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

• Published in: Alimentary pharmacology & therapeutics 2010-10, Vol.32 (8), p.984-989
• Main Authors: 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.
• Format: Article
• Language: English
• Subjects: Acute Disease; Antibodies, Monoclonal - therapeutic use; Biological and medical sciences; Clinical Medicine; Colectomy - statistics & numerical data; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - surgery; Digestive system; Follow-Up Studies; Gastroenterologi; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal Agents - therapeutic use; Humans; Infliximab; Klinisk medicin; Logistic Models; Medical and Health Sciences; Medical sciences; MEDICIN; Medicin och hälsovetenskap; MEDICINE; Other diseases. Semiology; Pharmacology. Drug treatments; Quality of Life; Severity of Illness Index; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumor Necrosis Factor-alpha - antagonists & inhibitors
• ISSN: 0269-2813; 1365-2036; 1365-2036
• DOI: 10.1111/j.1365-2036.2010.04435.x

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.