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

2010; Wiley; Volume: 32; Issue: 8 Linguagem: Inglês

10.1111/j.1365-2036.2010.04435.x

1365-2036

A. Gustavsson, G Järnerot, Erik Hertervig, Ingalill Friis–Liby, L. Blomquist, Per Karlén, Christer Grännö, M. Vilien, Morten B. Strøm, Hans Verbaan, Per M. Hellström, Anders Magnuson, Jonas Halfvarson, Curt Tysk,

Liver Diseases and Immunity

Aliment Pharmacol Ther 2010; 32: 984–989 Summary 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.