Clinical trial: colectomy after rescue therapy in ulcerative colitis – 3-year follow-up of the Swedish-Danish controlled infliximab study
Article first published online: 18 AUG 2010
© 2010 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 32, Issue 8, pages 984–989, October 2010
How to Cite
Gustavsson, A., Järnerot, G., Hertervig, E., Friis-Liby, I., Blomquist, L., Karlén, P., Grännö, C., Vilien, M., Ström, M., Verbaan, H., Hellström, P. M., Magnuson, A., Halfvarson, J. and Tysk, C. (2010), Clinical trial: colectomy after rescue therapy in ulcerative colitis – 3-year follow-up of the Swedish-Danish controlled infliximab study. Alimentary Pharmacology & Therapeutics, 32: 984–989. doi: 10.1111/j.1365-2036.2010.04435.x
- Issue published online: 26 SEP 2010
- Article first published online: 18 AUG 2010
- Publication data Submitted 12 February 2010 First decision 10 March 2010 Resubmitted 10 June 2010 Accepted 25 July 2010
Aliment Pharmacol Ther 2010; 32: 984–989
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.