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Resumen Introduccion La colitis ulcerosa es una enfermedad cronica del tracto digestivo, y hasta el 20-30% de los pacientes sufren un brote grave durante su evolucion. Aunque existen guias nacionales e internacionales sobre el tratamiento de la colitis ulcerosa aguda grave, desconocemos como se manejan en la practica clinica estos pacientes en nuestro medio. Metodos Realizamos una encuesta electronica y anonima entre los miembros del Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU), compuesta por 51 preguntas con respuestas predefinidas. Resultados Participaron 164 miembros (20%), en su mayoria especialistas de aparato digestivo (95%). El 59% trabajaban en hospitales terciarios, atendiendo a una mediana de 5 pacientes al ano (RIC: 3-8) con un brote grave de colitis ulcerosa. El 86% realizan un estudio endoscopico rutinario, habitualmente al ingreso (62%). El corticoide mas empleado es la metilprednisolona, habitualmente a una dosis de 60 mg/dia, y se evalua su respuesta pasados 3 dias (mediana, RIC: 3-5). El tratamiento de rescate usado con mas frecuencia es infliximab, tanto en pacientes naive como refractarios a tiopurinas. El 55% han indicado en alguna ocasion una dosis de infliximab mayor de 5 mg/kg durante la induccion, y el 73% han adelantado alguna de las sucesivas infusiones. Conclusiones El manejo de la colitis ulcerosa aguda grave en nuestro entorno se ajusta en general a las recomendaciones de tratamiento actuales. El tratamiento de rescate mas frecuentemente prescrito es el infliximab, y no es excepcional el empleo de pautas intensificadas o aceleradas de este biologico.

Introduction: Ulcerative colitis (UC) is a chronic disease of the digestive tract and up to 20-30% of UC patients may suffer a severe flare-up during the course of the disease. Although there are national and international recommendations about its clinical management, there is not enough information about the treatment of acute severe UC in clinical practice. Methods: An electronic and anonymous survey with 51 multiple-choice questions was performed among all the members of the Spanish Crohn's Disease and Ulcerative Colitis Working Group (GETECCU). Results: Out of the 164 responders (20%), most were gastroenterologists (95%), with 59% from tertiary hospitals treating a median of 5 patients per year (IQR: 3-8) with a severe flare-up of ulcerative colitis. An endoscopic examination was routinely performed in 86% of patients (62% at admission). The most commonly used corticosteroid was methylprednisolone, usually at a dose of 60 mg/day, and its response was assessed after a median of 3 days (IQR: 3-5). Both in thiopurine-naive and thiopurine-refractory patients, infliximab was the drug most frequently prescribed as rescue therapy. Half of responders (55%) had ever prescribed a first dose of infliximab higher than 5 mg/kg, and a higher proportion (73%) had ever prescribed an earlier dose of infliximab in the second or third infusion. Conclusions: Acute severe UC is generally managed according to current treatment guidelines in our setting. The rescue therapy most commonly prescribed is infliximab, and the use of intensified or accelerated regimens with this biological drug is not unusual. (C) 2018 Elsevier Espana, S.L.U. All rights reserved.

Patients with certain immune-mediated inflammatory diseases, such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), have an increased risk of severe infectious diseases than the general population, which are mainly associated with the immunosuppressive treatments that they receive. These treatments act on the immune system through different mechanisms, causing different degrees of immunosuppression and a variable risk depending on whether the pathogen is a virus, bacteria or fungus. This article reviews the most relevant literature on the subject, which was selected and discussed by a panel of experts. The aim of this article is to review the risk of infections in patients with IBD and RA, and the potential preventive measures. (C) 2021 The Author(s). Published by Elsevier Espana, S.L.U.

Background A significant percentage of patients treated with ustekinumab may lose response. Our aim was to evaluate the short-term efficacy and safety of intravenous re-induction with ustekinumab in patients with Crohn’s disease who have lost the response to the treatment. Methods This is a retrospective, observational, multicenter study. Treatment efficacy was measured at week 8 and 16; clinical remission was defined when the Harvey-Bradshaw Index was ≤4 points, and clinical response was defined as a decrease of ≥3 points in the index compared with the baseline. Adverse events and treatment decisions after re-induction were also collected. Results Fifty-three patients from 13 centers were included. Forty-nine percent had previously failed to respond to 2 biological treatments, and 24.5% had failed to respond to 3. The average exposure time to ustekinumab before re-induction was 17.7 ± 12.8 months. In 56.6% of patients, the administration interval had been shortened to every 4 to 6 weeks before re-induction. At week 8 and 16 after re-induction, 49.0% (n = 26) and 43.3% (n = 23), respectively, were in remission, whereas 64.1% (n = 34) and 52.8% (n = 28) had a clinical response. Patients who achieved remission at week 16 had lower C-reactive protein levels than those who did not respond (2.8 ± 1.6 vs 12.5 ± 9.5 mg/dL; P = 0.001). No serious adverse events related to re-induction were observed. Conclusion Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn’s disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.

Ustekinumab is a fully human IgG1 monoclonal antibody that has been approved for the treatment of moderate to severe Crohn's disease, and more recently moderate to severe ulcerative colitis. It binds with high affinity to the p40 subunit of human interleukin-12 and 23. This mechanism of action prevents the bioactivity of both interleukins, thus precluding their interaction with the cell surface receptor protein. The pivotal clinical trials (UNITI-1, UNITI-2 and IM-UNITI) demonstrated its clinical efficacy and safety, in naïve patients and also in those previously exposed to immunosuppressants and/or biologics. There is now an extensive experience with its use worldwide, corroborating its favorable profile even in patients with refractory disease. However, the number of medical treatment options available in inflammatory bowel disease are still limited. Hence, we should prioritize the treatments that have a greater probability of response in an individual patient. Our aim was to review and summarize all the available literature regarding the potential predictors of response to ustekinumab that can increase the success rate with this therapy in clinical practice.

Inflammatory bowel disease is a chronic and progressive disorder of the gastrointestinal tract. A relevant proportion of patients develop complicated lesions, defined as strictures, fistulas and/or abscesses already at diagnosis, and this proportion increases over time. The preclinical phase defines the period of time from the appearance of the first immune disturbances until the development of overt disease, and it may be present months to years before the diagnosis. Multiple biomarkers (e.g., C-reactive protein, interleukin-6, fecal calprotectin) and cellular mechanisms (e.g., complement cascade, lysosomes, innate immunity, and glycosaminoglycan metabolism) are already altered during this period. Research in this area allows the description of the initial immune disturbances that may identify potential targets and lead to the development of new drug therapies. During this period, different interventions in high-risk individuals, including drugs or environmental factors, will open the possibility of innovative strategies focused on the reduction of complications, or even prevention trials for inflammatory bowel disease. Here, we review the most relevant findings regarding the characteristics, prevalence and biomarkers associated with preclinical disease, along with their possible use in our future clinical practice.

Correspondence about Torres et al. on preclinical IBD

Pouchitis treatment is a complex entity that requires a close medical and surgical relationship. The elective treatment for acute pouchitis is antibiotics. After a first episode of pouchitis it is recommended prophylaxis therapy with a probiotic mix, nevertheless it is not clear the use of this formulation for preventing a first episode of pouchitis after surgery. First-line treatment for chronic pouchitis is an antibiotic combination. The next step in treatment should be oral budesonide. Selected cases of severe, chronic refractory pouchitis may benefit from biologic agents, and anti-TNF α should be recommended as the first option, leaving the new biologicals for multi-refractory patients. Permanent ileostomy may be an option in severe refractory cases to medical treatment.

Introduction: obscure gastrointestinal bleeding is defined as bleeding from a source that cannot be identified on upper or lower gastrointestinal endoscopy and capsule endoscopy is the next step in these patients. Some patients may be unsuitable for conventional endoscopy and performing a capsule panendoscopic test as a first line procedure might potentially reduce the number of endoscopies and their subsequent risk. Aim: to analyze our experience with capsule endoscopy in the bleeding setting. Methods: the first 100 panendoscopic capsule procedures performed in our center from August 2011 until December 2016 were retrospectively reviewed. Results: positive findings were observed in 61.2 % of patients; 46.26 % had a previous negative gastroscopy and the capsule detected small bowel lesions in 67.7 % and colonic findings in 80.64 %. Taking into consideration that our population were high-risk patients (mainly because of comorbidities) and that we used up to 45 ml of sodium phosphate, sodium, potassium and creatinine changes were analyzed before and after procedure. The mean “before” values were 140.68, 4.04 and 1.36, respectively. The mean “after” values were 140.28, 3.9 and 1.35 (p = n.s.). According to our findings, no other endoscopic studies would be needed in 64.5 % of patients with negative gastroscopy. According to capsule results, conventional endoscopy could have been avoided in 68.6 % of cases. Conclusion: panendoscopy with a capsule may be useful and safe in bleeding high-risk patients, by selecting those who need therapeutic endoscopy, avoiding up to 68.6 % of diagnostic endoscopies in our series.

Background The effectiveness of the switch to another anti–tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. Methods We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. Results A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8–3; P < 0.0001) and ulcerative colitis vs Crohn’s disease (HR, 1.6; 95% CI, 1.1–2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. Conclusions Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.

Background Tacrolimus is a calcineurin inhibitor commonly used for prophylaxis of rejection in renal and liver transplantation. There are limited but favourable data regarding its possible use in patients with inflammatory bowel disease (IBD). Aims To evaluate the efficacy and safety of tacrolimus in patients with IBD in clinical practice. Methods We performed a retrospective, multicentre study in 22 centres in Spain. All adult patients who received oral tacrolimus for luminal or perianal IBD were included. Clinical response was assessed by Harvey-Bradshaw index and partial Mayo score after 3 months. Perianal disease was evaluated by fistula drainage assessment. Results One hundred and forty-three patients were included (mean age 38 years; 51% male; median disease duration 110 months). In ulcerative colitis (UC) (n = 58), the partial Mayo score decreased after 3 months from median 6 to 3 (P = 0.0001), whereas in Crohn's disease (CD) (n = 85), the Harvey-Bradshaw index decreased after 3 months from median 9 to 7 (P = 0.011). In CD patients, blood tacrolimus concentrations during induction (>10 ng/mL vs

INTRODUCTION: Patients with Crohn's disease experiencing endoscopic postoperative recurrence (POR) may benefit from antitumor necrosis factor (TNF) agents but scarce data on this are available. Our aim was to assess the efficacy of anti-TNF in improving mucosal lesions in patients with endoscopic POR. METHODS: Multicenter, retrospective, study of patients with Crohn's disease who underwent therapy with anti-TNF agents for endoscopic POR (Rutgeerts score > i1). Treatment outcomes were assessed by the findings in the last ileocolonoscopy performed after anti-TNF therapy was initiated. Endoscopic improvement and remission were defined as any reduction in the baseline Rutgeerts score and by a Rutgeerts score < i2, respectively. RESULTS: A total of 179 patients were included, 83 were treated with infliximab and 96 with adalimumab. Median time on anti-TNF therapy at the last endoscopic assessment was 31 months (interquartile range, 13-54). Endoscopic improvement was observed in 61%, including 42% who achieved endoscopic remission. Concomitant use of thiopurines and treatment with infliximab were associated with endoscopic improvement (odds ratio [OR] 2.15, 95% confidence interval [CI] 1.04-4.46; P = 0.03, and OR 2.34, 95% CI 1.18-4.62; P < 0.01, respectively) and endoscopic remission (OR 3.16, 95% CI 1.65-6.05; P < 0.01, and OR 2.01, 95% CI 1.05-3.88; P = 0.04, respectively) in the multivariable logistic regression analysis. These results were confirmed in a propensity-matched score analysis. DISCUSSION: In patients with endoscopic POR, anti-TNF agents improve mucosal lesions in almost two-thirds of the patients. In this setting, concomitant use of thiopurines and use of infliximab seem to be more effective in improving mucosal lesions.

Background & Aims Inflammatory bowel disease (IBD) is a chronic disease usually diagnosed after the appearance of gastrointestinal symptoms. Little is known about IBD progression during its early and even preclinical phases. We aimed to determine the number of new incidental diagnoses of IBD in an older population, and evaluate disease progression from its early stages. Methods We performed a retrospective analysis of 31,005 colonoscopies performed during colorectal cancer screening of patients with positive results from fecal immunochemical tests, at 11 centers in the Basque Country (Spain) from 2009 through 2014. We collected clinical and laboratory data from all asymptomatic individuals suspected to have IBD during screening colonoscopies, with histologic confirmation. Results Colonoscopy screening led to 79 new diagnoses of ulcerative colitis, 24 of Crohn's disease, and 7 of unclassified colitis (average patient age, 57 y; interquartile range, 52–62 y; 57% male). Eleven patients had symptoms before colonoscopy and were excluded from the analysis. Among those patients who were asymptomatic at diagnosis, 36% developed symptoms after a follow-up period of 25 months (interquartile range, 10.5–42 mo), mostly rectal bleeding and diarrhea. Treatment was prescribed for 81 patients (88%), and 2 cases required surgery. Conclusions We analyzed data from a large cohort of patients with IBD diagnosed at early or even preclinical stages, from an older population. New incidental diagnoses of IBD were made in 0.35% of individuals undergoing a population-based screening colonoscopy—most were classified as ulcerative colitis. Approximately one third of patients developed symptoms during the follow-up period.

Introduction Aeromonas can cause several diseases in humans, with gastroenteritis accounting for most cases. The role of Aeromonas as a pathogen in human enterocolitis has been questioned in recent years. Objectives To determine the incidence of gastrointestinal infection caused by Aeromonas in our area and its possible relationship to inflammatory bowel disease. Patients and methods This was a retrospective observational study. All adult patients with a positive stool culture for Aeromonas were identified between January 2015 and December 2017 at Hospital Galdakao-Usansolo (Vizcaya, Spain). Results Ninety-eight patients were identified (median age 62 years; 51% women). Therefore, the incidence in our area was 32 cases per 105 inhabitants per year. Eleven per cent of them had been previously diagnosed with inflammatory bowel disease (four with ulcerative colitis and seven with Crohn's disease). Patients with inflammatory bowel disease more often received immunosuppressive therapy. Conversely, patients without inflammatory bowel disease suffered from more comorbidities. We also found comorbidity to be the risk factor most associated with Aeromonas infection. Conclusion Aeromonas infection is a common gastrointestinal infection that may occur in both immunocompetent and immunocompromised patients. Immunosuppression is a significant factor in inflammatory bowel disease patients, while comorbidity seems to confer a higher risk on patients without this disease.

Resumen La budesonida oral es un glucocorticoide de accion fundamentalmente local. En la especialidad de Aparato Digestivo, se emplea sobre todo en la enfermedad inflamatoria intestinal, aunque tambien en otras indicaciones. Esta revision aborda aspectos acerca de la farmacologia, la farmacodinamica y el empleo terapeutico de la budesonida. Se contemplan sus indicaciones reconocidas y se especula acerca de otras situaciones en las que podria desempenar un papel de interes, con el objeto de facilitar su uso y mejorar la exactitud de su prescripcion.

Background More than 2.5 million people in Europe suffer from inflammatory bowel diseases (IBD). IBD affects the quality of life, but also has important consequences for health systems. As IBD care and education might differ and might be linked to Gross Domestic Product (GDP), we conducted this European Variation In ibd PracticE suRvey (VIPER) to study potential differences. Methods This trainee-initiated survey, run through SurveyMonkey®, consisted of 47 questions inquiring basic demographics, IBD training and clinical care. The survey was distributed through social media and national GI societies from December 2020 - January 2021. Results were compared according to GDP per capita, for which countries were divided into 2 groups (low/high income, according to the World Bank). Differences between groups were calculated using the chi2 statistic. Results The online survey was completed by 1268 participants from 39 European countries (Figure 1). Most of the participants are specialists (65.3 %), followed by fellows in training (>/< 3 years, 19.1%, 15.6 %). Majority of the responders are working in academic institutions (50.4 %), others in public/district hospitals (33.3 %) or private practices (16.3 %). Despite significant differences in access to IBD-specific training between high (56.4%) and low (38.5%) GDP countries (p In the current COVID era, telemedicine is available in 58.4% vs 21.4% of the high/low GDP countries respectively (p Conclusion A lot of variability in IBD practice exists across Europe, with marked differences between high vs low GDP countries. Further work is required to help address some of these inequalities, aiming to improve and standardise IBD care across Europe.

BRACKGROUND: We aimed to examine associations between elevated symptoms of depression and anxiety and disease activity in inflammatory bowel disease (IBD). Previous findings have been inconsistent and have not accounted for variability in the courses of these conditions over time. METHODS: We followed 247 participants with IBD (153 Crohn’s disease [CD], 94 ulcerative colitis [UC]) for 3 years. Annually, participants underwent an abdominal examination, reported therapies used for IBD, and completed the Hospital Anxiety and Depression Scale (HADS) questionnaire. We evaluated associations of elevated symptoms (scores ≥11) of anxiety (HADS-A) and depression (HADS-D) with the presence of active IBD as measured using the Powell Tuck Index for UC and the Harvey-Bradshaw Disease Activity Index for CD. We employed logistic regression with generalized estimating equations, simultaneously estimating between-person and within-person effects. RESULTS: Of 247 participants, 15 (6.1%) had elevated symptoms of depression (HADS-D ≥11) at enrollment, 41 (16.6%) had elevated symptoms of anxiety (HADS-A ≥11), and 101 (40.9%) had active IBD. On average, individuals with elevated symptoms of depression (odds ratio [OR], 6.27; 95% CI, 1.39–28.2) and anxiety (OR, 2.17; 95% CI, 1.01–4.66) had increased odds of active IBD. Within individuals, elevations in symptoms of depression over time were associated with increased odds of active IBD (OR, 2.70; 95% CI, 1.15–6.34), but elevated symptoms of anxiety were not. After adjustment for covariates (including disease activity), elevated symptoms of depression were also associated with increased odds of biologic therapy use (OR, 2.02; 95% CI, 1.02–4.00). CONCLUSION: Symptoms of depression and anxiety are associated with disease activity in IBD over time. Reducing these symptoms should be incorporated into the management of IBD.

Background The Basque Colorectal Cancer Screening Programme has both high participation rate and high compliance rate of colonoscopy after a positive faecal occult blood test (FIT). Although, colorectal cancer (CRC) screening with biannual (FIT) has shown to reduce CRC mortality, the ultimate effectiveness of the screening programmes depends on the accuracy of FIT and post-FIT colonoscopy, and thus, harms related to false results might not be underestimated. Current CRC screening programmes use a single faecal haemoglobin concentration (f-Hb) cut-off for colonoscopy referral for both sexes and all ages. We aimed to determine optimum f-Hb cut-offs by sex and age without compromising neoplasia detection and interval cancer proportion. Methods Prospective cohort study using a single-sample faecal immunochemical test (FIT) on 444,582 invited average-risk subjects aged 50–69 years. A result was considered positive at ≥20 μg Hb/g faeces. Outcome measures were analysed by sex and age for a wide range of f-Hb cut-offs. Results We analysed 17,387 positive participants in the programme who underwent colonoscopy. Participation rate was 66.5%. Men had a positivity rate for f-Hb of 8.3% and women 4.8% (p

Biologic anti-tumor necrosis factor (TNF) drugs have demonstrated their efficacy for the treatment of ulcerative colitis. Nevertheless, some patients will not respond to this therapy or will develop loss of response. Leukapheresis is the main non-pharmacological therapy for some immune-mediated diseases. The aim of our study was to describe our experience with this therapy in ulcerative colitis patients after loss of response to anti-TNF treatment. Leukapheresis was indicated in four patients with left-sided or extensive colitis because of partial response to biological therapy or secondary loss of response to it. All patients received 8 to 10 sessions in an intensive regimen. Globally, a decrease in the Mayo score was observed. The overall response rate was 50% with one patient who displayed sustained response. No patients have required colectomy during follow-up. Adjuvant treatment with leukapheresis in patients with inadequate response to anti-TNF treatment showed some beneficial effect, although of limited duration, in patients with ulcerative colitis.

Background: Inflammatory bowel disease, including both Crohn’s disease and ulcerative colitis, are two chronic and progressive disorders affecting the gastrointestinal tract. Research on the molecular mechanisms of both diseases has led to the introduction of targeted therapies which are able to selectively block the key inflammatory mediators. Methods: Here, we discuss the current evidence about the mechanism of action with an up to date review of the efficacy and safety of Janus kinase inhibitors in inflammatory bowel disease. Results: Multiple small molecule drugs have been evaluated for their use in both ulcerative colitis and Crohn’s disease. Janus kinase inhibitors represent the most important family of these drugs, as their particular mechanism of action enables a simultaneous and effective blockade of multiple cytokines involved in the pathogenesis of the disease. Conclusion: Janus kinase inhibitors represent a promising therapeutic strategy, especially in ulcerative colitis. More data are still necessary regarding its efficacy and safety in clinical practice.

Este artículo es continuado por una segunda parte: http://hdl.handle.net/10486/701801, La reservoritis es una complicación frecuente en los pacientes con colitis ulcerosa tratados mediante una proctocolectomía total. Consiste en una inflamación inespecífica del reservorio ileo-anal, cuya etiología no se conoce aún por completo. Esta inflamación induce la aparición de síntomas como urgencia, diarrea, rectorragia y dolor abdominal, alterando la calidad de vida de los pacientes que la padecen. Para su diagnóstico, además de los síntomas, es necesario realizar una endoscopia con toma de biopsias. El índice recomendado para valorar su actividad es el Pouchitis Disease Activity Index (PDAI), aunque puede emplearse su forma modificada (PDAIm). De acuerdo con la duración de los síntomas, la reservoritis se clasifica en aguda (< 4 semanas) o crónica (> 4 semanas). Según su curso evolutivo, se clasifica en infrecuente (< 4 episodios/año), recurrente (> 4 episodios/año) o de curso continuo, Pouchitis is a common complication in ulcerative colitis patients after total proctocolectomy. This is an unspecific inflammation of the ileo-anal pouch, the aetiology of which is not fully known. This inflammation induces the onset of symptoms such as urgency, diarrhoea, rectal bleeding and abdominal pain. Many patients suffering from pouchitis have a lower quality of life. In addition to symptoms, an endoscopy with biopsies is mandatory in order to establish a definite diagnosis. The recommended index to assess its activity is the Pouchitis Disease Activity Index (PDAI), but its modified version (PDAIm) can be used in clinical practice. In accordance with the duration of symptoms, pouchitis can be classified as acute (4 weeks), and, regarding its course, pouchitis can be infrequent (4 episodes per year) or continuous

Gastrointestinal (GI) symptoms can precede by many years the motor symptoms of Parkinson's disease (PD) and these patients can show some degree of inflammation associated with abnormal aggregates of alpha-synuclein in the GI tract. The abnormal accumulation of alpha-synuclein and the spreading of the aggregates from the gut to the brain might be promoted by inflammation, rising the hypothesis of a possible relationship between inflammatory bowel disease and PD. Many population-based studies have explored this association, but they have found conflicting results. It is essential to clarify this hypothesis and to try to elucidate the milestones of this relationship. There is no clear concordance between the results and the interpretation of different previous findings, probably due to many confounding factors such as drugs with anti-inflammatory activity, surgery, genetic predisposition and also selection bias. If there is a real association between both diseases, gastroenterologists and neurologists should be able to detect possible triggers of the disease or on the other hand, protective factors, that may be considered in clinical practice.

Objectives To assess the effectiveness and safety of combining granulocyte-monocyte apheresis (GMA) and vedolizumab (VDZ) in patients with refractory ulcerative colitis (UC). Methods This retrospective, multicentre pilot study included all UC patients receiving both GMA and VDZ. We recorded data on GMA sessions, demographic characteristics, and clinical response. Effectiveness was assessed 1 and 6 months after finishing the GMA using the partial Mayo score, C-reactive protein, and fecal calprotectin levels. Data were also compiled on VDZ intensification, use of new immunomodulators and colectomy during follow-up. Results Eight patients were included (mean age 46 years; 63% female; mean disease duration, 132 months; 50% E3). GMA was started after a loss of response to VDZ in all cases (25% primary nonresponse and 75% secondary loss of response). All had previously received anti-TNF agents. VDZ was prescribed as the second-, third-, or fourth-line biologic in 37%, 50%, and 13% of cases, respectively. Patients had a mean baseline partial Mayo score of 7.5 (SD 2.1) and received a median of 15 GMA sessions (range 5-38). After a median follow-up of 7.5 months (IQR 5-12), partial Mayo score decreased after 1 and 6 months (P = .01 and .06, respectively). Three patients (38%) achieved steroid-free clinical remission and five (63%) withdrew VDZ. Colectomy rate was 38%. No adverse events were observed during the combination therapy. Conclusions This small case series suggests that combining GMA with VDZ could be a treatment option in selected cases of UC with an inadequate response to this biologic agent.

Introduction Immunomodulators and biologics are two of the main drugs used for the treatment of inflammatory bowel disease (IBD). Some of these agents have been associated with certain infections and lymphoproliferative disorders, including Epstein–Barr virus (EBV) infection. Our aim was to determine the influence of immunosuppression in the EBV viral load in patients with IBD. Materials and methods We prospectively included naive patients with IBD who were starting immunosuppressive therapy in four IBD Units. All patients were assessed at baseline and four months after starting immunosuppression for clinical disease activity, biomarkers, EBV serology (IgM VCA, IgG VCA and IgG EBNA) and viral load. Results Thirty-two patients were included. At baseline, all patients showed positive results for IgG VCA or IgG EBNA with undetectable EBV viral load. No patient showed detectable EBV viral load after starting the immunosuppressive therapy. Conclusion Immunosuppression did not influence on EBV viral load in the short-term in naive IBD patients.

Nivolumab, a monoclonal antibody-targeting programmed cell death protein-1, is being increasingly used for the treatment of some advanced neoplasms. Several of its adverse effects are a result of the upregulation of T cells, with colitis as one of the most severe, and a challenging differential diagnosis with ulcerative colitis. However, few real-life clinical practice cases have been reported beyond trials. Our aim was to report a series of new cases, reviewing previously communicated endoscopic-proven nivolumab-induced colitis. All patients treated with nivolumab in three university centers were identified and those who developed immune-mediated colitis (defined as the presence of diarrhea and evidence of colitis demonstrated by colonoscopy) were described. Additionally, a review of case reports of nivolumab-induced colitis reported in the literature up to March 2018 was performed. Six new cases of nivolumab-induced colitis and 13 previously reported cases out of randomized clinical trials are described. Colonoscopy showed a mucosal pattern mimicking ulcerative colitis in a large proportion of patients. Clostridium difficile superinfection was observed in two out of 19 cases. All but three patients definitively discontinued nivolumab therapy. Most patients were initially managed with oral or intravenous corticosteroids, but five of them required rescue therapy with infliximab. Nivolumab-induced colitis may mimic ulcerative colitis. Steroid therapy (oral or intravenously) is often efficient, but one-fourth of patients need rescue therapy with anti-TNF. Intestinal superinfection with Clostridium difficile or cytomegalovirus should be ruled out before starting immunosuppressive therapy.

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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.

Background : In patients with Crohn's disease (CD), endoscopic recurrence precedes clinical recurrence after ileocolonic resection. Guidelines recommend ileocolonoscopy within the first year after surgery. The study examined endoscopic monitoring and treatment decisions in CD patients in a real-world setting. Methods : The Practicrohn study involved adult patients from 26 Spanish hospitals who underwent ileocolonic resection with anastomosis from 2007 to 2010. Medical records data were collected retrospectively from diagnosis to index surgery and up to 5 years after surgery. Results : Of 314 analyzed patients, 262 (83%) underwent endoscopic evaluation, but only 30% (n = 95) had planned endoscopy as part of follow-up within the first year after surgery. An upward trend was observed in the proportion of endoscopies performed or planned within the first year after surgery across the selection period. More patients with than without endoscopic recurrence in the first year after surgery had a medication change, mainly for endoscopic activity in the absence of clinical symptoms (54 vs 13%; p = 0.02). Conclusions : Between 2007 and 2010, endoscopic monitoring of patients within the first year after CD-related surgery was less than adequate based on current standards, but showed improvement. Medication changes were in general agreement with current guideline recommendations. This work was presented as a poster (number P686) by M. Barreiro-de Acosta et al. at ECCO (European Crohn's and Colitis Organisation) '18 in Vienna, Austria, 14-17 February 2018.

Background Self-medication, when agreed with the treating physician, is an essential component of self-care. We describe the associated factors and the reasons related to the practice of self-medication with steroids, aminosalcylates (AS) or analgesics in patients with ulcerative colitis (UC) in Spain. Methods Information was anonymoulsy provided by patients through a web-based cross-sectional survey developed by 3 inflammatory bowel disease (IBD) experts from the Spanish working group on IBD (GETECCU), one nurse from the Spanish nursing working group on IBD (GETEII) and two patients from the Spanish confederation of associations of patients with IBD (ACCU). Participants voluntarily answered to the survey based on their own experiences from February to April 2019. Reasons for self-medication are described as frequencies and associated factors through logistic regression models. Results A total of 546 patients (61% women, mean age 40 years old) responded. Of these, 36 (7%) patients self-medicated with corticosteroids, and was associated with higher number of UC self-reported flares during the past year [OR 7 (95% CI: 1–32), p < 0.001] and follow-up by a general gastroenterologist instead of in an IBD unit [OR 0.08 (0.01–0.5), p = 0.007]. Self-medication with AS was reported by 90 patients (16%) [oral 20 (22%) and topic 70 (78%)], and was associated with treatment with topical AS [OR 3 (95% CI: 2–4), p < 0.001]. Finally, 320 patients (59%) self-medicated with analgesics and this was associated with female gender [OR 2 (95% CI: 1–3), p < 0.001], need of intravenous (IV) biological therapy [OR 3 (95% CI: 2–5) p < 0.001] and emergency room visits within the past year [OR 3 (95% CI: 2–4), p < 0.001]. The main reasons for self-medication were ‘need for quick relief of symptoms’, ‘fear of worsening’ and, for AS, ‘agreed with the doctor’ (Table 1). Conclusion Self-medication in UC is not a common practice, but most of the times it is not agreed with the treating physician. Self-medication with analgesics was more frequent, probably reflecting a need of self-care. Female sex, number of flares, IV treatment, and need of emergency room care were factors associated to self-medication. This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.

Ulcerative colitis (UC) is a chronic disease of the digestive tract and up to 20-30% of UC patients may suffer a severe flare-up during the course of the disease. Although there are national and international recommendations about its clinical management, there is not enough information about the treatment of acute severe UC in clinical practice.An electronic and anonymous survey with 51 multiple-choice questions was performed among all the members of the Spanish Crohn's Disease and Ulcerative Colitis Working Group (GETECCU).Out of the 164 responders (20%), most were gastroenterologists (95%), with 59% from tertiary hospitals treating a median of 5 patients per year (IQR: 3-8) with a severe flare-up of ulcerative colitis. An endoscopic examination was routinely performed in 86% of patients (62% at admission). The most commonly used corticosteroid was methylprednisolone, usually at a dose of 60mg/day, and its response was assessed after a median of 3days (IQR: 3-5). Both in thiopurine-naïve and thiopurine-refractory patients, infliximab was the drug most frequently prescribed as rescue therapy. Half of responders (55%) had ever prescribed a first dose of infliximab higher than 5 mg/kg, and a higher proportion (73%) had ever prescribed an earlier dose of infliximab in the second or third infusion.Acute severe UC is generally managed according to current treatment guidelines in our setting. The rescue therapy most commonly prescribed is infliximab, and the use of intensified or accelerated regimens with this biological drug is not unusual.

Oral budesonide is a glucocorticoid of primarily local action. In the field of digestive diseases, it is used mainly in inflammatory bowel disease, but also in other indications. This review addresses the pharmacology, pharmacodynamics and therapeutic use of budesonide. Its approved indications are reviewed, as well as other clinical scenarios in which it could play a role, in order to facilitate its use and improve the accuracy of its prescription.

Background The 'United Registries for Clinical Assessment and Research' [UR-CARE] database is an initiative of the European Crohn's and Colitis Organisation [ECCO] to facilitate daily patient care and research studies in inflammatory bowel disease [IBD]. Herein, we sought to validate the database by using fictional case histories of patients with IBD that were to be entered by observers of varying experience in IBD. Methods Nineteen observers entered five patient case histories into the database. After 6 weeks, all observers entered the same case histories again. For each case history, 20 key variables were selected to calculate the accuracy for each observer. We assumed that the database was such that ≥ 90% of the entered data would be correct. The overall proportion of correctly entered data was calculated using a beta-binomial regression model to account for inter-observer variation and compared to the expected level of validity. Re-test reliability was assessed using McNemar's test. Results For all case histories, the overall proportion of correctly entered items and their confidence intervals included the target of 90% (Case 1: 92% [88-94%]; Case 2: 87% [83-91%]; Case 3: 93% [90-95%]; Case 4: 97% [94-99%]; Case 5: 91% [87-93%]). These numbers did not differ significantly from those found 6 weeks later [NcNemar's test p > 0.05]. Conclusion The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR-CARE has the potential to enhance future European collaborations regarding clinical research in IBD.

Background Granulocyte and monocyte apheresis is the main non-pharmacological treatment for inflammatory bowel disease (IBD), but we do not know how well accepted it is by patients in our setting. Aim To determine how granulocyte and monocyte apheresis is perceived by patients in clinical practice in Spain. Methods Outpatients treated with granulocyte and monocyte apheresis in five IBD Units in Spain were asked to fill in a 14-item questionnaire. Results Fifty-two patients completed the questionnaire (88% ulcerative colitis, 12% Crohn's disease; 44% female; age 35 years [IQR 23–51]). Granulocyte and monocyte apheresis was generally well tolerated and well accepted. Very few of the participants regarded the length of the sessions as a limitation. The gastrointestinal symptoms, however, were a frequent concern, both in terms of attending to receive treatment and during the sessions. Overall, 44% were satisfied with the treatment effectiveness. Sixty percent (60%) claimed to be satisfied with the therapy overall, but this was influenced by the patients’ clinical response to the therapy. Eighty-two percent (82%) of participants said they would agree to be treated with this technique again in the future, regardless of the response to the treatment. Conclusions Granulocyte and monocyte apheresis is well tolerated and accepted by patients with IBD. Although we found no significant differences according to type of IBD or apheresis regimen, patient perception was affected by clinical effectiveness.

BACKGROUND: Despite the increased use of rescue medical therapies for steroid refractory acute severe ulcerative colitis, mortality related to this entity still remains high. We aimed to assess the mortality and morbidity related to colectomy and their predictive factors in steroid refractory acute severe ulcerative colitis, and to evaluate the changes in mortality rates, complications, indications of colectomy, and the use of rescue therapy over time. METHODS: We performed a multicenter observational study of patients with steroid refractory acute severe ulcerative colitis requiring colectomy, admitted to 23 Spanish hospitals included in the ENEIDA registry (GETECCU) from 1989 to 2014. Independent predictive factors of mortality were assessed by binary logistic regression analysis. Mortality along the study was calculated using the age-standardized rate. RESULTS: During the study period, 429 patients underwent colectomy, presenting an overall mortality rate of 6.3% (range, 0-30%). The main causes of death were infections and post-operative complications. Independent predictive factors of mortality were: age =50 years (OR 23.34; 95% CI: 6.46-84.311; p < 0.0001), undergoing surgery in a secondary care hospital (OR 3.07; 95% CI: 1.01-9.35; p = 0.047), and in an emergency setting (OR 10.47; 95% CI: 1.26-86.55; p = 0.029). Neither the use of rescue medical treatment nor the type of surgical technique used (laparoscopy vs. open laparotomy) influenced mortality. The proportion of patients undergoing surgery in an emergency setting decreased over time (p < 0.0001), whereas the use of rescue medical therapy prior to colectomy progressively increased (p > 0.001). CONCLUSIONS: The mortality rate related to colectomy in steroid refractory acute severe ulcerative colitis varies greatly among hospitals, reinforcing the need for a continuous audit to achieve quality standards. The increasing use of rescue therapy is not associated with a worse outcome and may contribute to reducing emergency surgical interventions and improve outcomes.