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SC Shapira1, R Panaccione2, K Croitoru3, AH Steinhart1

1Department of Medicine, University of Toronto, Toronto, Ontario; 2Department of Medicine, University of Calgary, Calgary, Alberta; 3Department of Medicine, McMaster University, Hamilton, Ontario

BACKGROUND: Severe steroid-refractory ulcerative colitis (UC) has traditionally been treated with a trial of IV cyclosporine or colectomy. The morbidity associated with these options has motivated the search for new approaches for the management of severe UC. Infliximab has proven efficacy in steroid and immunomodulator-refractory Crohn's disease. It is hypothesized that Infliximab may be efficacious in the treatment of steroid refractory UC as well. Preliminary studies have reported improved outcomes with the use of Infliximab in severe steroid refractory UC (Chey WY, Inflamm Bowel Dis 2001; Sands B et al, Inflamm Bowel Dis 2001). Clinical experience as well as a recent trial has not confirmed this (Probert CSJ, Gastroenterology 2002). The purpose of this study is to further evaluate Infliximab therapy for UC.
METHODS: Six patients with steroid refractory UC from 3 Canadian centres were studied prospectively. Severe disease was considered a Powell-Tuck (PT) score of 5 or greater. Patients received an Infliximab infusion of 5 mg/kg after a minimum of 5 days of high-dose corticosteroid with no significant improvement and sigmoidoscopic confirmation of active disease. Patients underwent clinical, biochemical and endoscopic assessment on day 0, 7, and 28 after the Infliximab infusion.
The primary outcome was a clinical improvement by Day 7 (PT score change by 3 or more). The secondary outcome was discharge from hospital without surgery and clinical remission at Day 28 (PT score of 4 or less).
RESULTS: Three patients were treated in hospital and three as outpatients. At day 7, 4/6 had clinical and/or endoscopic improvement as defined by the PT score. All hospitalized patients were discharged without surgery after Infliximab treatment. At Day 28, only one patient was in clinical remission. Three patients in this series eventually required colectomy. The time to surgical procedure was delayed by more than five months in two of these patients.
CONCLUSIONS: This study suggests that Infliximab may delay time to surgery but may not lead to long-term clinical or endoscopic improvement in individuals with steroid refractory UC. Further research is warranted to evaluate the potential role of Infliximab as a treatment modality in this population.

This study received funding from Schering Canada Inc.