Clinical trial: colectomy after rescue therapy in ulcerative colitis - 3-year follow-up of the Swedish-Danish controlled infliximab study

Aliment Pharmacol Ther. 2010 Oct;32(8):984-9. doi: 10.1111/j.1365-2036.2010.04435.x. Epub 2010 Aug 18.

Abstract

Background: The long-term efficacy of infliximab as rescue therapy in steroid-refractory ulcerative colitis is not well described.

Aim: To examine the long-term efficacy of infliximab as a rescue therapy through a 3-year follow-up of a previous placebo-controlled trial of infliximab in acute steroid-refractory ulcerative colitis.

Method: In the original study, 45 patients were randomized to a single infusion of infliximab 5 mg/kg or placebo, and at 3 months, 7/24 patients given infliximab were operated vs. 14/21 patients given placebo. Three years or later, patients were asked to participate in a clinical follow-up.

Results: Another seven patients underwent colectomy during follow-up: five in the infliximab group and two in the placebo group. After 3 years, a total of 12/24 (50%) patients given infliximab and 16/21 (76%) given placebo (P = 0.012) had a colectomy. None of eight patients in endoscopic remission at 3 months later had a colectomy compared with 7/14 (50%) patients who were not in remission (P=0.02). There was no mortality.

Conclusion: The benefit of rescue therapy with infliximab in steroid-refractory acute ulcerative colitis remained after 3 years. The main advantage of infliximab treatment occurred during the first 3 months, whereas subsequent colectomy rates were similar in the two groups. Mucosal healing at 3 months influenced later risk of colectomy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Antibodies, Monoclonal / therapeutic use*
  • Colectomy / statistics & numerical data*
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / surgery*
  • Follow-Up Studies
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Infliximab
  • Logistic Models
  • Quality of Life
  • Severity of Illness Index
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*

Substances

  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • Infliximab