al.Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open‑ label randomised controlled trial. Lancet 2012; 380(9857): 1909– 1915 doi: 10.1016/S0140-6736(12)61084-8..
54. Chang KH, Burke JP, Coffey JC. Infliximab versus cyclosporine as rescue therapy in acute severe steroid‑ refractory ulcerative colitis: a systematic review and meta‑analysis. Int J Colorectal Dis 2013; 28(3): 287– 293. doi: 10.1007/ s00384‑ 012‑ 1602‑ 8.
55. Rosen MJ, Minar P, Vinks AA. Review article: applying pharmacokinetics to optimise dosing of anti‑TNF biologics in acute severe ulcerative colitis. Aliment Pharmacol Ther 2015; 41(11): 1094– 1103. doi: 10.1111/ apt.13175.
56. Gibson DJ, Heetun ZS, Redmond CE et al. An accelerated infliximab induction regimen reduces the need for early colectomy in patients with acute severe ulcerative colitis. Clin Gastroenterol Hepatol 2015; 13: 330– 335.
57. Narula N, Fine M, Colombel JF et al. Systematic Review: Sequential Rescue Therapy in Severe Ulcerative Colitis: Do the Benefits Outweigh the Risks? Inflamm Bowel Dis 2015; 21(7): 1683– 1694. doi: 10.1097/ MIB.0000000000000350.
58. Sandborn WJ, Hanauer SB. Infliximab in the treatment of Crohn's disease: a user's guide for clinicians. Am J Gastroenterol 2002; 97(12): 2962– 2972.
59. Gisbert JP, Marín AC, McNicholl AG et al. Systematic review with meta‑analysis: the efficacy of a second anti‑TNF in patients with inflammatory bowel disease whose previous anti‑TNF treatment has failed. Aliment Pharmacol Ther 2015; 41(7): 613– 623. doi: 10.1111/ apt.13083.
60. Rahier JF, Ben‑ Horin S, Chowers Y et al.European evidence‑based Consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease. J Crohns Colitis 2009; 3(2): 47– 91. doi: 10.1016/ j.crohns.2009.02.010.
61. Stehlík J, Mareš K, Lukáš M et al. Doporučení pro vakcinaci nemocných s Crohnovou chorobou a ulcerózní kolitidou na imunosupresivní a biologické léčbě. Čes a Slov Gastroent a Hepatol 2010; 64(1): 40– 48.
62. 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(15): 1098– 1104.
63. Nathan DM, Angus PW, Gibson PR. Hepatitis B and C virus infections and anti‑tumor necrosis factor‑alpha therapy: guidelines for clinical approach. J Gastroenterol Hepatol 2006; 21(9): 1366– 1371.
64. Šperl J, Špičák J, Lukáš M. Hepatologický dodatek ke článku: Doporučení pro vakcinaci a profylaxi infekčních chorob u nemocných s Crohnovou chorobou a ulcerózní kolitidou léčených imunosupresivy a biologickou léčbou. Čes a Slov Gastroent a Hepatol; 64(2): 37– 38.
65. Husa P, Šperl J, Urbánek P et al. Doporučený postup diagnostiky a léčby chronické hepatitidy B. Gastroent Hepatol 2014; 68(6): 514– 526.
66. Mohan N, Edwards ET, Cupps TR et al. Demyelination occurring during anti‑tumor necrosis factor alpha therapy for inflammatory arthritides. Arthritis Rheum 2001; 44(12): 2862– 2869.
67. Thomas CW, Weinshenker BG, Sandborn WJ. Demyelination during anti‑tumor necrosis factor alpha therapy with infliximab for Crohn's disease. Inflamm Bowel Dis 2004; 10(1): 28– 31.
68. Cleynen I, Vermeire S. Paradoxical inflam-mation induced by anti-TNF agents in patients with IBD. Nat Rev Gastroenterol Hepatol 2012; 9(9): 496–503. doi: 10.1038/nrgastro.2012.125.
69. Chung ES, Packer M, Lo KH et al. Randomized, double‑blind, placebo‑ controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor‑alpha, in patients with moderate‑ to‑ severe heart failure: results of the anti‑TNF Therapy Against Congestive Heart Failure (ATTACH) trial. Circulation 2003; 107(25): 3133– 3140.
70. Kalman RS, Hartshorn K Farraye FA. Does a personal or family history of malignancy preclude the use of immunomodulators and biologics in IBD. Inflamm Bowel Dis 2015; 21(2): 428– 435. doi: 10.1097/ MIB.0000000000000211.
71. Van Assche G, Lewis JD, Lichtenstein GRet al. The London position statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn's and Colitis Organisation: safety. Am J Gastroenterol 2011; 106(9): 1594– 1602; quiz 1593, 1603. doi: 10.1038/ ajg.2011.211.
72. Jauregui‑ Amezaga A, Turon F, Ordás Iet al. Risk of developing tuberculosis under anti‑TNF treatment despite latent infection screening. J Crohns Colitis 2013; 7(3): 208– 212. doi: 10.1016/ j.crohns.2012.05.012.
73. European Medicines Agency. EPAR – Product Information. Entyvio. EMA: Volume 2016, 2016.
74. Goodhand JR, Alazawi W Rampton DS. Systematic review: Clostridium difficile and inflammatory bowel disease. Aliment Pharmacol Ther 2011; 33(4): 428– 441. doi: 10.1111/ j.1365‑ 2036.2010.04548.x.
75. Sinh P, Barrett TA, Yun L. Clostridium difficile infection and inflammatory bowel disease: a review. Gastroenterol Res Pract 2011; 2011: 136064. doi: 10.1155/ 2011/ 136064.
76. Issa M, Vijayapal A, Graham MB et al. Impact of Clostridium difficile on inflammatory bowel disease. Clin Gastroenterol Hepatol 2007; 5(3): 345– 351.
77. Annese V, Duricova D, Gower‑ Rousseau C et al. Impact of new treatments on hospitalisation, surgery, infection, and mortality in IBD: a focus paper by the epidemiology committee of ECCO. J Crohns Colitis 2016; 10(2): 216– 225. doi: 10.1093/ ecco‑ jcc/ jjv190.
78. 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.
79. Fasanmade AA, Adedokun OJ, Olson Aet al. 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.
80. Malíčková K, Bortlík M, Ďuricová D et al. Vliv albuminemie na farmakokinetiku infliximabu u nemocných s idiopatickými střevními záněty. Čes a Slov Gastroent a Hepatol 2011; 65(2): 7– 74.
81. 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(2): 249– 255. doi: 10.1136/ gutjnl‑ 2014‑ 308099.
82. Oussalah A, Evesque L, Laharie D et al. A multicenter experience with infliximab for ulcerative colitis: outcomes and predictors of response, optimization, colectomy, and hospitalization. Am J Gastroenterol 2010; 105(12): 2617– 2625. doi: 10.1038/ ajg.2010.345.
83. Schnitzler F, Fidder H, Ferrante M 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. doi: 10.1136/ gut.2008.155812.
84. Colombel JF, Sandborn WJ, Reinisch Wet al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362(15): 1383– 1395. doi: 10.1056/ NEJMoa0904492.
85. Panaccione R, Ghosh S, Middleton S et al.Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis. Gastroenterology 2014; 146(2): 392– 400.
86. 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– 47; quiz 48. doi: 10.1038/ ajg.2012.363.
87. Yarur AJ, Deshpande AR, Sussman DA et al. Serum adalimumab levels and antibodies correlate with endoscopic intestinal inflammation and inflammatory markers in patients with inflammatory bowel disease. Gastroenterology 2013; 144(5): S774– S775.
88. 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(9): 1226– 1231.
89. Feagan BG, McDonald JW, Panaccione Ret al. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease. Gastroenterology 2014; 146(3): 681– 688. doi: 10.1053/ j.gastro.2013.11.024.
90. Sokol H, Seksik P, Carrat F et al. Usefulness of co‑ treatment with immunomodulators in patients with inflammatory bowel disease treated with scheduled infliximab maintenance therapy. Gut 2010; 59(10): 1363– 1368. doi: 10.1136/ gut.2010.212712.
91. Osterman MT, Haynes K, Delzell E et al.Effectiveness and safety of immunomodulators with anti‑tumor necrosis factor therapy in Crohn's disease. Clin Gastroenterol Hepatol 2015; 13(7): 1293– 1301; quiz e70, e72. doi: 10.1016/ j.cgh.2015.02.017.
92. Oussalah A, Chevaux JB, Fay R et al.Predictors of infliximab failure after azathioprine withdrawal in Crohn's disease treated with combination therapy. Am J Gastroenterol 2010; 105(5): 1142– 1149. doi: 10.1038/ ajg.2010.158.
93. Drobne D, Bossuyt P, Breynaert C et al. Withdrawal of immunomodulators after co‑ treatment does not reduce trough level of infliximab in patients with Crohn's disease. Clin Gastroenterol Hepatol 2015; 13(3): 514– 521. doi: 10.1016/ j.cgh.2014.07.027.
94. Paul S, Moreau AC, Del Tedesco E et al.Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta‑analysis. Inflamm Bowel Dis 2014; 20(7): 1288– 1295. doi: 10.1097/ MIB.0000000000000037.
95. Gisbert JP, Panés J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009;104(3): 760– 767. doi: 10.1038/ ajg.2008.88.
96. Caspersen S, Elkjaer M, Riis L et al. Infliximab for inflammatory bowel disease in Denmark 1999– 2005: clinical outcome and follow‑up evaluation of malignancy and mortality. Clin Gastroenterol Hepatol 2008; 6(11): 1212– 1217; quiz 1176. doi: 10.1016/ j.cgh.2008.05.010.
97. Bortlik M, Duricova D, Malickova K et al. Infliximab trough levels may predict sustained response to infliximab in patients with Crohn's disease. J Crohns Colitis 2013; 7(9): 736– 743. doi: 10.1016/ j.crohns.2012.10.019.
98. Vande Casteele N, Ferrante M, Van Assche G et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology 2015; 148(7): 1320– 1329. doi: 10.1053/ j.gastro.2015.02.031.
99. Brandse JF, Mathôt RA, van der Kleij D et al. Pharmacokinetic features and presence of antidrug antibodies associate with response to infliximab induction therapy in patients with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol 2015; 14(2): 251– 258. doi: 10.1016/ j.cgh.2015.10.029.
100. Adedokun OJ, Sandborn WJ, Feagan BG et al. Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis. Gastroenterology 2014; 147(6): 1296– 1307. doi: 10.1053/ j.gastro.2014.08.035.
101. Mazor Y, Almog R, Kopylov U et al. Adalimumab drug and antibody levels as predictors of clinical and laboratory response in patients with Crohn's disease. Aliment Pharmacol Ther 2014; 40(6): 620– 628. doi: 10.1111/ apt.12869.
102. Steenholdt C, Brynskov J, Thomsen O et al. Individualised therapy is more cost‑effective than dose intensification in patients with Crohn's dis-ease who lose response to anti‑TNF treatment: a randomised, controlled trial. Gut 2014; 63(6): 919– 927. doi: 10.1136/ gutjnl‑ 2013‑ 305279.
103. Roblin X, Marotte H, Rinaudo M et al. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 2014; 12(1): 80– 84. doi: 10.1016/ j.cgh.2013.07.010.
104. 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.
105. Afif W, Loftus 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(5): 1133– 1139. doi: 10.1038/ ajg.2010.9.
106. 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(8): 1250– 1256. doi: 10.1038/ ajg.2014.146.
107. Steenholdt C, Molazahi A, Ainsworth MA et al. Outcome after discontinuation of infliximab in patients with inflammatory bowel disease in clinical remission: an observational Danish single center study. Scand J Gastroenterol 2012; 47(5): 518– 527. doi: 10.3109/ 00365521.2012.660541.
108. Louis E, Mary JY, Vernier‑ Massouille Get al. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology 2012; 142: 63– 70; quiz e31. doi: 10.1053/ j.gastro.2011.09.034.
109. Molander P, Färkkilä M, Salminen K et al. Outcome after discontinuation of TNFα‑blocking therapy in patients with inflammatory bowel diseasein deep remission. Inflamm Bowel Dis 2014; 20(6): 1021– 1028. doi: 10.1097/ MIB.0000000000000052.
110. Bortlik M, Duricova D, Machkova N et al. Discontinuation of anti‑tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation. Scand J Gastroenterol 2016; 51(2): 196– 202. doi: 10.3109/ 00365521.2015.1079924.
111. Torres J, Boyapati RK, Kennedy NA et al. Systematic review of effects of withdrawal of immunomodulators or biologic agents from patients with inflammatory bowel disease. Gastroenterology 2015; 149(7): 1716– 1730. doi: 10.1053/ j.gastro.2015.08.055.
112. Pariente B, Laharie D. Review article: why, when and how to de‑ escalate therapy in inflammatory bowel diseases. Aliment Pharmacol Ther 2014; 40(4): 338– 353. doi: 10.1111/ apt.12838.
113. van der Woude CJ, Ardizzone S, Bengtson MB et al. The second European evidenced‑based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis 2015; 9(2): 107– 124.
114. Nguyen GC, Seow CH, Maxwell C et al. The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy. Gastroenterology 2015. S0016– 5085(15)01773– 4. doi: 10.1053/ j.gastro.2015.12.003.
115. Bortlik M, Machkova N, Duricova D et al. Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti‑TNF‑α therapy during pregnancy: three‑ center study. Scand J Gastroenterol 2013; 48(8): 951– 958. doi: 10.3109/ 00365521.2013.812141.
116. Bortlik M, Duricova D, Machkova Net al. Impact of anti‑tumor necrosis factor alpha antibodies administered to pregnant women with inflammatory bowel disease on long‑term outcome of exposed children. Inflamm Bowel Dis 2014; 20(3): 495– 501. doi: 10.1097/ 01.MIB.0000440984.86659.4f.
117. 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; quiz e24. doi: 10.1016/ j.cgh.2012.11.011.
118. Zelinkova Z, van der Ent C, Bruin KF et al. Effects of discontinuing anti‑tumor necrosis factor therapy during pregnancy on the course of inflammatory bowel disease and neonatal exposure. Clin Gastroenterol Hepatol 2013; 11(3): 318– 321. doi: 10.1016/ j.cgh.2012.10.024.
119. Šerclová Z, Ryska O, Bortlík M et al. Doporučené postupy chirurgické léčby pacientů s nespecifickými střevními záněty – 1. část: předoperační příprava. Gastroent Hepatol 2015; 69(1): 12– 24. doi: 10.14735/ amgh201512.
120. Panés J, Bouzas R, Chaparro M et al. Systematic review: the use of ultrasonography, computed tomography and magnetic resonance imaging for the diagnosis, assessment of activity and abdominal complications of Crohn's disease. Aliment Pharmacol Ther 2011; 34(2): 125– 145. doi: 10.1111/ j.1365‑ 2036.2011.04710.x.
121. Narula N, Charleton D, Marshall JK. Meta‑analysis: peri‑ operative anti‑TNFα treatment and post‑operative complications in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2013; 37(11): 1057– 1064. doi: 10.1111/ apt.12313.
122. Kopylov U, Ben‑ Horin S, Zmora O et al.Anti‑tumor necrosis factor and postoperative complications in Crohn's disease: systematic review and meta‑analysis. Inflamm Bowel Dis 2012; 18(12): 2404– 2413. doi: 10.1002/ ibd.22954.
123. Rosenfeld G, Qian H, Bressler B. The risks of post‑operative complications following pre‑operative infliximab therapy for Crohn's disease in patients undergoing abdominal surgery: a systematic review and meta‑analysis. J Crohns Colitis 2013; 7(11): 868– 877. doi: 10.1016/ j.crohns.2013.01.019.
124. Lau C, Dubinsky M, Melmed G et al. The impact of preoperative serum anti‑TNFα therapy levels on early postoperative outcomes in inflammatory bowel disease surgery. Ann Surg 2015; 261(3): 487– 496. doi: 10.1097/ SLA.0000000000000757.
125. Liu Z, Song H, Shen B. Pouchitis: prevention and treatment. Curr Opin Clin Nutr Metab Care 2014; 17(5): 489– 495. doi: 10.1097/ MCO.0000000000000094.
126. Pardi DS, D'Haens G, Shen B et al. Clinical guidelines for the management of pouchitis. Inflamm Bowel Dis 2009; 15(9): 1424– 1431. doi: 10.1002/ ibd.21039.
127. Herfarth HH, Long MD, Isaacs KL. Use of biologics in pouchitis: a systematic review. J Clin Gastroenterol 2015; 49(8): 647– 654. doi: 10.1097/ MCG.0000000000000367.
128. Bajer L, Kamenář D, Sticová E et al. Idiopatický střevní zánět u pacientů s primární sklerozující cholangitidou – samostatný fenotyp IBD. Gastroent Hepatol 2014; 68(1): 24– 35.
129. Hyams J, Crandall W, Kugathasan Set al. Induction and maintenance infliximab therapy for the treatment of moderate‑ to‑ severe Crohn's disease in children. Gastroenterology 2007; 132(3): 863– 873.
130. Hyams JS, Griffiths A, Markowitz J et al. Safety and efficacy of adalimumab for moderate to severe Crohn's dis-ease in children. Gastroenterology 2012; 143(2): 365– 374. doi: 10.1053/ j.gastro.2012.04.046.
131. Hyams J, Damaraju L, Blank M et al. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol 2012; 10(4): 391– 399. doi: 10.1016/ j.cgh.2011.11.026.
132. Turner D, Travis SP, Griffiths AM et al.Consensus for managing acute severe ulcerative colitis in children: a systematic review and joint statement from ECCO, ESPGHAN, and the Porto IBD Working Group of ESPGHAN. Am J Gastroenterol 2011; 106(4): 574– 588. doi: 10.1038/ ajg.2010.481.
133. De Ridder L, Rings EH, Damen GM et al. Infliximab dependency in pediatric Crohn's disease: long‑term follow‑up of an unselected cohort. Inflamm Bowel Dis 2008; 14(3): 353– 358.
134. Duricova D, Pedersen N, Lenicek M et al. Infliximab dependency in children with Crohn's disease. Aliment Pharmacol Ther 2009; 29(7): 792– 799. doi: 10.1111/ j.1365‑ 2036.2009.03926.x.
135. Wewer V, Riis L, Vind I et al. Infliximab dependency in a national cohort of children with Crohn's disease. J Pediatr Gastroenterol Nutr 2006; 42(1): 40– 45.
136. Volonaki E, Mutalib M, Kiparissi F et al. Adalimumab as a second-line biological therapy in children with refractory ulcerative colitis. Eur J Gastroenterol Hepatol 2015; 27(12): 1425–1428. doi: 10.1097/MEG.0000000000000470.
137. Steenholdt C, Svenson M, Bendtzen Ket al. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2011; 34(1): 51– 58. doi: 10.1111/ j.1365‑ 2036.2011.04682.x.
138. Lichtenstein GR, Feagan BG, Cohen RDet al. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow‑up in the TREAT™ registry. Am J Gastroenterol 2012; 107(9): 1409– 1422. doi: 10.1038/ ajg.2012.218.
139. Toruner M, Loftus EV, Harmsen WSet al. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology 2008; 134(4): 929– 936. doi: 10.1053/ j.gastro.2008.01.012.
140. Fidder H, Schnitzler F, Ferrante Met al. Long‑term safety of infliximab for the treatment of inflammatory bowel disease: a single‑centre cohort study. Gut 2009; 58(4): 501– 508. doi: 10.1136/ gut.2008.163642.
141. Schneeweiss S, Korzenik J, Solomon DHet al. Infliximab and other immunomodulating drugs in patients with inflammatory bowel disease and the risk of serious bacterial infections. Aliment Pharmacol Ther 2009; 30(3): 253– 264. doi: 10.1111/ j.1365‑ 2036.2009.04037.x.
142. Duricova D, Bortlik M, Komarek V et al. W1906 skin complications during therapy with anti‑TNF preparations: experience of a single centre. Gastroenterology 2010; 138: S763.
143. Fiorino G, Allez M, Malesci A et al. Review article: anti TNF‑alpha induced psoriasis in patients with inflammatory bowel disease. Aliment Pharmacol Ther 2009; 29(9): 921– 927. doi: 10.1111/ j.1365‑ 2036.2009.03955.x.
144. Rahier JF, Buche S, Peyrin‑Biroulet L et al. Severe skin lesions cause patients with inflammatory bowel disease to discontinue anti‑tumor necrosis factor therapy. Clin Gastroenterol Hepatol 2010; 8(12): 1048– 1055. doi: 10.1016/ j.cgh.2010.07.022.
145. Beigel F, Schnitzler F, Paul Laubender R et al. Formation of antinuclear and double‑strand DNA antibodies and frequency of lupus‑like syndrome in anti‑TNF‑α antibody‑treated patients with inflammatory bowel disease. Inflamm Bowel Dis 2011; 17(1): 91– 98. doi: 10.1002/ ibd.21362.
146. Vermeire S, Noman M, Van Assche G et al. Autoimmunity associated with anti‑tumor necrosis factor alpha treatment in Crohn's disease: a prospective cohort study. Gastroenterology 2003; 125(1): 32– 39.
147. Subramanian S, Yajnik V, Sands BE et al. Characterization of patients with infliximab‑induced lupus erythematosus and outcomes after retreatment with a second anti‑TNF agent. Inflamm Bowel Dis 2011; 17(1): 99– 104. doi: 10.1002/ ibd.21370.
148. Peyrin‑Biroulet L, Deltenre P, de Suray Net al. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta‑analysis of placebo‑ controlled trials. Clin Gastroenterol Hepatol 2008; 6(6): 644– 653. doi: 10.1016/ j.cgh.2008.03.014.
149. Long MD, Martin CF, Pipkin CA et al.Risk of melanoma and nonmelanoma skin cancer among patients with inflammatory bowel disease. Gastroenterology 2012; 143(2): 390– 399. doi: 10.1053/ j.gastro.2012.05.004.
150. Singh S, Nagpal SJ, Murad MH et al. Inflammatory bowel disease is associated with an increased risk of melanoma: a systematic review and meta‑analysis. Clin Gastroenterol Hepatol 2014; 12(2): 210– 218. doi: 10.1016/ j.cgh.2013.04.033.
151. Siegel CA, Marden SM, Persing SM et al. Risk of lymphoma associated with combination anti‑tumor necrosis factor and immunomodulator therapy for the treatment of Crohn's disease: a meta‑analysis. Clin Gastroenterol Hepatol 2009; 7(8): 874– 881. doi: 10.1016/ j.cgh.2009.01.004.
152. Mackey AC, Green L, Leptak C et al. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease: update. J Pediatr Gastroenterol Nutr 2009; 48(3): 386– 388.
153. Magro F, Peyrin‑Biroulet L, Sokol H et al.Extra‑ intestinal malignancies in inflammatory bowel disease: results of the 3rd ECCO Pathogenesis Scientific Workshop (III). J Crohns Colitis 2014; 8(1): 31– 44. doi: 10.1016/ j.crohns.2013.04.006.
154. Schreiber S, Panés J, Kwon B et al.Biosimilar infliximab for inflammatory bowel disease: from concepts to clinical practice. Case study illustrated with CT‑ P13. Expert Rev Gastroenterol Hepatol 2015; 9 (Suppl 1): 5– 15. doi: 10.1586/ 17474124.2015.1091304.
155. European Medicines Agency. Questions and answers on biological medicines (similar biological medicinal products). EMA: Volume 2016, 2012.
156. Reinisch W, Louis E, Danese S. The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT‑ P13. Expert Rev Gastroenterol Hepatol 2015; 9 (Suppl 1): 17– 26. doi: 10.1586/ 17474124.2015.1091306.
157. Park W, Hrycaj P, Jeka S et al. A randomised, double‑blind, multicentre, parallel‑ group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT‑ P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72: 1605– 1612.
158. Yoo DH, Hrycaj P, Miranda P et al. A randomised, double‑blind, parallel‑ group study to demonstrate equivalence in efficacy and safety of CT‑ P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013; 72(10): 1613– 1620. doi: 10.1136/ annrheumdis‑ 2012‑ 203090.
159. Hlavaty T, Letkovsky J. Biosimilars in the therapy of inflammatory bowel diseases. Eur J Gastroenterol Hepatol 2014; 26(6): 581– 587. doi: 10.1097/ MEG.0000000000000098.
160. Lukáš M. Remsima™ – první biosimilární infliximab. Gastroent Hepatol 2014; 68(2): 178– 179.
161. Jung YS, Park DI, Kim YH et al. Efficacy and safety of CT‑ P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol 2015; 30(12): 1705– 1712. doi: 10.1111/ jgh.12997.
162. Farkas K, Rutka M, Bálint A et al. Efficacy of the new infliximab biosimilar CT‑ P13 induction therapy in Crohn's disease and ulcerative colitis – experiences from a single center. Expert Opin Biol Ther 2015; 15(9): 1257– 1262. doi: 10.1517/ 14712598.2015.1064893.
163. Gecse KB, Lovász BD, Farkas K et al. Efficacy and safety of the biosimilar infliximab CT‑ P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J CrohnsColitis 2016; 10(2): 133– 140. doi: 10.1093/ ecco‑ jcc/ jjv220.
164. Konečný M. Naše zkušenosti s podáváním biosimilárního infliximabu nemocným s IBD. Gastroent Hepatol 2014; 68 (Suppl 2): 2S13.
165. Jahnsen J, Detlie TE, Vatn S et al. Biosimilar infliximab (CT‑ P13) in the treatment of inflammatory bowel disease: A Norwegian observational study. Expert Rev Gastroenterol Hepatol 2015; 9 (Suppl 1): 45– 52. doi: 10.1586/ 17474124.2015.1091308.
166. Ben‑ Horin S, Yavzori M, Benhar I et al. Cross‑ immunogenicity: antibodies to infliximab in Remicade‑treated patients with IBD similarly recognise the biosimilar Remsima. Gut 2015; pii: gutjnl‑ 2015- 309290. doi: 10.1136/ gutjnl‑ 2015‑ 309290.
167. Malíčková K, Ďuricová D, Bortlík Met al. Serum trough infliximab levels: a comparison of three different immunoassays for the monitoring of CT‑ P13 (infliximab) treatment in patients with inflammatory bowel disease. Biologicals 2016; 44(1): 33– 36. doi: 10.1016/ j.biologicals.2015.09.005.
168. Sieczkowska J, Jarzębicka D, Banaszkiewicz A et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis 2016; 10(2): 127– 132. doi: 10.1093/ ecco‑ jcc/ jjv233.
169. Nikiphorou E, Kautiainen H, Hannonen P et al. Clinical effectiveness of CT‑ P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 2015; 15(12): 1677– 1683. doi: 10.1517/ 14712598.2015.1103733.
170. Park SH, Kim YH, Lee JH et al. Post‑marketing study of biosimilar infliximab (CT‑ P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 2015; 9 (Suppl 1): 35– 44. doi: 10.1586/ 17474124.2015.1091309.
Štítky
Paediatric gastroenterology Gastroenterology and hepatology SurgeryČlánok vyšiel v časopise
Gastroenterology and Hepatology
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