Use of biological molecules in the treatment of inflammatory bowel disease

Journal of Internal Medicine

Volumn 270, Issue 1, 2011, Pages 15-28

  Nielsen, O H ^a   Seidelin, J B ^a   Munck, L K ^b   Rogler, G ^c  

^a GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

Author keywords

Biologicals; Crohn's disease; Inflammatory bowel disease; Therapy; Ulcerative colitis

Indexed keywords

ADALIMUMAB; ALPHA4 INTEGRIN; AMFEBUTAMONE; ANTIHISTAMINIC AGENT; ANTIINFECTIVE AGENT; AZATHIOPRINE; C REACTIVE PROTEIN; CALGRANULIN; CERTOLIZUMAB PEGOL; CYCLOSPORIN; ETANERCEPT; GLUCOCORTICOID; HEMOGLOBIN; IMMUNOGLOBULIN G; IMMUNOGLOBULIN G1; INFLIXIMAB; MERCAPTOPURINE; METHOTREXATE; NATALIZUMAB; PARACETAMOL; PLACEBO; TUMOR NECROSIS FACTOR ALPHA; VARENICLINE;

ACUTE FEBRILE NEUTROPHILIC DERMATOSIS; ANAPHYLAXIS; ANTIGEN BINDING; ARTHRALGIA; BINDING AFFINITY; BIOAVAILABILITY; BIOLOGICAL THERAPY; CANCER RISK; CELL ADHESION; CLINICAL TRIAL (TOPIC); CROHN DISEASE; DEMYELINATING NEUROPATHY; DISEASE ACTIVITY; DISEASE ASSOCIATION; DISEASE COURSE; DRUG ACTIVITY; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFECT; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERANCE; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ENTERITIS; ERYTHEMA NODOSUM; FEVER; FOLLOW UP; HEALING; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERSENSITIVITY; HYPOTENSION; IMMUNOGENICITY; IMMUNOSUPPRESSIVE TREATMENT; IN VITRO STUDY; INFECTION RISK; INJECTION SITE REACTION; LEUKOCYTE MIGRATION; LONG TERM CARE; MONOTHERAPY; MUCOSAL HEALING; MULTIPLE SCLEROSIS; MYALGIA; OPTIC NEURITIS; PATIENT SELECTION; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PYODERMA GANGRENOSUM; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; REMISSION; RETROSPECTIVE STUDY; REVIEW; SENSITIVITY AND SPECIFICITY; SHOCK; SINGLE DRUG DOSE; SMOKING CESSATION; T LYMPHOCYTE; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; ULCERATIVE COLITIS; UVEITIS;

ADULT; DRUG ADMINISTRATION SCHEDULE; HUMANS; IMMUNOLOGIC FACTORS; INFLAMMATORY BOWEL DISEASES; PATIENT SELECTION; TUMOR NECROSIS FACTOR-ALPHA;

EID: 79551493970     PISSN: 09546820     EISSN: 13652796     Source Type: Journal    
DOI: 10.1111/j.1365-2796.2011.02344.x     Document Type: Review

References (129)

1. 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: [Epub ahead of print].
2. Feagan BG, Panaccione R, Sandborn WJ et al. Effects of adalimumab therapy on incidence of hospitalization and surgery in Crohn's disease: results from the CHARM study. Gastroenterology 2008; 135: 1493-9.
3. 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.
4. Sandborn WJ, Rutgeerts P, Feagan BG et al. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology 2009; 137: 1250-60.
5. Cohen RD. The pharmacoeconomics of biologic therapy for IBD. Nat Rev Gastroenterol Hepatol 2010; 7: 103-9.
6. 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.
7. Targan SR, Hanauer SB, van Deventer SJ et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med 1997; 337: 1029-35.
8. Breedveld FC. Therapeutic monoclonal antibodies. Lancet 2000; 355: 735-40.
9. Colombel JF, Schwartz DA, Sandborn WJ et al. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut 2009; 58: 940-8.
10. Schreiber S, Sandborn WJ. CLASSIC-I study the efficacy of adalimumab. Gastroenterology 2006; 130: 1929-30.
11. 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.
12. 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.
13. 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.
14. 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.
15. Yousry TA, Major EO, Ryschkewitsch C et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med 2006; 354: 924-33.
16. Edula RG, Picco MF. An evidence-based review of natalizumab therapy in the management of Crohn's disease. Ther Clin Risk Manag 2009; 5: 935-42.
17. Peyrin-Biroulet L, Deltenre P, de SN, Branche J, Sandborn WJ, Colombel JF. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2008; 6: 644-53.
18. D'Haens G, Baert F, van AG et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet 2008; 371: 660-7.
19. Lawson MM, Thomas AG, Akobeng AK. Tumour necrosis factor alpha blocking agents for induction of remission in ulcerative colitis. Cochrane Database Syst Rev 2006; 3: CD005112.
20. Reinisch W, Sandborn W, Hommes D et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis. Gut 2011; 60: [Epub ahead of print].
21. Oussalah A, Danese S, Peyrin-Biroulet L. Efficacy of TNF antagonists beyond one year in adult and pediatric inflammatory bowel diseases: a systematic review. Curr Drug Targets 2010; 11: 156-75.
22. Kaser A, Zeissig S, Blumberg RS. Inflammatory bowel disease. Annu Rev Immunol 2010; 28: 573-621.
23. Schmidt KJ, Buning J, Jankowiak C, Lehnert H, Fellermann K. Crohn's targeted therapy: myth or real goal? Curr Drug Discov Technol 2009; 6: 290-8.
24. Sands BE, Anderson FH, Bernstein CN et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004; 350: 876-85.
25. Allez M, Vermeire S, Mozziconacci N et al. The efficacy and safety of a third anti-TNF monoclonal antibody in Crohn's disease after failure of two other anti-TNF antibodies. Aliment Pharmacol Ther 2010; 31: 92-101.
26. Sandborn WJ, Rutgeerts P, Enns R et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med 2007; 146: 829-38.
27. Schoepfer AM, Vavricka SR, Binek J et al. Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey. Inflamm Bowel Dis 2010; 16: 933-8.
28. Lindberg E, Jarnerot G, Huitfeldt B. Smoking in Crohn's disease: effect on localisation and clinical course. Gut 1992; 33: 779-82.
29. Reese GE, Nanidis T, Borysiewicz C, Yamamoto T, Orchard T, Tekkis PP. The effect of smoking after surgery for Crohn's disease: a meta-analysis of observational studies. Int J Colorectal Dis 2008; 23: 1213-21.
30. Seksik P, Nion-Larmurier I, Sokol H, Beaugerie L, Cosnes J. Effects of light smoking consumption on the clinical course of Crohn's disease. Inflamm Bowel Dis 2009; 15: 734-41.
31. Cosnes J, Beaugerie L, Carbonnel F, Gendre JP. Smoking cessation and the course of Crohn's disease: an intervention study. Gastroenterology 2001; 120: 1093-9.
32. Parsi MA. Does smoking decrease the response to infliximab in patients with Crohn's disease? Inflamm Bowel Dis 2008; 14(Suppl 2): S18-9.
33. Arnott ID, McNeill G, Satsangi J. An analysis of factors influencing short-term and sustained response to infliximab treatment for Crohn's disease. Aliment Pharmacol Ther 2003; 17: 1451-7.
34. Parsi MA, Achkar JP, Richardson S et al. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology 2002; 123: 707-13.
35. Fefferman DS, Lodhavia PJ, Alsahli M et al. Smoking and immunomodulators do not influence the response or duration of response to infliximab in Crohn's disease. Inflamm Bowel Dis 2004; 10: 346-51.
36. Orlando A, Colombo E, Kohn A et al. Infliximab in the treatment of Crohn's disease: predictors of response in an Italian multicentric open study. Dig Liver Dis 2005; 37: 577-83.
37. Vermeire S, Louis E, Carbonez A et al. Demographic and clinical parameters influencing the short-term outcome of anti-tumor necrosis factor (infliximab) treatment in Crohn's disease. Am J Gastroenterol 2002; 97: 2357-63.
38. 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.
39. Jarnerot 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: 1805-11.
40. Halfvarson J, Jarnerot G. Treatment of choice for acute severe steroid-refractory ulcerative colitis is remicade. Inflamm Bowel Dis 2009; 15: 143-5.
41. Larsen S, Bendtzen K, Nielsen OH. Extraintestinal manifestations of inflammatory bowel disease: epidemiology, diagnosis, and management. Ann Med 2010; 42: 97-114.
42. Sieper J, Rudwaleit M, Baraliakos X et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 2009; 68(Suppl 2): ii1-44.
43. Agrawal D, Rukkannagari S, Kethu S. Pathogenesis and clinical approach to extraintestinal manifestations of inflammatory bowel disease. Minerva Gastroenterol Dietol 2007; 53: 233-48.
44. Traczewski P, Rudnicka L. Adalimumab in dermatology. Br J Clin Pharmacol 2008; 66: 618-25.
45. 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: 505-9.
46. Cohen PR. Sweet's syndrome - a comprehensive review of an acute febrile neutrophilic dermatosis. Orphanet J Rare Dis 2007; 2: 34.
47. Foster EN, Nguyen KK, Sheikh RA, Prindiville TP. Crohn's disease associated with Sweet's syndrome and Sjogren's syndrome treated with infliximab. Clin Dev Immunol 2005; 12: 145-9.
48. Ally MR, Veerappan GR, Koff JM. Treatment of recurrent Crohn's uveitis with infliximab. Am J Gastroenterol 2008; 103: 2150-1.
49. Barrie A, Regueiro M. Biologic therapy in the management of extraintestinal manifestations of inflammatory bowel disease. Inflamm Bowel Dis 2007; 13: 1424-9.
50. 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: 2688-90.
51. Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol 2010; 105: 289-97.
52. Bernell O, Lapidus A, Hellers G. Risk factors for surgery and postoperative recurrence in Crohn's disease. Ann Surg 2000; 231: 38-45.
53. Lapidus A, Bernell O, Hellers G, Lofberg R. Clinical course of colorectal Crohn's disease: a 35-year follow-up study of 507 patients. Gastroenterology 1998; 114: 1151-60.
54. Oriuchi T, Hiwatashi N, Kinouchi Y et al. Clinical course and longterm prognosis of Japanese patients with Crohn's disease: predictive factors, rates of operation, and mortality. J Gastroenterol 2003; 38: 942-53.
55. Jess T, Riis L, Vind I et al. Changes in clinical characteristics, course, and prognosis of inflammatory bowel disease during the last 5 decades: a population-based study from Copenhagen, Denmark. Inflamm Bowel Dis 2007; 13: 481-9.
56. Bachmann F, Nast A, Sterry W, Philipp S. Safety and efficacy of the tumor necrosis factor antagonists. Semin Cutan Med Surg 2010; 29: 35-47.
57. Stallmach A, Hagel S, Bruns T. Adverse effects of biologics used for treating IBD. Best Pract Res Clin Gastroenterol 2010; 24: 167-82.
58. Campi P, Benucci M, Manfredi M, Demoly P. Hypersensitivity reactions to biological agents with special emphasis on tumor necrosis factor-alpha antagonists. Curr Opin Allergy Clin Immunol 2007; 7: 393-403.
59. The diagnosis and management of anaphylaxis. Joint Task Force on Practice Parameters, American Academy of Allergy, Asthma and Immunology, American College of Allergy, Asthma and Immunology, and the Joint Council of Allergy, Asthma and Immunology. J Allergy Clin Immunol 1998; 101(6 Pt 2): S465-528.
60. Sandborn WJ, Hanauer SB. Infliximab in the treatment of Crohn's disease: a user's guide for clinicians. Am J Gastroenterol 2002; 97: 2962-72.
61. Gamarra RM, McGraw SD, Drelichman VS, Maas LC. Serum sickness-like reactions in patients receiving intravenous infliximab. J Emerg Med 2006; 30: 41-4.
62. McIlwain L, Carter JD, Bin-Sagheer S, Vasey FB, Nord J. Hypersensitivity vasculitis with leukocytoclastic vasculitis secondary to infliximab. J Clin Gastroenterol 2003; 36: 411-3.
63. Vermeire S, van AG, Rutgeerts P. Serum sickness, encephalitis and other complications of anti-cytokine therapy. Best Pract Res Clin Gastroenterol 2009; 23: 101-12.
64. Du Pan SM, Dehler S, Ciurea A, Ziswiler HR, Gabay C, Finckh A. Comparison of drug retention rates and causes of drug discontinuation between anti-tumor necrosis factor agents in rheumatoid arthritis. Arthritis Rheum 2009; 61: 560-8.
65. Toruner M, Loftus EV Jr, Harmsen WS et al. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology 2008; 134: 929-36.
66. Papa A, Mocci G, Bonizzi M et al. Use of infliximab in particular clinical settings: management based on current evidence. Am J Gastroenterol 2009; 104: 1575-86.
67. 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.
68. 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: 1098-104.
69. del VG-S, Gomez-Camacho F, Poyato-Gonzalez A, Iglesias-Flores EM, de Dios-Vega JF, Sancho-Zapatero R. Infliximab therapy in a patient with Crohn's disease and chronic hepatitis B virus infection. Inflamm Bowel Dis 2004; 10: 701-2.
70. Esteve M, Saro C, Gonzalez-Huix F, Suarez F, Forne M, Viver JM. Chronic hepatitis B reactivation following infliximab therapy in Crohn's disease patients: need for primary prophylaxis. Gut 2004; 53: 1363-5.
71. Lalvani A. Diagnosing tuberculosis infection in the 21st century: new tools to tackle an old enemy. Chest 2007; 131: 1898-906.
72. Chevaux JB, Nani A, Oussalah A et al. Prevalence of hepatitis B and C and risk factors for nonvaccination in inflammatory bowel disease patients in Northeast France. Inflamm Bowel Dis 2010; 10: 916-24.
73. Lozeron P, Denier C, Lacroix C, Adams D. Long-term course of demyelinating neuropathies occurring during tumor necrosis factor-alpha-blocker therapy. Arch Neurol 2009; 66: 490-7.
74. Benavente L, Moris G. Neurologic disorders associated with inflammatory bowel disease. Eur J Neurol 2011; 18: 138-43.
75. Boisse L, Chisholm SP, Lukewich MK, Lomax AE. Clinical and experimental evidence of sympathetic neural dysfunction during inflammatory bowel disease. Clin Exp Pharmacol Physiol 2009; 36: 1026-33.
76. Marehbian J, Arrighi HM, Hass S, Tian H, Sandborn WJ. Adverse events associated with common therapy regimens for moderate-to-severe Crohn's disease. Am J Gastroenterol 2009; 104: 2524-33.
77. Jones JL, Loftus EV Jr. Lymphoma risk in inflammatory bowel disease: is it the disease or its treatment? Inflamm Bowel Dis 2007; 13: 1299-307.
78. Biancone L, Calabrese E, Petruzziello C, Pallone F. Treatment with biologic therapies and the risk of cancer in patients with IBD. Nat Clin Pract Gastroenterol Hepatol 2007; 4: 78-91.
79. Winther KV, Jess T, Langholz E, Munkholm P, Binder V. Long-term risk of cancer in ulcerative colitis: a population-based cohort study from Copenhagen County. Clin Gastroenterol Hepatol 2004; 2: 1088-95.
80. Beaugerie L, Brousse N, Bouvier AM et al. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet 2009; 374: 1617-25.
81. Shale M, Kanfer E, Panaccione R, Ghosh S. Hepatosplenic T cell lymphoma in inflammatory bowel disease. Gut 2008; 57: 1639-41.
82. Kandiel A, Fraser AG, Korelitz BI, Brensinger C, Lewis JD. Increased risk of lymphoma among inflammatory bowel disease patients treated with azathioprine and 6-mercaptopurine. Gut 2005; 54: 1121-5.
83. Navarro JT, Ribera JM, Mate JL et al. Hepatosplenic T-gammadelta lymphoma in a patient with Crohn's disease treated with azathioprine. Leuk Lymphoma 2003; 44: 531-3.
84. Hemminki K, Li X, Sundquist J, Sundquist K. Cancer risks in Crohn disease patients. Ann Oncol 2009; 20: 574-80.
85. D'Haens G. Risks and benefits of biologic therapy for inflammatory bowel diseases. Gut 2007; 56: 725-32.
86. Vermeire S, Noman M, van AG, Baert F, D'Haens G, Rutgeerts P. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 2007; 56: 1226-31.
87. Baert F, Noman M, Vermeire S et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003; 348: 601-8.
88. Lemann M, Mary JY, Duclos B et al. Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial. Gastroenterology 2006; 130: 1054-61.
89. Fergan BG, McDonald JW, Panaccione R et al. A randomised trial of methotrexate in combination with infliximab for the treatment of Crohn's disease. Gastroenterology 2008; 135: 194-5.
90. van Assche G, Magdelaine-Beuzelin C, D'Haens G et al. Withdrawal of immunosuppression in Crohn's disease treated with scheduled infliximab maintenance: a randomized trial. Gastroenterology 2008; 134: 1861-8.
91. Oussalah A, Chevaux JB, Fay R, Sandborn WJ, Bigard MA, Peyrin-Biroulet L. Predictors of infliximab failure after azathioprine withdrawal in Crohn's disease treated with combination therapy. Am J Gastroenterol 2010; 105: 1142-9.
92. Shah SB, Hanauer SB. Risks and benefits of the use of concomitant immunosuppressives and biologics in inflammatory bowel disease. Rev Gastroenterol Disord 2008; 8: 159-68.
93. Karmiris K, Paintaud G, Noman M et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology 2009; 137: 1628-40.
94. Fineberg SE, Galloway JA, Fineberg NS, Rathbun MJ, Hufferd S. Immunogenicity of recombinant DNA human insulin. Diabetologia 1983; 25: 465-9.
95. Bray GL, Gomperts ED, Courter S et al. A multicenter study of recombinant factor VIII (recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. The Recombinate Study Group. Blood 1994; 83: 2428-35.
96. Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther 2002; 24: 1720-40.
97. Lichtenstein GR, Diamond RH, Wagner CL et al. Clinical trial: benefits and risks of immunomodulators and maintenance infliximab for IBD-subgroup analyses across four randomized trials. Aliment Pharmacol Ther 2009; 30: 210-26.
98. Cassinotti A, Ardizzone S, Porro GB. Adalimumab for the treatment of Crohn's disease. Biologics 2008; 2: 763-77.
99. Rivkin A. Certolizumab pegol for the management of Crohn's disease in adults. Clin Ther 2009; 31: 1158-76.
100. Hanauer SB, Wagner CL, Bala M et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol 2004; 2: 542-53.
101. Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol 2006; 4: 1248-54.
102. Bartelds GM, Wijbrandts CA, Nurmohamed MT et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007; 66: 921-6.
103. Radstake TR, Svenson M, Eijsbouts AM et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis 2009; 68: 1739-45.
104. Magdelaine-Beuzelin C, Vermeire S, Goodall M et al. IgG1 heavy chain-coding gene polymorphism (G1m allotypes) and development of antibodies-to-infliximab. Pharmacogenet Genomics 2009; 19: 383-7.
105. Rutgeerts P, Vermeire S, van Assche G. Predicting the response to infliximab from trough serum levels. Gut 2010; 59: 7-8.
106. Plosker GL, Lyseng-Williamson KA. Adalimumab: in Crohn's disease. BioDrugs 2007; 21: 125-32.
107. Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut 2010; 59: 49-54.
108. Ainsworth MA, Bendtzen K, Brynskov J. Tumor necrosis factor-alpha binding capacity and anti-infliximab antibodies measured by fluid-phase radioimmunoassays as predictors of clinical efficacy of infliximab in Crohn's disease. Am J Gastroenterol 2008; 103: 944-8.
109. Afif W, Loftus EV Jr, 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: 1133-9.
110. Bendtzen K, Ainsworth M, Steenholdt C, Thomsen OO, Brynskov J. Individual medicine in inflammatory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies. Scand J Gastroenterol 2009; 44: 774-81.
111. Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359: 1541-9.
112. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006; 295: 2275-85.
113. Svenson M, Geborek P, Saxne T, Bendtzen K. Monitoring patients treated with anti-TNF-alpha biopharmaceuticals: assessing serum infliximab and anti-infliximab antibodies. Rheumatology (Oxford) 2007; 46: 1828-34.
114. Steenholdt C, Thomsen OØ, Brynskov J, Bendtzen K, Ainsworth MA. Discriminating between response types in infliximab-treated patients with Crohn's disease: sensitivity and specificity of combined assessment of infliximab trough levels and anti-drug antibodies. Gastroenterology 2010; 138(suppl. 1): 687-8.
115. Louis E, Belaiche J, Reenaers C. Anti-TNF and Crohn's disease: when should we stop? Curr Drug Targets 2010; 11: 148-51.
116. 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: 492-500.
117. Sandborn WJ, Feagan BG, Hanauer SB et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease. Gastroenterology 2002; 122: 512-30.
118. Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976; 70: 439-44.
119. Vermeire S, Schreiber S, Sandborn WJ, Dubois C, Rutgeerts P. Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity. Clin Gastroenterol Hepatol 2010; 8: 357-63.
120. Best WR. Predicting the Crohn's disease activity index from the Harvey-Bradshaw Index. Inflamm Bowel Dis 2006; 12: 304-10.
121. Gisbert JP, McNicholl AG. Questions and answers on the role of faecal calprotectin as a biological marker in inflammatory bowel disease. Dig Liver Dis 2009; 41: 56-66.
122. von Roon AC, Karamountzos L, Purkayastha S et al. Diagnostic precision of fecal calprotectin for inflammatory bowel disease and colorectal malignancy. Am J Gastroenterol 2007; 102: 803-13.
123. D'Haens G, van DS, Van HR et al. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: a European multicenter trial. Gastroenterology 1999; 116: 1029-34.
124. Louis E, Vernier-Massouille G, Grimaud J et al. Infliximab discontinuation in Crohn's disease patients in stable remission on combined therapy with immunosuppressors: interim analysis of a prospective cohort study. 16th United European Gastroenterology Week 2008; Vienna, October 18-22.
125. Nielsen OH, Rogler G, Hahnloser D, Thomsen OO. Diagnosis and management of fistulizing Crohn's disease. Nat Clin Pract Gastroenterol Hepatol 2009; 6: 92-106.
126. Klareskog L, Catrina AI, Paget S. Rheumatoid arthritis. Lancet 2009; 373: 659-72.
127. Colombel JF, Rutgeerts P, Sandborn WJ et al. Deep remission for adalimumab-treated patients with moderate to severe ileocolonic Crohn's disease. ECCO 2010; Prague, February 25-27.
128. Lichtenstein GR, Cohen RDFBG, Salzberg B et al. Safety of infliximab and other Crohn's disease therapies: TREAT registry data with 27, 762 patient-years of follow-up. Gastroenterology 2010; 138(suppl. 1): S475.
129. Burmester GR, Mease P, Dijkmans BA et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009; 68: 1863-9.