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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 The usefulness of therapeutic drug monitoring(TDM) of infliximab during induction and its relationship with clinical outcome in patients with inflammatory bowel disease(IBD) is well established. However, the optimal time of monitoring in terms of clinical outcomes remains unclear. The aim is to evaluate the TDM at various times during induction and its association with clinical remission. Methods An observational, retrospective and single-centre study of patients with active disease ,Crohn’s disease (CD) or ulcerative colitis(UC), was performed. Induction treatment with infliximab 0, 2, 6 weeks was conducted and if there was response, maintenance therapy was provided. Antibody levels were measured in serum samples at week 2 and week 14 by using an enzyme-linked immunosorbent assay, within the therapeutic range(3-8 µg/ml). Patients were followed at least for one year or until loss of response. The clinical response was assessed in week 14 and week 52 by Harvey-Bradshaw Index in CD and Mayo Partial Index in UC. Results Out of 93 patients that were evaluated, 23 with UC(24.73%) and 70 with CD(75.27%,), 65 (69.89%) and 58 patients(62.37%) achieved remission at week 14 and week 52 respectively. Infliximab levels at week 14 but not at week 2 were significantly higher in patients who achieved clinical remission in both week 14 (5.8 vs 2.1 µg/ml; p=0.0002) as in week 52 (6.4 vs 1.9 µg/ml; p=0.0001). The levels at week 14, but not at week 2 had predictive value of remission, in both week 14 [OR 1,4 (CI 1.14-1.76) p=0.001] and week 52 [OR 1.4 (CI 1.15-1.87); p=0.001]. The patients with immunosuppressants at week 14 presented the highest rate of remission in week 52 (77.78 vs 52.63; p=0.014). The intensification of treatment was a negative factor to achieve remission both in week 14 and at week 52. Conclusion The levels of infliximab in week 14 are higher and have predictive value of clinical remission both in early (week 14) and long-term (week 52). Levels of infliximab in week 2 did not provide significant predictive value of clinical response. The use of immunosuppressants could be a favourable factor of clinical outcome.

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 1,5) and data Mining mathematical model(p-value 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 The exhaustive registry of COVID-19 cases in patients with IBD is a unique opportunity to learn how to deal with this infection, especially in reference to the management of immunosuppressive treatment, isolation measures or if the disease is more severe in IBD patients due to immunosuppression. With these premises, the aims of this study were to know the incidence and characteristics of COVID-19 in the ENEIDA cohort during the first wave of the pandemic; the outcomes among those under immunosuppressants/biologics for IBD; the risk factors for contracting the infection and poor outcomes; and the impact of the infection after three-month follow-up. Methods Prospective observational cohort study of all IBD patients with COVID-19 included in the ENEIDA registry (with 60.512 patients in that period) between March and July 2020, with at least 3 months of follow-up. Any patient with a confirmed (by PCR or SARS-CoV-2 serology) or probable (suggestive clinical picture) infection was considered as a case. Results A total of 484 patients with COVID-19 from 63 centres were included: 247 Crohn’s disease, 223 ulcerative colitis and 14 unclassified colitis; median age 52 years (IQR: 42–61), 48% women and 44% ≥1 comorbidity. Diagnosis was made by PCR: 63% and serology: 35%. The most frequent symptoms: fever (69%), followed by cough (63%) and asthenia (38%). During lockdown 78% followed strict isolation. 35% required hospital admission (ICU: 2.7%) and 12% fulfilled criteria for SIRS upon admission. 16 patients died from COVID-19 (mortality:3.3%). 12% stop IBD medication during COVID-19. At 3 months, taken into account all included cases, 76% were in remission of IBD. Male gender (OR 1.56; 95%CI:1–2.4, p=0.05), ≥40 years of age (OR 2.55; 95% CI:1.4–4.8; p=0.004), Charlson score ≥1 (OR 2.1; 95% CI:1.3–3.5; p=0.004), and systemic steroids Conclusion IBD does not seem to worsen the prognosis of COVID-19, even when immunosuppressants and biological drugs are used. Age and comorbidity are the most important prognostic factors for more severe COVID-19 in IBD patients. The use of aminosalicylates and the risk of a worse outcome deserves a deeper analysis. Funded by the Carlos III Health Institute (COV20 / 00227).

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 Infliximab is effective as rescue therapy in moderate-severe Ulcerative Colitis (UC). Subsequently, a biosimilar of infliximab has been approved for the same indications, as its effectiveness is considered similar to the original infliximab. Our aim was to analyse the colectomy rate and the efficacy of original infliximab (Remicade®) versus biosimilar infliximab (Inflectra®) in patients with moderate-severe UC who failed to respond to intravenous corticosteroids. Methods We performed a retrospective and observational study in two hospitals in the Basque Country. All patients hospitalised between 2010–2020 with moderate-severe UC, without response to intravenous corticosteroids and rescue treatment with infliximab were consecutively included. Two cohorts were established: the first one from 2010 to 2015 in patients treated with Remicade®, and the second one from 2015 to 2020 in patients with Inflectra®. We assessed all patients that had received at least one dose of infliximab. Patients were followed for a period of one year until loss of response or colectomy. Early colectomy is the surgery performed until week 12, and late colectomy between week 12 and one year. At the moment of hospitalisation all patients were clinically and endoscopically evaluated by Mayo Score. The clinical response was assessed in week 14 and 52. Results A total of 85 patients were evaluated, 53 (64.4%) in Remicade® group and 32 (37.6%) in Inflectra® group. 21.17% (18/85) of the patients had a colectomy in one year. 77.7% of the colectomies took place in the first 12 weeks (14/18, 7 patient in each group). Rates of early (13.8% vs 21.9%, p=0.297) and late colectomy (17% vs 28.1%, p=0.223) showed a numerical but non-statistically significant difference in favour of Remicade®. Transfusion (OR=4.20, IC 95% [1.38–12.77], p=0.011) and the presence of cytomegalovirus in the colonic mucosa (OR=4.07, IC 95% [1.31–12.63], p=0.015) were univariate predictors of colectomy. A statistically significant difference was found in clinical remission at week 14 (49.1% vs 25%, p=0.040) but not at week 52 (73.7% vs 50%, p=0.074) in patients with Remicade® versus Inflectra®. Neither clinical activity nor mucosa activity showed relationship with risk of colectomy. Conclusion 1. The rescue therapy with infliximab in patients with moderate-severe Ulcerative Colitis who failed to respond to intravenous corticosteroids could show a favourable trend for Remicade® against Inflectra®. However, further research is needed to confirm it. 2. The need of transfusion and the presence of cytomegalovirus in the colonic mucosa could be predictive factors of colectomy.

Introduccion Las fistulas y perforaciones benignas de esofago, bien post-quirurgicas, espontaneas o iatrogenicas, representan una patologia con una notable morbi-mortalidad que conlleva frecuentemente reintervenciones y largas estancias hospitalarias.Su tratamiento con protesis autoexpandibles recubiertas puede constituir una opcion razonable. Metodos Se realizo una revision de la casuistica en nuestro servicio desde octubre 2004 hasta octubre 2008 encontrandose 27 casos. 22 de ellos debidos a fistulas/dehiscencias post-quirurgicas, 3 casos tras perforacion iatrogenica, uno tras perforacion espontanea y otropor aparicion de un trayecto fistuloso sobre una esofagitis peptica cardial. Se colocaron protesis autoexpandibles metalicas recubiertas, Hanaro-,Choo-stent™ (M.I.Tech, Seoul, Korea), de 18 o 22 mm de diametro y longitud variable. Se utilizaron 34 protesis en total, con un tiempo medio de permanencia de 62 dias. Resultados Cierre de las fistulas en 21 casos (77,7%), un caso perdido, otro aun en evolucion y en 4 casos el tratamiento fracaso (14,8%). La complicacion mas frecuente observada ha sido la migracion de la protesis en 9 casos (33%). En uno de los casos el proceso de recuperacion endoscopica produjo una perforacion en ileon terminal que requirio cirugia. Otras complicaciones fueron la dificultad en la extraccion de la protesis en 2 casos (7%) y en 1 caso (4%) tras el procedimiento endoscopico se produjo un neumotorax a tension. Conclusion El tratamiento endoscopico de las fistulas-perforaciones esofagicas benignas mediante la insercion de protesis metalicas temporales es un tratamiento eficaz, poco invasivo y con escasa morbi-mortalidad. Su tiempo de permanencia no debe ser superior a 60–70 dias. La complicacion observada con mayor frecuencia ha sido la migracion-desplazamiento de la protesis. La perdida del cardias en los casos quirugicos se presenta como un factor de riesgo para la misma. Un cambio en el diseno de las protesis podria ser de utilidad.