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Resumen Introduccion La capsula endoscopica de intestino delgado (CEID) es una tecnica diagnostica poco invasiva cuyo empleo en la enfermedad inflamatoria intestinal (EII) se ha extendido. Se ha desarrollado recientemente una capsula panenterica, PillCamCrohn's (PCC). Carecemos de informacion sobre la disponibilidad y el uso de la CEID y la PCC 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 y la Asociacion Espanola de Gastroenterologia consistente en 37 preguntas de respuesta multiple. Resultados Participaron 150 miembros, la mayoria con dedicacion especial a la EII (69,3%). El 72,8% trabajaban en centros con unidad de EII. El 79% tenian la CEID disponible en su hospital, y el 14% la derivaban a otro centro. El 22% tenian disponible la PCC, y el 9% la derivaban a otro centro. El 79,3% de encuestados con CEID disponible la utilizaban en un pequeno porcentaje de pacientes con EII y el 15,6% en la mayoria. Los escenarios mas frecuentes fueron la sospecha de enfermedad de Crohn (76,3%), la valoracion de actividad inflamatoria (54,7%) y la evaluacion de la extension de la enfermedad (54,7%). Mas de la mitad (59,7%) utilizaban preferentemente la capsula Patency® para valoracion de la permeabilidad intestinal. Casi todos los encuestados (99,3%) consideraban que se deberian implementar recursos formativos en esta tecnica. Conclusiones La CEID cuenta con una amplia disponibilidad en los hospitales espanoles para el manejo de la EII, si bien su uso es todavia limitado. Existe una oportunidad para aumentar la formacion en esta tecnica, y, con ella, su empleo.

BACKGROUND Crohn's disease (CD) with upper gastrointestinal involvement (UGI) may have a more aggressive and refractory course. However, evidence on this phenotype of patients is scarce. AIMS To identify the clinical characteristics, therapeutic requirements and complications associated with UGI in CD METHODS: Nationwide study of cases (UGI, UGI plus ileal/ileocolonic involvement) paired with controls (ileal/ileocolonic involvement) from the ENEIDA registry. Cases were matched to 2 controls by year of diagnosis ± 2.5 years. Patients with exclusive/predominant colonic location or complex perianal fistula were excluded. RESULTS Of 24 738 patients with CD in the ENEIDA registry, we identified 4058 with UGI (16% of the total CD cohort). Finally, 854 cases and 1708 controls were included. Cases were independently associated to extensive involvement (OR 2.7 [2.2-3.3], P

Colonic inflammatory bowel diseases have a higher risk of developing colorectal cancer compared to the general population, which is why they require endoscopic screening techniques with specific follow-up intervals based on the different risk factors described on the literature. This position paper analyzes the current scientific evidence for the different endoscopic techniques available today, how their implementation should be carried out in endoscopic units and describes in detail how their implementation should be carried out, in which patients and with what interval, and finally, what should be the response to finding dysplasia, proposing a specific follow-up algorithm.

espanolLa ecografia tiene un excelente rendimiento diagnostico tanto cuando se sospecha una enfermedad de Crohn como en la valoracion de la actividad o en determinar su extension y localizacion, muy similar a otras exploraciones como resonancia magnetica o tomografia computarizada. Tiene una buena correlacion con las lesiones endoscopicas y permite la deteccion de complicaciones como estenosis, fistulas o abscesos. Complementa a la colonoscopia en el diagnostico y dada su tolerancia, coste e inmediatez, es una buena herramienta para la monitorizacion de la enfermedad. En la colitis ulcerosa su papel es menos relevante, limitandose a valorar la extension y actividad cuando no sea posible o haya dudas con otras tecnicas diagnosticas. A pesar de sus ventajas, su empleo en la enfermedad inflamatoria intestinal (EII) no esta muy extendido en nuestro pais. Por este motivo, el presente documento revisa las virtudes e inconvenientes de la tecnica para favorecer su conocimiento e implantacion en las Unidades de EII. EnglishUltrasound has an excellent diagnostic performance when Crohn's disease is suspected, when performing an activity assessment, or determining the extension and location of Crohn's disease, very similar to other examinations such as MRI or CT. It has a good correlation with endoscopic lesions and allows the detection of complications such as strictures, fistulas or abscesses. It complements colonoscopy in the diagnosis and, given its tolerance, cost and immediacy, it can be considered as a good tool for disease monitoring. In ulcerative colitis, its role is less relevant, being limited to assessing the extent and activity when it is not possible with other diagnostic techniques or if there are doubts with these. Despite its advantages, its use in inflammatory bowel disease (IBD) is not widespread in Spain. For this reason, this document reviews the advantages and disadvantages of the technique to promote knowledge about it and implementation of it in IBD Units.

Ultrasound has an excellent diagnostic performance when Crohn's disease is suspected, when performing an activity assessment, or determining the extension and location of Crohn's disease, very similar to other examinations such as MRI or CT. It has a good correlation with endoscopic lesions and allows the detection of complications such as strictures, fistulas or abscesses. It complements colonoscopy in the diagnosis and, given its tolerance, cost and immediacy, it can be considered as a good tool for disease monitoring. In ulcerative colitis, its role is less relevant, being limited to assessing the extent and activity when it is not possible with other diagnostic techniques or if there are doubts with these. Despite its advantages, its use in inflammatory bowel disease (IBD) is not widespread in Spain. For this reason, this document reviews the advantages and disadvantages of the technique to promote knowledge about it and implementation of it in IBD Units. (C) 2020 The Authors. Published by Elsevier Espana, S.L.U.

Resumen La evidencia de que el seguimiento de las recomendaciones sobre el cribado y tratamiento de la infeccion tuberculosa no evita totalmente la aparicion de tuberculosis en pacientes con enfermedad inflamatoria intestinal, y el uso reciente de nuevos farmacos biologicos y de nuevos inmunomoduladores, ha llevado al Grupo Espanol de Trabajo en Enfermedad de Crohn y en Colitis Ulcerosa a actualizar sus recomendaciones para la prevencion de la tuberculosis en los pacientes con enfermedad inflamatoria intestinal. Se revisan los metodos de diagnostico de la infeccion tuberculosa latente, los distintos escenarios en los que se va a realizar el cribado, las estrategias para disminuir el riesgo de tuberculosis una vez iniciado el tratamiento biologico, las pautas de quimioprofilaxis de la infeccion tuberculosa latente y el manejo de la tuberculosis activa durante el tratamiento biologico. Finalmente, se resumen las recomendaciones en el texto y en un algoritmo.

The ENEIDA registry, promoted by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU), was created in 2005 by a group of gastroenterologists interested in improving the management of patients with inflammatory bowel disease. The main objectives of the registry were to facilitate the collection of clinical data of interest for clinical care practice, as well as to carry out collaborative studies using clinical data and biological samples. In its 15 years of existence, ENEIDA has evolved in many aspects, from its content or technological support to the number of participating centres, to become one of the reference registries for the study and care of patients with inflammatory bowel disease, with a continuous and high quality scientific production that has positioned it as an example of collaborative scientific exploitation at an international level. This article reviews the objectives, design, structural characteristics, monitoring and scientific exploitation of the ENEIDA registry. (C) 2020 The Author(s). Published by Elsevier Espana, S.L.U.

Background and Aims Patient-reported outcome measures [PROMs] aim to measure patients’ perception of how their disorder influences everyday functioning. The objective of this study was to develop a PROM to assess disease activity in microscopic colitis [MC] fulfilling the requirements of the Food and Drug Administration [FDA]. Methods The European Microscopic Colitis Activity Index [E-MCAI] was developed in four steps. [1] A list of symptoms associated with active MC was created by a group of experts in the field. [2] Content validity of the symptoms was performed by experts [n = 14] and patients [n = 79] using the Content Validity Index. [3] Questions and response alternatives were created for each symptom, and validity of the E-MCAI was evaluated with cognitive interviews with patients [n = 7] and by the experts. [4] A pilot postal survey was performed to ensure usability. Results Seven of the symptoms related to active MC fulfilled the criteria for content validity and were included in the E-MCAI: stool consistency, stool frequency, stools at night, feel a need to pass more stools shortly after a bowel movement, urgent need to empty the bowel, leakage of stool and abdominal pain. The development and validation process resulted in the current version of the E-MCAI consisting of six questions related to MC. Conclusions The E-MCAI was developed using the methods advocated by the FDA. The evaluation indicates good content validity. Further evaluation will be performed to achieve construct validity, reliability and responsiveness in future cross-sectional and longitudinal studies.

Introducción: Diferentes vacunas frente a SARS-CoV-2 están actualmente en el mercado y se recomiendan en pacientes con Enfermedad Inflamatoria Intestinal (EII). No tenemos suficiente evidencia sobre la aceptación de este tipo de vacunas. El objetivo del estudio fue evaluar la aceptación de la vacuna frente a SARS-CoV-2 por parte de gastroenterólogos y pacientes con EII. Métodos: Se realizó una encuesta online a 8000 pacientes de ACCU-España y 1000 miembros de GETECCU. Se enviaron tres invitaciones entre Octubre-Diciembre 2020. Se realizó un análisis descriptivo, comparando las respuestas de médicos y pacientes. Resultados: 144 gastroenterólogos [63% mujeres, edad media 43 años (DE 9,5)], y1302 pacientes [72% mujeres, edad media 43 años (DE 12)] respondieron a la encuesta. 95% de los médicos recomendaban la vacuna frente a SARS-CoV-2 en pacientes con EII, 87% consideraron que su estrategia de vacunación frente a diferentes vacunas no había cambiado tras la pandemia frente al 12% que consideraban que actualmente remitían más pacientes a vacunación. En cuanto a los pacientes con EII, sólo 43% aceptaban la vacunación frente a SARS-CoV-2, frente a 43% que no estaban seguros. El sexo masculino (p

BACKGROUND: There is no information regarding the outcome of Crohn's disease (CD) patients treated with endoscopic balloon dilation (EBD) in non-referral hospitals, nor on the efficacy of EBD in ulcerative colitis (UC). We report herein the results of the largest series published to date.; AIM: To assess the efficacy and safety of EBD for inflammatory bowel disease (IBD) stenosis performed in 19 hospitals with different levels of complexity and to determine factors related to therapeutic success.; METHODS: We identified IBD patients undergoing EBD in the ENEIDA database. Efficacy of EBD was compared between CD and UC and between secondary and tertiary hospitals. Predictive factors of therapeutic success were assessed with multivariate analysis.; RESULTS: Four-hundred dilations (41.2% anastomotic) were performed in 187 IBD patients (13 UC/Indeterminate colitis). Technical and therapeutic success per dilation was achieved in 79.5% and 55.3%, respectively. Therapeutic success per patient was achieved in 78.1% of cases (median follow-up: 40months) with 49.7% requiring more than one dilation. No differences related to either diagnosis or hospital complexity was found. Technical success [OR 4.12 (95%CI 2.4-7.1)] and not receiving anti-TNF at the time of dilation [OR 1.7 (95% CI 1.1-2.6)] were independently related to therapeutic success per dilation. A stricture length=2cm [HR 2.43 (95% CI 1.11-5.31)] was a predictive factor of long-term success per patient. The rate of major complications was 1.3%.; CONCLUSIONS: EBD can be performed with similar efficacy and safety in hospitals with differing levels of complexity and it might be a suitable treatment for UC with short stenosis. To achieve a technical success and the short length of the stenosis seem to be critical for long-term therapeutic success.

There is evidence that following the recommendations on screening and treatment of tuberculosis infection does not completely prevent the onset of tuberculosis in patients with inflammatory bowel disease. This fact, and the increasing use of new biologics and immunomodulators, has led the Spanish Group Working on Crohn's Disease and Ulcerative Colitis to update their recommendations for the prevention of tuberculosis in patients with inflammatory bowel disease. Diagnostic methods for latent tuberculosis infection, different scenarios in which screening is to be performed, strategies to reduce the risk of tuberculosis once biological treatment is initiated and chemoprophylaxis guidelines for latent tuberculosis infection are reviewed, as well as the management of active tuberculosis during biological treatment. Finally, there is a summary of the current recommendations within the paper and in an algorithm. (C) 2020 The Authors. Published by Elsevier Espana, S.L.U.

Background and Aims The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life. Methods Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16. Results A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. Conclusions Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

INTRODUCTION : The introduction and broad use of new immunosuppressive agents, including biologic agents and JAK inhibitors, have revolutionised treatment of inflammatory bowel disease [IBD] in recent decades. With such immunosuppression, the potential for opportunistic infection is a key safety concern. [...]

Background: One of the most valued targets in inflammatory bowel disease (IBD) is for physicians to provide and patients to receive a high-level quality of care. This study aimed to evaluate the implementation of a nationwide quality certification programme for IBD units. Methods: Identification of quality indicators (QI) for IBD Unit certification was based on Delphi methodology that selected 53 QI, which were subjected to a normalisation process. Selected QI were then used in the certification process. Coordinated by GETECCU, this process began with a consulting round and an audit drill followed by a formal audit carried out by an independent certifying agency. This audit involved the scrutiny of the selected QI in medical records. If 80%–90% compliance was achieved, the IBD unit audited received the qualification of “advanced”, and if it exceeded 90% the rating was “excellence”. Afterwards, an anonymous survey was conducted among certified units to assess satisfaction with the programme for IBD units. Results: As of January 2021, 66 IBD units adhere to the nationwide certification programme. Among the 53 units already audited by January 2021, 31 achieved the certification of excellence, 20 the advanced certification, and two did not obtain the certification. The main survey results indicated high satisfaction with an average score of 8.5 out of 10. Conclusion: Certification of inflammatory bowel disease units by GETECCU is the largest nationwide certification programme for IBD units reported. More than 90% of IBD units adhered to the programme achieved the certification, AbbVie sponsored the CUE programme. AbbVie had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Background The outbreak of COVID-19 has rapidly evolved into a pandemic that has represented a challenge to health systems worldwide. Inflammatory bowel disease (IBD) units have been forced to change their practices to address the disease and to ensure the quality of care. Methods We conducted a national survey among IBD gastroenterologist members of the Spanish Working Group on Crohn’s Disease and Colitis regarding changes of practice, IBD treatments, and diagnosis and treatment of COVID-19. Results We received 54 answers from Spanish hospitals. One hundred percent of the IBD units rescheduled onsite visits to telematic consultation, and elective endoscopic and surgical procedures were delayed. Protective measures were also taken in the infusion units (100% of health centers) and hospital pharmacies, with 40.7% sending subcutaneous medications to patients. No switching between intravenous and subcutaneous anti-tumor necrosis factor drugs were made. We also found that 96.1% of IBD units advised their patients to maintain treatment if they were asymptomatic for COVID-19. For patients with COVID-19 symptoms, 92.6% of IBD units referred them to primary care or the emergency department. In addition, 7.5% of IBD units made a COVID-19 diagnosis through polymerase chain reaction and/or chest x-ray. Modifications in IBD treatment and treatment recommended for COVID-19 are also discussed. Conclusions We report a representative national survey of changes made in the structure, diagnosis of COVID-19, and modifications in IBD treatments within IBD units.

Introduction Microscopic colitis is a chronic inflammatory bowel disease characterised by normal or almost normal endoscopic appearance of the colon, chronic watery, non-bloody diarrhoea and distinct histological abnormalities, which identify three histological subtypes, the collagenous colitis, the lymphocytic colitis and the incomplete microscopic colitis. With ongoing uncertainties and new developments in the clinical management of microscopic colitis, there is a need for evidence-based guidelines to improve the medical care of patients suffering from this disorder. Methods Guidelines were developed by members from the European Microscopic Colitis Group and United European Gastroenterology in accordance with the Appraisal of Guidelines for Research and Evaluation II instrument. Following a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the certainty of the evidence. Statements and recommendations were developed by working groups consisting of gastroenterologists, pathologists and basic scientists, and voted upon using the Delphi method. Results These guidelines provide information on epidemiology and risk factors of microscopic colitis, as well as evidence-based statements and recommendations on diagnostic criteria and treatment options, including oral budesonide, bile acid binders, immunomodulators and biologics. Recommendations on the clinical management of microscopic colitis are provided based on evidence, expert opinion and best clinical practice. Conclusion These guidelines may support clinicians worldwide to improve the clinical management of patients with microscopic colitis. Funding Agencies|UEG Activity Grant

Patients with ulcerative colitis (UC) have an increased risk of colorectal cancer. Scarce data regarding the development of adenomas in these patients are available both for normal and colitic mucosa.The objective of this article is to evaluate the prevalence of adenomatous polyps and associated risk factors in patients with UC.Patients with UC were identified from the databases of two tertiary referral centers. Medical, endoscopic and histologic reports were reviewed.A total of 403 patients were included (53% male; 33% extensive colitis) and 1065 colonoscopies (median per patient, 2) were recorded and analyzed. Seventy-four adenomas in 47 patients (11.7%) and three cases of colorectal cancer were found during a median follow-up of 6.3 years. The cumulative risk of colorectal adenoma was 4.7%, 16.7%, 23.6% and 34.4% at 10, 20, 30 and 40 years from UC diagnosis, respectively. The cumulative risk of developing metachronous colorectal adenoma was 66.7%, 87.9%, and 90.9% at 5, 10, and 15 years from first adenoma detection. Older age at UC diagnosis and longer disease duration were independent risk factors for colorectal adenoma development.The prevalence of colorectal adenomas among UC patients seems to be higher than previously reported, although lower than in the background population.

Background: Onset during old age has been reported in upto 10% of total cases of inflammatory bowel disease (IBD). Aim: To evaluate phenotypic characteristics and the use of therapeutic resources in patients with elderly onset IBD. Methods: Case-control study including all those patients diagnosed with IBD over the age of 60 years since 2000 who were followed-up for >12 months, identified from the IBD databases. Elderly onset cases were compared with IBD patients aged 18 to 40 years at diagnosis, matched by year of diagnosis, gender and type of IBD (adult-onset). Results: One thousand three hundred and seventy-four elderly onset and 1374 adult-onset cases were included (62% ulcerative colitis (UC), 38% Crohn's disease (CD)). Among UC patients, elderly onset cases had a lower proportion of extensive disease (33% vs 39%; P < 0.0001). In CD, elderly onset cases showed an increased rate of stenosing pattern (24% vs 13%; P < 0.0001) and exclusive colonic location (28% vs 16%; P < 0.0001), whereas penetrating pattern (12% vs 19%; P < 0.0001) was significantly less frequent. Regarding the use of therapeutic resources, there was a significantly lower use of corticosteroids (P < 0.0001), immunosuppressants (P < 0.0001) and anti-TNFs agents (P < 0.0001) in elderly onset cases. Regarding surgery, we found a significantly higher surgery rate among elderly onset UC cases (8.3% vs 5.1%; P < 0.009). Finally, elderly onset cases were characterised by a higher rate of hospitalisations (66% vs 49%; P < 0.0001) and neoplasms (14% vs 0.5%; P < 0.0001). Conclusions: Elderly onset IBD shows specific characteristics and they are managed differently, with a lower use of immunosuppressants and a higher rate of surgery in UC.

Introduction: The study of intraepithelial lymphocytes (IEL) by flow cytometry is a useful tool in the diagnosis of coeliac disease (CD). Previous data showed that an increase in %TCRγδ+ and decrease of %CD3− IEL constitute a typical CD cytometric pattern with a specificity of 100%. However, there are no data regarding whether there are differences in the %TCRγδ+ related to sex, age, titers of serology, and degree of histological lesion. Study aims: To confirm the high diagnostic accuracy of the coeliac cytometric patterns. To determine if there are differences between sex, age, serology titers, and histological lesion grade. Results: We selected all patients who fulfilled “4 of 5” rule for CD diagnosis (n = 169). There were no differences in %TCRγδ+ between sexes (p = 0.909), age groups (p = 0.986), serology titers (p = 0.53) and histological lesion grades (p = 0.41). The diagnostic accuracy of complete CD cytometric pattern was: specificity 100%, sensitivity 82%, PPV 100%, NPV 47%. Conclusion: We confirmed, in a validation cohort, the high diagnostic accuracy of complete CD pattern irrespective of sex, age, serology titers, and grade of mucosal lesion.

Resumen Colitis microscopica es un termino generico que incluye 2 formas principales, colitis colagena y colitis linfocitica, que describe una forma de enfermedad inflamatoria intestinal con curso cronico y recidivante. La incidencia de colitis microscopica es entre 2 y 8 veces mas alta en mujeres que en hombres; sin embargo, la edad contribuye mas que el sexo en el riesgo de colitis colagena (OR 8,3 para edad ≥ 65 vs.

Background &amp, Aims: Determining whether patients with lymphocytic enteritis (LE) have coeliac disease is a challenge. We analysed the variables associated with a low-grade coeliac enteropathy diagnosis in patients with suspected coeliac disease but without villous atrophy, and developed a scoring system to identify them. Methods: We collected data from 2010 through to 2016 on patients with lymphocytic enteritis and persistent symptoms compatible with the clinical spectrum of coeliac disease. One hundred and four patients starting on a gluten-free diet (GFD) were included. Duodenal biopsies were collected before the GFD and analysed for numbers of CD3+ T-cell receptor gamma delta+ (TCR&gamma, &delta, +), and CD3&minus, intraepithelial lymphocytes. We performed a logistic regression analysis to identify factors associated with a low-grade coeliac enteropathy diagnosis. Results: Sixty-two patients achieved clinical remission after the GFD. Fifty of these 62 patients were diagnosed with low-grade coeliac enteropathy. Multivariate analysis identified the presence of &gt, 25% intraepithelial lymphocytosis, HLA-DQ2.5, positive serology, and increased numbers of TCR&gamma, + cells with a low-grade coeliac enteropathy diagnosis. We developed a scoring system that identified patients with an area under the ROC curve (AUC) of 0.91. Scores of &gt, 10 had 86% sensitivity and 85% specificity. Conclusion: We developed a scoring system that identifies patients likely to be diagnosed with low-grade coeliac enteropathy with an AUC value of 0.91.

BACKGROUND Thiopurines are the most widely used immunosuppressants in IBD although drug-related adverse events (AE) occur in 20%-30% of cases. AIM To evaluate the safety of thiopurines in elderly IBD patients METHODS: Cohort study including all adult patients in the ENEIDA registry who received thiopurines. Patients were grouped in terms of age at the beginning of thiopurine treatment, specifically in those who started thiopurines over 60 years or between 18 and 50 years of age. Thiopurine-related AEs registered in the ENEIDA database were compared. RESULTS Out of 48 752 patients, 1888 started thiopurines when over 60 years of age and 15 477 under 50 years of age. Median treatment duration was significantly shorter for those who started thiopurines >60 years (13 [IQR 2-55] vs 32 [IQR 5-82] months; P 60 years had higher rates of all types of myelotoxicity, digestive intolerance and hepatotoxicity. Thiopurines were discontinued due to AEs (excluding malignancies and infections) in more patients starting >60 years (67.2% vs 63.1%; P

Background and Aims There is controversy as to whether the risk of relevant infection in IBD is related to immunosuppressants or the disease itself. The aims of this study were to evaluate: [1] the life-long prevalence and types of relevant infections in patients with IBD related to immunosuppressive treatment, and [2] the relationship of both infection and patient comorbidity to mortality. Methods Observational multicentre retrospective study of IBD patients that presented a relevant infection. For each case, four periods of infection exposure were analysed: P1: pre-IBD diagnosis, P2: from IBD diagnosis to immunosuppressant initiation, P3: during immunosuppressant therapy, and P4: after treatment withdrawal. Results The life-long prevalence of relevant infection in the total cohort of patients [6914] was 3%, and 5% in immunosuppressed patients [4202]. 366 relevant infections were found in 212 patients [P1: 9, P2: 17, P3: 334, and P4: 6]. Differences between periods were significant [p < 0.0001]. The most frequent types of infection were respiratory, intestinal and urinary. The most frequent opportunistic infections were tuberculosis [prevalence: 2.6/1000] and herpes zoster [prevalence: 3.9/1000]. Herpes zoster infection was associated with thiopurines alone or in combination with anti-TNF in 75% of the cases, whereas tuberculosis was associated with anti-TNF in 94% of patients. The overall mortality was 4.2%. Infection-related mortality was 2.8% and it was not influenced by comorbidity. Conclusions Relevant infections in IBD patients are rare and appear to be related to immunosuppression. Relevant infection is a major cause of death in IBD.

Background and Aims: There is very limited information regarding region-specific immunological response in human intestine. We aimed to determine differences in immune compartmentalisation between ileum and colon in healthy and inflamed mucosa. Methods: T cell profile and its apoptosis were measured by flow cytometry, Th1, Th17, Treg [CD4+CD25+FOXP3+], double positive [DP, CD3+CD4+CD8+] and double negative T cells [DN, CD3+CD4-CD8-], immunohistochemistry \[FOXP3, caspase-3], and real-time polymerase chain reaction [PCR\] \[IFN-γ, IL-17-A, and FOXP3\] on biopsies from different regions of healthy intestine and of intestine in inflammatory bowel diseases. Results: Healthy colon showed higher percentages of Treg, Th17, and DN, and lower numbers of DP T cells compared with ileum [ p < 0.05]. Some but not all region-specific differences were lost in inflammatory conditions. Disease-specific patterns were found: a Th1/Th17 pattern and a Th17 pattern in Crohn’s disease and ulcerative colitis respectively, whereas a reduction in Th1/Th17 was found in microscopic colitis. In colonic Crohn’s disease and microscopic colitis, DN T cells had a pattern inverse to that of Th1/Th17 (increase in microscopic colitis [ p < 0.05] and decrease in Crohn’s disease [ p < 0.005]). Higher levels of lymphocyte apoptosis were found in healthy colon compared with the ileal counterparts [ p = 0.001]. All forms of colonic inflammation presented a dramatic decrease in apoptosis compared with healthy colon. By contrast ileal Crohn’s disease showed higher levels of cleaved-Caspase+ CD3+ cells. Conclusions: Immunological differences exist in healthy gastrointestinal tract. Inflammatory processes overwhelm some location-specific differences, whereas others are maintained. Care has to be taken when analysing immune response in intestinal inflammation, as location-specific differences may be relevant.

Aims: (1) Assess the population-based incidence of severe olmesartan-associated enteropathy. (2) To describe patients of the Spanish registry. (3) Evaluate markers of potential coeliac disease and associated autoimmunity. Methods: Crude incidence rates in the area of Terrassa (Catalonia) were calculated. Clinical characteristics of patients in the Spanish registry were collected. Duodenal lymphocyte subpopulations and anti-TG2 IgA deposits were assessed in a subset of patients. Results: Annual incidence rates (2011-2014) ranged from 0 to 22 cases per 104 treated patients. Twenty patients were included in the Spanish registry. Nineteen (95%) exhibited villous atrophy and 16 (80%) had severe enteropathy. Lupus-like disease occurred during olmesartan treatment in 3 patients. HLA-DQ2/DQ8 was positive in 64%. Markers of potential coeliac disease were present in 4 out of 8 patients (positive anti-TG2 deposits and/or increased CD3+ gammadelta+ intraepithelial lymphocytes and reduced CD3-). Histopathological changes and clinical manifestations including autoimmune disorders improved after olmesartan discontinuation but not after gluten-free diet, irrespective of the presence or absence of coeliac markers. Conclusions: Incidence of severe olmesartan-associated enteropathy was low. Autoimmune phenomena were present in a subset of cases and reversed after olmesartan removal. A genetic coeliac disease background and the presence of potential coeliac markers might uncover predisposing factors. (C) 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Background and Aim Thiopurines prevent Crohn's disease (CD) endoscopic recurrence (ER) at least in 50% of patients 1 year after surgery. This study aimed to evaluate the value of adding mesalazine in patients with subclinical ER despite preventive thiopurine therapy. Methods Crohn's disease patients with ileocecal resection treated with thiopurines for postsurgical recurrence prevention in whom mesalazine was added (cases) to treat ER without clinical recurrence (CR) were identified and compared with those in whom no treatment was added to thiopurines (controls). All patients were followed up for at least 1 year from the index endoscopy. Development of CR as well as evolution of mucosal lesions was evaluated. Results Thirty-seven patients were included (19 cases and 18 controls). Initial Rutgeerts' score was i2 in 16 patients (9 cases and 7 controls), and i3 in 21 patients (10 cases and 11 controls). After a median clinical follow-up of 59 months (interquartile range 22–100) from the index endoscopy, six cases (32%) and two controls (11%) developed CR (P = 0.2). After a median time to last endoscopic follow-up of 23 months (interquartile range 17–71), 18 patients (49%) showed improvement in Rutgeerts' score, 11 patients (30%) demonstrated progression of mucosal lesions, and 8 (22%) had no changes, with no differences between study groups. Conclusions The addition of mesalazine seems to be of no benefit in patients with subclinical endoscopic recurrence while on thiopurine prevention. Moderate endoscopic postsurgical recurrence while on thiopurines may even revert with no additional therapy in some patients.

Background: Active smoking has been associated with a higher risk of developing Crohn's disease (CD). However, its impact on clinical outcomes has been controversial among studies. Aims: To evaluate the influence of active smoking on initial manifestations of CD, the development of disease-related complications, and therapeutic requirements. Methods: Patients diagnosed with CD within a ten-year period (1994-2003) were identified. Clinical and therapeutic features until October 2008 or loss of follow-up were recorded. Smoking status was assessed at each major disease-related event (e.g. penetrating and stricturing complications, perianal disease, intestinal resection, introduction of immunomodulators or biological agents). Results: A total of 259 patients were included in the study with a median follow-up period of 91 months. At diagnosis, 50.5% were active smokers and only 12% of them quit smoking during follow-up, mostly after a major disease-related event occurred. Smoking at diagnosis was not associated with a particular CD presentation. Active smoking did not influence the development of strictures, intraabdominal and perianal penetrating complications, or increased resectional surgery, biological therapy or immunomodulators requirements. Conclusions: Patients who develop CD while smoking seem to have a similar disease course to those who never smoked. (c) 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

Sexuality is important when assessing quality of life (QoL), which is often disturbed in inflammatory bowel disease (IBD). However, sexuality is not addressed in most QoL questionnaires. To evaluate the prevalence and predisposing factors of sexual dysfunction among IBD patients, and their own perception. A postal survey was conducted in IBD patients 25–65 years of age from two tertiary centres. Patients were asked to provide a control of the same gender and age without IBD. The questionnaire assessed patient perception of the impact of IBD on their sexuality, and also allowed calculation of the Erectile Function International Index or the Female Sexual Function Index. A total of 355 patients and 200 controls were available for the final analysis. Both groups were comparable except for a higher proportion of individuals who had been treated for depression among patients. Half of the female and one-third of the male patients considered that both sexual desire and satisfaction worsened after IBD diagnosis. As compared to controls, both men and women with IBD showed significantly lower scores in sexual function indexes, but a higher prevalence of sexual dysfunction was only noticed among women. Independent predictors of sexual dysfunction among IBD patients were the use of corticosteroids in women, and the use of biological agents, depression and diabetes in men. Sexuality is often disturbed in IBD patients, particularly among women. Many factors seem to contribute to worsened intimacy. Sexuality should be considered when QoL is assessed in these patients.

Background and aims: Few studies have assessed the prevalence of microscopic colitis (MC) and the natural history of this disease is not well known. The aim of this study was to evaluate the prevalence rate of MC, the burden of disease in terms of loss of health and the long-term natural history of MC in a population-based cohort study. Methods: Cases were obtained from the pathology department registry Hospital Universitari Mutua Terrassa. Belonging to the catchment area, maintaining residence in that area, and being alive on August 31, 2014 were confirmed for each case. Adjusted prevalence rates were calculated. Current active drugs for MC and diarrhoea persistence in every patient were recorded. Results: The prevalence rate of MC was 107 per 105 inhabitants. The rate of patients with active disease, i.e. those representing the true burden of the disease in terms of loss of health, was 31 per 105 inhabitants. After a follow-up of 7.8±0.38 years from diagnosis, 75% of the patients experienced prolonged disease remission, defined as clinical remission without requiring drugs for 1 year or more. The only variable associated with prolonged MC remission was how clinical remission was achieved (spontaneous 93.3%, drug-induced, 60.5%; odds ratio 8.4, 95% confidence interval 2.7–26). Conclusions: The rate of patients with MC and active disease, which represents the true disease burden in terms of loss of health, is low. Most patients with MC experience prolonged disease remission, with key differences between spontaneous and drug-induced clinical remission.

Background: Fecal calprotectin (FC) is the best noninvasive biomarker of disease activity in inflammatory bowel disease. Its correlation with endoscopic mucosal lesions could save inconvenient, expensive, and repeated endoscopic examinations in particular clinical settings. Patients and Methods: To assess the correlation between FC and the existence and severity of endoscopic postoperative recurrence (POR), a group of clinically stable outpatients with Crohn's disease for whom an ileocolonoscopy was routinely planned to assess POR were invited to collect a stool sample before starting bowel cleansing to measure FC. POR was graded by means of Rutgeerts endoscopic score. Results: One hundred nineteen ileocolonoscopies were included, 42% with endoscopic POR. FC was significantly lower in the absence of endoscopic POR and in the absence of any endoscopic lesion. The area under the receiver operating characteristic curve was 0.76 (95% confidence interval, 0.68-0.85) for the diagnosis of the absence of lesions and 0.75 (95% confidence interval, 0.66-0.84) for endoscopic POR. Better sensitivity and negative predictive value were observed when combining FC and serum C-reactive protein (CRP), leading to a sensitivity of 82%, a specificity of 53%, and negative and positive predictive values of 81% and 54%, respectively, for the prediction of endoscopic POR with a combination of FC 100 mu g/g and CRP 5 mg/L cutoff values. Conclusions: FC correlates closely with endoscopic POR in clinically stable postoperative patients with Crohn's disease and, when used in combination with CRP, might save endoscopic examinations and allow for a high-grade suspicion of endoscopic POR in the long-term monitoring of these patients.

Microscopic colitis is a generic term that includes 2 main forms, collagenous colitis and lymphocytic colitis, and describes a form of inflammatory bowel disease with a chronic and relapsing course. The incidence of microscopic colitis is between 2 and 8 times higher in women than in men, although age, more than sex, increases the risk of collagenous colitis (odds ratio [OR] 8.3 for age ≥65 vs.

Portal hypertension (PH) is a complication that may occur in patients with inflammatory bowel disease (IBD). In these patients, the etiology of PH may not be alcoholic or viral cirrhosis (which cause 90% of cases in the general population). Consequently, etiologic study of PH in patients with IBD should always include a wide spectrum of possibilities. Moreover, the development of PH in IBD patients often requires a distinct therapeutic approach to IBD (both medical and surgical) as PH may be a contraindication for some drugs and is a risk factor for surgical morbidity and mortality. We present the cases of two patients with IBD who developed PH and review the most likely causes of PH in IBD, as well as preventive and therapeutic strategies.

Appendectomy is associated with a reduced risk of developing ulcerative colitis (UC). In addition, there may be appendicular involvement in UC in patients with extensive or even left-sided disease. However, no data are available on the incidence, clinical presentation and outcome of acute appendicitis in patients previously diagnosed with UC. The impact of appendectomy in this subset of patients also remains to be determined. We describe 2 cases of acute appendicitis in the setting of inactive extensive ulcerative colitis and compare their histologic features with those of the surgical specimens of 2 further UC patients colectomized for refractory and extensive disease.

Summary Background Idiopathic bile acid malabsorption (BAM) has been suggested as a cause of chronic watery diarrhoea, with a response to colestyramine in 70% of patients. However, the efficacy of this drug has never been investigated in placebo-controlled trials. Aim To evaluate the efficacy of colestyramine as compared with hydroxypropyl cellulose in the treatment of functional chronic watery diarrhoea. Methods Patients with chronic watery diarrhoea were randomly assigned to groups given colestyramine sachets 4 g twice daily (n = 13) or identical hydroxypropyl cellulose sachets (n = 13) for 8 weeks. The primary end-point was clinical remission defined as a mean of 3 or fewer stools per day during the week before the visit, with less than 1 watery stool per day. A secondary end-point was the reduction in daily watery stool number. SeHCAT test was performed in all patients, but an abnormal test was not a prerequisite to be included. Results All included patients had a SeHCAT 7-day retention ≤20%. There were no statistical differences in the percentage of patients in clinical remission at week 8 between colestyramine and hydroxypropyl cellulose with either intention-to-treat (53.8% vs. 38.4%; P = 0.43) or per-protocol (63.6% vs. 38.4%; P = 0.22) analyses. However, the mean per cent decrease in watery stool number was significantly higher with colestyramine than with hydroxypropyl cellulose (−92.4 ± 3.5% vs. −75.8 ± 7.1%; P = 0.048). The rate of adverse events related to study drugs did not differ between groups. Conclusions Colestyramine (4 g twice daily) is effective and safe for short-term treatment of patients with chronic watery diarrhoea presumably secondary to BAM. Clinical Trials Register number EudraCT 2009-011149-14.

The aim was to assess the impact of inflammatory bowel disease (IBD) and its treatment on fertility, pregnancy outcomes, and breastfeeding. IBD is a chronic inflammatory condition that is usually diagnosed in young adulthood. Patients are often concerned about fertility and pregnancy outcomes.A structured questionnaire was posted to 850 adults with IBD followed-up on in a single center.A total of 503 patients (59%) with a median age of 40 years and equally distributed for gender and type of IBD returned the questionnaire. Overall, 71% of the patients had a total of 659 children, 36% of whom were born after the diagnosis. A total of 132 miscarriages were registered, 46% after the diagnosis of IBD. Most childless patients stated that having no children was a personal decision, and only 6% of them were evaluated and diagnosed with infertility. Pregnancies after diagnosis of IBD had a higher probability of caesarean section and preterm delivery. IBD-related drug therapy was discontinued in 16% of the pregnancies, mainly as a result of medical advice. Babies born after the diagnosis of IBD were less often breastfed.The infertility rate among IBD patients seems to be similar to that seen in the general population. However, a large proportion of patients chose to remain childless. Vaginal delivery and breastfeeding are less likely to occur in babies born after the diagnosis. Suitable information for patients to avoid unwarranted concerns about adverse reproductive outcomes, as well as improved obstetrical and perinatal management, still seems to be necessary.

Introduccion: Ningun estudio ha demostrado de forma especifica la presencia de predictores de un curso favorable en la enfermedad de Crohn (EC), hecho que permitiria un enfoque mas conservador. Objetivos: Identificar en el momento del diagnostico de la EC los factores predictivos de un curso favorable en la evolucion de la enfermedad. Metodos: Se identificaron e incluyeron todos los pacientes diagnosticados entre enero 1994 y diciembre de 2003, con una EC de patron inflamatorio, sin afectacion perianal en el momento del diagnostico y con un minimo de 5 anos de seguimiento. Se recogieron las caracteristicas clinicas y de tratamiento hasta diciembre de 2008 o perdida de seguimiento. Definimos como curso favorable la ausencia de complicaciones estenosantes o penetrantes (incluida la enfermedad perianal), asi como la no necesidad de terapia anti-TNF o cirugia resectiva en el seguimiento. Resultados: Ciento cuarenta y cinco pacientes fueron incluidos y seguidos por una media de 96 meses (IIQ, 79-140). Al diagnostico, la afectacion fue ileal en 39%, colica en el 28% e ileocolica en el 32%. Asi mismo, el 50% de los pacientes era fumador activo y el 41% uso inmunomoduladores desde el momento del inicio. Ochenta y dos pacientes (57%) presentaron criterios de curso favorable al final del seguimiento. Solo la afectacion exclusivamente colica se asocio a un curso favorable (p = 0,022) cumpliendo en este subgrupo en un 73% los criterios de curso favorable. Conclusiones: El curso favorable de una EC no complicada al inicio no es facilmente predecible mediante el analisis de factores clinicos y epidemiologicos. De todas formas, parece ser que los pacientes con afectacion colica exclusiva presentan con menor frecuencia un curso agresivo.

Background: Although the early outcomes of ulcerative colitis after a first course of corticosteroids are well known, data on long-term disease evolution in patients responding to a first corticosteroid course are scarce. Aims: To evaluate the long-term clinical evolution in ulcerative colitis patients responding to a first course of corticosteroids and to identify those factors associated with a poorer outcome. Methods: Retrospective review of 114 patients diagnosed with ulcerative colitis who responded to the first corticosteroid course, and did not start thereafter maintenance therapy with thiopurines were included. Results: Corticosteroids were prescribed because of a moderate (78%) or a severe flare (22%). All but two patients followed maintenance treatment with mesalazine after corticosteroid discontinuation. After a median follow-up of 83 months (7-156), 72% of patients suffered new relapses leading to corticosteroid reintroduction in 65% of patients. The earlier corticosteroids were introduced in the course of ulcerative colitis, the higher the risk of relapse and corticosteroid reintroduction. Thiopurines were started in 51%, and infliximab in 19%. Eleven percent of patients underwent colectomy. No predictors of thiopurine use or colectomy were found. Conclusions: Half of the ulcerative colitis patients responding to a first course of corticosteroids will require immunosuppressors mainly because of steroid-dependence. (C) 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Background: Patients with ulcerative colitis (UC) and concomitant perianal disease (PAD) are occasionally seen, but the impact of PAD on UC outcome has been scarcely assessed. Aims: To evaluate the prevalence, clinical features and outcomes of PAD among UC patients. Methods: Patients with an initial diagnosis of UC who ever developed PAD were identified from three IBD hospital databases. Each case was matched by age, disease extent at diagnosis, and year of diagnosis, with two UC patients who never developed PAD. Results: Thirty-seven UC patients (5% of the whole series) developed PAD (complex in about a half of them), being more frequent among men (62%), with distal (50%) or extense (34%) disease. Proximal spread of UC occurred in 19% of cases. No differences in demographic features, rate of proximal spread or colectomy during follow-up were found as compared to controls, but greater requirements of steroids (P=0.019) were detected in UC-PAD patients. A change in disease diagnosis occurred in 6 patients mainly because of transmural involvement in colectomy specimen, small intestinal involvement, and/or endoscopic appearance. Conclusions: PAD may occur in up to 5% of UC patients. When complex it leads to a change in disease diagnosis in one third of cases. UC-related therapeutic requirements are not increased in these patients, except for steroids. (C) 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

Background: Corticosteroids are the treatment of choice for moderate-to-severe active ulcerative colitis (UC) but up to 30%–40% of patients fail to respond. It has been reported that early clinical-biological parameters may identify those patients at high risk of colectomy. The aim was to identify predictors of rapid response to systemic steroids in moderate-to-severe attacks of UC. Methods: Consecutive patients treated with prednisone 1 mg/kg/day for moderate-to-severe attacks of UC were prospectively included. Clinical and biological parameters at 3 and 7 days after starting steroids were recorded. Response was defined as mild or inactive UC activity at day 7 (as assessed by the Montreal Classification of severity) together with no need for rescue therapies (cyclosporin, infliximab, or colectomy). A logistic regression analysis was performed to identify those independent predictors of response. In addition, a decision-tree analysis was also performed. Results: Sixty-eight percent of patients (64 out of 94) responded to steroids. In the univariate analysis the number of bowel movements, rectal bleeding, platelet count, and C-reactive protein (CRP) levels at day 3 were associated with response at day 7, but only rectal bleeding was found to be an independent predictor in the logistic regression analysis. Conversely, the classification and regression tree (CART) model included these four variables. The decision-tree model showed a higher sensitivity in predicting a rapid response to steroids than the logistic regression one. Conclusions: Rapid response to steroids in active UC attacks can be predicted after 3 days of treatment by simple clinical and biological parameters. A decision-tree model for early introduction of rescue therapies is provided. (Inflamm Bowel Dis 2011)

Aliment Pharmacol Ther 31, 553–560 Summary Background Most available data on infliximab therapy come from large, short-term, pivotal RCTs and concerns about long-term safety profile still remain. Aim To evaluate the long-term safety profile of infliximab in inflammatory bowel disease (IBD) in a clinical practice setting. Methods Since 1999, all IBD patients treated with infliximab were registered and clinical outcomes prospectively recorded up to March 2008, loss of follow-up or patient’s death. Infliximab regimens and preventive measures were in accordance with the prevalent guidelines or with the manufacturer’s recommendations. Results One hundred fifty-two patients were included (121 Crohn’s disease, 24 ulcerative colitis, 7 indeterminate colitis), with a median of 5 infliximab infusions (IQR 3–8) and 87% of patients received at least three infusions. Seventy-nine per cent of them received concomitant immunomodulators and 70% were pre-medicated with hydrocortisone from the first infusion. After a median follow-up of 142 weeks, 13% presented infusion reactions, 13% viral or bacterial infections and two patients developed neoplasia. The mortality rate was 2.6% (four patients). Conclusions Infliximab therapy is safe when the recommended preventive measures are implemented, with a rate of serious adverse events less than 10%. No new safety signals were found.

Background Systemic amyloidosis is a rare but life-threatening complication of inflammatory bowel disease (IBD), most cases being reported among Crohn's disease (CD) patients. The only two available retrospective studies showed a prevalence ranging from 0.9% to 3% among CD patients. Aims To evaluate the prevalence of secondary systemic amyloidosis in a large IBD cohort of a referral centre, and to describe its clinical characteristics and outcome. Methods Patients diagnosed with amyloidosis were identified among 1006 IBD patients included in the IBD database of our centre, and their medical records were carefully reviewed. Results Among a total of 1006 IBD patients, 5 cases of amyloidosis were identified, all of them with CD, resulting in a prevalence of 0.5% for IBD and 1% for CD. Two patients died after developing renal failure. Two patients were treated with anti-TNF agents, showing a clinical improvement of their amyloidosis. Conclusions Secondary amyloidosis occurs mainly in long-lasting, complicated, Crohn's disease and seems to be as prevalent among IBD patients as previously reported.

Summary Background Infliximab (IFX) could change the course of Crohn’s disease (CD) by reducing steroid use, surgery or prompting earlier introduction of immunomodulators (IMM). Aim To evaluate the impact of IFX availability on the course of early CD. Methods Two cohorts of newly diagnosed CD patients were identified: The first cohort included patients diagnosed from January 1994 to December 1997 and the second from January 2000 to December 2003. All patients were diagnosed, treated and followed up in the same centre until December 1999 (first cohort) or December 2005 (second cohort). Development of disease-related complications, steroid, IMM or IFX requirements and intestinal resections during follow-up were registered. Results A total of 328 patients were included (146 first cohort, 182 second cohort). A similar proportion of patients in both cohorts received steroids, but steroid exposure resulted significantly more intense in the first cohort (P = 0.001). In the second cohort, 14% of patients received IFX. Thiopurines were used more (P = 0.001) and earlier (P = 0.012) in the second cohort. No differences in surgical requirements or the development of disease-related complications were found. Conclusions Following a step-up therapeutic algorithm, IFX availability did not reduce surgical requirements or the development of disease-related complications. Aliment Pharmacol Ther 31, 233–239

Episodic infliximab (IFX) treatment is associated with a higher risk for acute infusion reactions (AIR) and secondary loss of response (SLR), but this has not been evaluated in patients initially treated with an induction regimen with 3 IFX infusions.To evaluate whether IFX reintroduction afteror = 4 months in patients treated with a 3-infusion induction regimen is associated with a higher incidence of AIR or SLR.Incidence of immunogenic adverse effects was assessed in patients with inflammatory bowel disease who receivedor = 4 consecutive IFX infusions (3 infusions at weeks 0, 2, and 6, plusor = 1 maintenance infusion) (Continuous, n=47) and patients who were treated with a successful initial 3-infusion induction scheme and in whom IFX was then discontinued because of a complete response but reintroducedor = 4 months later (Reintro, n=29).AIR rate was 17% in both groups, and SLR rate was 26% in the Continuous group and 15% in the Reintro group (not significant). The lack of concomitant immunomodulators and/or pretreatment with hydrocortisone were associated with AIR development (P=0.002).In patients who completed a 3-infusion induction regimen, IFX can be safely reintroduced even after a long time from discontinuation.

Background: Preventive actions are advised since the use of anti-tumor necrosis factor (TNF) agents is known to increase the risk of tuberculosis (TB). No data related to the effectiveness and safety of the preventive chemoprophylaxis (ChP) for TB in inflammatory bowel disease (IBD) patients are available. The goal was to evaluate the requirements, effectiveness, and safety profile of ChP in IBD patient candidates for anti-TNF therapy. Methods: All IBD patients diagnosed with latent TB while evaluated for anti-TNF therapy from the IBD database of 9 Spanish centers were included. Epidemiological and clinical data, risk factors for hepatotoxicity, ChP regimens, and side effects were registered. Results: Sixty-three out of 497 IBD evaluated patients (12.5%) had latent TB. Sixty-eight percent were on immunomodulators and 42% on systemic corticosteroids when a TB skin test (TST) was performed. The detection of a positive TST was done in 86% after a single exposure, but 14% needed a booster. All but 1 were treated with isoniazid alone for 6 or 9 months, and only 1 case required ChP discontinuation because of hepatotoxicity. No risk factors for hepatotoxicity were found. No cases of active TB were noticed in the 67 patients further treated with anti-TNF therapy. Conclusions: More than 10% of Spanish IBD patients who are candidates for anti-TNF therapy have latent TB. TST retest is required to identify at least 14% of such patients; therefore, it should be considered if the initial TST is negative. ChP is safe in IBD patients even in those taking concomitant, potentially hepatotoxic drugs. (Inflamm Bowel Dis 2008)

Goals: To assess the efficacy and safety profile of methotrexate (MTX) for the treatment of Crohn's disease (CD) in clinical practice. Background: MTX is widely used for some chronic immunologic diseases. Although some randomized controlled trials suggest its efficacy in CD, this drug remains a second-line, underused, immunomodulator. Study: Medical records of all patients treated with MTX for CD in our center (n = 44) were reviewed. Clinical and epidemiologic parameters, including risk factors for hepatotoxicity, were registered. Results: MTX was prescribed mainly for steroid-dependency (n = 22) and as concomitant treatment to infliximab (n = 18). Mean duration of treatment was 22.9 ± 19 months, with a mean cumulative dose of MTX of 1169 ± 784 mg. Thirty-nine percent of patients developed drug-related side effects, hepatotoxicity being the most frequent [13 patients (30%)]. However, only 5 patients (11%) had to discontinue MTX. In steroid-dependent CD patients, disease remission and complete steroid withdrawal was achieved in 77% of cases. Seven patients lost their initial response to MTX during follow-up, leading to a cumulative probability of remission of 39% after 3 years of treatment. Conclusions: MTX is well tolerated in most CD patients. Although a great proportion of steroid-dependent CD patients achieve disease remission and steroid withdrawal, there is a trend to a loss of efficacy with time. Larger, long-term studies are necessary to establish the role of MTX in the management of CD.

Background: One-third of patients with steroid-refractory ulcerative colitis (UC) do not respond to cyclosporine and require colectomy. Since alternative pharmacological treatments for this condition are available, it is pertinent to identify factors that predict response. The objective of this study was to determine predictive factors of response prior to cyclosporine administration, with validation in an independent cohort. Methods: The 2 cohorts of patients were identified from prospectively established databases. All patients had received 1 mg/kg/day prednisolone or equivalent for at least 5 days before cyclosporine. The efficacy measure was need of early surgery (within 3 months). Results: From 1998 to 2005, 34 patients were treated in 1 institution (derivation cohort) and 38 patients in the second institution (validation cohort). Eleven patients in the derivation cohort and 9 patients in the validation cohort underwent early colectomy. Univariate analysis in the derivation cohort demonstrated a significant association of colectomy with C-reactive protein (P = 0.012) and the Ho index before initiation of cyclosporine (P = 0.013). Regression analysis showed that only the Ho index (P = 0.011) had an independent predictive value. The Ho index predicted need of colectomy, with an area under the characteristic receiver operating curve of 0.79 (95% confidence interval [CI], 0.59–0.99) in the derivation cohort and 0.74 (95% CI, 0.53–0.96) in the validation cohort. The cutoff point with the best sensitivity and specificity ratio was ≥5. Conclusions: The Ho-based predictive score is a good predictor of response to cyclosporine and avoidance of colectomy, and may aid in the indication of this treatment for management of steroid-resistant UC. (Inflamm Bowel Dis 2007)