The london position statement of the world congress of gastroenterology on biological therapy for IBD with the european crohn's and colitis organisation: Safety

American Journal of Gastroenterology

Volumn 106, Issue 9, 2011, Pages 1594-1602

  Van Assche, Gert ^a   Lewis, James D ^b   Lichtenstein, Gary R ^b   Loftus, Edward V ^c   Ouyang, Qin ^d   Panes, Julian ^e   Siegel, Corey A ^f   Sandborn, William J ^g   Travis, Simon P L ^h   Colombel, Jean Frederic ⁱ  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c MAYO CLINIC   (United States)

^d SICHUAN UNIVERSITY   (China)

^e INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^f DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h JOHN RADCLIFFE HOSPITAL   (United Kingdom)

ⁱ LILLE UNIVERSITY HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; INFLIXIMAB; MERCAPTOPURINE; NATALIZUMAB; PLACEBO; TUMOR NECROSIS FACTOR ANTIBODY;

AUTOIMMUNITY; BIOLOGICAL THERAPY; CANCER GROWTH; CANCER RECURRENCE; CANCER RISK; CROHN DISEASE; DEMYELINATION; DRUG EFFICACY; DRUG SAFETY; ECZEMA; ERYTHEMA; HEADACHE; HEPATOSPLENIC T CELL LYMPHOMA; HOSPITALIZATION; HUMAN; IMMUNOGENICITY; IMMUNOMODULATION; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; INFECTION RISK; INJECTION SITE REACTION; LISTERIOSIS; LYMPHOPROLIFERATIVE DISEASE; MYCOSIS; OPPORTUNISTIC INFECTION; OPTIC NEURITIS; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; REVIEW; RHEUMATOID ARTHRITIS; T CELL LYMPHOMA; TUBERCULIN TEST; TUBERCULOSIS; ULCERATIVE COLITIS; URTICARIA; VIRUS INFECTION;

ANTI-INFLAMMATORY AGENTS; ANTIBODIES, MONOCLONAL; HUMANS; INFLAMMATORY BOWEL DISEASES; NEOPLASMS; OPPORTUNISTIC INFECTIONS; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TUMOR NECROSIS FACTOR-ALPHA;

EID: 80052477721     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2011.211     Document Type: Review

References (93)

1. D' Haens G, Panaccione R, Higgins PDR et al. The London Position Statement of the World Congress of Gastroenterology on biological therapy for IBD with the European Crohn's and Colitis Organisation: when to start, when to stop, which drug to choose and how to predict response? Am J Gastroenterol 2011; 106: 199-212.
2. Mahadevan U, Cucchiara S, Hyams J et al. The London Position Statement of the World Congress of Gastroenterology on biological therapy for IBD with the European Crohn's and Colitis Organisation: pregnancy and paediatrics . Am J Gastroenterol 2011; 106: 214-23.
3. Hoentjen F, van Bodegraven AA. Safety of anti-tumor necrosis factor therapy in inflammatory bowel disease. World J Gastroenterol 2009; 15: 2067-73.
4. Listing J, Strangfeld A, Kary S et al. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005; 52: 3403-12. (Pubitemid 41612206)
5. Wolfe F, Caplan L, Michaud K. Treatment for rheumatoid arthritis and the risk of hospitalization for pneumonia-associations with prednisone, disease-modifying antirheumatic drugs, and anti-tumor necrosis factor therapy. Arthritis Rheum 2006; 54: 628-34. (Pubitemid 43228641)
6. Westhovens R, Yocum D, Han J et al. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities-a large, randomized, placebo-controlled trial. Arthritis Rheum 2006; 54: 1075-86. (Pubitemid 43672920)
7. Bongartz T, Sutton AJ, Sweeting MJ et al. 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. (Pubitemid 43736578)
8. Peyrin-Biroulet L, Deltenre P, de Suray N et al. Efficacy and safety of tumor necrosis factor antagonists in Crohn's disease: meta-analysis of placebocontrolled trials. Clin Gastroenterol Hepatol 2008; 6: 644-53. (Pubitemid 351783447)
9. 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. (Pubitemid 41770166)
10. Colombel JF, Sandborn WJ, Panaccione ne R et al. Adalimumab safety in global clinical trials of patients with Crohn's disease. Inflamm Bowel Dis 2009; 9: 1308-19.
11. 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. (Pubitemid 41565956)
12. 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. (Pubitemid 46695722)
13. Lichtenstein GR, Feagan BG, Cohen RD et al. Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol 2006; 4: 621-30.
14. Lichtenstein G, Cohen R, Feagan B et al. Safety of infliximab and other Crohn's disease therapies: TREATTM registry data with 24,575 patientyears of follow-up. Am J Gastroenterol 2008; 103: S436.
15. Colombel JF, Loft us EV Jr, Tremaine WJ et al. The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients. Gastroenterology 2004; 126: 19-31.
16. Caspersen S, Elkjaer M, Riis L et al. Infliximab for inflammatory bowel disease in Denmark 1999-2005: clinical outcome and follow-up evaluation of malignancy and mortality. Clin Gastroenterol Hepatol 2008; 6: 1212-7.
17. Fidder H, Schnitzler F, Ferrante M et al. Long-term safety of infliximab for the treatment of inflammatory bowel disease: a single-centre cohort study. Gut 2009; 58: 501-8.
18. Rahier J-F, Ben-Horin S, Eser A et al. European guidelines on the prevention, detection and management of opportunistic infections in inflammatory bowel disease. J Crohn's Colitis 2009; 3: 47-91.
19. Toruner M, Loft us EV Jr, Harmsen WS et al. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology 2008; 134: 929-36. (Pubitemid 351451967)
20. Colombel JF, Sandborn WJ, Reinisch W et al. SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med 2010; 362: 1383-95.
21. Winthrop KL, Siegel JN, Jereb J et al. Tuberculosis associated with therapy against tumor necrosis factor alpha. Arthritis Rheum 2005; 52: 2968-74. (Pubitemid 41447075)
22. 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.
23. Gomez-Reino JJ, Carmona L, Valverde VR et al. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk-a multicenter active-surveillance report. Arthritis Rheum 2003; 48: 2122-7. (Pubitemid 36959191)
24. Keane J. TNF-blocking agents and tuberculosis: new drugs illuminate an old topic. Rheumatology 2005; 44: 714-20. (Pubitemid 41487198)
25. Askling J, Fored CM, Brandt L et al. Risk and case characteristics of tuberculosis in rheumatoid arthritis associated with tumor necrosis factor antagonists in Sweden. Arthritis Rheum 2005; 52: 1986-92. (Pubitemid 40994319)
26. Wolfe F, Michaud K, Anderson J et al. Tuberculosis infection in patients with rheumatoid arthritis and the effect of infliximab therapy. Arthritis Rheum 2004; 50: 372-9. (Pubitemid 38198820)
27. Schiff MH, Burmester GR, Kent JD et al. Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis. Ann Rheum Dis 2006; 65: 889-94.
28. Centers for Disease Control and Prevention. Tuberculosis associated with blocking agents against tumor necrosis factor-alpha-California, 2002-2003. Morb Mortal Wkly Rep 2004; 53: 683-6.
29. Mow WS, Abreu-Martin MT, Papadakis KA et al. High incidence of anergy in inflammatory bowel disease patients limits the usefulness of PPD screening before infliximab therapy. Clin Gastroenterol Hepatol 2004; 2: 309-13. (Pubitemid 38447195)
30. Rampton DS. Preventing TB in patients with Crohn's disease needing infliximab or other anti-TNF therapy. Gut 2005; 54: 1360-2. (Pubitemid 41375186)
31. Lee JH, Slifman NR, Gershon SK et al. Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor alpha antagonists infliximab and etanercept. Arthritis Rheum 2002; 46: 2565-70. (Pubitemid 36118917)
32. Wood KL, Hage CA, Knox KS et al. Histoplasmosis aft er treatment with anti-tumor necrosis factor-alpha therapy. Am J Respir Crit Care Med 2003; 167: 1279-82. (Pubitemid 36555102)
33. Wallis RS, Broder MS, Wong JY et al. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clin Infect Dis 2004; 38: 1261-5. (Pubitemid 38608568)
34. Belda A, Hinojosa J, Serra B et al. Systemic candidiasis and infliximab therapy. Gastroenterol Hepatol 2004; 27: 365-7. (Pubitemid 38924002)
35. Kaur N, Mahl TC. Pneumocystis jiroveci (carinii) pneumonia aft er infliximab therapy: a review of 84 cases. Dig Dis Sci 2007; 52: 1481-4. (Pubitemid 46776482)
36. Komano Y, Harigai M, Koike R et al. Pneumocystis jiroveci pneumonia in patients with rheumatoid arthritis treated with infliximab: a retrospective review and case-control study of 21 patients. Arthritis Rheum 2009; 61: 305-12.
37. Van der Klooster JM, Bosman RJ, Oudemans-van Straaten HM et al. Disseminated tuberculosis, pulmonary aspergillosis and cutaneous herpes simplex infection in a patient treated with infliximab and methotrexate. Intensive Care Med 2003; 29: 2327-9. (Pubitemid 38030689)
38. Warris A, Bjorneklett A, Gaustad P. Invasive pulmonary aspergillosis associated with infliximab therapy. N Engl J Med 2001; 344: 1099-100. (Pubitemid 32267986)
39. De Rosa FG, Shaz D, Campagna AC et al. Invasive pulmonary aspergillosis soon aft er therapy with infliximab, a tumor necrosis factor-alpha-neutralizing antibody: a possible healthcare-associated case? Infect Control Hosp Epidemiol 2003; 24: 477-82. (Pubitemid 36919265)
40. Gottlieb GS, Lesser CF, Holmes KK et al. Disseminated sporotrichosis associated with treatment with immunosuppressants and tumor necrosis factor-alpha antagonists. Clin Infect Dis 2003; 37: 838-40. (Pubitemid 37153666)
41. Singh SM, Rau NV, Cohen LB et al. Cutaneous nocardiosis complicating management of Crohn's disease with infliximab and prednisone. CMAJ 2004; 171: 1063-4. (Pubitemid 39468715)
42. Shrestha RK, Stoller JK, Honari G et al. Pneumonia due to Cryptococcus neoformans in a patient receiving infliximab: possible zoonotic transmission from a pet cockatiel. Respir Care 2004; 49: 606-8.
43. Arend SM, Kuijper EJ, Allaart CF et al. Cavitating pneumonia after treatment with infliximab and prednisone. Eur J Clin Microbiol Infect Dis 2004; 23: 638-41. (Pubitemid 39222640)
44. Bergstrom L, Yocum DE, Ampel NM et al. Increased risk of coccidioidomycosis in patients treated with tumor necrosis factor alpha antagonists. Arthritis Rheum 2004; 50: 1959-66. (Pubitemid 38725108)
45. Izb é ki F, Roszt ó czy AI, Yobuta JS et al. Severe Listeria meningoencephalitis in an infliximab-treated patient with Crohn's disease. Inflamm Bowel Dis 2008; 14: 429-31. (Pubitemid 351441336)
46. Kesteman T, Yombi JC, Gigi J et al. Listeria infections associated with infliximab: case reports. Clin Rheumatol 2007; 26: 2173-5. (Pubitemid 350120364)
47. Jairath V, Wood E, Hall A et al. Primum non nocere. Gut 2009; 58 (Suppl 1): A39.
48. Haerter G, Manfras BJ, de Jong-Hesse Y et al. Cytomegalovirus retinitis in a patient treated with anti-tumor necrosis factor alpha antibody therapy for rheumatoid arthritis. Clin Infect Dis 2004; 39: E88-94.
49. Helbling D, Breitbach TH, Krause M. Disseminated cytomegalovirus infection in Crohn's disease following anti-tumour necrosis factor therapy. Eur J Gastroenterol Hepatol 2002; 14: 1393-5. (Pubitemid 36054931)
50. Justice EA, Khan SY, Logan S et al. Disseminated cutaneous Herpes Simplex Virus-1 in a woman with rheumatoid arthritis receiving infliximab: a case report. J Med Case Rep 2008; 2: 282.
51. Torre-Cisneros J, del Castillo M, Caston JJ et al. Infliximab does not activate replication of lymphotropic herpesviruses in patients with refractory rheumatoid arthritis. Rheumatology 2005; 44: 1132-5. (Pubitemid 41236019)
52. Major EO. Progressive multifocal leukoencephalopathy in patients on immunomodulatory therapies. Annu Rev Med 2010; 61: 35-47.
53. Clifford DB. Natalizumab and PML: a risky business? Gut 2008; 57: 1347-9.
54. Carson KR, Focosi D, Major EO et al. Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab, and efalizumab: a Review from the Research on Adverse Drug Events and Reports (RADAR) Project. Lancet Oncol 2009; 10: 816-24.
55. Chen Y, Bord E, Tompkins T et al. Asymptomatic reactivation of JC virus in patients treated with natalizumab. N Engl J Med 2009; 361: 1067-74.
56. Adelman B, Sandrock A, Panzara MA. Natalizumab and progressive multifocal leukoencephalopathy. N Engl J Med 2005; 353: 432-3.
57. Lindå H, von Heijne A, Major EO et al. Progressive multifocal leuko encephalopathy aft er natalizumab monotherapy. N Engl J Med 2009; 361: 1081-7.
58. Hanauer SB, Feagan BG, Lichtenstein GR et al. Maintenance infliximab for Crohn's disease: the ACCENT 1 randomised trial. Lancet 2002; 359: 1541-9. (Pubitemid 34621118)
59. Sands BE, Anderson FH, Bernstein CN et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med 2004; 350: 876-85. (Pubitemid 38252535)
60. Colombel JF, Sandborn WJ, Panaccione R et al. Adalimumab safety in global clinical trials of patients with Crohn's disease. Inflamm Bowel Dis 2009; 15: 1308-19.
61. 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. (Pubitemid 47080387)
62. 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. (Pubitemid 47300424)
63. 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. (Pubitemid 47080388)
64. Biancone L, Orlando A, Kohn A et al. Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study. Gut 2006; 55: 228-33. (Pubitemid 43117283)
65. Suissa S. Immortal time bias in observational studies of drug effects. Pharmacoepidemiol Drug Saf 2007; 16: 241-9. (Pubitemid 46431687)
66. Wolfe F, Michaud K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,562 patients during 89,710 person-years of observation. Arthritis Rheum 2007; 56: 1433-9. (Pubitemid 46764070)
67. Burmester GR, Mease PJ, 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.
68. Rennard SI, Fogarty C, Kelsen S et al. The safety and efficacy of infliximab in moderate to severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2007; 175: 926-34. (Pubitemid 46684703)
69. Lees CW, Ali AI, Thompson AI et al. The safety profile of anti-tumour necrosis factor therapy in inflammatory bowel disease in clinical practice: analysis of 620 patient-years follow-up. Aliment Pharmacol Ther 2009; 29: 286-97.
70. Bernstein CN, Blanchard JF, Kliewer E et al. Cancer risk in patients with inflammatory bowel disease: a population-based study. Cancer 2001; 91: 854-62. (Pubitemid 32173312)
71. Palli D, Trallori G, Bagnoli S et al. Hodgkin's disease risk is increased in patients with ulcerative colitis. Gastroenterology 2000; 119: 647-53.
72. Baecklund E, Ekbom A, Spar é n P et al. Disease activity and risk of lymphoma in patients with rheumatoid arthritis: nested case-control study. Br Med J 1998; 317: 180-1. (Pubitemid 28325543)
73. Lewis JD, Bilker WB, Brensinger C et al. Inflammatory bowel disease is not associated with an increased risk of lymphoma. Gastroenterology 2001; 121: 1080-7. (Pubitemid 33022087)
74. Kandiel A, Fraser AG, Korelitz BI et al. Increased risk of lymphoma among inflammatory bowel disease patients treated with azathioprine and 6-mercaptopurine. Gut 2005; 54: 1121-5. (Pubitemid 41025906)
75. Baecklund E, Iliadou A, Askling J et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arth Rheum 2006; 54: 692-701.
76. 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.
77. Siegel CA, Marden SM, Persing SM et al. Risk of lymphoma associated with anti-TNF agents for the treatment of Crohn's disease: a meta-analysis. Clin Gastroenterol Hepatol 2009; 7: 874-81.
78. Mackey AC, Green L, Leptak C et al. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease: update. J Pediatr Gastroenterol Nutr 2009; 48: 386-8.
79. Mackey AC, Green L, Liang LC et al. Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2007; 44: 265-7. (Pubitemid 46175082)
80. Rosh JR, Gross T, Mamula P et al. Hepatosplenic T-cell lymphoma in adolescents and young adults with Crohn's disease: a cautionary tale? Inflamm Bowel Dis 2007; 13: 1024-30. (Pubitemid 47309975)
81. Mittal S, Milner BJ, Johnston PW et al. A case of hepatosplenic gamma-delta T-cell lymphoma with a transient response to fludarabine and alemtuzumab . Eur J Haematol 2006; 76: 531-4.
82. Moran G, Dillon J, Green J. Crohn's disease, hepatosplenic T-cell lymphoma and no biological therapy: are we barking up the wrong tree? Inflamm Bowel Dis 2009; 15: 1281-2.
83. Dixon WG, Watson KD, Lunt M, et al., British Society For Rheumatology Biologics Register Control Centre Consortium; British Society for Rheumatology Biologics Register. Influence of anti-tumor necrosis factor therapy on cancer incidence in patients with rheumatoid arthritis who have had a prior malignancy: results from the British Society for Rheumatology Biologics Register. Arthritis Care Res 2010; 62: 755-63.
84. Cassinnotti A, Travis SPL. Incidence and clinical significance of immunogenicity to infliximab in Crohn's disease: a critical systematic review. Inflamm Bowel Dis 2009; 15: 1264-75.
85. Hanauer SB, Wagner CL, Bala M et al. Incidence and importance of antibody responses to infliximab aft er maintenance or episodic treatment in Crohn's disease. Clin Gastroenterol Hepatol 2004; 2: 542-53. (Pubitemid 38834038)
86. 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. (Pubitemid 36204954)
87. Farrell RJ, Alsahli M, Jeen YT et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology 2003; 124: 917-24. (Pubitemid 36389794)
88. Sandborn WJ. Preventing antibodies to infliximab in patients with Crohn's disease: optimize not immunize. Gastroenterology 2003; 124: 1140-5. (Pubitemid 36389813)
89. Afif W, Loft us EV, Faubion WA et al. Clinical utility of measuring infliximab and human anti-chimeric antibody levels in patients with inflammatory bowel disease. Gastroenterology 2009; 132 (Suppl 2): Abstract 962.
90. Vermeire S, Noman M, Van Assche G et al. Autoimmunity associated with anti tumor necrosis factor alpha therapy in Crohn's disease. A prospective cohort study. Gastroenterology 2003; 125: 32-9. (Pubitemid 36799104)
91. De Bandt M, Sibilia J, Le Lo ë t X et al. Club Rheumatismes et Inflammation. Systemic lupus erythematosus induced by anti-tumour necrosis factor alpha therapy: a French national survey. Arthritis Res Ther 2005; 7: R545-51.
92. Setoguchi S, Schneeweiss S, Avorn J et al. Tumor necrosis factor-alpha antagonist use and heart failure in elderly patients with rheumatoid arthritis. Am Heart J 2008; 156: 336-41.
93. Listing J, Strangfeld A, Kekow J et al. Does tumor necrosis factor alpha inhibition promote or prevent heart failure in patients with rheumatoid arthritis? Arthritis Rheum 2008; 58: 667-77. (Pubitemid 351364864)