ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ПРИМЕНЕНИЯ ВЕДОЛИЗУМАБА ПРИ БОЛЕЗНИ КРОНА (обзор литературы)

Болезнь Крона, воспалительные заболевания кишечника, ведолизумаб, моноклональные антитела к а4р7-интегрину, ингибиторы ФНО-а, безопасность, эффективность

1. Molodecky, N.A. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. / N.A.Molodecky, I.S.Soon, D.M.Rabi et al. // Gastroenterology. - 2012; 142 (1): 46-54.

2. Munkholm, P. Intestinal cancer risk and mortality in patients with Crohn’s disease. / P.Munkholm, E.Langholz, M.Davidsen et al. // Gastroenterology. -1993; 105 (6): 1716-23.

3. Dignass, A. The second European evidence-based consensus on the diagnosis and management of Crohn’s disease: Current management. / A.Dignass, G.Assche, J.O.Lindsay et al. // J. Crohns Colitis. -2010; 4: 28-62.

4. Peyrin-Biroulet, L. Impact of azathioprine and tumour necrosis factor antagonists on the need for surgery in newly diagnosed Crohn’s disease. / L.Peyrin-Biroulet, A.Oussalah, N.Williet et al. // Gut. - 2011; 60 (7): 930-36.

5. Sandborn, W.J. Current directions in IBD therapy: what goals are feasible with biological modifiers? / W.J.Sandborn // Gastroenterology. - 2008; 135 (5): 1442-44.

6. Vester-Andersen, M.K. Disease course and surgery rates in inflammatory bowel disease: a population-based, 7-year follow-up study in the era of immunomodulating therapy. / M.K.Vester-Andersen, M.V.Prosberg, T.Jess // Am. J. Gastroenterol. - 2014; 109 (5): 705-14.

7. Schreiber, S. Maintenance therapy with certolizumab pegol for Crohn’s disease. /S.Schreiber, M.Khaliq-Kareemi, I.C.Lawrance et al. // N. Engl. J. Med. - 2007; 357 (3): 239-50.

8. Hanauer, S.B. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. /S.B.Hanauer, B.G.Feagan, G.R.Lichtenstein et al. // Lancet. - 2002; 359 (9317): 1541-49.

9. Allez, M. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: definitions, frequency and pharmacological aspects. / M.Allez, K.Karmiris, E.Louis et al. // J. Crohns Colitis. - 2010; 4 (4): 355-66.

10. Hanauer, S.B. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn‘s disease: The Classic-I Trial. / S.B.Hanauer, W.J.Sandborn, P.Rutgeerts et al. // Gastroenterology. - 2006; 130 (2): 323-33.

11. Colombel, J. Adalimumab for maintenance of clinical response and remission in patients with Crohn‘s disease: the charm trial. / J.Colombel, W.J.Sandborn, P.Rutgeerts et al. // Gastroenterology. - 2007; 132 (1): 52-65.

12. Gisbert, J.P. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: a review. / J.P.Gisbert, J.Panés // Am. J. Gastroenterol. - 2009; 104 (3): 760-67.

13. Ben-Horin, S. Review article: loss of response to anti-TNF treatments in Crohn’s disease. / S.Ben-Horin, Y.Chowers // Aliment. Pharmacol. Ther. -2011; 33 (9): 987-95.

14. Gisbert, J.P. Systematic review with metaanalysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed. /J.P.Gisbert, A.C.Marin, A.G.McNicholl et al. // Aliment. Pharmacol. Ther. -2015; 41 (7): 613-23.

15. Hoentjen, F. Safety of anti-tumor necrosis factor therapy in inflammatory bowel disease. /F.Hoentjen, A.A.Bodegraven // World J. Gastroenterol. - 2009; 15 (17): 2067-73.

16. Lichtenstein, G.R. Serious Infection and Mortality in Patients With Crohn’s Disease: More Than 5 Years of Follow-Up in the TREAT™ Registry. /G.R.Lichtenstein, B.G.Feagan, R.D.Cohen // Am. J. Gastroenterol. -2012; 107 (9): 1409-22.

17. Tubach, F. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. / F.Tubach, D.Salmon, P.Ravaud et al. // Arthritis Rheum. - 2009; 60 (7): 1884-94.

18. Stallmach, А. Adverse effects of biologics used for treating IBD. / А.Stallmach, S.Haqel, T.Bruns // Best Pract. Res. Clin. Gastroenterol. - 2010; 24: 167-82.

19. Siegel, C.A. Risk of lymphoma associated with combination anti-tumor necrosis factor and immunomodulator therapy for the treatment of Crohn’s disease: a meta-analysis. / C.A.Siegel, S.M.Marden, S.M.Persing et al. // Clin. Gastroenterol. Hepatol. - 2009; 7 (8): 874-81.

20. Soler, D. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. / D.Soler, T.Chapman, L.L.Yang et al. // J. Pharmacol. Exp.Ther. - 2009; 330 (3): 864-75.

21. Milch, C. Vedolizumab, a monoclonal antibody to the gut homing а4β7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype. / C.Milch, T.Wyant, J.Xu // J. Neuroimmunol. - 2013; 264 (1-2): 123-26.

22. Hesterberg, P.E. Rapid resolution of chronic colitis in the cotton-top tamarin with an antibody to a gut-homing integrin alpha 4 beta 7. / P.E.Hesterberg, D.Winsor-Hines, M.J.Briskin et al. // Gastroenterology. - 1996; 111 (5): 1373-80.

23. Feagan, B.G. Treatment of active Crohn’s disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. / B.G.Feagan, G.R.Greenberg, G.Wild et al. // Clin. Gastroenterol. Hepatol. - 2008; 6 (12): 1370-77.

24. Sandborn, W.J. Vedolizumab as induction and maintenance therapy for Crohn’s disease. / W.J.Sandborn, B.G.Feagan, P.Rutgeerts et al. //N. Engl. J. Med. - 2013; 369 (8): 711-21.

25. Hanauer, S. Long-term efficacy of vedolizumab therapy for Crohn’s disease. / S.Hanauer, P.Rutgeerts, J.Xu et al. // United Eur. Gastroenterol. J. - 2014;(suppl 1): A66. Abstract 0P205.

26. Sands, B.E. Efficacy and safety of retreatment with vedolizumab in patients with Crohn’s disease. / B.E.Sands, I.Shafran, F.A.Farraye et al. // J. Crohns Colitis. - 2015; 9 (suppl. 1): S. 377.

27. Sands, B.E. Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failed. / B.E.Sands, B.G.Feagan, P.Rutgeerts et al. // Gastroenterology. - 2014; 147 (3): 618-627.

28. Bryant, R.V. Introducing vedolizumab to clinical practice: who, when, and how? / R.V.Bryant, W.J.Sandborn, S.P.Travis // J. Crohns Colitis. - 2015; 9 (4): 356-66.

29. Christensen, B. Vedolizumab in the treatment of IBD: the University of Chicago experience. / B.Christensen, R.G.Sarah, J.C.Ruben et al. // Gastroenterology. - 2015; 148 (4): 866.

30. Shelton, E. Efficacy of vedolizumab as induction therapy in refractory IBD patients. / E.Shelton, J.R.Allegretti, B.Stevens et al. // Inflamm. Bowel Dis. - 2015; 21 (12): 2879-85.

31. Amiot, A. Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease. / A.Amiot, J.C.Grimaud, L.Peyrin-Biroulet et al. // Clin. Gastroenterol Hepatol. - 2016.

32. Chaudrey, K. Efficacy and safety of vedolizumab for inflammatory bowel disease in clinical practice. / K.Chaudrey, A.Lightner, S.Singh et al. // Inflamm. Bowel Dis. - 2016; 22 (suppl 1): S19-S20. Abstract P033.

33. Vivio, E.E. Vedolizumab effectiveness and safety over the first year of use in an IBD clinical practice. / E.E.Vivio, N.Kanuri, J.J.Gilbertsen et al. // J. Crohns Colitis. - 2016; 10 (4): 402-9.

34. Papamichail, O. Long-term outcome of IBD patients with primary non-response to anti-TNF therapy. / O.Papamichail, O.Rivals, T.Billiet et al. // Gastroenterology. - 2015; 148 (4): S864. Abstract Tu1343.

35. Hanauer, S. Vedolizumab maintenance therapy for Crohn’s disease: results of GEMINI II, a randomized, placebo-controlled, double-blind, multicenter phase 3 trial. / S.Hanauer, J.F.Colombel, F.Beagan et al. // Am. J. Gastroenterol. - 2012; 107 (Suppl. 1): S. 620.

36. Lam, M.C.W. Vedolizumab for induction of remission in Crohn’s disease in adults, a systematic review and meta-analysis. / M.C.W.Lam, N.Fu, B.Bressler et al. // Gastroenterology. - 2015; 148 (4) Suppl. 1: S. 271-272.

37. Colombel, J.F. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. / J.F.Colombel, B.E.Sands, P.Rutgeerts et al. // Gut. - 2016.

38. Scheinfeld, N. A comprehensive review and evaluation of the side-effects of the tumor necrosis factor alpha blockers etanercept, infliximab and adalimumab. / N.Scheinfeld // J. Dermatolog. Treat. -2004; 15 (5): 280-94.

39. Hochberg, M.C. The benefit/risk profile of TNF-blocking agents: findings of a consensus panel. / M.C.Hochberg, M.G.Lebwohl, S.E.Plevy et al. // Semin. Arthritis Rheum. - 2005; 34 (6): 819-36.

40. Hazlewood, G.S. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis. / G.S.Hazlewood, A.Rezaie, M.Borman et al. // Gastroenterology. - 2015; 148 (2): 344-54.

41. Magro, F. Extra-intestinal malignancies in inflammatory bowel disease: results of the 3rd ECCO Pathogenesis Scientific Workshop (III). / F.Magro, L.Peyrin-Biroulet, H.Sokol et al. // J. Crohns Colitis. -2014; 8: 31-44.

42. Kappelman, M.D. Risk of cancer in patients with inflammatory bowel diseases: a nationwide population-based cohort study with 30 years of follow-up evaluation. / M.D.Kappelman, D.K.Farkas, M.D.Long et al. // Clin. Gastroenterol. Hepatol. -2014; 12: 265-73.

43. Armuzzi, А. Expert consensus paper on the use of Vedolizumab for the management of patients with moderate-to-severe Inflammatory Bowel Disease. / A.Armuzzi, P.Gionchetti, M.Daperno et al. // Dig. Liver Dis. - 2016; 48 (4): 360-70.

44. Colombel, J. et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s Disease: The CHARM Trial. / J.Colombel et al. // Gastroenterology. - 2007 132: 52-65.

45. Schreiber, S. Maintenance Therapy with Certolizumab Pegol for Crohn’s Disease / S.Schreiber et al. // N. Engl. J. Med. - 2007 357: 239-25.

46. Hanauer, S.B. et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. / S.B.Hanauer et al. // Lancet. - 2002 359 (9317): 1541-154.

47. Инструкция по применению лекарственного препарата для медицинского применения Энтивио®.