Clinical—Alimentary TractColectomy Rate Comparison After Treatment of Ulcerative Colitis With Placebo or Infliximab
Section snippets
Patients, Design of the Studies, and Sources of Data
ACT-1 and -2 were randomized, double-blind, placebo-controlled trials conducted at 117 sites between March 2002 and March 2005. Patients were outpatients with moderately to severely active ulcerative colitis defined as a Mayo Clinic score14 of 6 to 12 points and an endoscopic subscore of at least 2 points despite concurrent treatment with corticosteroids and/or azathioprine or 6-mercaptopurine and/or 5-aminosalicylate-containing medications (ACT-2 only). Patients who received intravenous
Patient Disposition and Baseline Characteristics
In the ACT-1 and -2 trials, 728 patients were randomized to treatment: 244 to placebo and 242 each to infliximab 5 and 10 mg/kg. The baseline characteristics were generally similar among treatment groups (Table 1). One hundred forty-two patients from ACT-2 entered the extension trial (31 in the placebo group, and 52 and 59 in the infliximab 5- and 10-mg/kg groups, respectively), 284 patients from ACT-1 and -2 entered RESULTS-UC, and 135 patients with incomplete colectomy data through 54 weeks
Discussion
There has been a paucity of data published on colectomy outcomes in patients with ulcerative colitis who are treated with biologic therapy. Prior to the publication of the ACT trial results, 2 placebo-controlled pilot studies suggested that infliximab might reduce short-term colectomy rates in hospitalized patients with corticosteroid-refractory ulcerative colitis: in 1 study, 3 of 3 patients in the placebo group and 4 of 8 patients in the infliximab group underwent colectomy during short-term
Acknowledgments
The authors thank James Barrett and Mary Whitman, PhD, employees of the Medical Affairs Publications Group, Centocor Ortho Biotech, Inc, for editorial and writing support and Prasheen Agarwal, PhD, an employee of Centocor Research and Development, Inc, for statistical support.
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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 theAGA'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.