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Background and Aims Primary sclerosing cholangitis [PSC] is usually associated with inflammatory bowel disease [IBD]. An increased risk of malignancies, mainly colorectal cancer [CRC] and cholangiocarcinoma [CCA], has been reported in PSC-IBD patients. Our aim was to determine the clinical characteristics and management of PSC in IBD patients, and the factors associated with malignancies. Methods PSC-IBD patients were identified from the Spanish ENEIDA registry of GETECCU. Additional data were collected using the AEG-REDCap electronic data capture tool. Results In total, 277 PSC-IBD patients were included, with an incidence rate of 61 PSC cases per 100 000 IBD patient-years, 69.7% men, 67.5% ulcerative colitis and mean age at PSC diagnosis of 40 ± 16 years. Most patients [85.2%] were treated with ursodeoxycholic acid. Liver transplantation was required in 35 patients [12.6%] after 79 months (interquartile range [IQR] 50–139). It was more common in intra- and extrahepatic PSC compared with small-duct PSC (16.3% vs 3.3%; odds ratio [OR] 5.7: 95% confidence interval [CI] = 1.7–19.3). The incidence rate of CRC since PSC diagnosis was 3.3 cases per 1000 patient-years [95% CI = 1.9–5.6]. Having symptoms of PSC at PSC diagnosis was the only factor related to an increased risk of CRC after IBD diagnosis [hazard ratio= 3.3: 95% CI = 1.1–9.9]. CCA was detected in seven patients [2.5%] with intra- and extrahepatic PSC, with median age of 42 years [IQR 39–53], and presented a lower life expectancy compared with patients without CCA and patients with or without CRC. Conclusions PSC-IBD patients with symptoms of PSC at PSC diagnosis have an increased risk of CRC. CCA was only diagnosed in patients with intra- and extrahepatic PSC and was associated with poor survival.

BackgroundPrevious studies comparing immigrant ethnic groups and native patients with IBD have yielded clinical and phenotypic differences. To date, no study has focused on the immigrant IBD population in Spain.MethodsProspective, observational, multicenter study comparing cohorts of IBD patients from ENEIDA-registry who were born outside Spain with a cohort of native patients.ResultsWe included 13,524 patients (1,864 immigrant and 11,660 native). The immigrants were younger (45 ± 12 vs. 54 ± 16 years, p < 0.001), had been diagnosed younger (31 ± 12 vs. 36 ± 15 years, p < 0.001), and had a shorter disease duration (14 ± 7 vs. 18 ± 8 years, p < 0.001) than native patients. Family history of IBD (9 vs. 14%, p < 0.001) and smoking (30 vs. 40%, p < 0.001) were more frequent among native patients. The most prevalent ethnic groups among immigrants were Caucasian (41.5%), followed by Latin American (30.8%), Arab (18.3%), and Asian (6.7%). Extraintestinal manifestations, mainly musculoskeletal affections, were more frequent in immigrants (19 vs. 11%, p < 0.001). Use of biologics, mainly anti-TNF, was greater in immigrants (36 vs. 29%, p < 0.001). The risk of having extraintestinal manifestations [OR: 2.23 (1.92–2.58, p < 0.001)] and using biologics [OR: 1.13 (1.0–1.26, p = 0.042)] was independently associated with immigrant status in the multivariate analyses.ConclusionsCompared with native-born patients, first-generation-immigrant IBD patients in Spain were younger at disease onset and showed an increased risk of having extraintestinal manifestations and using biologics. Our study suggests a featured phenotype of immigrant IBD patients in Spain, and constitutes a new landmark in the epidemiological characterization of immigrant IBD populations in Southern Europe.

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Background Drug-induced lupus (DIL) has been described as an adverse event of an immunological nature, in relation to treatment with anti-TNFα drugs. It is considered as a manifestation uncommon in patients with inflammatory bowel disease (IBD). The main objective of the study was to know the prevalence of DIL, the main characteristics and the management of IBD patients. The secondary objetive was to identify predictive factors related to the pathology. Methods We conducted a retrospective study, between January 2017- March 2020, in patients with IBD treated with anti-TNFα drugs during this time, in a single center. The information was obtained from the clinical history of the hospital. Patients with different degrees of data incompleteness were dismissed. Although there are no accepted diagnostic criteria, diagnosis was based on the criteria proposed by De Bandt: (i) the presence of immunologic abnormalities: ANA+ and/or anti-dsDNA+; (ii) at least two clinical features; (iii) clear temporal association with exposure to the anti-TNFα. The serum concentration of Infliximab (IFX) was considered optimal within the interval 3–7 μg/mL2. For Adalimumab (ADA) the optimal interval was 5–8 μg/mL3. Results We identified 248 patients with anti-TNFα therapy. 15 of them were dismissed due to incomplete data. We found 8 patients with a DIL diagnosis (3.34%). The manifestations of DIL occurred after a mean of treatment duration of 29.63 months. The clinical features of DIL included arthritis (87.5%), fatigue (75%), fever (25%), vasculitis, cutaneous manifestations, and nephropaty (12.5%) each. All patients required specific treatment and in 7 of them (87.5%) the anti-TNFα drug was discontinued followed by complete clinical resolution in all of them. Patients with DIL had a higher prevalence of suboptimal serum concentration of anti-TNFα drug than the rest of the patients (83.33% versus 29.89%, p = 0.012). In addition, the combination therapy with immunomodulators (IMM) was less frequent in the DIL group (0% versus 64.37%, p = 0.003). Antinuclear antibodies (ANA) had a higher prevalence in DIL cases (100% versus 25.36%, p>0.001). No differences were found regarding the type of disease (CD versus UC), duration of anti-TNFα treatment, previous treatment with another anti-TNFα or with the type of anti-TNFα (IFX versus ADA). Conclusion The prevalence of DIL in IBD patients undergoing anti-TNFα treatment could be even higher than described due to the lack of knowledge of the disease and the absence of clearly reported diagnostic criteria. The DIL does not seem to be related to the type of disease, or the type of anti-TNFα. Suboptimal serum concentrations of anti-TNFα, as well as monotherapy treatment (without IMM) could be related to the development of DIL.

Background Currently,endoscopy,an invasive medical procedure, is the gold standard for diagnosis of inflammatory bowel disease (IBD) and to determine mucosal activity.Our main goal was to identify biomarkers in saliva samples that can be used as a screening tool for the diagnosis of ulcerative colitis(UC) and Crohn`s disease(CD). Methods 100 saliva samples were collected from: healthy individuals(20), UC-active stage(10),UC-remission stage(31),CD-active stage(7) and CD-remission stage(32) patients. The samples were thawed on ice and centrifugated at 10,000g for 15 min at 4ºC.The supernatants were aliquoted and stored at -80ºC. The protein extracts were digested with trypsin and peptides resulting from digestion were loaded onto a nano Acquity UPLC chromatograph and analysed in a nano Elute coupled on-line to a timsTOF Pro(Bruker).The data obtained was then processed and loaded onto the Progenesis LC-MS software (Nonlinear Dynamics) for Orbitrap data and PEAKS(Bioinformatics Solutions Inc.) for timsTOF Pro data. Finally, this information was converted to deregulation patterns at protein level and relative quantification was done. Saliva protein levels were compared between healthy (always as control) and CD remission,UC remission,UC active and CD active stages respectively.The identification of potential biomarkers was carried out with classical statistic methods(p value<0,05 and ratio> 1,5) and data Mining mathematical model(p-value<0,05, balanced accuracy ≥ 70, sensitivity ≥ 60 and specificity ≥ 60). Results We have chosen the most relevant classifiers according to statistical and biological criteria, based on their biological function and the pathogenesis of UC or CD(figure 1). We have identified 152 classifiers(biomarkers),118 single and 34 dual, defined by one or two proteins of a list of 135 proteins(table 1).The classifiers are shown for each cohort compared to healthy control:42 biomarkers were found in Active UC,16 in Remission UC, 99 in Active CD and 13 in Remission CD,all of them compared to healthy controls. Conclusion Multiple potential biomarkers have been identified in saliva in relation to IBD. Biomarkers with significant value have been found for identifying and classifying UC as well as CD, compared to controls.The number of biomarkers found in CD has been higher than in UC. The simple biomarker option(versus dual) is recommended,since its application involves fewer errors.

Background Previous studies comparing inflammatory bowel disease(IBD) features between migrant and native patients have shown clinical phenotype differences. To date, no study has focused on IBD immigrants(MP) in Spain. The aim of this study was to explore the features of MP in Spain and to compare age of disease onset, IBD phenotype and therapeutic requirements with native-born IBD patients(NP). Methods This was an observational, multicentric and case-control study of the nationwide ENEIDA registry. We selected all IBD patients who were born outside of Spain and compared with a control cohort of NP. All included patients were diagnosed with IBD before 2015. Results A total of 13,524 patients were included(1864 MP and 11660 NP).The most prevalent ethnic migrant group was Caucasian(771, 41%), followed by Latin American(572, 31%) and Arabian(341,18%), whereas Asian represented only 6%. Table 1 summarizes the demographic and phenotypic features. 71% of MP were diagnosed with IBD in Spain. There was not a gender predisposition to IBD in the overall migrant group, however more female UC MP were detected compared to UC NP(52 % vs 45%, p<0.001). MP were younger at the onset of the disease and had a shorter disease duration compared to NP, in both UC and CD patients. Significantly more CD patients were diagnosed under 16 years(A1) among MP, and more patients over 40 years(A3) among NB. More NB patients had CD stricturing phenotype(24% vs 19%, p=0,002) compared to MP. Disease extension in CD and UC did not differ between groups. The overall proportion of abdominal or perianal surgery was similar in both groups but the use of biologic therapy was more common in MP(36% vs 30%, p=0,001). Conclusion In the largest cohort of migrant IBD patients in Spain, immigrants were younger, had a shorter disease duration and required a higher use of biologics than natives, pointing phenotypic differences in this population and a universal access to the healthcare system all over the country.

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