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

Anders Gustavsson (1) , Gunnar Järnerot (1) , Erik Hertervig (2) , Ingalill Friis-Liby (3) , Lars Blomquist (4) , Per Karlén (5) , Christer Grännö (6) , Mogens Vilien (7) , Magnus Ström (8) , Hans Verbaan (9) , Per M Hellström (4) , Anders Magnuson (10) , Jonas Halfvarson (1) , Curt Tysk (11)

1 Dept of Medicine, Div of Gastroenterology
2 Dept of Medicine, Div of Gastroenterology
3 Department of Medicine, Division of Gastroenterology
4 Department of Gastroenterology and Hepatology
5 Department of Medicine, Division of Gastroenterology
6 Department of Medicine, Division of Gastroenterology
7 Division of Gastroenterology
8 Gastroenterology
9 Department of Medicine, Division of Gastroenterology
10 Unit of Statistics and Epidemiology, Centre for Clinical Research
11 Dept of Medicine, Div of Gastroenterology

Background The long-term efficacy of infliximab as rescue therapy in steroid-refractory ulcerative colitis is not well described. Aim We report 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 randomised to a single infusion of infliximab 5 mg/kg or placebo, and at three months 7/24 patients given infliximab were operated versus 14/21 patients given placebo. Three years or later patients were asked to participate in a clinical follow-up. Results Another 7 patients underwent colectomy during follow-up; 5 in the infliximab group and 2 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 had a colectomy. None of 8 patients in endoscopic remission at 3 months later had a colectomy compared with 7/14 (50%) patients not being 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 colectomy risk.

Mots clés: Medicine

Anders Gustavsson, Gunnar Järnerot, Erik Hertervig, Ingalill Friis-Liby, Lars Blomquist, et al.. Clinical trial: colectomy after rescue therapy in ulcerative colitis; 3-year follow-up of the Swedish-Danish controlled infliximab study. Alimentary Pharmacology and Therapeutics, 2010, 32 (8), pp.984. ⟨10.1111/j.1365-2036.2010.04435.x⟩. ⟨hal-00567043⟩