DOP045 Predicting undesirable disease in newly diagnosed IBD patients – results from the Delta cohort

DOP045 Predicting undesirable disease in newly diagnosed IBD patients – results from the Delta cohort

S36 Digital oral poster presentations Conclusions: TP use is associated with a 40% lowered risk of surgical resection in patients with CD. Despite s...

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S36

Digital oral poster presentations

Conclusions: TP use is associated with a 40% lowered risk of surgical resection in patients with CD. Despite significant reductions in rates of surgical resection in patients with CD over the last 5 decades and increasing use of TPs a large proportion of patients with CD still require resectional surgery.

particular group, efforts should be maximized to motivate this high-risk population for adherence.

DOP044 Patient education in a 14 month randomized trial fails to improve adherence in ulcerative colitis: Influence of demographic and clinical parameters on non-adherence

DOP045 Predicting undesirable disease in newly diagnosed IBD patients results from the Delta cohort

S. Nikolaus1 *, S. Schreiber1 , B. Siegmund2 , B. Bokemeyer3,4 , E. B¨ astlein5 , O. Bachmann6 , W. Kruis7 , German IBD Study Group8 . 1 University Hospital Schleswig-Holstein, Campus Kiel, 1st Med. Department, Kiel, Germany, 2 Charit´ e Universit¨ atsmedizin Berlin, Gastroenterology, Infectious Diseases and Rheumatology, Berlin, Germany, 3 Gastroenterology Practice, Minden, Minden, Germany, 4 Gastroenterology Practice, Minden, Germany, 5 Magen Darm Zentrum K¨ oln, MDZ K¨ oln, K¨ oln, Germany, 6 Medizinische Hochschule Hannover, Gastroenterology, Hannover, Germany, 7 Evangelisches Krankenhaus Kalk, Gastroenterology, K¨ oln, Germany, 8 Charit´ e Universit¨ atsmedizin Berlin, Gastroenterology, Berlin, Germany Background: Recent observatory studies suggest that nonadherence to 5-ASA therapy during remission is a main factor for relapse in ulcerative colitis (UC) (1). Patient education may improve adherence. We investigated demographic and clinical parameters associated with non-adherence and influence of patient education on 5-ASA adherence in a randomized, prospective clinical trial. Methods: 247 patients with inactive or mildly active UC (CAI < 9) were randomized to standard care alone (n = 122) or an additional standardized patient education programme within 4 weeks after inclusion (n = 125). All patients had to receive 5-ASA (1.2 4.8 g/d). Six visits were scheduled during the 14 months trial period. At each visit urine samples were collected to assess 5-ASA exposure (non adherence= absence of 5-ASA). Primary endpoint was adherence at all visits. Secondary endpoints were quality of life (IBDQ), disease activity, partial adherence, white-coat compliance and self-assessment of adherence. Results: Patients were well balanced (disease activity, disease localization, concomitant therapy, clinical and sociodemographic characteristics). Baseline non-adherence was high (52.4%) without difference between the groups. The primary endpoint was not met with non-adherence in 52.4% of patients in the education group vs. 52.5% in the standard care group (P = 0.99). Overall, between 17.1 24.6% of patients had mild to moderate disease (CAI 4 9) and <5% had an acute relapse without difference in adherence at any time point between the groups. No difference was seen between the standard care- and intervention group with regard to all secondary endpoints. Most interestingly, particularly patients with young age were non-adherent (18 40 yrs: 70%; 63/90 vs. 40 60 yrs: 47%; 54/115 and >60 yrs: 30.2%; 13/43). High levels of non-adherence were associated with short duration of disease (2 5 yrs: 55.9%; 57/102 vs. 5 10 yrs: 52.2%; 35/67, 10 15 yrs: 51.2%; 21/41 and >15 yrs: 44.7%; 17/38). A trend for a relationship between nonadherence and low education levels was seen (low education (only basic school): 63.8%, 30/47 vs. higher education levels (trade school): 41.8%, 28/67 and “Abitur”/university: 58%, 65/112). Conclusions: Although >25% of the population were not in remission throughout the study no relationship between disease activity and adherence was seen. Non adherence was associated with younger age, short duration of disease and lower education levels. While a structured intervention using a patient education program failed to improve adherence in this

Reference(s) [1] Khan et al., Aliment Pharmacol Therap 2012

V. Nuij1 *, G. Fuhler1 , C. Looman2 , R. Beukers3 , R. Ouwendijk4 , M. Rijk5 , A. van Tilburg6 , R. Quispel7 , K. Bruin8 , T. Tang9 , H. Smalbraak10 , F. Lindenburg11 , L. Peyrin-Biroulet12 , C.J. van der Woude1 . 1 ErasmusMC University Medical Center, Gastroenterology and Hepatology, Rotterdam, Netherlands, 2 ErasmusMC University Medical Center, Public Health, Rotterdam, Netherlands, 3 Albert Schweitzer Hospital, Gastroenterology and Hepatology, Rotterdam, Netherlands, 4 Ikazia Hospital, Gastroenterology and Hepatology, Rotterdam, Netherlands, 5 Amphia Hospital, Gastroenterology and Hepatology, Breda, Netherlands, 6 Sint Franciscus Gasthuis, Gastroenterology and Hepatology, Rotterdam, Netherlands, 7 Reinier de Graaf Gasthuis, Gastroenterology and Hepatology, Rotterdam, Netherlands, 8 Tweesteden Hospital, Gastroenterology and Hepatology, Tilburg, Netherlands, 9 IJsselland Hospital, Gastroenterology and Hepatology, Capelle aan den IJssel, Netherlands, 10 Lievensberg Hospital, Internal Medicine, Bergen op Zoom, Netherlands, 11 Franciscus Hospital, Gastroenterology and Hepatology, Roosendaal, Netherlands, 12 Nancy University Hospital, Universit´ e de Lorraine, Gastroenterology and Hepatology, Vandoeuvre-les-Nancy, France Background: In patients with inflammatory bowel disease there is increasing evidence that timely initiation of potent immunosuppressive therapies leads to a less adverse disease course. This could be especially beneficial for patients with more severe disease course. However, upon first presentation, prediction of future disease course is difficult. The aim of the current study was to define predictors for undesirable disease outcome at diagnosis in a population based cohort in the antiTNF era. Methods: IBD patients from the Delta cohort, newly diagnosed in 2006, were included. Patient and disease characteristics were obtained from the patients’ medical records. Logistic regression analysis and cox-regression analysis were used to assess factors associated with an undesirable disease outcome as determined by previously published criteria and by the Delta Criteria (DC). The DC were defined as having fistula and/or abscesses, major extra-intestinal manifestations (EIM), hospitalization, IBD-related surgery and progression of disease according to Montreal classification during follow-up. Results: In total, 413 IBD patients were included, (201 CD, 188 UC, and 24 IBDU). Previously published adverse disease outcome criteria were tested on this cohort, however, they were not applicable at diagnosis and there was no correlation with these criteria and adverse outcomes such as surgery. We therefore developed a new predicting model based on undesirable disease outcome as determined by the DC criteria, according to which 42% of patients had undesirable disease. In a cox-regression analysis, having CD (HR 2.1, CI 1.5 2.8), age >35 years (OR 0.68, CI 0.51 0.92), endoscopic disease severity at diagnosis (p = 0.002) and histologic disease severity at diagnosis (p = 0.043) were univariately associated with the DC. In a multivariate analysis, histologic disease severity and having CD remained significantly associated with a more disabling subtype. Strikingly, we also observed that treatment initiation correlates with endoscopic disease severity (steroids p = 0.001, immunosuppressants p < 0.0001, anti-TNF p < 0.0001), but not with histological disease severity.

DOP Session 6

Predicting outcome

Conclusions: Previously published adverse disease outcome criteria are unfit for determining at diagnosis whether patients will have an undesirable disease outcome. CD, age >35 years, endoscopic and histologic disease severity at diagnosis are valuable predictors for an undesirable disease course. Multivariate analysis suggests that aiming for early deep remission will prevent disease progression and that histologic disease severity should be more central in deciding treatment strategies.

DOP Session 6

Predicting outcome

DOP046 A multicenter evaluation of clinical and surgical risk factors for anastomotic leak after restorative proctocolectomy with ileal pouch-anal anastomosis S. Sahami1 *, C. Buskens1 , R. Lindeboom2 , T. Young-Fadok3 , A. de Buck van Overstraeten4 , A. D’Hoore4 , W. Bemelman1 . 1 Academic Medical Center, Surgery, Amsterdam, Netherlands, 2 Academic Medical Centre, Divisions of Clinical Methods and Public Health, Amsterdam, Netherlands, 3 Mayo Clinic, Surgery, Phoenix, United States, 4 University of Leuven, Surgery, Leuven, Belgium Background: Anastomotic leakage (AL) is one of the most feared complications after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) that could negatively impact long-term patient outcome in pouch function and quality of life. Although previous studies have identified several risk factors for AL, predictive factors in the specific current IBD patient remain subject of debate. Since timely identification of high-risk patients could influence surgical decision-making and diminish the risk for complications, the aim of our study is to identify clinical and surgical parameters associated with AL. Methods: Between September 1990 and April 2013, a total of 691 patients who underwent IPAA for IBD, dysplasia, or FAP were identified from prospectively maintained databases of 3 colorectal tertiary referral centres. Retrospective chart review identified data on demographic and surgical variables. AL was defined as any leak confirmed by either contrast extravasation on imaging or during re-laparotomy (leak grades B; drainage and C; re-laparotomy). Multivariate regression models were developed to identify risk factors for AL. Results: A total of 691 patients (55.7% male) were included with a median age of 39 years (17 77). One hundred and two (14.8%) patients developed postoperative AL. Univariate analysis identified, age at surgery (>55 years), long-term disease course (>5 years), overweight (BMI >25), high ASA classification (>3), steroids (>20 mg), anti-TNF (<3 months preoperatively) and the combination of both therapies as risk factors. Surgical factors were multistaged procedures (primary IPAA vs subtotal colectomy with completion proctectomy and IPAA at a later stage), J-pouch and perioperative blood transfusion. Multivariate regression models demonstrated, long-term disease course (OR 2.01, 95% CI 1.27 3.19), high ASA score (OR 1.94, 95% CI 1.09 3.47) and a combination of anti-TNF and steroid treatment (OR 5.61, 95% CI 1.71 18.48) as independent preoperative risk factors for AL. The only surgical risk factor that was independently associated with decreased leak rate was subtotal colectomy with IPAA at a later stage (OR 0.53, 95% CI 0.33 0.846). Since a staged procedure was therefore considered as a confounding variable, subgroup analysis of patients with primary IPAA demonstrated that long-term disease course (OR 1.79, 95% CI 1.03 3.14) and a combination of anti-TNF and steroids (OR 3.96, 95% CI 1.15 13.77) remained independent preoperative risk factors. Conclusions: Long-term disease course, high ASA score, and a combination of anti-TNF and steroid treatment within 3 months

S37 before IPAA surgery were all independent preoperative risk factors for AL. A staged procedure seems an appropriate strategy when these risk factors are identified. DOP047 Is hospitalization predicting the disease course in UC? Prevalence and predictors of hospitalization and re-hospitalization in ulcerative colitis in a population-based inception cohort between 2000 2012 B. Lovasz1 *, M. Mandel1 , P.A. Golovics1 , I. Szita2 , Z. Vegh1 , L. Kiss1 , A. Horvath3 , T. Pandur2 , M. Balogh4 , A. Mohas1 , B. Szilagyi1 , L. Lakatos2 , P. Lakatos1 . 1 Semmelweis University, 1st Department of Medicine, Budapest, Hungary, 2 Csolnoky F. Province Hospital, Department of Medicine, Veszprem, Hungary, 3 Csolnoky F. Province Hospital, Department of Pediatrics, Veszprem, Hungary, 4 Grof Eszterhazy Hospital, Department of Medicine, Papa, Hungary Background: Limited data are available on the hospitalization rates in population-based studies. Since this is a very important outcome measure, the aim of this study was to analyze prospectively if early hospitalization is associated with the later disease course as well as to determine the prevalence and predictors of hospitalization and re-hospitalization in the population-based UC inception cohort in the Veszprem province database between 2000 and 2012. Methods: Data of 347 incident UC patients diagnosed between January 1, 2000 and December 31, 2010 were analyzed (m/f: 200/147, median age at diagnosis: 36, IQR: 26 50 years, duration: 7, IQR 4 10 years). Both in- and outpatient records were collected and comprehensively reviewed. Results: Probabilities of first UC-related hospitalization and first re-hospitalization were 28.6%, 53.7%, 66.2% and 23.7%, 55.8% and 74.6% after 1, 5 and 10 years of follow-up in Kaplan Meier analysis. Main reasons for first hospitalization were diagnostic procedures (26.7%), disease activity (22.4%) or UC related surgery (4.8%), but the majority of the hospitalizations were unrelated to UC (44.8%). In Kaplan Meier and Cox-regression analysis disease extent at diagnosis (HR: 1.35, p = 0.018, HRextensive: 1.79, p = 0.02 vs. proctitis) or at last follow-up (HR: 1.56, p = 0.001), need for steroids (HR: 1.98, p < 0.001), azathioprine (HR: 1.55, p = 0.038) and anti-TNF (HR: 2.28, p < 0.001) were associated with the risk of UC-related hospitalization. Early hospitalization was not associated with a specific disease phenotype, however 46.2% of all colectomies were performed in the year of diagnosis. Conclusions: Hospitalization and re-hospitalization rates are relatively high in this population-based UC cohort. Early hospitalization was not predictive for the later disease course. DOP048 Is hospitalization predicting the disease course in Crohn’s disease? Prevalence and predictors of hospitalization and re-hospitalization in Crohn’s disease in a population based inception cohort between 2000 2012 P.A. Golovics1 *, M. Mandel1 , B. Lovasz1 , Z. Vegh1 , I. Szita2 , L. Kiss1 , M. Balogh3 , A. Mohas1 , B. Szilagyi1 , T. Pandur2 , L. Lakatos2 , P. Lakatos1 . 1 Semmelweis University, 1st Department of Medicine, Budapest, Hungary, 2 Csolnoky F. Province Hospital, Department of Medicine, Veszprem, Hungary, 3 Grof Eszterhazy Hospital, Department of Medicine, Papa, Hungary Background: Limited data are available on the hospitalization rates in population-based studies. Since this is a very important outcome measure, the aim of this study was to analyze prospectively if early hospitalization is associated with the later disease course as well as to determine the prevalence and predictors of hospitalization and re-hospitalization in a