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Background The management of inflammatory bowel disease (IBD) has substantially changed in the last decades, both in relation to medical and surgical treatments. Aims Principal: To know the rate of surgery in a newly diagnosed IBD cohort within the first year after diagnosis. Secondary: To describe the type of surgeries and indications in this cohort, and to identify predictive factors for surgery (focused on intestinal resection) in these patients. Methods Prospective, population-based nationwide registry. Adult patients diagnosed with IBD -Crohn’s disease (CD) and ulcerative colitis (UC)- during 2017 in Spain were included and were followed-up for 1 year. Kaplan-Meier curves were used to calculate the rate of surgery. In patients with intestinal resections, only medical treatments before surgery were considered. Predictive factors for surgery were identified by Cox-regression analysis. Results 3,454 patients (1,647 CD and 1,807 UC) were included (table 1). The incidence rate for surgery was significantly higher among CD patients (figure 1). A total of 197 patients (6%) underwent surgery within the first 12 months: 126 (64%) intestinal resections, and 71 (36%) perianal surgeries. Fifty-seven percent of intestinal resections were urgent, and 43% elective. The main indications for intestinal resections were: intestinal obstruction in 37%, abscess/fistula in 27%, perforation/acute abdomen in 25%, and refractoriness to medical treatment in 18% of cases. A total of 174 CD patients (10.6%) underwent surgery ¾61% intestinal resections and 39% perianal. Twenty-three UC patients (1.3%) were operated on; the number of surgeries in UC was too low to identify predictive factors. In CD patients, to have been treated with thiopurines [Hazard ratio (HR)=0.2, 95% confidence interval (CI)=0.1–0.3) was associated with lower likelihood of intestinal resection. Disease behaviour at diagnosis [stricturing vs. inflammatory (HR=6.5, 95%CI=4–10) and fistulising vs. inflammatory (HR=13, 95%CI=9–21)] was associated with the risk of intestinal resection. Biologic treatment was not associated with the likelihood of intestinal resection (figure 2). Conclusion Six percent of IBD patients undergo surgery within the first year of diagnosis, being higher in CD (11%) than in UC (1.3%). Sixty percent of intestinal resections are urgent procedures. The risk of surgery is increased in CD patients with fistulising and stricturing behaviour. Thiopurine, but not biologic treatment, is associated with lower risk of surgery.

Background A less aggressive phenotype of Crohn’s disease (CD) has been reported in patients with elderly onset CD. Despite this, similar surgical rates among younger and older CD patients have been reported. However, scarce data are available about the risk of postoperative recurrence (POR) regarding the age, and no data are available about the use of immunosuppressants and biological agents for prevention of POR in elderly patients. Our aim was to evaluate the management of CD in the postoperative setting and the rate of surgical POR in CD patients according to the age at surgery. Methods Cohort study including all adult CD patients in the ENEIDA registry (a prospectively-maintained database of the Spanish Working Group in IBD –GETECCU-) who underwent a first intestinal resection with ileo-colonic anastomosis. Patients were grouped regarding their age at the moment of the first surgery: over 60 years (elderly) and between 18 and 60 years of age (controls). Preventive treatment for POR, surgical POR (need for a further intestinal resection) and postoperative morbidity were compared between both groups. Results Out of the 69,740 IBD patients included in the ENEIDA database, 3,982 had a first intestinal resection for Crohn’s disease with an ileo-colonic anastomosis between 2005 and 2020. Of them, 535 were elderly and 3,454 controls. Time from IBD diagnosis to surgery was significantly longer in the elderly (114±128 vs. 93±97 months; p Conclusion The elderly patients show similar rates of surgical POR as compared to younger patients. Given the high risk of thiopurine and anti-TNF-related adverse events, elderly patients with inflammatory pattern would benefit from preventive therapy with safer biologicals.

Background The prevalence of penetrating disease in Crohn’s disease (CD) increases progressively over time, and evidence on the medical treatment of this complication is limited. The aim of this study was to evaluate the efficacy of biologic agents in CD complicated with internal fistulising disease. Methods A retrospective analysis of all adult patients from the ENEIDA registry (>68,000 patients) with CD who received at least one biologic agent -anti-TNF, ustekinumab or vedolizumab- for penetrating disease was performed. Exclusion criteria comprised treatment for perianal disease, enterocutaneous, anastomotic or periostomal fistula tracts. The main outcomes were fistula-related surgery and fistula closure on cross-sectional imaging. Preestablished secondary outcomes included the rate of abdominal abscess, the need for percutaneous drainage, the changes in the number of fistula tracts, fistula closure rates, and the safety profile.The baseline characteristics were analyzed by means of descriptive statistics and were compared by non-parametric tests. Predictive factors associated with surgery and fistula closure were evaluated by a multivariable logistic regression and survival analyses. Results A total of 710 patients (median age 38 years [IQR, 28-48], 59% male, 55% L3) receiving 791 biologic treatments were included at 53 sites (701 anti-TNF, 71 ustekinumab, and 19 vedolizumab). Patients had a median of 1 (range 1-5) fistula tracts, 49% of them entero-enteric followed by entero-colic (28%). After a median follow-up of 59 months (IQR, 27-105), 244 patients (31%) required surgery due to internal fistulising complications after 8.5 months (IQR, 3-24). Patients with ileocolonic disease (OR 1.99 [1.22-3.23]), entero-urinary fistulas (OR 2.35 [1.17-4.73]), or with a stricture distal to the fistula (OR 2.1 [1.31-3.36]) showed a higher risk of surgery, with no differences between biologic drugs (Figure 1). Combination therapy reduced the risk of surgery (HR 0.58 [0.37-0.90]). Fistula closure was observed in 24% of patients after a median of 15 months (IQR, 7.5-27). Patients with a lower number of fistula tracts showed a higher probability of closure (OR 1.72 [1.09-2.7]). Conclusion A high proportion of patients with internal fistulizing CD benefit from biologic treatment after a median of 5 years. During this follow-up, around two thirds of patients are free of surgery and one in every four patients achieves fistula closure.

Background Crohn’s disease (CD) can develop fistulizing complications at any time during the disease course. Enterocutaneous fistulas (ECF) are disabling lesions with a significant impact on quality of life. The aim of this study was to describe the characteristics and natural history of ECF complicating CD, and to analyze its medical and/or surgical management. Methods A retrospective analysis of all adult patients with fistulizing CD with at least one episode of ECF from the ENEIDA registry (over 68,000 patients) was performed. ECF were defined as a communication between the gastrointestinal tract and the skin producing leakage of luminal contents. Additional data describing the ECF and its medical or surgical management were gathered. The main endpoint was any ECF-related surgical intervention. Fistula closure was defined as the absence of drainage, with no new abscess or surgery for at least 6 months. A comparison of the characteristics and outcomes after the availability of biologic agents (Jan/2000) was also performed. The baseline characteristics were analyzed by means of descriptive statistics and were compared by non-parametric tests. Factors associated with surgery were further evaluated in a binary multivariable regression and survival analysis. Results A total of 301 ECF in 286 patients from 46 hospitals diagnosed between Jan/1970-Sept/2020 were included (median age 34 years (IQR, 27–46); 59% male; 67% L3). ECF had a median of 1 external opening (range 1–10), 59% with concomitant internal fistulas, and usually involved the ileum (67%) or colon (23%). After 146 months (IQR, 69–233) of follow-up, 37% received thiopurines, 40% anti-TNF, 6% ustekinumab and 2% vedolizumab. Surgery was performed in 208 patients (69%) after a median of 4 months (IQR, 1.4–12). Fistula closure was achieved in 253 patients (84%) after 30 months (IQR, 4–84), mostly after surgery (54%) and in one third after medical therapy. Fistula recurrence was uncommon (11%) after closure. Patient and fistula characteristics were significantly different after the availability of biologics. In fact, anti-TNF biologics and thiopurines reduced surgery risk (HR 0.5; 0.38–0.67; HR 0.64; 0.47–0.86, respectively). The surgery rate in the biologic era tends to be lower than before (OR 0.63;0.33–1.09) while timing is similar. Closure rates are also comparable, but it was obtained more frequently after medical therapy once biologicals were available (OR 2.21; 1.13–4.29). Conclusion ECF complicating CD entail a high burden of medical and surgical resources. Closure rates are high, usually after surgery, and fistula recurrence is uncommon. A number of patients can benefit from medical therapy and achieve fistula closure.

Aim To assess the likelihood of detecting latent tuberculosis infection [LTBI] by the positive conversion of a serial tuberculin skin test [TST] at 1 year in inflammatory bowel disease [IBD] patients with negative baseline two-step TST. Methods In this multicentre prospective cohort study, we evaluated rate and predictors of conversion of TST at 1 year in patients with negative baseline TST. We also evaluated management of patients who had a positive TST at baseline or a conversion at 1 year. In all patients we assessed TB cases occurring during follow-up. Results Of the 192 IBD patients receiving anti-tumour necrosis factor [TNF] and 220 IBD controls not receiving anti-TNF, 35 [8.5%, 95% CI 5.7-11.3] had positive conversion (median TST induration 13 mm, interquartile range [IQR] 9-16). Ten anti-TNF cohort patients [5.2%, 95% CI 2.5-9.5] versus 25 controls [11.4%, 95% CI 7.5-16.3] had TST conversion [p = 0.029]. In multivariate analysis, conversion was associated with smoking habit (odds ratio [OR] 2.19, 95% CI 1.08-3.97; p = 0.028). Anti-TNF-treated patients had a lower conversion rate [OR 0.41, 95% CI 0.20-0.83; p = 0.013]. The likelihood of conversion correlates with fewer immunosuppressive therapies between baseline TST and TST at 1 year [p = 0.042]. One case of active TB [isoniazid-resistant strain] occurred in a patient with positive baseline TST receiving anti-TNF [0.05 events/100 patient-years]. Conclusions Serial TST at 1 year can detect LTBI in IBD patients receiving anti-TNF therapy with negative baseline TST. Serial TST seems to be advisable to reduce the risk of TB cases associated with inability to detect LTBI in pre-treatment screening.

[Background and Aims] Steroid-dependency occurs in up to 30% of patients with ulcerative colitis [UC]. In this setting, few drugs have demonstrated efficacy in inducing steroid-free remission. The aim of this study was to evaluate the efficacy and safety of adding granulocyte/monocyte apheresis [GMA] to oral prednisone in patients with steroid-dependent UC., [Methods] This was a randomized, multicentre, open trial comparing 7 weekly sessions of GMA plus oral prednisone [40 mg/day and tapering] with prednisone alone, in patients with active, steroid-dependent UC [Mayo score 4–10 and inability to withdraw corticosteroids in 3 months or relapse within the first 3 months after discontinuation]. Patients were stratified by concomitant use of thiopurines at inclusion. A 9-week tapering schedule of prednisone was pre-established in both study groups. The primary endpoint was steroid-free remission [defined as a total Mayo score ≤2, with no subscore >1] at Week 24, with no re-introduction of corticosteroids. [Results] In all 123 patients were included [63 GMA group, 62 prednisone alone]. In the intention-to-treat analysis, steroid-free remission at Week 24 was achieved in 13% (95% confidence interval [CI] 6–24) in the GMA group and 7% [95% CI 2–16] in the control group [p = 0.11]. In the GMA group, time to relapse was significantly longer (hazard ratio [HR] 1.7 [1.16–2.48], P = 0.005) and steroid-related adverse events were significantly lower [6% vs 20%, P < 0.05]. [Conclusions] In a randomized trial, the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, though it delayed clinical relapse., This work was supported by an unrestricted research grant from Otsuka Pharmaceuticals.

Background Ulcerative colitis (UC) and Crohn’s disease (CD) are two chronic conditions of the gastrointestinal tract. Previous data suggest that a subclinical inflammatory process precedes the initial symptoms. Our aim was to determine if patients with UC or CD have an increase in healthcare utilization in the years preceding the disease onset. Methods A single-centre retrospective case-control study was performed at Hospital de Galdakao (Spain). We included all consecutive patients with a new diagnosis of UC/CD between 01/01/2018 and 31/12/2019. Cases were matched 1:3 with controls adjusted by sex, age and date, excluding those subjects with any visit to Gastroenterology Department. The main outcomes were the number of outpatient or Emergency visits, hospital admissions, radiological examinations (ultrasound, CT, MRI), sick-leaves, and prescriptions (antibiotics, steroids) in the 5 years before the diagnosis of UC/CD. Descriptive statistics were used, followed by chi-square tests and a multivariable hurdle regression model, adjusted by smoking habits and Charlson index, in order to perform a per year analysis. Additional grouped comparisons of the preceding 3 and 5 years were performed, and also excluding the 12 months prior to diagnosis. Results A total of 305 cases were included (160 UC, 168 CD; median 48 years; 53% female) and compared with 915 controls. Baseline characteristics including age, smoking habits, and comorbidities were comparable. Grouped analysis (excluding 12 months prior to UC/CD diagnosis) are summarized in Table 1. Patients had an increase in the number of hospital admissions, visits to the Emergency room or Primary Care physician, sick-leaves, radiological examinations, and prescription of antibiotics or corticosteroids in the previous 3 to 5 years, excluding the 12 months prior to diagnosis of UC/CD. Conclusion Patients with UC and CD show an increased use of healthcare resources in the years prior to the diagnosis. Diagnostic tools should focus in early predictors of disease onset as they may prompt an earlier identification of patients with IBD.

Background The diagnosis of ulcerative colitis (UC) is usually established after the development of symptoms, but preclinical disease may be present even years before the final diagnosis. Around 25% of UC patients may show a proximal extension of the disease. The primary aim of the study was to define the main characteristics and the risk of progression of preclinical UC. Methods We performed a multicentric, retrospective study of all patients included in the colorectal cancer screening programme in 11 centres between 2009–2014. All subjects were initially assessed with a faecal occult blood test (OC-Sensor, Eiken Chemical Co., Tokyo, Japan) and, if this test was positive (cut-off 20 μg Hgb/g), a colonoscopy was performed. All patients were asymptomatic and had an incidental diagnosis of UC confirmed by histology during a screening colonoscopy. The main outcomes were the risk of developing symptomatic disease and proximal disease extension. A chi-square test was performed in order to assess the risk factors of proximal extension and symptomatic disease. Results During this period we performed 31 005 colonoscopies after 498 227 FIT. We included 79 patients with a new diagnosis of UC (age 58 years [IQR, 52–63], 37% non-smokers]). At baseline, disease extension was E1 in 32%, E2 in 33% and E3 in 35%. After a median follow-up of 29 months (IQR, 17–41), 76% received some treatment, and no patient showed proximal disease extension. In 45% (33% E3 and 12% E2) we observed a reduction of the disease extension. Among those subjects who were asymptomatic at diagnosis, 32% developed symptomatic disease after a median of 7.5 months (IQR, 1–14). Disease extent at diagnosis did not influence the risk of symptomatic disease during follow-up (p = 0.85). Those patients with left-sided or extensive UC were more frequently treated with mesalazine, systemic steroids or thiopurines, compared with those with proctitis (p = 0.001, 0.023 and 0.047, respectively). Conclusion Approximately one-third of patients with preclinical UC develop symptomatic disease, but there is no risk of proximal disease extension after 2 years of follow-up.

Background The diagnosis of inflammatory bowel disease (IBD) is usually established after the development of symptoms, but preclinical disease may be present years before the final diagnosis. Recently, histology has become one of the main outcomes of IBD treatment. The primary aim of our study was to define the main histological findings of preclinical IBD and its association with the natural history of the disease. Methods This multicentric, retrospective study included all patients who participated in the colorectal cancer screening programme in 11 centres between 2009–2014. All patients were firstly assessed by a faecal immunochemical test (OC-Sensor, Eiken Chemical Co., Tokyo, Japan) and, if this test was positive (cut-off 20 μg Hgb/g), a colonoscopy was performed. All patients had an incidental diagnosis of IBD confirmed by histology, according to current ECCO criteria, during a screening colonoscopy. Three histologic findings were evaluated at diagnosis: presence of granuloma, crypt abscesses and/or eosinophilic infiltrate. The main outcomes were the development of symptoms and the risk of proximal disease extension. The frequency of each finding was described separately by IBD subtype and the chi-square test was used to describe possible association with the main outcomes. Results During this period we performed 31,005 colonoscopies after 498,227 FIT. Finally, 110 patients were included with an incidental diagnosis of ulcerative colitis (UC, 79 cases), Crohn’s disease (CD, 24 cases) or IBD-Unclassified (IBD-U, 7 cases). Crypt abscesses were present in 56%, 33% and 57% of UC, CD and IBD-U patients, respectively (Figure 1). An eosinophilic infiltrate was observed in 27%, 25% and 57% of patients, respectively. Granuloma were only observed in 4% of CD patients. There were no statistically significant differences in these findings according to IBD subtype (p = 0.14, 0.22 and 0.17 for crypt abscesses, eosinophilic infiltrate and granuloma, respectively). After a median follow-up of 25 months (IQR, 11–42), 36% of patients developed symptomatic disease. Neither of the histological findings were associated with a higher risk of developing symptomatic disease (p = 0.29, 0.78 and 0.3, respectively). No patient showed proximal extension of UC. Conclusion Preclinical IBD is frequently associated with the presence of crypt abscesses, especially in UC. Granuloma is probably a late finding in CD. Around one third of patients show a eosinophilic infiltrate in the early phases of the disease.

Background & aims: Disease outcome has been found to be poorer in familial inflammatory bowel disease (IBD) than in sporadic forms, but assessment of phenotypic concordance in familial IBD provided controversial results. We assessed the concordance for disease type and phenotypic features in IBD families. Methods: Patients with familial IBD were identified from the IBD Spanish database ENEIDA. Families in whom at least two members were in the database were selected for concordance analysis (K index). Concordance for type of IBD [Crohn's disease (CD) vs. ulcerative colitis (UC)], as well as for disease extent, localization and behaviour, perianal disease, extraintestinal manifestations, and indicators of severe disease (i.e., need for immunosuppressors, biological agents, and surgery) for those pairs concordant for IBD type, were analyzed. Results: 798 out of 11,905 IBD patients (7%) in ENEIDA had familial history of IBD. Complete data of 107 families (231 patients and 144 consanguineous pairs) were available for concordance analyses. The youngest members of the pairs were diagnosed with IBD at a significantly younger age (p < 0.001) than the oldest ones. Seventy-six percent of pairs matched up for the IBD type (kappa = 0.58; 95%CI: 0.42-0.73, moderate concordance). There was no relevant concordance for any of the phenotypic items assessed in both diseases. Conclusions: Familial IBD is associated with diagnostic anticipation in younger individuals. Familial history does not allow predicting any phenotypic feature other than IBD type. (C) 2013 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

surgery was 40.4% at one year and 59.3% at two years with a median time to surgery of 22 months (range 0.5 84 months). Patients who were steroid refractory, or dependent, prior to starting tacrolimus were more likely to have surgery (P= 0.006), while patients who were able to achieve or maintain a clinical response with tacrolimus by 90-days were less likely (P= 0.004). Conclusions: Tacrolimus is able to induce a clinical response in a third and remission in a fifth of medically refractory IBD patients at one year. A 90 day therapeutic trial is worthwhile in difficult to treat patients.