Details

Autor(en) / Beteiligte

• 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.
• Tysk, C.

Titel

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

Ist Teil von

• Alimentary pharmacology & therapeutics, 2010-10, Vol.32 (8), p.984-989

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2010

Quelle

Access via Wiley Online Library

Beschreibungen/Notizen

• 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.