Burden of disease and increasing prevalence of inflammatory bowel disease in a population-based cohort in the Netherlands.

BACKGROUND: Reported epidemiology and phenotype distributions vary widely and disease burden of inflammatory bowel disease (IBD) is poorly described. Our aim was to establish these features in a population-based cohort covering 319 976 inhabitants. Furthermore, differences between tertiary referral and peripheral hospital patients were quantified. METHODS: IBD patients in the adherence area of three peripheral hospitals (2004-2012) were included. Medical and surgical treatment data were obtained. Quality of life and disease activity were evaluated. An outpatient cohort from a tertiary referral centre was accrued. RESULTS: A total of 1461 patients were included: 761 (52.1%) with ulcerative colitis (UC), 579 (39.5%) with Crohn's disease (CD) and 121 (8.3%) with IBD-unspecified. Point prevalence of IBD was 432.1 per 100 000 inhabitants in 2010, which increased significantly over time, P-value of less than 0.0001. The mean annual incidence was 17.2 for UC, 10.5 for CD and 2.2 for IBD-unspecified. Tertiary referral Crohn's patients used thiopurines and biological therapy and underwent surgery significantly more often than patients in peripheral hospitals (P<0.0001). Disease activity correlated negatively with quality of life (P<0.0001) in UC and CD. CONCLUSION: The prevalence of IBD is still increasing. Burden of disease was significantly more severe, mainly in Crohn's patients, in the referral centre, highlighting the importance of population-based studies to accurately describe phenotype distribution and disease burden.

Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial.

BACKGROUND: Currently there is no guideline for the treatment of patients with Crohn's disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs. METHODS/DESIGN: This is a multicentre, randomized controlled trial. Patients with Crohn's disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs. DISCUSSION: The PISA trial is a multicentre, randomised controlled trial of patients with Crohn's disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).

Length of hospital stay and associated hospital costs with infliximab versus cyclosporine in severe ulcerative colitis.

BACKGROUND: Cyclosporine and infliximab (IFX) seem equally effective as rescue therapy in hospitalized patients with severe ulcerative colitis (UC), although associated hospital stay and costs may differ. AIM: The aim of this study was to compare the duration of hospital stay and associated costs from initiation of rescue therapy to time of discharge in hospitalized patients with corticosteroid-refractory UC receiving cyclosporine or IFX. Colectomy rates after 6 months were used as the outcome parameter for treatment success. PATIENTS AND METHODS: Hospital records of patients admitted between November 2003 and August 2012 at a tertiary referral center were analyzed. RESULTS: Forty-two patients were included (cyclosporine group: 26 patients; IFX group: 16 patients). Patient characteristics were comparable, with the exception that cyclosporine-treated patients more often had a pancolitis (89 vs. 63%, P=0.046). The median length of hospital stay was 11.0 (interquartile range 7.75-13.25) versus 4.0 days (interquartile range 4.0-5.75) in the cyclosporine and IFX group (P<0.01), respectively. The mean in-hospital costs were significantly higher in the cyclosporine-treated versus IFX-treated patients (6121 vs. 4853 euros, P<0.05), whereas the total costs up to 3 months after initiation of rescue therapy were significantly higher in the IFX group (6787 vs. 9983 euros, P<0.01). There were no significant differences in colectomy rates at 6 months (23 and 31% for cyclosporine and IFX, P=0.50). More side-effects were observed during treatment with cyclosporine. CONCLUSION: Length of hospital stay and in-hospital costs have been reduced significantly since the introduction of IFX as rescue therapy for severe UC instead of cyclosporine. However, the total treatment costs are higher in IFX-treated patients.