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.

  • Image Result

    Enrollment and treatment of patients in the ACT-1 and -2 trials. Data sources for colectomy follow-up through 54 weeks include ACT-1, ACT-2, ACT-2 extension, RESULTS-UC, and retrospective data collect

    Enrollment and treatment of patients in the ACT-1 and -2 trials. Data sources for colectomy follow-up through 54 weeks include ACT-1, ACT-2, ACT-2 extension, RESULTS-UC, and retrospective data collection.

  • Image Result
    (A) Kaplan–Meier estimate of the proportion of patients free of colectomy through 54 weeks for the placebo and combined infliximab groups in ACT-1 and -2. (B) Summary of hazard ratios by subgroup for

    (A) Kaplan–Meier estimate of the proportion of patients free of colectomy through 54 weeks for the placebo and combined infliximab groups in ACT-1 and -2. (B) Summary of hazard ratios by subgroup for time to colectomy through 54 weeks after the first infusion in ACT-1 and -2. The vertical solid line represents the treatment effect for the overall population. CI, confidence interval; NAP, not applicable; UC, ulcerative colitis; 5-ASA, 5-aminosalicylates; 6-MP, 6-mercaptopurine. (C) Summary of hazard ratios by treatment group and by study for time to colectomy or commercial infliximab use through 54 weeks after the first infusion in ACT-1 and -2.

 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

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