Gastroenterology
Volume 137, Issue 4 , Pages 1250-1260 , October 2009

Colectomy Rate Comparison After Treatment of Ulcerative Colitis With Placebo or Infliximab

  • William J. Sandborn

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
    • Corresponding Author InformationReprint requests Address requests for reprints to: William J. Sandborn, MD, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905. fax: (507) 266-0335
  • ,
  • Paul Rutgeerts

      Affiliations

    • Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium
  • ,
  • Brian G. Feagan

      Affiliations

    • Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada
  • ,
  • Walter Reinisch

      Affiliations

    • Department of Gastroenterology and Hepatology, Univ Klinik Innere Medizin IV, AKH Wien, Vienna, Austria
  • ,
  • Allan Olson

      Affiliations

    • R. W. Johnson Pharmaceutical Research and Development, San Diego, California
  • ,
  • Jewel Johanns

      Affiliations

    • Centocor Research & Development, Inc., Malvern, Pennsylvania
  • ,
  • Jiandong Lu

      Affiliations

    • Centocor Research & Development, Inc., Malvern, Pennsylvania
  • ,
  • Kevin Horgan

      Affiliations

    • Centocor Research & Development, Inc., Malvern, Pennsylvania
  • ,
  • Daniel Rachmilewitz

      Affiliations

    • Division of Medicine, Shaare Zedak Medical Center, Jerusalem, Israel
  • ,
  • Stephen B. Hanauer

      Affiliations

    • Division of Gastroenterology, University of Chicago, Chicago, Illinois
  • ,
  • Gary R. Lichtenstein

      Affiliations

    • Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
  • ,
  • Willem J.S. de Villiers

      Affiliations

    • Division of Digestive Diseases and Nutrition, Department of Medicine, University of Kentucky, Lexington, Kentucky
  • ,
  • Daniel Present

      Affiliations

    • Division of Gastroenterology, Department of Medicine, Mount Sinai Medical Center, New York, New York
  • ,
  • Bruce E. Sands

      Affiliations

    • Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts
  • ,
  • Jean Frédéric Colombel

      Affiliations

    • Department of Hepatogastroenterology, Hopital Claude Huriez and Centre d'Investigation Clinique, Centre Hospitalier Universitaire de Lille, Lille, France

Received 17 April 2009 ,Accepted 30 June 2009.

References 

  1. Hoie O, Wolters FL, Riis L, et al. Low colectomy rates in ulcerative colitis in an unselected European cohort followed for 10 years. Gastroenterology. 2007;132:507–515
  2. Jess T, Loftus EV, Velayos FS, et al. Risk of intestinal cancer in inflammatory bowel disease: a population-based study from Olmsted County, Minnesota (comment). Gastroenterology. 2006;130:1039–1046
  3. Winther KV, Jess T, Langholz E, et al. Long-term risk of cancer in ulcerative colitis: a population-based cohort study from Copenhagen County. Clin Gastroenterol Hepatol. 2004;2:1088–1095
  4. Penna C, Dozois R, Tremaine W, et al. Pouchitis after ileal pouch-anal anastomosis for ulcerative colitis occurs with increased frequency in patients with associated primary sclerosing cholangitis. Gut. 1996;38:234–239
  5. Waljee A, Waljee J, Morris AM, et al. Three-fold increased risk of infertility: a meta-analysis of infertility after ileal pouch anal anastomosis in ulcerative colitis. Gut. 2006;55:1575–1580
  6. Hahnloser D, Pemberton JH, Wolff BG, et al. The effect of ageing on function and quality of life in ileal pouch patients: a single cohort experience of 409 patients with chronic ulcerative colitis. Ann Surg. 2004;240:615–623
  7. Kornbluth A, Sachar DB. Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2004;99:1371–1385
  8. Carter MJ, Lobo AJ, Travis SP. Guidelines for the management of inflammatory bowel disease in adults (comment). Gut. 2004;53(Suppl 5):V1–V16
  9. Lichtiger S, Present DH, Kornbluth A, et al. Cyclosporine in severe ulcerative colitis refractory to steroid therapy. N Engl J Med. 1994;330:1841–1845
  10. Sands BE, Tremaine WJ, Sandborn WJ, et al. Infliximab in the treatment of severe, steroid-refractory ulcerative colitis: a pilot study. Inflamm Bowel Dis. 2001;7:83–88
  11. 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;128:1805–1811
  12. Knight DM, Trinh H, Le J, et al. Construction and initial characterization of a mouse-human chimeric anti-TNF antibody. Mol Immunol. 1993;30:1443–1453
  13. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476
  14. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis (A randomized study). N Engl J Med. 1987;317:1625–1629
  15. 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
  16. Aratari A, Papi C, Clemente V, et al. Colectomy rate in acute severe ulcerative colitis in the infliximab era. Dig Liver Dis. 2008;40:821–826
  17. Willert RP, Lawrance IC. Use of infliximab in the prevention and delay of colectomy in severe steroid dependent and refractory ulcerative colitis. World J Gastroenterol. 2008;14:2544–2549
  18. Reinisch W, Sandborn WJ, Rutgeerts P, et al. Infliximab treatment for ulcerative colitis: comparable clinical response, clinical remission, and mucosal healing in patients with disease duration <3 years vs ≥3 years. San Diego, CA: Poster presented at: Digestive Disease Week; 2008;
  19. Hay AR, Hay JW. Inflammatory bowel disease: medical cost algorithms. J Clin Gastroenterol. 1992;14:318–327
  20. Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992;14:309–317
  21. Blomqvist P, Ekbom A. Inflammatory bowel diseases: health care and costs in Sweden in 1994. Scand J Gastroenterol. 1997;32:1134–1139
  22. Odes S, Vardi H, Friger M, et al. Cost analysis and cost determinants in a European inflammatory bowel disease inception cohort with 10 years of follow-up evaluation. Gastroenterology. 2006;131:719–728
  23. Nguyen GC, Tuskey A, Dassopoulos T, et al. Rising hospitalization rates for inflammatory bowel disease in the United States between 1998 and 2004. Inflamm Bowel Dis. 2007;13:1529–1535
  24. Bernstein CN, Nabalamba A. Hospitalization, surgery, and readmission rates of IBD in Canada: a population-based study. Am J Gastroenterol. 2006;101:110–118
  25. Bewtra M, Su C, Lewis JD. Trends in hospitalization rates for inflammatory bowel disease in the United States. Clin Gastroenterol Hepatol. 2007;5:597–601
  26. Prescribing information for Remicade (infliximab) [package insert]. Malvern, PA: Centocor Ortho Biotech, Inc, 2008.
  27. Biancone L, Calabrese E, Petruzziello C, et al. Treatment with biologic therapies and the risk of cancer in patients with IBD. Nat Clin Pract Gastroenterol Hepatol. 2007;4:78–91
  28. D'Haens G. Risks and benefits of biologic therapy for inflammatory bowel diseases. Gut. 2007;56:725–732
  29. Schultz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002;359:781–785

 This article has an accompanying continuing medical education activity on page 1520. Learning Objective: Upon completion of reading this article, successful learners will be able to apply the results of the study to their practice by weighing the potential benefits and the risk of infliximab in individual patients with moderate to severe ulcerative colitis.

 To view this article's video abstract, go to the AGA's YouTube Channel.

 Conflicts of interest The authors disclose the following: William J. Sandborn, Paul Rutgeerts, Brian G. Feagan, Walter Reinisch, Stephen B. Hanauer, Gary R. Lichtenstein, Willem J. S. de Villiers, Bruce E. Sands, and Jean Frédéric Colombel have served as consultants for and received honoraria and research grants from Centocor Ortho Biotech, Inc. Daniel Present has served as a consultant for and received a research grant from Centocor Research and Development, Inc. Jewel Johanns and Jiandong Lu are employees of Centocor Clinical Research and Development, Inc., a subsidiary of Johnson & Johnson, and own stock in Johnson & Johnson. Allan Olson is a former employee of Centocor Clinical Research and Development, Inc., is currently employed at R. W. Johnson Pharmaceutical Research and Development, and owns stock in Johnson & Johnson. Kevin Horgan is a former employee of Centocor Clinical Research and Development, Inc.

 Funding Supported by a research grant from Centocor Research and Development, Inc, Malvern, Pennsylvania, and Schering Plough, Kenilworth, New Jersey. Supported by a grant (1-UL1-RR024150-01) from the National Center for Research Resources, a component of the National Institutes of Health (NIH) and the NIH Roadmap for Medical Research.

 Some of the results presented in this article were published as an abstract and presented at The American College of Gastroenterology 2007 annual meeting in Philadelphia, Pennsylvania (Am J Gastroenterol 2007;102[Suppl 2]:Abs984); United European Gastroenterology Week 2007 annual meeting in Paris, France (Gut 2007;39:A26); and 2007 CCFA National Research and Clinical Conference, 6th Annual Advances in the Inflammatory Bowel Diseases in Aventura, Florida (Inflamm Bowel Dis 2007;14[Suppl 1]:AbsO-006).

 ClinicalTrials.gov numbers, NCT00036439, NCT00096655, NCT00207688.

PII: S0016-5085(09)01153-6

doi: 10.1053/j.gastro.2009.06.061

Gastroenterology
Volume 137, Issue 4 , Pages 1250-1260 , October 2009