A retrospective analysis of the efficacy and safety of infliximab as rescue therapy in acute severe ulcerative colitis C. W. LEES*, D. HEYS*, G. T. HO*, C. L. NOBLE*, A. G. SHAND*, C. MOWAT  , R. BOULTON-JONES à , A. WILLIAMS§, N. CHURCH – , J. SATSANGI* & I. D. R. ARNOTT* ON BEHALF OF THE SCOTTISH SOCIETY OF GASTROENTEROLOGY INFLIXIMAB GROUP *Gastrointestinal Unit, Western General Hospital, Edinburgh;  Gastrointestinal Unit, Ninewells Hospital, Dundee; àGastrointestinal Unit, Victoria Infirmary, Glasgow; §Gastrointestinal Unit, St John’s Hospital, Livingston; –Gastrointestinal Unit, Queen Margaret Hospital, Dunfermline, Scotland, UK Correspondence to: Dr C. W. Lees, Gastrointestinal Unit, Molecular Medicine Centre, University of Edinburgh, Western General Hospital, Crewe Road, Edinburgh, EH4 2XU, UK. E-mail: Charlie.lees@ed.ac.uk Publication data Submitted 14 March 2007 First decision 9 April 2007 Resubmitted 14 May 2007 Accepted 15 May 2007 SUMMARY Background Forty per cent of patients with acute severe ulcerative colitis will not respond to intravenous corticosteroids and require second-line medical therapy or colectomy. A recent controlled trial has suggested that inf- liximab may be effective as rescue therapy. Aim To assess the value of infliximab as rescue therapy for acute severe colitis in a retrospective cohort of ulcerative colitis patients in Scotland. Methods All patients satisfied Truelove and Witts criteria on admission, failed to respond to intravenous corticosteroids and received infliximab (5 mg / kg) as rescue therapy. Response was defined as need for colectomy at hospital discharge and by 90 days. Results A total of 39 patients (median age 31.7 years) were treated. 26 / 39 (66%) responded, avoiding colectomy during the acute admission, and were followed up for a median of 203 days (Interquartile range = 135.5–328.5). Hypoalbuminaemia was a consistent predictor of non-response on univariate and multivariate analysis. At day 3 of intravenous steroids, 9 / 18 (50.0%) with serum albumin <34 g / L had urgent colectomy vs. 1 / 13 (7.7%) ‡34 g / L(P = 0.02, OR = 12.0, C.I. 1.28–112.7). Two serious adverse events occurred – one death due to Pseudomonas pneumonia, and one post-operative fungal septicaemia. Conclusions Infliximab represents a moderately effective rescue therapy for patients with acute severe ulcerative colitis. Serious adverse events, including death, do occur and should be discussed with patients prior to therapy. Aliment Pharmacol Ther 26, 411–419 Alimentary Pharmacology & Therapeutics ª 2007 The Authors 411 Journal compilation ª 2007 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2007.03383.x