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Фармакотерапия воспалительных заболеваний кишечника: управление эффективностью и безопасностью
Фармакотерапия воспалительных заболеваний кишечника: управление эффективностью и безопасностью
Бакулин И.Г., Скалинская М.И., Маев И.В., Сказываева Е.В., Журавлева М.С., Гайковая Л.Б., Бакулина Н.В., Ермаков А.И., Алексеенко Е.С., Иванова К.Н., Соловьев М.В. Фармакотерапия воспалительных заболеваний кишечника: управление эффективностью и безопасностью. Терапевтический архив. 2021; 93 (8): 841–852. DOI: 10.26442/00403660.2021.08.200982
DOI: 10.26442/00403660.2021.08.200982
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DOI: 10.26442/00403660.2021.08.200982
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
Лечение воспалительных заболеваний кишечника – ВЗК (язвенного колита и болезни Крона) направлено на достижение клинической, эндоскопической и гистологической ремиссии, минимизацию хирургических осложнений, обеспечение нормального качества жизни. Однако применение медикаментозной терапии потенциально связано с разными нежелательными явлениями, среди которых особый риск представляют инфекционные осложнения, злокачественные новообразования, а также миелотоксичность, гепатотоксичность, поражения кожи и некоторые другие. Риск побочных эффектов зависит от вида лекарственной терапии (препараты 5-аминосалициловой кислоты, тиопурины, препараты биологической терапии и т.д.), длительности лечения, наличия внекишечных проявлений и т.д. В статье приводится обзор данных как по эффективности, так и по частоте разных побочных эффектов основных классов препаратов, применяемых при ВЗК, представлены методы исследования, на основе которых можно прогнозировать эффективность и развитие побочных эффектов и выполнение которых может рассматриваться как вариант персонифицированной терапии при ВЗК.
Ключевые слова: воспалительные заболевания кишечника, болезнь Крона, язвенный колит, нежелательные явления, 5-аминосалициловая кислота, тиопурины, биологическая терапия
the duration of treatment, the presence of extra-intestinal manifestations, etc. The article provides an overview of data on both the effectiveness and frequency of various side effects of the main classes of drugs in IBD, presents methods of investigation which can predict the effectiveness and development of side effects, the implementation of which can be considered as a variant of personalized therapy in IBD.
Keywords: inflammatory bowel diseases, Crohn’s disease, ulcerative colitis, safety of inflammatory bowel diseases therapy, efficacy of inflammatory bowel diseases therapy, 5-aminosalicylates, thiopurines, biologic therapy
Ключевые слова: воспалительные заболевания кишечника, болезнь Крона, язвенный колит, нежелательные явления, 5-аминосалициловая кислота, тиопурины, биологическая терапия
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the duration of treatment, the presence of extra-intestinal manifestations, etc. The article provides an overview of data on both the effectiveness and frequency of various side effects of the main classes of drugs in IBD, presents methods of investigation which can predict the effectiveness and development of side effects, the implementation of which can be considered as a variant of personalized therapy in IBD.
Keywords: inflammatory bowel diseases, Crohn’s disease, ulcerative colitis, safety of inflammatory bowel diseases therapy, efficacy of inflammatory bowel diseases therapy, 5-aminosalicylates, thiopurines, biologic therapy
Полный текст
Список литературы
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2. Veselov AV, Belousova EA, Bakulin IG, et al. Otsenka ekonomicheskogo bremeni i tekushchego sostoianiia organizatsii lekarstvennogo obespecheniia patsientov s immunovospalitel’nymi zabolevaniiami (na primere iazvennogo kolita i bolezni Krona) v Rossiiskoi Federatsii. Problemy sotsial’noi gigieny, zdravookhraneniia i istorii meditsiny. 2020;28(S2):1137-45 (in Russian) DOI:10.32687/0869-866X-2020-28-s2-1137-1145
3. Bakulin IG, Avalueva EB, Skazyvaeva EV, et al. Inflammatory bowel diseases: Pocket recommendations for doctors on the management of patients with inflammatory bowel diseases. Moscow; Saint Petersburg: Gruppa Remedium, 2018 (in Russian)
4. Bakulin IG, Zhigalova TN, Latariia EL, et al. Experience of implementing a federal register of patients with inflammatory bowel diseases in St. Petersburg. Farmateka. 2017;S5:56-9 (in Russian)
5. Giraud EL, Thomas PWA, van Lint JA, et al. Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the
IBDREAM Registry. Drug Saf. 2021. DOI:10.1007/s40264-021-01045-3
6. Mouyis M, Flint JD, Giles IP. Safety of anti-rheumatic drugs in men trying to conceive: A systematic review and analysis of published evidence. Semin Arthritis Rheum. 2019;48(5):911-20. DOI:10.1016/j.semarthrit.2018.07.011
7. Ransford RA, Langman MJ. Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines. Gut. 2002;51(4):536-9. DOI:10.1136/gut.51.4.536
8. Nguyen NH, Fumery M, Dulai PS, et al. Comparative efficacy and tolerability of pharmacological agents for management of mild to moderate ulcerative colitis: a systematic review and network meta-analyses. Lancet Gastroenterol Hepatol. 2018;3(11):742-53. DOI:10.1016/S2468-1253(18)30231-0
9. Adiga A, Goldfarb DS. The Association of Mesalamine With Kidney Disease. Adv Chronic Kidney Dis. 2020;27(1):72-6. DOI:10.1053/j.ackd.2019.09.002
10. Ambruzs JM, Walker PD, Larsen CP. The histopathologic spectrum of kidney biopsies in patients with inflammatory bowel disease. Clin J Am Soc Nephrol. 2014;9(2):265-70. DOI:10.2215/cjn.04660513
11. Corica D, Romano C. Renal involvement in inflammatory bowel diseases. J Crohns Colitis. 2016;10(2):226-35. DOI:10.1093/ecco-jcc/jjv138
12. Van Staa TP, Travis S, Leufkens HG, Logan RF. 5-aminosalicylic acids and the risk of renal disease: a large British epidemiologic study. Gastroenterology. 2004;126(7):1733-9. DOI:10.1053/j.gastro.2004.03.016
13. Le Berre C, Roda G, Protic NM, et al. Modern use of 5-aminosalicylic acid compounds for ulcerative colitis. Expert Opin Biol Ther. 2020;20(4):363-78. DOI:10.1080/14712598.2019.1666101
14. Heap GA, So K, Weedon M, et al. Clinical features and HLA association of 5-aminosalicylate (5-ASA)-induced nephrotoxicity in inflammatory bowel disease. J Crohns Colitis. 2016;10(2):149-58. DOI:10.1093/ecco-jcc/jjv219
15. Kornbluth A, Sachar DB. Practice Parameters Committee of the American College of Gastroenterology Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501-23;quiz 524. DOI:10.1038/ajg.2010.52
16. 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
17. Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011;60(5):571-607. DOI:10.1136/gut.2010.224154
18. Hibiya S, Matsuyama Y, Fujii T, et al. 5-aminosalicylate-intolerant patients are at increased risk of colectomy for ulcerative colitis. Aliment Pharmacol Ther. 2021;53(1):103-13. DOI:10.1111/apt.16120
19. Annex I. Summary of product characteristics. Committee for Proprietary Medicinal Products. The European Public Assessment Report (EPAR). Stocrin. The European Agency for the Evaluation of Medicinal Products. London, 1999.
20. Biemans VBC, Savelkoul E, Gabriëls RY, et al. A comparative analysis of tioguanine versus low-dose thiopurines combined with allopurinol in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2020;51(11):1076-86. DOI:10.1111/apt.15730
21. Coenen MJ, de Jong DJ, van Marrewijk CJ, et al.; TOPIC Recruitment Team. Identification of patients with variants in TPMT and dose reduction reduces hematologic events during thiopurine treatment of inflammatory bowel disease. Gastroenterology. 2015;149(4):907-17.e7. DOI:10.1053/j.gastro.2015.06.002
22. Calafat M, Mañosa M, Cañete F, et al.; ENEIDA registry of GETECCU. Increased risk of thiopurine-related adverse events in elderly patients with IBD. Aliment Pharmacol Ther. 2019;50(7):780-8. DOI:10.1111/apt.15458
23. Macaluso FS, Renna S, Maida M, et al. Tolerability profile of thiopurines in inflammatory bowel disease: a prospective experience. Scand J Gastroenterol. 2017;52(9):981-7. DOI:10.1080/00365521.2017.1333626
24. López-Martín C, Chaparro M, Espinosa L, et al. Adverse events of thiopurine immunomodulators in patients with inflammatory bowel disease. Gastroenterol Hepatol. 2011;34(6):385-92. DOI:10.1016/j.gastrohep.2011.03.023
25. de Jong DJ, Derijks LJ, Naber AH, et al. Scand Safety of thiopurines in the treatment of inflammatory bowel disease. J Gastroenterol Suppl. 2003;239:69-72. DOI:10.1080/00855920310002726
26. Saibeni S, Virgilio T, D’Incà R, et al. The use of thiopurines for the treatment of inflammatory bowel diseases in clinical practice. Dig Liver Dis. 2008;40(10):814-20. DOI:10.1016/j.dld.2008.03.016
27. Jharap B, Seinen ML, de Boer NK, et al. Thiopurine therapy in inflammatory bowel disease patients: analyses of two 8-year intercept cohorts. Inflamm Bowel Dis. 2010;16(9):1541-9. DOI:10.1002/ibd.21221
28. Costantino G, Furfaro F, Belvedere A, et al. Thiopurine treatment in inflammatory bowel disease: response predictors, safety, and withdrawal in follow-up.
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30. Van Asseldonk DP, de Boer NK, Peters GJ, et al. On therapeutic drug monitoring of thiopurines in inflammatory bowel disease; pharmacology, pharmacogenomics, drug intolerance and clinical relevance. Curr Drug Metab. 2009;10(9):981-97. DOI:10.2174/138920009790711887
31. de Boer NKH, Peyrin-Biroulet L, Jharap B, et al. Thiopurines in Inflammatory Bowel Disease: New Findings and Perspectives. J Crohns Colitis. 2018;12(5):610-20.
DOI:10.1093/ecco-jcc/jjx181
32. Roberts RL, Barclay ML. Update on thiopurine pharmacogenetics in inflammatory bowel disease. Pharmacogenomics. 2015;16:891-903. DOI:10.2217/pgs.15.29
33. Wong DR, Coenen MJ, Vermeulen SH, et al.; TOPIC recruitment team. Early assessment of thiopurine metabolites identifies patients at risk of thiopurine-induced leukopenia in inflammatory bowel disease. J Crohns Colitis. 2017;11:175-84. DOI:10.1093/ecco-jcc/jjw130
34. Wong DR, Coenen MJ, Derijks LJ, et al.; TOPIC Recruitment Team. Early prediction of thiopurine-induced hepatotoxicity in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45:391-402. DOI:10.1111/apt.13879
35. Relling MV, Schwab M, Whirl-Carrillo M, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for Thiopurine Dosing Based on TPMT and NUDT15 Genotypes: 2018 Update. Clin Pharmacol Ther. 2019;105(5):1095-105. DOI:10.1002/cpt.1304
36. Suiter CC, Moriyama T, Matreyek KA, et al. Massively parallel variant characterization identifies NUDT15 alleles associated with thiopurine toxicity. Proc Natl Acad Sci USA. 2020;117(10):5394-401. DOI:10.1073/pnas.1915680117
37. Kang B, Kim TJ, Choi J, et al. Adjustment of azathioprine dose should be based on a lower 6-TGN target level to avoid leucopenia in NUDT15 intermediate metabolisers. Aliment Pharmacol Ther. 2020;52(3):459-70. DOI:10.1111/apt.15810
38. Teich N, Mohl W, Bokemeyer B, et al.; German IBD Study Group. Azathioprine-induced Acute Pancreatitis in Patients with Inflammatory Bowel Diseases – A Prospective Study on Incidence and Severity. J Crohns Colitis. 2016;10(1):61-8. DOI:10.1093/ecco-jcc/jjv188
39. Timmer A, Patton PH, Chande N, et al. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016;2016(5):CD000478. DOI:10.1002/14651858
40. Lakatos PL, Kiss LS. Current status of thiopurine analogues in the treatment in Crohn’s disease. World J Gastroenterol. 2011;17(39):4372-81.
DOI:10.3748/wjg.v17.i39.4372
41. Siegel CA. Review article: explaining risks of inflammatory bowel disease therapy to patients. Aliment Pharmacol Ther. 2011;33(1):23-32. DOI:10.1111/j.1365-2036.2010.04489.x
42. Jess T, Horváth-Puhó E, Fallingborg J, et al. Cancer Risk in Inflammatory Bowel Disease According to Patient Phenotype and Treatment: A Danish Population-Based Cohort Study. Am J Gastroenterol. 2013. DOI:10.1038/ajg.2013.249
43. Ariyaratnam J, Subramanian V. Association between thiopurine use and nonmelanoma skin cancers in patients with inflammatory bowel disease: a meta-analysis. Am J Gastroenterol. 2014;109:163-9. DOI:10.1038/ajg.2013.451
44. Peyrin-Biroulet L, Chevaux JB, Bouvier AM, et al. Risk of melanoma in patients who receive thiopurines for inflammatory bowel disease is not increased. Am J Gastroenterol. 2012;107:1443-4. DOI:10.1038/ajg.2012.181
45. Jess T, Lopez A, Andersson M, et al. Thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel disease: a meta-analysis. Clin Gastroenterol Hepatol. 2014;12:1793-800.e1. DOI:10.1016/j.cgh.2014.05.019
46. Kotlyar DS, Lewis JD, Beaugerie L, et al. Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis. Clin Gastroenterol Hepatol. 2015;13:847-58.e4;quiz e48-50. DOI:10.1016/j.cgh.2015.03.008
47. Bourrier A, Carrat F, Colombel JF, et al.; CESAME study group. Excess risk of urinary tract cancers in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Aliment Pharmacol Ther. 2016;43:252-61. DOI:10.1111/apt.13466
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IBDREAM Registry. Drug Saf. 2021. DOI:10.1007/s40264-021-01045-3
6. Mouyis M, Flint JD, Giles IP. Safety of anti-rheumatic drugs in men trying to conceive: A systematic review and analysis of published evidence. Semin Arthritis Rheum. 2019;48(5):911-20. DOI:10.1016/j.semarthrit.2018.07.011
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8. Nguyen NH, Fumery M, Dulai PS, et al. Comparative efficacy and tolerability of pharmacological agents for management of mild to moderate ulcerative colitis: a systematic review and network meta-analyses. Lancet Gastroenterol Hepatol. 2018;3(11):742-53. DOI:10.1016/S2468-1253(18)30231-0
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11. Corica D, Romano C. Renal involvement in inflammatory bowel diseases. J Crohns Colitis. 2016;10(2):226-35. DOI:10.1093/ecco-jcc/jjv138
12. Van Staa TP, Travis S, Leufkens HG, Logan RF. 5-aminosalicylic acids and the risk of renal disease: a large British epidemiologic study. Gastroenterology. 2004;126(7):1733-9. DOI:10.1053/j.gastro.2004.03.016
13. Le Berre C, Roda G, Protic NM, et al. Modern use of 5-aminosalicylic acid compounds for ulcerative colitis. Expert Opin Biol Ther. 2020;20(4):363-78. DOI:10.1080/14712598.2019.1666101
14. Heap GA, So K, Weedon M, et al. Clinical features and HLA association of 5-aminosalicylate (5-ASA)-induced nephrotoxicity in inflammatory bowel disease. J Crohns Colitis. 2016;10(2):149-58. DOI:10.1093/ecco-jcc/jjv219
15. Kornbluth A, Sachar DB. Practice Parameters Committee of the American College of Gastroenterology Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501-23;quiz 524. DOI:10.1038/ajg.2010.52
16. 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
17. Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011;60(5):571-607. DOI:10.1136/gut.2010.224154
18. Hibiya S, Matsuyama Y, Fujii T, et al. 5-aminosalicylate-intolerant patients are at increased risk of colectomy for ulcerative colitis. Aliment Pharmacol Ther. 2021;53(1):103-13. DOI:10.1111/apt.16120
19. Annex I. Summary of product characteristics. Committee for Proprietary Medicinal Products. The European Public Assessment Report (EPAR). Stocrin. The European Agency for the Evaluation of Medicinal Products. London, 1999.
20. Biemans VBC, Savelkoul E, Gabriëls RY, et al. A comparative analysis of tioguanine versus low-dose thiopurines combined with allopurinol in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2020;51(11):1076-86. DOI:10.1111/apt.15730
21. Coenen MJ, de Jong DJ, van Marrewijk CJ, et al.; TOPIC Recruitment Team. Identification of patients with variants in TPMT and dose reduction reduces hematologic events during thiopurine treatment of inflammatory bowel disease. Gastroenterology. 2015;149(4):907-17.e7. DOI:10.1053/j.gastro.2015.06.002
22. Calafat M, Mañosa M, Cañete F, et al.; ENEIDA registry of GETECCU. Increased risk of thiopurine-related adverse events in elderly patients with IBD. Aliment Pharmacol Ther. 2019;50(7):780-8. DOI:10.1111/apt.15458
23. Macaluso FS, Renna S, Maida M, et al. Tolerability profile of thiopurines in inflammatory bowel disease: a prospective experience. Scand J Gastroenterol. 2017;52(9):981-7. DOI:10.1080/00365521.2017.1333626
24. López-Martín C, Chaparro M, Espinosa L, et al. Adverse events of thiopurine immunomodulators in patients with inflammatory bowel disease. Gastroenterol Hepatol. 2011;34(6):385-92. DOI:10.1016/j.gastrohep.2011.03.023
25. de Jong DJ, Derijks LJ, Naber AH, et al. Scand Safety of thiopurines in the treatment of inflammatory bowel disease. J Gastroenterol Suppl. 2003;239:69-72. DOI:10.1080/00855920310002726
26. Saibeni S, Virgilio T, D’Incà R, et al. The use of thiopurines for the treatment of inflammatory bowel diseases in clinical practice. Dig Liver Dis. 2008;40(10):814-20. DOI:10.1016/j.dld.2008.03.016
27. Jharap B, Seinen ML, de Boer NK, et al. Thiopurine therapy in inflammatory bowel disease patients: analyses of two 8-year intercept cohorts. Inflamm Bowel Dis. 2010;16(9):1541-9. DOI:10.1002/ibd.21221
28. Costantino G, Furfaro F, Belvedere A, et al. Thiopurine treatment in inflammatory bowel disease: response predictors, safety, and withdrawal in follow-up.
J Crohns Colitis. 2012;6(5):588-96. DOI:10.1016/j.crohns.2011.11.007
29. Moran GW, Dubeau MF, Kaplan GG, et al. Clinical predictors of thiopurine-related adverse events in Crohn’s disease. World J Gastroenterol. 2015;21(25):7795-804. DOI:10.3748/wjg.v21.i25.7795
30. Van Asseldonk DP, de Boer NK, Peters GJ, et al. On therapeutic drug monitoring of thiopurines in inflammatory bowel disease; pharmacology, pharmacogenomics, drug intolerance and clinical relevance. Curr Drug Metab. 2009;10(9):981-97.
DOI:10.2174/138920009790711887
31. de Boer NKH, Peyrin-Biroulet L, Jharap B, et al. Thiopurines in Inflammatory Bowel Disease: New Findings and Perspectives. J Crohns Colitis. 2018;12(5):610-20. DOI:10.1093/ecco-jcc/jjx181
32. Roberts RL, Barclay ML. Update on thiopurine pharmacogenetics in inflammatory bowel disease. Pharmacogenomics. 2015;16:891-903. DOI:10.2217/pgs.15.29
33. Wong DR, Coenen MJ, Vermeulen SH, et al.; TOPIC recruitment team. Early assessment of thiopurine metabolites identifies patients at risk of thiopurine-induced leukopenia in inflammatory bowel disease. J Crohns Colitis. 2017;11:175-84. DOI:10.1093/ecco-jcc/jjw130
34. Wong DR, Coenen MJ, Derijks LJ, et al.; TOPIC Recruitment Team. Early prediction of thiopurine-induced hepatotoxicity in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45:391-402. DOI:10.1111/apt.13879
35. Relling MV, Schwab M, Whirl-Carrillo M, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for Thiopurine Dosing Based on TPMT and NUDT15 Genotypes: 2018 Update. Clin Pharmacol Ther. 2019;105(5):1095-105. DOI:10.1002/cpt.1304
36. Suiter CC, Moriyama T, Matreyek KA, et al. Massively parallel variant characterization identifies NUDT15 alleles associated with thiopurine toxicity. Proc Natl Acad Sci USA. 2020;117(10):5394-401. DOI:10.1073/pnas.1915680117
37. Kang B, Kim TJ, Choi J, et al. Adjustment of azathioprine dose should be based on a lower 6-TGN target level to avoid leucopenia in NUDT15 intermediate metabolisers. Aliment Pharmacol Ther. 2020;52(3):459-70. DOI:10.1111/apt.15810
38. Teich N, Mohl W, Bokemeyer B, et al.; German IBD Study Group. Azathioprine-induced Acute Pancreatitis in Patients with Inflammatory Bowel Diseases – A Prospective Study on Incidence and Severity. J Crohns Colitis. 2016;10(1):61-8. DOI:10.1093/ecco-jcc/jjv188
39. Timmer A, Patton PH, Chande N, et al. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016;2016(5):CD000478. DOI:10.1002/14651858
40. Lakatos PL, Kiss LS. Current status of thiopurine analogues in the treatment in Crohn’s disease. World J Gastroenterol. 2011;17(39):4372-81.
DOI:10.3748/wjg.v17.i39.4372
41. Siegel CA. Review article: explaining risks of inflammatory bowel disease therapy to patients. Aliment Pharmacol Ther. 2011;33(1):23-32. DOI:10.1111/j.1365-2036.2010.04489.x
42. Jess T, Horváth-Puhó E, Fallingborg J, et al. Cancer Risk in Inflammatory Bowel Disease According to Patient Phenotype and Treatment: A Danish Population-Based Cohort Study. Am J Gastroenterol. 2013. DOI:10.1038/ajg.2013.249
43. Ariyaratnam J, Subramanian V. Association between thiopurine use and nonmelanoma skin cancers in patients with inflammatory bowel disease: a meta-analysis. Am J Gastroenterol. 2014;109:163-9. DOI:10.1038/ajg.2013.451
44. Peyrin-Biroulet L, Chevaux JB, Bouvier AM, et al. Risk of melanoma in patients who receive thiopurines for inflammatory bowel disease is not increased. Am J Gastroenterol. 2012;107:1443-4. DOI:10.1038/ajg.2012.181
45. Jess T, Lopez A, Andersson M, et al. Thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel disease: a meta-analysis. Clin Gastroenterol Hepatol. 2014;12:1793-800.e1. DOI:10.1016/j.cgh.2014.05.019
46. Kotlyar DS, Lewis JD, Beaugerie L, et al. Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis. Clin Gastroenterol Hepatol. 2015;13:847-58.e4;quiz e48-50. DOI:10.1016/j.cgh.2015.03.008
47. Bourrier A, Carrat F, Colombel JF, et al.; CESAME study group. Excess risk of urinary tract cancers in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Aliment Pharmacol Ther. 2016;43:252-61. DOI:10.1111/apt.13466
48. Sokol H, Beaugerie L, Maynadié M, et al.; CESAME Study Group. Excess primary intestinal lymphoproliferative disorders in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012;18:2063-71. DOI:10.1002/ibd.22889
49. Mitrev N, Leong RW. Therapeutic drug monitoring of anti-tumour necrosis factor-α agents in inflammatory bowel disease. Expert Opin Drug Saf. 2016;16:303-17. DOI:10.1080/14740338.2017.1269169
50. Lichtenstein GR, Feagan BG, Cohen RD, et 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;107:1409-22. DOI:10.1038/ajg.2012.218
51. Bonovas S, Fiorino G, Allocca M, et al. Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease: a systematic review and network meta-analysis. Clin Gastroenterol Hepatol. 2016;14:1385-97. DOI:10.1016/j.cgh.2016.04.039
52. Meserve J, Aniwan S, Koliani-Pace JL, et al. Retrospective analysis of safety of vedolizumab in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2019;17:1533-40. DOI:10.1016/j.cgh.2018.09.035
53. D’Haens G, Reinisch W, Colombel JF, et al.; ENCORE investigators. Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn’s Disease Treated With Infliximab [Remicade®] or Conventional Therapy. J Crohns Colitis. 2017;11(6):680-9. DOI:10.1093/ecco-jcc/jjw221
54. Kirchgesner J, Lemaitre M, Carrat F, et al. Risk of Serious and Opportunistic Infections Associated With Treatment of Inflammatory Bowel Diseases. Gastroenterology. 2018;155(2):337-46.e10. DOI:10.1053/j.gastro.2018.04.012
55. Andersen N, Pasternak B, Friis-Møller N, et al. Association between tumour necrosis factor-α inhibitors and risk of serious infections in people with inflammatory bowel disease: nationwide Danish cohort study. NMJ. 2015;350:h2809. DOI:10.1136/bmj.h2809
56. Yiu ZZN, Smith CH, Ashcroft DM, et al.; BADBIR Study Group. Risk of Serious Infection in Patients with Psoriasis Receiving Biologic Therapies: A Prospective Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol. 2018;138(3):534-41. DOI:10.1016/j.jid.2017.10.005
57. Papp K, Gottlieb AB, Naldi L, et al. Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Drugs Dermatol. 2015;14(7):706-14.
58. Sandborn WJ, Su C, Sands BE, et al. OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017;376(18):1723-36. DOI:10.1056/nejmoa1606910
59. Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut. 2017;66(5):839-51. DOI:10.1136/gutjnl-2015-311079
60. Dulai PS, Singh S, Jiang X, et al. The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn’s Disease: Results From the US VICTORY Consortium. Am J Gastroenterol. 2016;111(8):1147-55. DOI:10.1038/ajg.2016.236
61. Ko JM, Gottlieb AB, Kerbleski JF. Induction and exacerbation of psoriasis with TNF-blockade therapy: A review and analysis of 127 cases. J Dermatolog Treat. 2009;20:100-8. DOI:10.1080/09546630802441234
62. Cleynen I, Moerkercke WV, Billiet T, et al. Characteristics of Skin Lesions Associated With Anti-Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease. Ann Intern Med. 2015;164:10. DOI:10.7326/m15-0729
63. Osterman MT, Sandborn WJ, Colombel JF, et al. Increased Risk of Malignancy With Adalimumab Combination Therapy, Compared With Monotherapy, for Crohns Disease. Gastroenterology. 2014;146(4). DOI:10.1053/j.gastro.2013.12.025
64. Deepak P, Sifuentes H, Sherid M, et al. T-Cell Non-Hodgkin’s Lymphomas Reported to the FDA AERS With Tumor Necrosis Factor-Alpha (TNF-α) Inhibitors: Results of the REFURBISH Study. Am J Gastroenterol. 2013;108:99-105. DOI:10.1038/ajg.2012.334
65. Lemaitre M, Kirchgesner J, Rudnichi A, et al. Association Between Use of Thiopurines or Tumor Necrosis Factor Antagonists Alone or in Combination and Risk of Lymphoma in Patients With Inflammatory Bowel Disease. JAMA. 2017;318:1679. DOI:10.1001/jama.2017.16071
66. Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs. 2017;31(4):299-316.
DOI:10.1007/s40259-017-0231-8
67. Vermeire S, Gils A, Accossato P, et al. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol. 2018;11:1-13. DOI:10.1177/1756283x17750355
68. Reinhold I, Blümel S, Schreiner J, et al. Clinical Relevance of Anti-TNF Antibody Trough Levels and Anti-Drug Antibodies in Treating Inflammatory Bowel Disease Patients. Inflamm Intest Dis. 2021;6(1):38-47. DOI:10.1159/000511296
69. Grinman AB, de Souza MDGC, Bouskela E, et al. Clinical and laboratory markers associated with anti-TNF-alpha trough levels and anti-drug antibodies in patients with inflammatory bowel diseases. Medicine (Baltimore). 2020;99(10):e19359.
DOI:10.1097/MD.0000000000019359
70. Wilson A, Peel C, Wang Q, et al. HLADQA1*05 genotype predicts anti-drug antibody formation and loss of response during infliximab therapy for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;51(3):356-63. DOI:10.1111/apt.15563
________________________________________________
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33. Wong DR, Coenen MJ, Vermeulen SH, et al.; TOPIC recruitment team. Early assessment of thiopurine metabolites identifies patients at risk of thiopurine-induced leukopenia in inflammatory bowel disease. J Crohns Colitis. 2017;11:175-84. DOI:10.1093/ecco-jcc/jjw130
34. Wong DR, Coenen MJ, Derijks LJ, et al.; TOPIC Recruitment Team. Early prediction of thiopurine-induced hepatotoxicity in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45:391-402. DOI:10.1111/apt.13879
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37. Kang B, Kim TJ, Choi J, et al. Adjustment of azathioprine dose should be based on a lower 6-TGN target level to avoid leucopenia in NUDT15 intermediate metabolisers. Aliment Pharmacol Ther. 2020;52(3):459-70. DOI:10.1111/apt.15810
38. Teich N, Mohl W, Bokemeyer B, et al.; German IBD Study Group. Azathioprine-induced Acute Pancreatitis in Patients with Inflammatory Bowel Diseases – A Prospective Study on Incidence and Severity. J Crohns Colitis. 2016;10(1):61-8. DOI:10.1093/ecco-jcc/jjv188
39. Timmer A, Patton PH, Chande N, et al. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016;2016(5):CD000478. DOI:10.1002/14651858
40. Lakatos PL, Kiss LS. Current status of thiopurine analogues in the treatment in Crohn’s disease. World J Gastroenterol. 2011;17(39):4372-81.
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41. Siegel CA. Review article: explaining risks of inflammatory bowel disease therapy to patients. Aliment Pharmacol Ther. 2011;33(1):23-32. DOI:10.1111/j.1365-2036.2010.04489.x
42. Jess T, Horváth-Puhó E, Fallingborg J, et al. Cancer Risk in Inflammatory Bowel Disease According to Patient Phenotype and Treatment: A Danish Population-Based Cohort Study. Am J Gastroenterol. 2013. DOI:10.1038/ajg.2013.249
43. Ariyaratnam J, Subramanian V. Association between thiopurine use and nonmelanoma skin cancers in patients with inflammatory bowel disease: a meta-analysis. Am J Gastroenterol. 2014;109:163-9. DOI:10.1038/ajg.2013.451
44. Peyrin-Biroulet L, Chevaux JB, Bouvier AM, et al. Risk of melanoma in patients who receive thiopurines for inflammatory bowel disease is not increased. Am J Gastroenterol. 2012;107:1443-4. DOI:10.1038/ajg.2012.181
45. Jess T, Lopez A, Andersson M, et al. Thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel disease: a meta-analysis. Clin Gastroenterol Hepatol. 2014;12:1793-800.e1. DOI:10.1016/j.cgh.2014.05.019
46. Kotlyar DS, Lewis JD, Beaugerie L, et al. Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis. Clin Gastroenterol Hepatol. 2015;13:847-58.e4;quiz e48-50. DOI:10.1016/j.cgh.2015.03.008
47. Bourrier A, Carrat F, Colombel JF, et al.; CESAME study group. Excess risk of urinary tract cancers in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Aliment Pharmacol Ther. 2016;43:252-61. DOI:10.1111/apt.13466
48. Sokol H, Beaugerie L, Maynadié M, et al.; CESAME Study Group. Excess primary intestinal lymphoproliferative disorders in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012;18:2063-71. DOI:10.1002/ibd.22889
49. Mitrev N, Leong RW. Therapeutic drug monitoring of anti-tumour necrosis factor-α agents in inflammatory bowel disease. Expert Opin Drug Saf. 2016;16:303-17. DOI:10.1080/14740338.2017.1269169
50. Lichtenstein GR, Feagan BG, Cohen RD, et 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;107:1409-22. DOI:10.1038/ajg.2012.218
51. Bonovas S, Fiorino G, Allocca M, et al. Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease: a systematic review and network meta-analysis. Clin Gastroenterol Hepatol. 2016;14:1385-97. DOI:10.1016/j.cgh.2016.04.039
52. Meserve J, Aniwan S, Koliani-Pace JL, et al. Retrospective analysis of safety of vedolizumab in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2019;17:1533-40. DOI:10.1016/j.cgh.2018.09.035
53. D’Haens G, Reinisch W, Colombel JF, et al.; ENCORE investigators. Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn’s Disease Treated With Infliximab [Remicade®] or Conventional Therapy. J Crohns Colitis. 2017;11(6):680-9. DOI:10.1093/ecco-jcc/jjw221
54. Kirchgesner J, Lemaitre M, Carrat F, et al. Risk of Serious and Opportunistic Infections Associated With Treatment of Inflammatory Bowel Diseases. Gastroenterology. 2018;155(2):337-46.e10. DOI:10.1053/j.gastro.2018.04.012
55. Andersen N, Pasternak B, Friis-Møller N, et al. Association between tumour necrosis factor-α inhibitors and risk of serious infections in people with inflammatory bowel disease: nationwide Danish cohort study. NMJ. 2015;350:h2809. DOI:10.1136/bmj.h2809
56. Yiu ZZN, Smith CH, Ashcroft DM, et al.; BADBIR Study Group. Risk of Serious Infection in Patients with Psoriasis Receiving Biologic Therapies: A Prospective Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol. 2018;138(3):534-41. DOI:10.1016/j.jid.2017.10.005
57. Papp K, Gottlieb AB, Naldi L, et al. Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Drugs Dermatol. 2015;14(7):706-14.
58. Sandborn WJ, Su C, Sands BE, et al. OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017;376(18):1723-36. DOI:10.1056/nejmoa1606910
59. Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut. 2017;66(5):839-51. DOI:10.1136/gutjnl-2015-311079
60. Dulai PS, Singh S, Jiang X, et al. The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn’s Disease: Results From the US VICTORY Consortium. Am J Gastroenterol. 2016;111(8):1147-55. DOI:10.1038/ajg.2016.236
61. Ko JM, Gottlieb AB, Kerbleski JF. Induction and exacerbation of psoriasis with TNF-blockade therapy: A review and analysis of 127 cases. J Dermatolog Treat. 2009;20:100-8. DOI:10.1080/09546630802441234
62. Cleynen I, Moerkercke WV, Billiet T, et al. Characteristics of Skin Lesions Associated With Anti-Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease. Ann Intern Med. 2015;164:10. DOI:10.7326/m15-0729
63. Osterman MT, Sandborn WJ, Colombel JF, et al. Increased Risk of Malignancy With Adalimumab Combination Therapy, Compared With Monotherapy, for Crohns Disease. Gastroenterology. 2014;146(4). DOI:10.1053/j.gastro.2013.12.025
64. Deepak P, Sifuentes H, Sherid M, et al. T-Cell Non-Hodgkin’s Lymphomas Reported to the FDA AERS With Tumor Necrosis Factor-Alpha (TNF-α) Inhibitors: Results of the REFURBISH Study. Am J Gastroenterol. 2013;108:99-105. DOI:10.1038/ajg.2012.334
65. Lemaitre M, Kirchgesner J, Rudnichi A, et al. Association Between Use of Thiopurines or Tumor Necrosis Factor Antagonists Alone or in Combination and Risk of Lymphoma in Patients With Inflammatory Bowel Disease. JAMA. 2017;318:1679. DOI:10.1001/jama.2017.16071
66. Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs. 2017;31(4):299-316.
DOI:10.1007/s40259-017-0231-8
67. Vermeire S, Gils A, Accossato P, et al. Immunogenicity of biologics in inflammatory bowel disease. Therap Adv Gastroenterol. 2018;11:1-13. DOI:10.1177/1756283x17750355
68. Reinhold I, Blümel S, Schreiner J, et al. Clinical Relevance of Anti-TNF Antibody Trough Levels and Anti-Drug Antibodies in Treating Inflammatory Bowel Disease Patients. Inflamm Intest Dis. 2021;6(1):38-47. DOI:10.1159/000511296
69. Grinman AB, de Souza MDGC, Bouskela E, et al. Clinical and laboratory markers associated with anti-TNF-alpha trough levels and anti-drug antibodies in patients with inflammatory bowel diseases. Medicine (Baltimore). 2020;99(10):e19359.
DOI:10.1097/MD.0000000000019359
70. Wilson A, Peel C, Wang Q, et al. HLADQA1*05 genotype predicts anti-drug antibody formation and loss of response during infliximab therapy for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;51(3):356-63. DOI:10.1111/apt.15563
Авторы
И.Г. Бакулин1, М.И. Скалинская*1, И.В. Маев2, Е.В. Сказываева1, М.С. Журавлева1, Л.Б. Гайковая1, Н.В. Бакулина1, А.И. Ермаков1, Е.С. Алексеенко1, К.Н. Иванова1, М.В. Соловьев3
1 ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия;
2 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия;
3 ФГБВОУ ВО «Военно-медицинская академия им. С.М. Кирова» Минобороны России, Санкт-Петербург, Россия
* mskalinskaya@yahoo.com
1 Mechnikov North-Western State Medical University, Saint Petersburg, Russia;
2 Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia;
3 Kirov Military Medical Academy, Saint Petersburg, Russia
* mskalinskaya@yahoo.com
1 ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия;
2 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия;
3 ФГБВОУ ВО «Военно-медицинская академия им. С.М. Кирова» Минобороны России, Санкт-Петербург, Россия
* mskalinskaya@yahoo.com
________________________________________________
1 Mechnikov North-Western State Medical University, Saint Petersburg, Russia;
2 Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia;
3 Kirov Military Medical Academy, Saint Petersburg, Russia
* mskalinskaya@yahoo.com
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