Gastroenterology
Volume 134, Issue 7 , Pages 1861-1868 , June 2008

Withdrawal of Immunosuppression in Crohn's Disease Treated With Scheduled Infliximab Maintenance: A Randomized Trial

  • Gert Van Assche

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
    • Corresponding Author InformationAddress requests for reprints to: Gert Van Assche, MD, PhD, Division of Gastroenterology, University of Leuven Hospitals, 49-Herestraat, 3000 Leuven, Belgium. fax: (32) 1624419.
    • ,
  • Charlotte Magdelaine–Beuzelin

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
    • ,
  • Geert D'Haens

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
    • Imelda Clinical trials Center, Imelda Hospital, Bonheiden, Belgium
    • ,
  • Filip Baert

      Affiliations

    • Heilig Hart Ziekenhuis Roeselare, Roeselare, Belgium
    • ,
  • Maja Noman

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
    • ,
  • Séverine Vermeire

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium
    • ,
  • David Ternant

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
    • ,
  • Hervé Watier

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
    • ,
  • Gilles Paintaud

      Affiliations

    • Université François Rabelais Tours, Immunopharmacogenetics of Therapeutic Antibodies, Tours, France
    • ,
  • Paul Rutgeerts

      Affiliations

    • Division of Gastroenterology, University of Leuven Hospitals, Leuven, Belgium

Received 16 October 2007 ,Accepted 6 March 2008.

References 

  1. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn's disease (Crohn's Disease cA2 Study Group). N Engl J Med. 1997;337:1029–1035
  2. 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;340:1398–1405
  3. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549
  4. Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004;350:876–885
  5. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476
  6. Parsi MA, Achkar JP, Richardson S, et al. Predictors of response to infliximab in patients with Crohn's disease. Gastroenterology. 2002;123:707–713
  7. 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;17:1451–1457
  8. 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;97:2357–2363
  9. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Eng J Med. 2003;348:601–608
  10. 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;124:917–924
  11. 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;2:542–553
  12. Maser EA, Villela R, Silverberg MS, et al. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006;4:1248–1254
  13. Vermeire S, Noman M, van Assche G, et al. The effectiviness of concomitant immunosuppressive therapy to suppress formation of antibodies to infliximab in Crohn's disease. Gut. 2007;56:1226–1231
  14. Toruner M, Loftus EV, Colombel JF, et al. Risk factors for opportunistic infections in inflammatory bowel disease: a case-control study (abstr). Gastroenterology. 2006;130:A71
  15. Wolfe F, Michaud K. The effect of methotrexate and anti-tumor necrosis factor therapy on the risk of lymphoma in rheumatoid arthritis in 19,652 patients during 89,710 person-years of observation. Arthritis Rheum. 2007;56:1433–1439
  16. 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;44:265–267
  17. Best WR, Becktel JM, Singleton JW, et al. Development of a Crohn's disease activity index (National Cooperative Crohn's Disease Study). Gastroenterology. 1976;70:439–444
  18. Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989;96:804–810
  19. Ternant D, Mulleman D, Degenne D, et al. An enzyme-linked immunosorbent assay for therapeutic drug monitoring of infliximab. Ther Drug Monit. 2006;28:169–174
  20. Daperno M, D'Haens G, Van Assche G, et al. Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc. 2004;60:505–512
  21. D'haens G, van Deventer S, van Hogezand R, et al. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: a European multicenter trial. Gastroenterology. 1999;116:1029–1034
  22. Rutgeerts P, Diamond RH, Bala M, et al. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006;63:433–442
  23. Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn's disease previously treated with infliximab. Ann Int Med. 2007;146:829–838
  24. St. Clair EW, Wagner CL, Fasanmade AA, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2002;46:1451–1459

 Support for study was not funded externally.Conflicts of interest that have been disclosed to study participants: Geert D'Haens, Paul Rutgeerts, and Gert Van Assche: Research support from Centocor and Schering Plough, Speaker's bureau of Schering Plough, consultancy for Centocor and Schering-Plough. Charlotte Magdelaine–Beuzelin: no conflict of interest. Filip Baert: no conflict of interest. Maja Noman: no conflict of interest. Séverine Vermeire: Speaker's bureau Schering-Plough. David Ternant: no conflict of interest. Hervé Watier: no conflict of interest. Gilles Paintaud: no conflict of interest. Paul Rutgeerts: Research support from Schering-Plough and Centocor.

PII: S0016-5085(08)00435-6

doi: 10.1053/j.gastro.2008.03.004

Gastroenterology
Volume 134, Issue 7 , Pages 1861-1868 , June 2008

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