O. Dewit

Multicenter randomized-control led clinical trial of probiotics (Lactobacillus johnsonii, LA1) on early endoscopic recurrence of Crohn's disease after ileo-caecal resection

Background Seventy percent of Crohns disease (CD) patients exhibit anastomotic recurrence within 1 year after ileo‐caecal surgery. Recent clinical trials suggest the beneficial use of probiotics in the control of intestinal inflammation in pouchitis and ulcerative colitis. This study is a multicenter clinical trial evaluating the efficacy of an oral administration of the probiotic LA1 on early postoperative endoscopic recurrence of CD. Methods Seventy patients with CD were enrolled prior to elective ileo‐caecal resection and randomly assigned after surgery to daily treatment with either Lactobacillus johnsonii, LA1, Nestlé (1010 colony‐forming units, CFU) (group A, n = 34) or placebo (group B, n = 36) for 12 weeks. The primary objective was to assess the effect of LA1 on the endoscopic recurrence rate at 12 weeks. Stratification was performed according to smoking status at randomization. Results Seven and 14 patients were excluded in the LA1 and placebo groups, respectively. In intention‐to‐treat analysis, the mean endoscopic score was not significantly different between the two treatment groups at 3 months (LA1 versus placebo: 1.50 ± 1.32 versus 1.22 ± 1.37, treatment effect: P = 0.48, smoke effect: P = 0.72). The percentage of patients with severe recurrence (i3 + i4) was 21% and 15% in the LA1 and placebo groups, respectively (P = 0.33). Using a per‐protocol (PP) analysis, the mean endoscopic score was not significantly different between the two treatment groups (LA1 versus placebo groups: 1.44 ± 1.31 versus 1.05 ± 1.21, P = 0.32). The percentage of patients with severe recurrence (i3 + i4) was 19% and 9% in the LA1 and placebo groups, respectively (P = 0.054). Clinical relapse rate (CDAI [CD activity index] > 150, with an increase of CDAI > 70 points or greater from baseline) in the LA1 and placebo groups was 15% (4/27) and 13.5% (3/22), respectively (PP analysis: chi‐square test, P = 0.91 and log‐rank test: P = 0.79). Conclusion Oral administration of the probiotic LA1 in patients with CD failed to prevent early endoscopic recurrence at 12 weeks after ileo‐caecal resection. (Inflamm Bowel Dis 2007)

Interaction between azathioprine and aminosalicylates: an in vivo study in patients with Crohn's disease.

The inhibition of thiopurine methyltransferase activity, one of the enzymes responsible for azathioprine metabolism, by aminosalicylates has been described in an in vitro study. This could result in a higher risk of bone marrow depression when using the two drugs together.

Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study.

Backgroundu2002 SPD476 (MMX™ mesalazine), is a novel, once daily, high‐strength mesalazine formulation (1.2u2003g/tablet) that utilizes Multi Matrix System™ (MMX) technology to delay and extend delivery of the active drug throughout the colon.

Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis.

Aminosalicylates are first‐choice treatment for mild‐to‐moderately active ulcerative colitis (UC); however, multi‐dosing regimens are inconvenient.

Thiopurine metabolism monitoring: implications in inflammatory bowel diseases.

Eur J Clin Invest 2010; 40 (11): 1037–1047

Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab

Objective Ciclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe UC (ASUC) refractory to intravenous steroids. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab. Design Between 2007 and 2010, 115 patients with steroid-refractory ASUC were randomised in 29 European centres to receive ciclosporin or infliximab in association with azathioprine. Patients were followed until death or last news up to January 2015. Colectomy-free survival rates at 1 and 5u2005years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test. Results After a median follow-up of 5.4u2005years, colectomy-free survival rates (95% CI) at 1 and 5u2005years were, respectively, 70.9% (59.2% to 82.6%) and 61.5% (48.7% to 74.2%) in patients who received ciclosporin and 69.1% (56.9% to 81.3%) and 65.1% (52.4% to 77.8%) in those who received infliximab (p=0.97). Cumulative incidence of first infliximab use at 1 and 5u2005years in patients initially treated with ciclosporin was, respectively, 45.7% (32.6% to 57.9%) and 57.1% (43.0% to 69.0%). Only four patients from the infliximab group were subsequently switched to ciclosporin. Three patients died during the follow-up, none directly related to UC or its treatment. Conclusions In this cohort of patients with steroid-refractory ASUC initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment. These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other. Trial registration number EudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results.

Safety And Cost Of Infliximab For The Treatment Of Belgian Pediatric Patients With Crohn’s Disease

Biologicals have become an important component in the treatment of Crohns disease in children. Their increased and long term use raises safety concerns. We describe safety and cost of infliximab in Belgian pediatric Crohns disease patients. All patients on infliximab as part of the present or past treatment for Crohns Disease until January 1st 2011 were selected from an existing database. Information on disease phenotype, medication and adverse events were extracted. Adverse events occurred in 25.9% of patients exposed to infliximab of which 29.6% were severe. In total 31.7% of patients stopped infliximab therapy. The main reasons for discontinuation were adverse events in 45.4% and loss of response in 30.3%. No malignancies or lethal complications occurred over this 241 patient year observation period. Immunomodulators were concomitant medication in 75% of patients and were discontinued subsequently in 38.4% of them. The cost of infliximab infusions per treated patient per year in the Belgian health care setting is approximately 9 474 euro, including only medication and hospital related costs. Even though infliximab is relatively safe in pediatric CD on the short term, close follow-up and an increased awareness of the possible adverse reactions is highly recommended. Adverse reactions appeared in 25.9% of all patients and were the main reason for discontinuation. Treatment cost has to be balanced against efficacy and modifications in disease course. In the Belgian health care system, the medication is available to all patients with moderate to severe CD.

OP07 Use of fecal calprotectin as marker of disease activity in patients under maintenance treatment with infliximab for ulcerative colitis

OP07 Use of fecal calprotectin as marker of disease activity in patients under maintenance treatment with infliximab for ulcerative colitis M. De Vos1 *, J. Jahnsen2, J. Vandervoort3, G. D’Haens4, O. Dewit5, E. Louis6, D. Franchimont7, F. Baert8, R. Torp9, P. Potvin10, P. Van Hootegem11, M. Henriksen12, B. Vander Cruyssen1, S. Vermeire13, on behalf of BIRD14. 1Ghent University Hospital, Department of Gastroenterology, Gent, Belgium, 2Oslo University Hospital, Department of Gastroenterology, Aker, Norway, 3OLV Hospital, Department of Gastroenterology, Aalst, Belgium, 4Imelda Hospital, Department of Gastroenterology, Bonheiden, Belgium, 5Clinique Universitaire St Luc, Department of Gastroenterology, Brussel, Belgium, 6University of Liege and CHU Liege, Department of Gastroenterology, Liege, Belgium, 7Erasme Hospital, Department of Gastroenterology, Brussel, Belgium, 8H. Hart Hospital, Department of Gastroenterology, Roeselare, Belgium, 9Innlandet Hospital, Department of Gastroenterology, Hammar, Norway, 10St-Jozephs Hospital, Department of Gastroenterology, Bornem, Belgium, 11AZ St Lucas, Department of Gastroenterology, Brugge, Belgium, 12Ostfold Fredrikstad Hospital, Department of Gastroenterology, Fredrikstad, Norway, 13University Hospital Gasthuisberg, Department of Gastroenterology, Leuven, Belgium, 14, Belgium

P653 Genetic predictors of non reversible tissue damage in inflammatory bowel disease

P653 Genetic predictors of non reversible tissue damage in inflammatory bowel disease J.M. Benitez1 *, J.M. Mahachie John2, E. Theâtre3, C. Reenaers3, M. De Vos4, O. Dewit5, K. Van Steen2, E. Louis3. 1Reina Sofia University Hospital, IMIBIC, CHU Liege, Gastroenterology, Cordoba, Spain, 2CHU de Liege, Bioinformatics and Modeling, Liege, Belgium, 3CHU de Liege, GIGA, Gastroenterology, Liege, Belgium, 4Ghent University Hospital, Gastroenterology, Ghent, Belgium, 5Saint-Luc Hospital, Gastroenterology, Brussels, Belgium

P495 Efficacy of switching to infliximab in Crohn's disease patients with loss of response to adalimumab

P495 Efficacy of switching to infliximab in Crohn’s disease patients with loss of response to adalimumab H. Peeters1 *, E. Louis2, F. Baert3, O. Dewit4, J.-C. Coche5, M. Ferrante6, G. Lambrecht7, A. Colard2, A. Van Gossum8, P. Bossuyt9, T. Moreels10, M. De Vos11. 1Hospital AZ Sint-Lucas, Gastroenterology, Gent, Belgium, 2CHU de Liege, Gastroenterologie, Liege, Belgium, 3AZ Delta Roeselare Menen, Gastroenterology, Roeselare, Belgium, 4UCL St-Luc, Gastroenterology, Brussels, Belgium, 5Clinique SaintPierre, Gastroenterology, Ottignies, Belgium, 6University Hospital Gasthuisberg, Gastroenterology, Leuven, Belgium, 7AZ Damiaan, Gastroenterology, Oostende, Belgium, 8Hopital Erasme ULB, Gastroenterology, Brussels, Belgium, 9Imelda Hospital, Gastroenterology, Bonheiden, Belgium, 10University Hospital Antwerpen (UZA), Gastroenterology, Antwerpen, Belgium, 11Gent University Hospital, Gastroenterology, Gent, Belgium