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Gastrointestinal complications are common after renal transplantation, and they have a wide clinical spectrum, varying from diarrhoea to post-transplant inflammatory bowel disease (IBD). Chronic immunosuppression may increase the risk of post-transplant infection and medication-related injury and may also be responsible for IBD in kidney transplant re-cipients despite immunosuppression. Differentiating the various forms of post-transplant colitis is challenging, since most have similar clinical and histological features. Drug-related colitis are the most frequently encountered colitis after kidney transplantation, particularly those related to the chronic use of mycophenolate mofetil, while de novo IBDs are quite rare. This review will explore colitis after kidney transplantation, with a particular focus on different clinical and histological features, attempting to clearly identify the right treatment, thereby improving the final outcome of patients.

Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis. To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response. Consecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system. A total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p

In patients with inflammatory bowel disease (IBD), the prevalence of traditional cardiovascular risk factors is lower than that observed in the general population. However, these patients experience an excess of cardiovascular events. We have described this (only apparent) contradiction as “

Background Inflammatory bowel disease ( IBD ) is characterized by a low prevalence of traditional risk factors, an increased aortic pulse‐wave velocity ( aPWV ), and an excess of cardiovascular events. We have previously hypothesized that the cardiovascular risk excess reported in these patients could be explained by chronic inflammation. Here, we tested the hypothesis that chronic inflammation is responsible for the increased aPWV previously reported in IBD patients and that anti‐TNFa (anti‐tumor necrosis factor‐alpha) therapy reduce aPWV in these patients. Methods and Results This was a multicenter longitudinal study. We enrolled 334 patients: 82 patients with ulcerative colitis, 85 patients with Crohn disease, and 167 healthy control subjects matched for age, sex, and mean blood pressure, from 3 centers in Europe, and followed them for 4 years (range, 2.5–5.7 years). At baseline, IBD patients had higher aPWV than controls. IBD patients in remission and those treated with anti–TNFa during follow‐up experienced an aortic destiffening, whereas aPWV increased in those with active disease and those treated with salicylates ( P =0.01). Disease duration ( P =0.02) was associated with aortic stiffening as was, in patients with ulcerative colitis, high‐sensitivity C‐reactive protein during follow‐up ( P =0.02). All these results were confirmed after adjustment for major confounders. Finally, the duration of anti–TNFa therapy was not associated with the magnitude of the reduction in aPWV at the end of follow‐up ( P =0.85). Conclusions Long‐term anti–TNFa therapy reduces aPWV , an established surrogate measure of cardiovascular risk, in patients with IBD . This suggests that effective control of inflammation may reduce cardiovascular risk in these patients.

The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars.

BACKGROUND Disease phenotype and outcome of late-onset Crohn's disease are still poorly defined. METHODS In this Italian nationwide multicentre retrospective study, patients diagnosed ≥65 years (late-onset) were compared with young adult-onset with 16-39 years and adult-onset Crohn's disease 40-64 years. Data were collected for 3 years following diagnosis. RESULTS A total of 631 patients (late-onset 153, adult-onset 161, young adult-onset 317) were included. Colonic disease was more frequent in late-onset (P < 0005), stenosing behaviour was more frequent than in adult-onset (P < 0003), but fistulising disease was uncommon. Surgery rates were not different between the three age groups. Systemic steroids were prescribed more frequently in young adult-onset in the first year, but low bioavailability steroids were used more frequently in late-onset in the first 2 years after diagnosis (P < 0.036, P < 0.041, respectively). The use of immunomodulators and anti-TNF's even in patients with more complicated disease, that is, B2 or B3 behaviour (Montreal classification), remained significantly inferior (P < 0.0001) in late-onset compared to young adult-onset. Age at diagnosis, Charlson comorbidity index, and steroid used in the first year were negatively associated with the use of immunomodulators and biologics. Comorbidities, related medications and hospitalizations were more frequent in late-onset. Polypharmacy was present in 56% of elderly Crohn's disease patients. CONCLUSION Thirty-two percent of late-onset Crohn's disease presented with complicated disease behaviour. Despite a comparable use of steroids and surgery, immunomodulators and biologics were used in a small number of patients.

Background and aims There is an unmet need to better understand the effectiveness of different biologics in inflammatory bowel diseases. We aimed at performing a multicentre, real-life comparison of the effectiveness of infliximab [IFX] and adalimumab [ADA] in Crohn's disease [CD]. Methods Data of consecutive patients with CD treated with IFX and ADA from January 2013 to May 2017 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. We used propensity score-matching accounting for the main baseline characteristics in TNF-α inhibitor-naive and non-naive patients. Results A total of 632 patients [735 total treatments] were included. Among naive patients, a clinical benefit [the sum of steroid-free remission plus clinical response] was achieved in 81.8% patients treated with ADA and in 77.6% patients treated with IFX (adjusted odds ratio [OR]: 1.23, 95% CI 0.63-2-44, p = 0.547] at 12 weeks; after 1 year, a clinical benefit was achieved in 69.2% of patients treated with ADA and in 64.5% patients treated with IFX [adjusted OR: 1.10, 95% CI 0.61-1.96, p = 0.766]. Among non-naive patients, a clinical benefit was achieved in 61.7% of patients treated with ADA and in 68.1% of patients treated with IFX [adjusted OR: 0.72, 95% CI 0.21-2.44, p = 0.600] at 12 weeks; after 1 year, a clinical benefit was achieved in 48.9% of patients treated with ADA and in 40.4% patients treated with IFX [adjusted OR: 1.23, 95% CI 0.54-2.86, p = 0.620]. Conclusions In this propensity score-matched comparison of ADA and IFX in CD, both drugs showed high rates of clinical benefit, without significant differences between them.

Background Adalimumab and golimumab are effective in the treatment of moderate to severe ulcerative colitis. Aims We reported the comparative effectiveness of adalimumab and golimumab in ulcerative colitis. Methods 118 patients treated with adalimumab and 79 treated with golimumab were included and evaluated at 8 weeks and at the end of follow up. Results Overall clinical benefit was 72.6% at 8 weeks and 58.9% at the end of follow up. Patients with longer disease duration and those treated with adalimumab had a better outcome. Clinical benefit was 78.8% in adalimumab patients and 63.3% in golimumab patients (p = 0.026) after 8 weeks; it was 66.9% in adalimumab patients and 46.8% in golimumab patients (p = 0.008) at the end of follow up. These data were confirmed by propensity score analysis. A further analysis considering adalimumab optimization as treatment failure showed that the difference between adalimumab and golimumab was not significant. Conclusion Adalimumab and golimumab are effective in the treatment of ulcerative colitis. Adalimumab seems to be more effective than golimumab. This difference is probably affected by the impossibility of golimumab to be optimized in Italy while adalimumab is.

Inflammatory bowel diseases (IBD) are associated with an increased cardiovascular risk that is not fully explained by traditional cardiovascular risk factors but may be due to inflammation and mediated by an increased arterial stiffness.Study 1, to investigate the relationship between inflammation and arterial stiffening; Study 2, to look whether aortic stiffening is reduced by immunomodulatory therapy in IBD.Study 1 (Cross-sectional study): pulse wave velocity (PWV) was measured in 74 IBD subjects (40 ulcerative colitis and 34 Crohn's disease) and 80 matched controls. Study 2 (Longitudinal study): the effect of therapy on PWV was measured at baseline and 3.4 ± 0.5 years later in 14 IBD subjects treated only with salicylates, 11 subjects treated with steroids and azathioprine, 7 subjects treated with anti TNF-alpha and 30 matched controls.Study 1: All parameters were comparable between subjects with ulcerative colitis and Crohn's disease. Compared to controls, subjects with ulcerative colitis and those with Crohn's disease have both higher carotid-femoral PWV (7.0 ± 1.1, 7.8 ± 1.7 and 8.0 ± 1.6 m/s, respectively; P0.001) and carotid-radial PWV (7.2 ± 0.9, 8.8 ± 1.4 and 8.8 ± 1.3 m/s, respectively; P0.001). In fully adjusted models carotid-femoral PWV was positively associated with disease duration whereas carotid-radial PWV was associated with C-reactive protein and history of relapse. Study 2: in fully adjusted model carotid-femoral PWV increased significantly at follow-up in IBD subjects treated with salicylates but not in those treated with steroids and azathioprine or anti TNF-alpha.Increased arterial stiffness in IBD is dependent upon inflammation and reduced by immunomodulatory drugs.

Objective:In patients with inflammatory bowel disease (IBD) the cardiovascular risk is increased despite the low prevalence of traditional cardiovascular risk factors. We have previously reported in IBD that aortic pulse wave velocity (aPWV) is increased and dependent upon chronic inflammation, and

Background and aims Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. Aims and methods This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLita cUre malatTIe crOniche intestiNali (SOLUTION-1) study. Results Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the “Continuity of Care” sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians’ and patients’ perceptions of quality of care, with the former over-rating their performance in “Continuity of Cares” and under-rating “Costs”, “Competence”, and “Accessibility” sub-domains of the score (p Conclusion Perceived quality of care in a large cohort of Italian patients with inflammatory bowel disease remains unchanged after one-year follow-up and was not significantly affected by disease activity or therapeutic interventions. Differences between physicians’ and patients’ perceptions of quality of care should be taken into account.

Background: Late-onset UC represents an important issue for the near future, but its outcomes and relative therapeutic strategies are yet poorly studied. Aim: To better define the natural history of late-onset ulcerative colitis. Methods: In a multicenter retrospective study, we investigated the disease presentation and course in the first 3 years in 1091 UC patients divided into 3 age-groups: diagnosis >65 years, 40-64 years, and

1.1.Background: Diffusion-weighted represents a new application of magnetic resonance imaging (DW-MRI) to assess inflammatory activity in Crohn’s disease. ADC is a quantitative parameter of this phenomenon. We aimed to verify the correlation between DWI findings both with patholo-gical evaluation of fibrosis in surgical specimen both with endoscopic recurrence. 1.2.Methods:31 pts undergoing ileocolonic resection for CD were submitted to DW-MRI. Conventional MRI findings of terminal or neo-terminal ileum were recorded together with a semiquantitative evaluation of DWI signal intensity and with ADC calculation. For the first aim, Acute Inflammatory (AIS) and Fibrostenosis score was correlated to ADC values of matched ileo-cecal segment. ROC curves analysis was used to find out an ADC cut-off value able to distinguish "low and high grade" severity of post-operative recurrence. 1.3.Results:Comparison of DWI findings with surgical specimens pathologic evaluation showed a very good correlation, inverse and statistically significant, between ADC and AIS total (r=- 0.90, p=0.013). The mean ADC value of the 5 pts with fibrosis was not statistically different from the 5 pts without. The comparison between ADC and Rutgeerts’score showed a good correlation, inverse and statistically significant (rho= -0.73, P=0.002). ROC curves analysis highlighted that a value of ADC ≤ 1.82 x10-3 mm2 /s could predict a severe recurrence (Rs >i2) with a sensitivity of 88.9% and a specificity of 83.3%. 1.4.Conclusion:This study showed the ability of DWI sequences to provide quantitative measures of inflammation, allowing a more objective assessment of CD. Further studies should clarify whether ADC evaluation could predict the presence of fibrosis in surgical specimens.

This study was undertaken to determine the diagnostic capabilities of diffusion-weighted magnetic resonance imaging (DWI) in detecting ileal inflammation in Crohn’s disease (CD), and to verify the correlation between the DWI sequences and the Harvey-Bradshaw index (HBI). Twenty patients with an endoscopic-histological diagnosis of CD of the terminal ileum and MR enterography with DWI sequences and HBI were retrospectively selected. Disease activity was visually evaluated on the DWI sequences. In quantitative analysis, the apparent diffusion coefficient (ADC) of the terminal ileum was compared with that of normal ileal loops. Pearson’s r was used to verify the correlation between the DWI findings and the HBI. On visual assessment, the accuracy, sensitivity and positive predictive value of DWI for the detection of inflammation were 100 %. In the quantitative assessment, the ADC value of the disease-active terminal ileum was significantly lower (p

P302 Utility of “trough levels” determination and anti-infliximab antibodies in patients with inflammatory bowel disease. Estimation of individual pharmacokinetic parameters (PK) through population pharmacokinetic model G. Juan1,2 *, A. Alvarino3,4, L. Oltra4, N. Maroto4, N. Cano2, I. Ferrer2, J. Hinojosa2,4. 1Hospital de Manises, Farmacia Hospitalaria, Valencia, Spain, 2Hospital de Manises, Digestivo, Manises, Spain, 3Hospital de Manises, LABCO, Valencia, Spain, 4Hospital de Manises, Gastroenterology, Valencia, Spain

Inflammatory bowel disease (IBD) is the result of a combination of environmental, genetic and immunologic factors that trigger an uncontrolled immune response within the intestine, which results in inflammation among genetically predisposed individuals. Several studies have reported that the prevalence of classic cardiovascular risk factors is lower among subjects with IBD than in the general population, including obesity, dyslipidaemia, diabetes and hypertension. Therefore, given the risk profile of IBD subjects, the expected cardiovascular morbidity and mortality should be lower in these patients than in the general population. However, this is not the case because the standardized mortality ratio is not reduced and the risk of coronary heart disease is increased in patients with IBD. It is reasonable to hypothesize that other factors not considered in the classical stratification of cardiovascular risk may be involved in these subjects. Therefore, IBD may be a useful model with which to evaluate the effects of chronic low-grade inflammation in the development of cardiovascular diseases. Arterial stiffness is both a marker of subclinical target organ damage and a cardiovascular risk factor. In diseases characterized by chronic systemic inflammation, there is evidence that the inflammation affects arterial properties and induces both endothelial dysfunction and arterial stiffening. It has been reported that decreasing inflammation via anti tumor necrosis factor alpha therapy decreases arterial stiffness and restores endothelial function in patients with chronic inflammatory disorders. Consistent with these results, several recent studies have been conducted to determine whether arterial properties are altered among patients with IBD. In this review, we discuss the evidence pertaining to arterial structure and function and present the available data regarding arterial stiffness and endothelial function in patients with IBD.

C. Luigiano ∗ ,1, G. Iabichino 2, S. Miraglia 1, C. Ferracane 2, A. Judica 2, N. Pagano 3, L.H. Eusebi 3, S. Siringo 1, G. Inserra 4, P. Castellino 4, C. Virgilio 1 1Unit of Gastroenterology and Digestive Endoscopy, ARNAS Garibaldi, Catania, Italy; 2Postgraduate School of Gastroenterology, University of Catania, Catania, Italy; 3Unit of Gastroenterology, S. Orsola-Malpighi University Hospital, Bologna, Italy; 4Department of Internal Medicine, University of Catania, Catania, Italy

Background: Crohn’s Disease (CD) and Ulcerative Colitis (UC) can be really considered systemic diseases since they are often associated with EIMs. In addition to the bowel, multiple other organs can be affected in IBD, including the bones and joints, skin, eyes and hepatobiliary system. The EIMs can occur prior to, in conjunction with, or subsequent to onset of IBD. The aim of this study was to investigate the prevalence of EIMs in IBD patients and the correlation between the presence of EIMs and the seat of CD. Methods: Three hundred and seven IBD patients, who referred to our centre from January 2004 to October 2012, were retrospectively studied. In each patient we recorded sex, age and the possible presence of EIMs. In CD patients we evaluated also the seat of disease, according to Montreal Classification. Three types of EIMs were considered: musculoskeletal manifestations (including axial and peripheral arthritis); dermatologic manifestations (including erythema nodosum, pyoderma gangrenosum and psoriasis); ocular manifestations (including uveitis and iridocyclitis) and sclerosing cholangitis. Each patient could have one or more manifestations. Results: We observed 161 patients with CD (mean age 43.4 years) and 146 with UC (mean age 47.1). One hundred and fifty-one were female (49%) and 156 were male (51%). We found 51 EIMs in 44 out of 307 patients with a prevalence of 16.6% (CD 22.3%, UC 10.2%). The prevalence of axial arthritis was 4% (CD 7.5%, UC 2%); peripheral arthritis was 3.5% (CD 4.3%, UC 2.7%); erythema nodosum was 2.6% (CD 3.7%, UC 1.3%); pyoderma gangrenosum was 1% (CD 0.3%, UC 1.3%); psoriasis was 2.2% (CD 2.4%, UC 2%); uveitis was 1.6% (CD 2.4%, UC 0.7%); iridocyclitis was 0.6% (CD 1.2%, UC 0%). No sclerosing cholangitis was found in our patients. Seven EIMs were found before the diagnosis of IBD, 34 after diagnosis and 10 were present at the time of diagnosis. The prevalence of EIMs in CD patients, according to the seat of disease was 21% for L1 patients, 17% for L2, 20% for L3 and 0% for L4. The correlation between the presence of EIMs and the seat of disease was not statistically significant. Conclusions: The prevalence of EIMs is in keeping with those reported in the literature. EIMs are more frequent in CD than UC and the musculoskeletal manifestations are the most common. EIMs are important in the management of patients with CD and UC. A multispecialty approach to the care of these patients can be helpful in optimizing management.