Skip to main content

Biologics and Inflammatory Bowel Disease

  • Chapter
  • First Online:
GI Surgery Annual

Part of the book series: GI Surgery Annual ((GISA,volume 25))

Abstract

Inflammatory bowel disease is an immune-mediated disorder involving a complex interplay of host genetics and environmental factors. With the unraveling of various immune mechanisms involved in the disease pathogenesis, various biologic drugs targeting the mediators in the inflammatory pathways have become an important part of the therapeutics of inflammatory bowel disease. The various biologics available, indications and efficacy of biologics in the management of inflammatory bowel diseases, the risks involved in their usage, and practical aspects in various clinical settings are discussed in the current review.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380:1590–605.

    Article  PubMed  Google Scholar 

  2. Ordas I, Eckmann L, Talamini M, Baumgart DC, Sandborn WJ. Ulcerative colitis. Lancet. 2012;380:1606–19.

    Article  PubMed  Google Scholar 

  3. Chen ML, Sundrud MS. Cytokine networks and T-cell subsets in inflammatory bowel diseases. Inflamm Bowel Dis. 2016;22:1157–67.

    Article  PubMed  Google Scholar 

  4. Mandel MD, Miheller P, Mullner K, Golovics PA, Lakatos PL. Have biologics changed the natural history of Crohn’s disease? Dig Dis. 2014;32:351–9.

    Article  PubMed  Google Scholar 

  5. Levin AD, Wildenberg ME, van den Brink GR. Mechanism of action of anti-TNF therapy in inflammatory bowel disease. J Crohns Colitis. 2016;10:989–97.

    Article  PubMed  Google Scholar 

  6. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–76.

    Article  CAS  PubMed  Google Scholar 

  7. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011;60:780–7.

    Article  CAS  PubMed  Google Scholar 

  8. 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;142:257–65.

    Article  CAS  PubMed  Google Scholar 

  9. 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;146:85–95.

    Article  CAS  PubMed  Google Scholar 

  10. Reinisch W, Sandborn WJ, Rutgeerts P, Feagan BG, Rachmilewitz D, et al. Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies. Inflamm Bowel Dis. 2012;18:201–11.

    Article  PubMed  Google Scholar 

  11. Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, et al. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2 and 3. Am J Gastroenterol. 2014;109:1771–80.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014;146:96–109.

    Article  CAS  PubMed  Google Scholar 

  13. Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, et al. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet. 2012;380:1909–15.

    Article  CAS  PubMed  Google Scholar 

  14. Laharie D, Bourreille A, Branche J, Allez M, Bouhnik Y, et al. Long-term outcomes in a cohort of patients with acute severe ulcerative colitis refractory to intravenous steroids treated with cyclosporine or infliximab. Gastroenterology. 2015;148(Suppl1):S–163.

    Google Scholar 

  15. Williams JG, Alam MF, Alrubaiy L, Arnott I, Clement C, et al. Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial. Lancet Gastroenterol Hepatol. 2016;1:15–24.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Targan SR, Hanauer SB, Van Deventer SJH, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor for Crohn’s disease. N Engl J Med. 1997;337:1029–36.

    Article  CAS  PubMed  Google Scholar 

  17. Lemann M, Mary J-Y, Duclos B, et al. Infliximab plus azathioprine for steroid-dependant Crohn’s disease patients: a randomized placebo-controlled trial. Gastroenterology. 2006;130:1054–61.

    Article  CAS  PubMed  Google Scholar 

  18. 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;130:323–33.

    Article  CAS  PubMed  Google Scholar 

  19. Watanabe M, Hibi T, Lomax KG, et al. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn’s disease. J Crohns Colitis. 2012;6:160–73.

    Article  PubMed  Google Scholar 

  20. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med. 2007;357:228–38.

    Article  CAS  PubMed  Google Scholar 

  21. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomized trial. Lancet. 2002;359:1541–9.

    Article  CAS  PubMed  Google Scholar 

  22. Sandborn WJ, Hanauer SB, Rutgeerts P, et al. Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial. Gut. 2007;56:1232–9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. 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;132:52–65.

    Article  CAS  PubMed  Google Scholar 

  24. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239–50.

    Article  CAS  PubMed  Google Scholar 

  25. D’haens G, Van Deventer S, Van Hogezand R, et al. Endoscopic and histologic healing with infliximab anti-tumor necrosis factor antibodies in Crohn’s disease: a European multicentre trial. Gastroenterology. 1999;116:1029–34.

    Article  PubMed  Google Scholar 

  26. Rutgeerts P, Feagan BG, Lichtenstein GR, et al. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn’s disease. Gastroenterology. 2004;126:402–13.

    Article  CAS  PubMed  Google Scholar 

  27. Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;362:1383–95.

    Article  CAS  PubMed  Google Scholar 

  28. Rutgeerts P, van Assche G, Sandborn WJ, et al. Adalimumab induces and maintains mucosal healing in patients with Crohn’s disease: data from the EXTEND trial. Gastroenterology. 2012;142:1102–11.

    Article  CAS  PubMed  Google Scholar 

  29. Hebuterne X, Lemann M, Bouhnik Y, et al. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn’s disease following treatment with certolizumab pegol. Gut. 2012;62:201–8.

    Article  PubMed  CAS  Google Scholar 

  30. Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn’s disease. N Engl J Med. 1999;340:1398–405.

    Article  CAS  PubMed  Google Scholar 

  31. Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulising Crohn’s disease. N Engl J Med. 2004;350:876–85.

    Article  CAS  PubMed  Google Scholar 

  32. West RL, van der Woude CJ, Hansen BE, et al. Clinical and endosonographic effect of ciprofloxacin on the treatment of perianal fistulae in Crohn’s disease with infliximab: a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2004;20:1329–36.

    Article  CAS  PubMed  Google Scholar 

  33. Bouguen G, Siproudhis L, Gizard E, et al. Long-term outcome of perianal fistulising Crohn’s disease treated with infliximab. Clin Gastroenterol Hepatol. 2013;11:975–81.

    Article  CAS  PubMed  Google Scholar 

  34. Dewint P, Hansen BE, Verhey E, et al. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn’s disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014;63:292–9.

    Article  CAS  PubMed  Google Scholar 

  35. Gaertner WB, Decanini A, Mellgren A, et al. Does infliximab infusion impact results of operative treatment for Crohn’s perianal fistulas? Dis Colon Rectum. 2007;50:1754–60.

    Article  PubMed  Google Scholar 

  36. Regueiro M, Mardini H. Treatment of perianal fistulising Crohn’s disease with infliximab alone or as an adjunct to exam under anaesthesia with seton placement. Inflamm Bowel Dis. 2003;9:98–103.

    Article  PubMed  Google Scholar 

  37. Amiot A, Setakhr V, Seksik P, et al. Long-term outcome of enterocutaneous fistula in patients with Crohn’s disease treated with anti-TNF therapy: a cohort study from the GETAID. Am J Gastroenterol. 2014;109:1443–9.

    Article  CAS  PubMed  Google Scholar 

  38. Bouhnik Y, Carbonnel F, Laharie D, et al. Efficacy of adalimumab in patients with Crohn’s disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study. Gut. 2017;67(1):53–60. pii: gutjnl-2016-312581.

    Article  PubMed  CAS  Google Scholar 

  39. D’Haens G, Baert F, van Assche G, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomized trial. Lancet. 2008;371:660–7.

    Article  PubMed  CAS  Google Scholar 

  40. Solberg IC, Vatn MH, Hoie O, et al. Clinical course in Crohn’s disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol. 2007;5:1430–8.

    Article  PubMed  Google Scholar 

  41. Regueiro M, Schraut W, Baidoo L, et al. Infliximab prevents Crohn’s disease recurrence after ileal resection. Gastroenterology. 2009;136:441–50.

    Article  CAS  PubMed  Google Scholar 

  42. Regueiro M, Kip KE, Baidoo L, et al. Postoperative therapy with infliximab prevents long-term Crohn’s disease recurrence. Clin Gastroenterol Hepatol. 2014;12:1494–502.

    Article  CAS  PubMed  Google Scholar 

  43. Regueiro M, Feagan BG, Zou B, et al. Infliximab reduces endoscopic, but not clinical, recurrence of Crohn’s disease after ileocolonic resection. Gastroenterology. 2016;7:1568–78.

    Article  CAS  Google Scholar 

  44. De Cruz P, Kamm MA, Hamilton AL, et al. Crohn’s disease management after intestinal resection: a randomised trial. Lancet. 2015;385:1406–17.

    Article  PubMed  Google Scholar 

  45. De Cruz P, Kamm MA, Hamilton AL, et al. Efficacy of thiopurines and adalimumab in preventing Crohn’s disease recurrence in high-risk patients – a POCER study analysis. Aliment Pharmacol Ther. 2015;42:867–79.

    Article  PubMed  CAS  Google Scholar 

  46. Qiu Y, Mao R, Chen BL, et al. Systematic review with meta-analysis of prospective studies: anti-tumour necrosis factor for prevention of postoperative Crohn’s disease recurrence. J Crohns Colitis. 2015;9:918–27.

    Article  PubMed  Google Scholar 

  47. Singh S, Garg SK, Pardi DS, et al. Comparative efficacy of pharmacologic interventions in preventing relapse of Crohn’s disease after surgery: a systematic review and network meta-analysis. Gastroenterology. 2015;148:64–76.

    Article  CAS  PubMed  Google Scholar 

  48. Feagan BG, McDonald JW, Panaccione R, et al. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn’s disease. Gastroenterology. 2014;146:681–8.

    Article  CAS  PubMed  Google Scholar 

  49. 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;146:392–400.

    Article  CAS  PubMed  Google Scholar 

  50. Jones JL, Kaplan GG, Peyrin-Biroulet L, et al. Effects of concomitant immunomodulator therapy on efficacy and safety of anti-tumor necrosis factor therapy for Crohn’s disease: a meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol. 2015;13:2233–40.

    Article  CAS  PubMed  Google Scholar 

  51. Kopylov U, Al-Taweel T, Yaghaabi M, et al. Adalimumab monotherapy versus combination therapy with immunomodulators in patients with Crohn’s disease: a systematic review and meta-analysis. J Crohns Colitis. 2014;8:1632–41.

    Article  PubMed  Google Scholar 

  52. Qiu Y, Mao R, Chen BL, et al. Effects of combination therapy with immunomodulators on trough levels and antibodies against tumor necrosis factor antagonists in patients with inflammatory bowel disease: a meta-analysis. Clin Gastroenterol Hepatol. 2017;15(9):1359–1372.e6.

    Article  CAS  PubMed  Google Scholar 

  53. Fiorino G, Manetti N, Armuzzi A, et al. The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar. Inflamm Bowel Dis. 2017;23:233–43.

    Article  PubMed  Google Scholar 

  54. Gecse KB, Lovasz 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 Crohns Colitis. 2016;10:133–40.

    Article  PubMed  Google Scholar 

  55. Molnar T, Farkas K, Rutka M, et al. P675 Infliximab biosimilar CT-P13 therapy is effective in maintaining clinical remission in Crohn’s disease and ulcerative colitis – 54 week data. J Crohns Colitis. 2017;11(Suppl1):S425–6.

    Article  Google Scholar 

  56. Farkas K, Rutka M, Golovics PA, et al. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis. 2016;10:1273–8.

    Article  PubMed  Google Scholar 

  57. Van Assche G, Vermeire S, Ballet V, et al. Switch to adalimumab in patients with Crohn’s disease controlled by maintenance infliximab: prospective randomised SWITCH trial. Gut. 2012;61:229–34.

    Article  PubMed  CAS  Google Scholar 

  58. Smits LJ, Derikx LA, de Jong DJ, et al. Clinical outcomes following a switch from remicade to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. J Crohns Colitis. 2016;10:1287–93.

    Article  PubMed  Google Scholar 

  59. Buer LC, Moum BA, Cvancarova M, et al. Switching from remicade to remsima is well tolerated and feasible: a prospective, open-label study. J Crohns Colitis. 2017;11:297–304.

    Article  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  61. Gisbert JP, Marin AC, Chaparro M. The risk of relapse after anti-TNF discontinuation in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2016;111:632–47.

    Article  CAS  PubMed  Google Scholar 

  62. Vavricka SR, Schoepfer SM, et al. Extraintestinal manifestations of inflammatory bowel disease. Inflamm Bowel Dis. 2015;21:1982–92.

    Article  PubMed  Google Scholar 

  63. Arivarasan K, Bhardwaj V, Sud S, et al. Biologics for the treatment of pyoderma gangrenosum in ulcerative colitis. Intest Res. 2016;14:365–8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  64. Targan SR, Feagan BG, Fedorak RN, et al. Natalizumab for the treatment of active Crohn’s disease: results of the ENCORE trial. Gastroenterology. 2007;132:1672–83.

    Article  CAS  PubMed  Google Scholar 

  65. Chandar AK, Singh S, Murad MH, et al. Efficacy and safety of natalizumab and vedolizumab for the management of Crohn’s disease: a systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:1695–708.

    Article  PubMed  Google Scholar 

  66. Sandborn WJ, Colombel JF, Enns R, et al. Natalizumab induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2005;353:1912–25.

    Article  CAS  PubMed  Google Scholar 

  67. Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699–710.

    Article  CAS  PubMed  Google Scholar 

  68. Mosli MH, MacDonald JK, Bickston SJ, et al. Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis. Inflamm Bowel Dis. 2015;21:1151–9.

    Article  PubMed  Google Scholar 

  69. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369:711–21.

    Article  CAS  PubMed  Google Scholar 

  70. 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;147:618–27.

    Article  CAS  PubMed  Google Scholar 

  71. Singh S, Garg SK, Pardi DS, et al. Comparative efficacy of biologic therapy in biologic-naïve patients with Crohn’s disease: a systematic review and network meta-analysis. Mayo Clin Proc. 2014;89:1621–35.

    Article  PubMed  Google Scholar 

  72. Vickers AD, Ainsworth C, Mody R, et al. Systematic review with network meta-analysis: comparative efficacy of biologics in the treatment of moderately to severely active ulcerative colitis. PLoS One. 2016;11:e0165435.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  73. Mahadevan U, Martin C, Sandler RS, et al. PIANO: a 1000 patient prospective registry of pregnancy outcomes in women with IBD exposed to immunomodulators and biologic. Gastroenterology. 2012;142:S149.

    Article  Google Scholar 

  74. Mozaffari S, Abdolqhaffari AH, Nikfar S, et al. Pregnancy outcomes in women with inflammatory bowel disease following exposure to thiopurines and anti tumor necrosis factor drugs: a systematic review with meta-analysis. Hum Exp Toxicol. 2015;34:445–59.

    Article  CAS  PubMed  Google Scholar 

  75. Firan M, Bawdon R, Radu C, et al. The MHC class I related receptor, FcRn, plays an essential role in the maternofetal transfer of gamma-globulin in humans. Int Immunol. 2001;13:993–1002.

    Article  CAS  PubMed  Google Scholar 

  76. Zelinkova Z, de Haar C, de Ridder L, et al. High intra-uterine exposure to infliximab following maternal anti-TNF treatment during pregnancy. Aliment Pharmacol Ther. 2011;33:1053–8.

    Article  CAS  PubMed  Google Scholar 

  77. 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;11:286–92.

    Article  CAS  PubMed  Google Scholar 

  78. Julsgaard M, Christensen LA, Gibson PR, et al. Concentrations of adalimumab and infliximab in mothers and newborns, and effects on infection. Gastroenterology. 2016;151:110–9.

    Article  CAS  PubMed  Google Scholar 

  79. de Lima A, Zelinkova Z, van der Ent C, et al. Tailored anti-TNF therapy during pregnancy in patients with IBD: maternal and fetal safety. Gut. 2016;65:1261–8.

    Article  PubMed  CAS  Google Scholar 

  80. Friend S, Richman S, Bloomgren G, et al. Evaluation of pregnancy outcomes from the Tysabri (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. 2016;16:150.

    Article  PubMed  PubMed Central  Google Scholar 

  81. Mahadevan U, Vermiere S, Lasch K, et al. Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45:941–50.

    Article  CAS  PubMed  Google Scholar 

  82. Sprakes MB, Ford AC, Warren L, et al. Efficacy, tolerability, and predictors of response to infliximab therapy for Crohn’s disease: a large single centre experience. J Crohns Colitis. 2012;6:143–53.

    Article  PubMed  Google Scholar 

  83. Ford AC, Sandborn WJ, Khan KJ, et al. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106:644–59.

    Article  CAS  PubMed  Google Scholar 

  84. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn’s disease: a review. Am J Gastroenterol. 2009;104:760–7.

    Article  CAS  PubMed  Google Scholar 

  85. Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn’s disease: a systematic review. Am J Gastroenterol. 2011;106:674–84.

    Article  CAS  PubMed  Google Scholar 

  86. Schintzler 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;58:492–500.

    Article  CAS  Google Scholar 

  87. Ma C, Huang V, Fedorak DK, et al. Adalimumab dose escalation is effective for managing secondary loss of response in Crohn’s disease. Aliment Pharmacol Ther. 2014;40:1044–55.

    Article  CAS  PubMed  Google Scholar 

  88. Ong DEH, Kamm MA, Hartono JL, et al. Addition of thiopurines can recapture response in patients with Crohn’s disease who have lost response to anti-tumor necrosis factor monotherapy. J Gastroenterol Hepatol. 2013;28:1595–9.

    CAS  PubMed  Google Scholar 

  89. Ben-Horin S, Waterman M, Kopylov U, et al. Addition of an immunomodulator to infliximab therapy eliminates antidrug antibodies in serum and restores clinical response of patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11:444–7.

    Article  CAS  PubMed  Google Scholar 

  90. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn’s disease previously treated with infliximab. Ann Intern Med. 2007;146:829–38.

    Article  PubMed  Google Scholar 

  91. Shelton E, Allegretti JR, Stevens B, et al. Efficacy of vedolizumab as induction therapy in refractory IBD patients: a multicentre cohort. Inflamm Bowel Dis. 2015;21:2879–85.

    Article  PubMed  Google Scholar 

  92. Steenholdt C. Personalized therapy with TNF-inhibitors in Crohn’s disease: optimizing treatment outcomes by monitoring drug levels and anti-drug antibodies. Dan Med J. 2016;63:B5270.

    PubMed  Google Scholar 

  93. Mariette X, Gottenberg JE, Ravaud P, et al. Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries. Rheumatology (Oxford). 2011;50:222–9.

    Article  Google Scholar 

  94. Puri AS, Desai D, Sood A, et al. Infliximab induced tuberculosis in patients with UC: experience from a country with high prevalence of tuberculosis – India. J Gastroenterol Hepatol. 2016;32(6):1191–4. https://doi.org/10.1111/jgh.13669.

    Article  CAS  Google Scholar 

  95. Winthrop KL, Baxter R, Liu L, et al. Mycobacterial diseases and antitumour necrosis factor therapy in USA. Ann Rheum Dis. 2013;72:37–42.

    Article  CAS  PubMed  Google Scholar 

  96. Rahier JF, Magro F, Abreu C, et al. Second European evidence-based consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease. J Crohns Colitis. 2014;8:443–68.

    Article  CAS  PubMed  Google Scholar 

  97. Nanau RM, Cohen LB, Neuman MG. Risk of infections of biological therapies with accent on inflammatory bowel disease. J Pharm Pharm Sci. 2014;17:485–531.

    Article  PubMed  Google Scholar 

  98. Mocci G, Marzo M, Papa A, et al. Dermatological adverse reactions during anti-TNF treatments: focus on inflammatory bowel disease. J Crohns Colitis. 2013;7:769–79.

    Article  PubMed  Google Scholar 

  99. Annese V, Beaugerie L, Egan L, et al. European evidence-based consensus: inflammatory bowel disease and malignancies. J Crohns Colitis. 2015;9:945–65.

    Article  PubMed  Google Scholar 

  100. Xiao X, Chang C. Diagnosis and classification of drug induced autoimmunity (DIA). J Autoimmun. 2014;48-49:66–72.

    Article  CAS  PubMed  Google Scholar 

  101. Lichtenstein L, Ron Y, Kivity S, et al. Infliximab-related infusion reactions: systematic review. J Crohns Colitis. 2015;9:806–15.

    Article  PubMed  PubMed Central  Google Scholar 

  102. Cacciapaglia F, Navarini L, Menna P, et al. Cardiovascular safety of anti-TNF-alpha therapies: facts and unsettled issues. Autoimmun Rev. 2011;10:631–5.

    Article  CAS  PubMed  Google Scholar 

  103. Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut. 2017;66:839–51.

    Article  CAS  PubMed  Google Scholar 

  104. Van Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn’s disease. N Engl J Med. 2005;353:362–8.

    Article  PubMed  Google Scholar 

  105. Bloomgren G, Richman S, Hotermans C, et al. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med. 2012;366:1870–80.

    Article  CAS  PubMed  Google Scholar 

  106. Agarwal A, Kedia S, Jain S, et al. High risk of tuberculosis during infliximab therapy despite tuberculosis screening in inflammatory bowel disease patients in India. Intest Res. 2018;16:588–98.

    Article  PubMed  PubMed Central  Google Scholar 

  107. Kamat N, Kedia S, Ghoshal U, et al. Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: a multicenter study. Indian J Gastroenterol. 2019. https://doi.org/10.1007/s12664-018-0922-1. Epub ahead of print.

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Indian Association of Surgical Gastroenterology

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Pratap Mouli, V., Ahuja, V. (2019). Biologics and Inflammatory Bowel Disease. In: Sahni, P., Pal, S. (eds) GI Surgery Annual. GI Surgery Annual, vol 25. Springer, Singapore. https://doi.org/10.1007/978-981-13-3227-2_3

Download citation

  • DOI: https://doi.org/10.1007/978-981-13-3227-2_3

  • Published:

  • Publisher Name: Springer, Singapore

  • Print ISBN: 978-981-13-3226-5

  • Online ISBN: 978-981-13-3227-2

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics