International Journal of Colorectal Disease

, Volume 20, Issue 1, pp 18–23

Effectiveness and tolerability of repeated treatment with infliximab in patients with Crohn’s disease: a retrospective data analysis in Germany

Original Article

Abstract

Aim

The aim was to evaluate the efficacy and safety of repeated treatment with infliximab in patients with chronic active Crohn’s disease under routine conditions in clinics and private practices.

Methods

Patients with active Crohn’s disease were treated with a total of 567 infusions (420 re-infusions) of infliximab. The treatment schedule was at the discretion of the treating physician. Efficacy and tolerability were documented by a standardized questionnaire.

Results

There were indications for therapy in 46% of patients with chronic active disease, fistulas in 15% and combined symptoms in 38%. The mean disease duration was 9.4 years. At the beginning of therapy, 76% of patients were on corticosteroids, 67% received 5-aminosalicylates and 48% azathioprine. The average dose of infliximab administered was 300 mg; the mean interval between individual infusions was 8.7 weeks. Following treatment with infliximab, steroids could be withdrawn in 47% and reduced in 33% of patients, whereas the dosage of 5-aminosalicylates and azathioprine mostly remained unchanged. The efficacy and tolerability of infliximab were judged by the physicians as being very good or good in 73.4 and 88.4% of patients respectively. Further treatment with the anti-TNFα antibody was planned for 61% of patients. Improvement of Crohn’s Disease Activity Index (CDAI), white blood cell (WBC) and C-reactive protein (CRP) levels was noted in almost all patients.

Conclusion

Infliximab used in an individually adapted regimen induced a significant clinical response in the majority of patients with refractory and fistulating Crohn’s disease. In nearly 80% of patients corticosteroids could be withdrawn or reduced and the majority of patients were on azathioprine at the end of follow-up procedures.

Keywords

Crohn’s disease Tumour necrosis factor Monoclonal Infliximab Product surveillance 

References

  1. 1.
    Lochs H, Adler G, Beglinger C, Duchmann R, Emmrich J, Ewe K et al (1999) Anti-TNF antibody in Crohn’s disease—status of information, comments and recommendations of an international working group. Z Gastroenterol 37:509–512PubMedGoogle Scholar
  2. 2.
    Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA et al (1999) Infliximab for the treatment of fistulas in patients with Crohn’s disease. N Engl J Med 340:1398–1405CrossRefPubMedGoogle Scholar
  3. 3.
    Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF et al (2002) Maintenance of infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 359:1541–1549CrossRefPubMedGoogle Scholar
  4. 4.
    Schreiber S, Campieri M, Colombel JF, van Deventer SJ, Feagan B, Fedorak R et al (2001) Use of anti-tumor necrosis factor agents in inflammatory bowel disease. European guidelines for 2001–2003. Int J Colorectal Dis 16:1–11CrossRefPubMedGoogle Scholar
  5. 5.
    Rutgeerts P, D’Haens G, Targan S, Vasiliauskas E, Hanauer SB, Present DH et al (1999) Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn’s disease. Gastroenterology 117:761–769PubMedGoogle Scholar
  6. 6.
    Hommes DW, van de Heisteeg BH, van der Spek M, Bartelsman JF, van Deventer SJ (2002) Infliximab treatment for Crohn’s disease: one year experience in a Dutch academic hospital. Inflamm Bowel Dis 8:81–86CrossRefPubMedGoogle Scholar
  7. 7.
    Sample C, Bailey RJ, Todoruk D, Sadowski D, Gramlich L, Milan M et al (2002) Clinical experience with infliximab for Crohn’s disease: the first 100 patients in Edmonton, Alberta. Can J Gastroenterol 16:165–170PubMedGoogle Scholar
  8. 8.
    Dotan I, Yeshurun D, Hallak A, Horowitz N, Tiomny E, Reif S et al (2001) Treatment of Crohn’s disease with anti TNF alpha antibodies—the experience in the Tel Aviv Medical Center. Harefuah 140:289–293PubMedGoogle Scholar
  9. 9.
    Mortimore M, Gibson PR, Selby WS, Radford-Smith GL, Florin TH (2001) Early Australian experience with infliximab, a chimeric antibody against tumour necrosis factor-alpha, in the treatment of Crohn’s disease: is its efficacy augmented by steroid-sparing immunosuppressive therapy? The Infliximab User Group. Intern Med J 31:146–150CrossRefPubMedGoogle Scholar
  10. 10.
    Ricart E, Panaccione R, Loftus EV, Tremaine WJ, Sandborn WJ (2001) Infliximab for Crohn’s disease in clinical practice at the Mayo Clinic: the first 100 patients. Am J Gastroenterol 96:722–729CrossRefPubMedGoogle Scholar
  11. 11.
    Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters JR, Travers SB, Blank MA, van Deventer SJ (2004) Infliximab maintenance therapy for fistulizing Crohn’s disease. N Engl J Med 350:876–885CrossRefPubMedGoogle Scholar
  12. 12.
    Shergy WJ, Isern RA, Cooley DA, Harshbarger JL, Huffstutter JE, Hughes GM et al (2002) Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis. J Rheumatol 29:667–677PubMedGoogle Scholar
  13. 13.
    Brandt J, Haibel H, Cornely D, Golder W, Gonzalez J, Reddig J et al (2000) Successful treatment of active ankylosing spondylitis with the anti-tumor necrosis factor alpha monoclonal antibody infliximab. Arthritis Rheum 43:1346–1352CrossRefPubMedGoogle Scholar
  14. 14.
    Braun J, Brandt J, Listing J, Zink A, Alten R, Golder W et al (2002) Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet 359:1187–1193CrossRefPubMedGoogle Scholar
  15. 15.
    Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T et al (1997) A short-term study of chimeric monoclonal antibody cA2 to tumour necrosis factor alpha for Crohn’s disease. Crohn’s disease cA2 Study Group. N Engl J Med 337:1029–1035CrossRefPubMedGoogle Scholar
  16. 16.
    Stange EF, Schreiber S, Raedler A, Stallmach A, Schoelmerich J, Loeschke K et al (1997) Therapy of Crohn’s disease—results of a consensus conference of the German Society of Digestive and Metabolic Diseases. Z Gastroenterol 35:541–554PubMedGoogle Scholar
  17. 17.
    Bernstein CN, Shanahan F (1996) Purine analogues and Crohn’s disease: learning more about the long-term. Gastroenterology 111:1774–1776PubMedGoogle Scholar
  18. 18.
    Maini RN, Breedveld FC, Kalden JR et al (1998) Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 41:15552–15563Google Scholar
  19. 19.
    Rovere Querini P, Vecellio M, Sabbadini MG, Ciboddo G (2002) Miliary tuberculosis after biological therapy for rheumatoid arthritis. Rheumatology 41:231CrossRefGoogle Scholar
  20. 20.
    Brown SL, Greene MH, Gershon SK, Edwards ET, Braun MM (2002) Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum 46:3151–3158CrossRefPubMedGoogle Scholar
  21. 21.
    Warris A, Bjorneklett A, Gaustad P (2002) Invasive pulmonary aspergillosis associated with infliximab therapy. N Engl J Med 344:1099–1100CrossRefGoogle Scholar
  22. 22.
    Marotte H, Charrin JE, Miossec P (2001) Infliximab-induced aseptic meningitis. Lancet 358:1784CrossRefPubMedGoogle Scholar
  23. 23.
    Kashyab AS, Kashyap S (2002) Infliximab-induced aseptic meningitis. Lancet 358:1252CrossRefGoogle Scholar
  24. 24.
    Riegert-Johnson DL, Godfrey JA, Myers JL, Hubmayr RD, Sandborn WJ, Loftus EV (2002) Delayed hypersensitivity reaction and acute respiratory distress syndrome following infliximab infusion. Inflamm Bowel Dis 8:186–191CrossRefPubMedGoogle Scholar
  25. 25.
    Colombel JF, Loftus EV Jr, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, Zinsmeister AR, Sandborn WJ (2004) The safety profile of infliximab in patients with Crohn’s disease: the Mayo clinic experience in 500 patients. Gastroenterology 126:19–31CrossRefGoogle Scholar
  26. 26.
    Bernstein C, Blanchard J, Kliewer E, Wajda A (2001) Cancer risk in patients with inflammatory bowel disease. Cancer 91:854–862CrossRefPubMedGoogle Scholar
  27. 27.
    Feagan BG, Enns R, Fedorak RN, Panaccione R, Pare P, Steinhart AH et al (2001) Infliximab for the treatment of Crohn’s disease: efficacy, safety and pharmacoeconomics. Can J Clin Pharmacol 8:188–198PubMedGoogle Scholar

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.Medical Clinic I, Division of GastroenterologyUniversity of Schleswig-HolsteinLübeckGermany

Personalised recommendations