Gastroenterology
Volume 136, Issue 2 , Pages 441-450.e1, February 2009

Infliximab Prevents Crohn's Disease Recurrence After Ileal Resection

  • Miguel Regueiro

      Affiliations

    • Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
    • Corresponding Author InformationAddress requests for reprints to: Miguel Regueiro, MD, Associate Professor of Medicine, University of Pittsburgh School of Medicine, Co-Director, Inflammatory Bowel Disease Center, Director, Gastroenterology, Hepatology, and Nutrition Fellowship Training Program, Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical Center, 200 Lothrop Street, PUH-C Wing Mezzanine Level, Pittsburgh, Pennsylvania 15213. fax: (412) 383-8913
  • ,
  • Wolfgang Schraut

      Affiliations

    • Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • ,
  • Leonard Baidoo

      Affiliations

    • Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • ,
  • Kevin E. Kip

      Affiliations

    • Research Center, University of South Florida, College of Nursing, Tampa, Florida
  • ,
  • Antonia R. Sepulveda

      Affiliations

    • Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
  • ,
  • Marilyn Pesci

      Affiliations

    • Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • ,
  • Janet Harrison

      Affiliations

    • Inflammatory Bowel Disease Center and Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
  • ,
  • Scott E. Plevy

      Affiliations

    • Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina

Received 3 September 2008; accepted 23 October 2008. published online 03 November 2008.

Background & Aims

Crohn's disease commonly recurs after intestinal resection. We evaluated whether the administration of infliximab after resective intestinal surgery for Crohn's disease reduces postoperative recurrence.

Methods

We randomly assigned 24 patients with Crohn's disease who had undergone ileocolonic resection to receive intravenous infliximab (5 mg/kg), administered within 4 weeks of surgery and continued for 1 year, or placebo. The primary end point was the proportion of patients with endoscopic recurrence at 1 year. Secondary end points were clinical recurrence and remission and histologic recurrence.

Results

The rate of endoscopic recurrence at 1 year was significantly lower in the infliximab group (1 of 11 patients; 9.1%) compared with the placebo group (11 of 13 patients; 84.6%) (P = .0006). There was a nonsignificant higher proportion of patients in clinical remission in the infliximab group (8 of 10; 80.0%) compared with the placebo group (7 of 13; 53.8%) (P = .38). The histologic recurrence rate at 1 year was significantly lower in the infliximab group (3 of 11 patients; 27.3%) compared with the placebo group (11 of 13 patients; 84.6%) (P = .01). The occurrence of adverse events was similar between the placebo and infliximab groups, and none occurred in the immediate postoperative period.

Conclusions

Administration of infliximab after intestinal resective surgery was effective at preventing endoscopic and histologic recurrence of Crohn's disease.

Abbreviations used in this paper: AZA, azathioprine, CDAI, Crohn's Disease Activity Index, CRP, C-reactive protein, ESR, erythrocyte sedimentation rate, 6MP, 6-mercaptopurine

 

 The authors disclose no conflicts.

 This work was funded in part by an unrestricted grant from Centocor, Inc Miguel Regueiro, Scott Plevy, and Leonard Baidoo participate or participated as a consultant or speaker for Centocor, Inc.

 Registered with www.clinicaltrials.gov (NCT00688636).

PII: S0016-5085(08)01889-1

doi:10.1053/j.gastro.2008.10.051

Refers to article:

  • Continuing Medical Education Exam 2, February 2009 , 22 December 2008

    Gastroenterology February 2009 (Vol. 136, Issue 2, Pages 716-717)

Gastroenterology
Volume 136, Issue 2 , Pages 441-450.e1, February 2009