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Vol. 70, No. 1, 2004
Issue release date: 2004

Safety Aspects of Infliximab in Inflammatory Bowel Disease Patients

A Retrospective Cohort Study in 100 Patients of a German University Hospital

Seiderer J. · Göke B. · Ochsenkühn T.
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Background: Infliximab, a chimeric anti-tumour necrosis factor monoclonal antibody with potent anti-inflammatory effects, represents an effective treatment option in patients with severe inflammatory bowel disease (IBD). Serious side-effects of such an immunomodulating therapy are speculated and therefore we reviewed our clinical experience in a retrospective safety study looking upon a single cohort of 100 IBD patients from a large German University Hospital. Methods: 100 patients with severe Crohn’s disease (n = 92), ulcerative colitis (n = 7) or indeterminate colitis (n = 1) treated with infliximab (5 mg/kg) from January 2000 to December 2003 were retrospectively analysed for acute and subacute adverse events by chart review. Results: Overall, infliximab therapy was generally well tolerated. No fatal complications, malignancies, autoimmune diseases, neurologic or cardiovascular complications were observed in the cohort during the study period. Overall, adverse events were observed in 10 patients: 2 patients showed an acute infusion reaction, 1 patient a serum sickness-like reaction, in 4 patients a bacterial or viral infection occurred, in 1 patient pancytopenia and 2 patients developed surgical complications. Only 6 patients with adverse events required admission to hospital. A case of tuberculosis after infliximab was not found. The lack of adverse side-effects was associated with young median age and infrequent comorbidities of the cohort. Conclusion: Regarding its strong immunomodulating capacity, infliximab appears to be an efficient and relatively safe therapeutic option for patients with severe IBD. However, the use of infliximab requires careful screening and close patient monitoring to identify patients at risk and the infrequent, but sometimes serious complications of infliximab.

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  1. Podolsky DK: Inflammatory bowel disease. N Engl J Med 2002;347:417–429.
  2. Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P: Maintenance infliximab for Crohn’s disease: The ACCENT I randomised trial. Lancet 2002;359:1541–1549.
  3. Sandborn WJ, Feagan BG, Hanauer SB, Present DH, Sutherland LR, Kamm MA, Wolf DC, Baker JP, Hawkey C, Archambault A, Bernstein CN, Novak C, Heath PK, Targan SR; CDP571 Crohn’s Disease Study Group: An engineered human antibody to TNF (CDP571) for active Crohn’s disease: A randomized double-blind placebo-controlled trial. Gastroenterology 2001;120:1330–1338.
  4. Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ: Infliximab for the treatment of fistulas in patients with Crohn’s disease. N Engl J Med 1999;340:1398–1405.
  5. D’Haens GR: Infliximab as disease-modifying therapy. Eur J Gastroenterol Hepatol 2003;15:233–237.
  6. Ochsenkühn T, Göke B, Sackmann M: Combining infliximab with 6-mercaptopurine/azathioprine for fistula therapy in Crohn’s disease. Am J Gastroenterol 2002;97:2022–2025.
  7. Lichtenstein GR, Bala M, Han C, DeWoody K, Schaible T: Infliximab improves quality of life in patients with Crohn’s disease. Inflamm Bowel Dis 2002;8:237–243.
  8. Grange F, Djialali-Bouzina F, Weiss AM, Polette A, Guillaume JC: Corticosteroid-resistant pyoderma gangrenosum associated with Crohn‘s disease: Rapid cure with infliximab. Dermatology 2002;205:278–280.
  9. Herfarth H, Obermeier F, Andus T, Rogler G, Nikolaus S, Kuehbacher T, Schreiber S: 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;97:2688–2690.
  10. Fries W, Giofre MR, Catanoso M, Lo Gullo R: Treatment of acute uveitis associated with Crohn’s disease and sacroileitis with infliximab. Am J Gastroenterol 2002;97:499–500.
  11. Keane J, Gershon S, Wise RP, Mirabile-Levens E, Kasznica J, Schwieterman WD, Siegel JN, Braun MM: Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001;345:1098–1104.
  12. Riegert-Johnson DL, Godfrey JA, Myers JL, Hubmayr RD, Sandborn WJ, Loftus EV Jr: Delayed hypersensitivity reaction and acute respiratory distress syndrome following infliximab infusion. Inflamm Bowel Dis 2002;8:186–191.
  13. Ritz MA, Jost R: Severe pneumococcal pneumonia following treatment with infliximab for Crohn’s disease. Inflamm Bowel Dis 2001;7:327.
  14. Ali Y, Shah S: Infliximab-induced systemic lupus erythematosus. Ann Intern Med. 2002;137:625–626.
  15. Cheifetz A, Smedley M, Martin S, Reiter M, Leone G, Mayer L, Plevy S: The incidence and management of infusion reactions to infliximab: A large center experience. Am J Gastroenterol 2003;98:1315–1324.
  16. Hommes DW, van Deventer SJ: Infliximab therapy in Crohn’s disease: Safety issues. Neth J Med 2003;61:100–104.
  17. Colombel JF, Loftus EV Jr, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, Zinsmeister AR, Sandborn WJ: The safety profile of infliximab in patients with Crohn’s disease: The Mayo clinic experience in 500 patients. Gastroenterology 2004;126:19–31.
  18. Ardizzone S, et al.: Infliximab in treatment of Crohn’s disease: The Milan experience. Dig Liver Dis 2002 34:411–418.
  19. Sample C, et al.: Clinical experience with infliximab for Crohn’s disease: The first 100 patients in Edmonton, Alberta. Can J Gastroenterol 2002;16:165–170.
  20. Cohen RD: Efficacy and safety of repeated Infliximab infusions for Crohn’s disease: 1-Year clinical experience. Inflamm Bowel Dis 2001;7(suppl 1):S17–S22.
  21. Hanauer S, Schaible T, DeWoody K, et al: Long-term follow-up of patients treated with infliximab in clinical trials. Gastroenterology 2000;18:A566.

    External Resources

  22. Baker D, Clark J, Keenan G, Jones S: Tuberculosis occurring in patients receiving the anti-TNF agent infliximab. Arthritis Rheum 2001;118(suppl):A569.
  23. Loddenkemper R, Brendel A, Sagebiel D, Forssbohm M: The state of tuberculosis in Germany in 2000. Pneumologie 2002;56:550–557.
  24. Hanauer SB: Immunogenicity of infliximab in Crohn’s disease. N Engl J Med 2003;348:2155–2156.
  25. Baert F, Noman M, Vermeire S, et al: Influence of the immunogenicity on the long-term efficacy of infliximab in Crohn’s disease. N Engl J Med 2003;348:601.
  26. Sandborn WJ: Preventing antibodies to infliximab in patients with Crohn’s disease: Optimize not immunize. Gastroenterology 2003;124:1140–1145.
  27. Puchner TC, Kugathasan S, Kelly KJ, et al: Successful desensitization and therapeutic use of infliximab in adult and pediatric Crohn’s disease patients with prior anaphylactic reaction. Inflamm Bowel Dis 2001;7:34–37.
  28. Menon Y, Cucurull E, Espinoza LR: Pancytopenia in a patient with scleroderma treated with infliximab. Rheumatology 2003;42:193–194.
  29. Marchesoni A, Arreghini M, Panni B, Battafarano N, Uziel L: Life-threatening reversible bone marrow toxicity in a rheumatoid arthritis patient switched from leflunomide to infliximab. Rheumatology (Oxford) 2003;42:1273–1274.
  30. Jani AL, Hamilos D: Bloody diarrhea, fever and pancytopenia in a patient with active ulcerative colitis. Ann Allergy Asthma Immunol 2003;90:383–388.
  31. Sijpkens YW, Allaart CF, Thompson J, van‘t Wout J, Kluin PM, den Ottolander GJ, Bieger R: Fever and progressive pancytopenia in a 20-year old woman with Crohn’s disease. Ann Hematol 1996;72:286–290.

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