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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.