Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.

Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders. Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders. Design: This was a retrospective and multicentre study. Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI). Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis (n = 37) or Crohn's disease of the pouch (n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy. Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option.

Recommendations on the management of severe obesity in patients with inflammatory bowel disease of the Spanish Group on Crohn's Disease and Ulcerative Colitis (GETECCU), Spanish Society of Obesity (SEEDO), Spanish Association of Surgery (AEC) and Spanish Society of Digestive Endoscopy (SEED). / Recomendaciones sobre el manejo de la obesidad grave en pacientes con enfermedad inflamatoria intestinal del Grupo Español de Trabajo en Enfermedad Inflamatoria Intestinal (GETECCU), Sociedad Española de Obesidad (SEEDO), Asociación Española de Cirugía (AEC) y Sociedad Española de Endoscopia Digestiva (SEED).

Obesity is a multifactorial, chronic, progressive and recurrent disease considered a public health issue worldwide and an important determinant of disability and death. In Spain, its current prevalence in the adult population is about 24% and an estimated prevalence in 2035 of 37%. Obesity increases the probability of several diseases linked to higher mortality such as diabetes, cardiovascular disease, hyperlipidemia, arterial hypertension, non-alcoholic fatty liver disease, several types of cancer, or obstructive sleep apnea. On the other hand, although the incidence of inflammatory bowel disease (IBD) is stabilizing in Western countries, its prevalence already exceeds 0.3%. Paralleling to general population, the current prevalence of obesity in adult patients with IBD is estimated at 15-40%. Obesity in patients with IBD could entail, in addition to its already known impact on disability and mortality, a worse evolution of the IBD itself and a worse response to treatments. The aim of this document, performed in collaboration by four scientific societies involved in the clinical care of severe obesity and IBD, is to establish clear and concise recommendations on the therapeutic possibilities of severe or typeIII obesity in patients with IBD. The document establishes general recommendations on dietary, pharmacological, endoscopic, and surgical treatment of severe obesity in patients with IBD, as well as pre- and post-treatment evaluation.

Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis on sexuality and inflammatory bowel disease. / Documento de posicionamiento. Recomendaciones del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa sobre sexualidad y enfermedad inflamatoria intestinal.

It is widely acknowledged that inflammatory bowel disease (IBD) is associated with a high prevalence of sexual dysfunction (SD). However, there is a notable paucity of specific literature in this field. This lack of information impacts various aspects, including the understanding and comprehensive care of SD in the context of IBD. Furthermore, patients themselves express a lack of necessary attention in this area within the treatment of their disease, thus creating an unmet need in terms of their well-being. The aim of this position statement by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is to provide a review on the most relevant aspects and potential areas of improvement in the detection, assessment, and management of SD in patients with IBD and to integrate the approach to sexual health into our clinical practice. Recommendations are established based on available scientific evidence and expert opinion. The development of these recommendations by GETECCU has been carried out through a collaborative multidisciplinary approach involving gastroenterologists, gynecologists, urologists, surgeons, nurses, psychologists, sexologists, and, of course, patients with IBD.

Hematological Composite Scores in Patients with Inflammatory Bowel Disease.

The neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), and the systemic immune-inflammatory index (SIRI, neutrophils × monocytes/lymphocytes) have been identified as potential inflammatory biomarkers. In this work we aimed to analyze whether the hematological composite scores differ between inflammatory bowel disease (IBD) patients and healthy controls, and if they are related to disease activity. A total of 197 IBD patients-130 Crohn's (CD) disease and 67 ulcerative colitis (UC)-and 208 age- and sex-matched healthy controls were enrolled. C-reactive protein and fecal calprotectin were assessed. Multivariable linear regression analysis was executed. After adjustment, NLR and PLR, but not SIRI and MLR, were significantly higher in IBD patients compared to controls. C-reactive protein and SIRI and NLR were correlated in IBD patients. However, fecal calprotectin was not related to any of these blood scores. Furthermore, disease activity parameters were not associated with any of the blood composite scores in both CD and UC patients. In conclusion, NLR and PLR, but not SIRI and MLR, are independently higher in IBD patients compared to controls. However, the four hematological scores are not related to disease activity in either CD or UC patients. Based on these results, blood-based inflammatory scores may not serve as subrogated biomarkers of disease activity in IBD.

Benefits of Paediatric to Adult Transition Programme in Inflammatory Bowel Disease: The BUTTERFLY Study of GETECCU and SEGHNP.

(1) Background: Transition is a planned movement of paediatric patients to adult healthcare systems, and its implementation is not yet established in all inflammatory bowel disease (IBD) units. The aim of the study was to evaluate the impact of transition on IBD outcomes. (2) Methods: Multicentre, retrospective and observational study of IBD paediatric patients transferred to an adult IBD unit between 2017-2020. Two groups were compared: transition (≥1 joint visit involving the gastroenterologist, the paediatrician, a programme coordinator, the parents and the patient) and no-transition. Outcomes within one year after transfer were analysed. The main variable was poor clinical outcome (IBD flare, hospitalisation, surgery or any change in the treatment because of a flare). Predictive factors of poor clinical outcome were identified with multivariable analysis. (3) Results: A total of 278 patients from 34 Spanish hospitals were included. One hundred eighty-five patients (67%) from twenty-two hospitals (65%) performed a structured transition. Eighty-nine patients had poor clinical outcome at one year after transfer: 27% in the transition and 43% in the no-transition group (p = 0.005). One year after transfer, no-transition patients were more likely to have a flare (36% vs. 22%; p = 0.018) and reported more hospitalisations (10% vs. 3%; p = 0.025). The lack of transition, as well as parameters at transfer, including IBD activity, body mass index < 18.5 and corticosteroid treatment, were associated with poor clinical outcome. One patient in the transition group (0.4%) was lost to follow-up. (4) Conclusion: Transition care programmes improve patients' outcomes after the transfer from paediatric to adult IBD units. Active IBD at transfer impairs outcomes.

Serum Levels of Lipoprotein Lipase Are Increased in Patients with Inflammatory Bowel Disease.

Disruption of the lipid profile is commonly found in patients with inflammatory bowel disease (IBD). Lipoprotein lipase (LPL) is a key molecule involved in triglyceride metabolism that plays a significant role in the progression of atherosclerosis. In this study, our aim was to study whether serum LPL levels are different in IBD patients and controls and whether IBD features are related to LPL. This was a cross-sectional study that encompassed 405 individuals; 197 IBD patients with a median disease duration of 12 years and 208 age- and sex-matched controls. LPL levels and a complete lipid profile were assessed in all individuals. A multivariable analysis was performed to determine whether LPL serum levels were altered in IBD and to study their relationship with IBD characteristics. After the fully multivariable analysis, including cardiovascular risk factors and the changes in lipid profile that the disease causes itself, patients with IBD showed significantly higher levels of circulating LPL (beta coefficient 196 (95% confidence interval from 113 to 259) ng/mL, p < 0.001). LPL serum levels did not differ between Crohn's disease and ulcerative colitis. However, serum C-reactive protein levels, disease duration, and the presence of an ileocolonic Crohn's disease phenotype were found to be significantly and independently positively related to LPL. In contrast, LPL was not associated with subclinical carotid atherosclerosis. In conclusion, serum LPL levels were independently upregulated in patients with IBD. Inflammatory markers, disease duration and disease phenotype were responsible for this upregulation.

Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety.

INTRODUCTION: The objective of this study was to assess the durability, short-term and long-term effectiveness, and safety of tofacitinib in ulcerative colitis (UC) in clinical practice. METHODS: This is a retrospective multicenter study including patients with UC who had received the first tofacitinib dose at least 8 weeks before the inclusion. Clinical effectiveness was based on partial Mayo score. RESULTS: A total of 408 patients were included. Of them, 184 (45%) withdrew tofacitinib during follow-up (mean = 18 months). The probability of maintaining tofacitinib was 67% at 6 m, 58% at 12 m, and 49% at 24 m. The main reason for tofacitinib withdrawal was primary nonresponse (44%). Older age at the start of tofacitinib and a higher severity of clinical activity were associated with tofacitinib withdrawal. The proportion of patients in remission was 38% at week 4, 45% at week 8, and 47% at week 16. Having moderate-to-severe vs mild disease activity at baseline and older age at tofacitinib start were associated with a lower and higher likelihood of remission at week 8, respectively. Of 171 patients in remission at week 8, 83 (49%) relapsed. The probability of maintaining response was 66% at 6 m and 54% at 12 m. There were 93 adverse events related to tofacitinib treatment (including 2 pulmonary thromboembolisms [in patients with risk factors] and 2 peripheral vascular thrombosis), and 29 led to tofacitinib discontinuation. DISCUSSION: Tofacitinib is effective in both short-term and long-term in patients with UC. The safety profile is similar to that previously reported.

Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry.

BACKGROUND: Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce. METHODS: All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered. RESULTS: Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection. CONCLUSIONS: Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies.

SARS-CoV-2 vaccine acceptance among gastroenterologists and inflammatory bowel disease patients: VACUNEII project / Aceptación de la vacuna frente a SARS-CoV-2 entre gastroenterólogos y pacientes con enfermedad inflamatoria intestinal: proyecto VACUNEII

Introduction: Several vaccines against SARS-CoV-2 are currently in use and are recommended in inflammatory bowel disease (IBD) patients. Data are scarce about the gastroenterologists and IBD patient's acceptance of SARS-CoV-2 vaccines. The aim of the study was to evaluate the intention to get vaccination with SARS-CoV-2 vaccine among IBD patients from gastroenterologists and patient's perspective. Methods: An online anonymous survey was sent to 8000 patients from ACCU-Spain and 1000 members of the GETECCU. Three invitations were sent between October-December 2020. Descriptive analyses were performed, comparing physicians and patients responses by standard statistical analyses. Results: 144 gastroenterologists [63% female, mean age 43 years (SD 9.5)], and 1302 patients [72% female, mean age 43 years (SD 12)] responded to the survey. 95% of the physicians recommended SARS-CoV-2 vaccine for IBD patients and 87% consider that their vaccination strategies has not changed after the pandemic compared to 12% who considered that they currently refer more patients to vaccination. Regarding to IBD patients, only 43% of patients were willing to receive the vaccine and 43% were not sure. Male sex (p<0.001) and mesalazine treatment (p=0.021) were positively associated with SARS-CoV-2 vaccine acceptance. After multivariate analysis, only male sex was significantly associated with vaccination intent (OR=1.6; 95% confidence interval=1.2–2.0; p=0.001). Conclusions: Gastroenterologists and patient's perspective about SARS-CoV-2 are different. Future efforts to increase COVID-19 vaccine and decrease unfounded beliefs among IBD patients are needed.(AU)

Introducción: Actualmente en el mercado hay diferentes vacunas frente a SARS-CoV-2 que 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 8.000 pacientes de ACCU-España y 1.000 miembros de GETECCU. Se enviaron tres invitaciones entre octubre y diciembre de 2020. Se realizó un análisis descriptivo, comparando las respuestas de médicos y pacientes. Resultados: 144 gastroenterólogos (63% mujeres, edad media 43años [DE9,5]) y 1.302 pacientes (72% mujeres, edad media 43años [DE12]) respondieron a la encuesta. El 95% de los médicos recomendaban la vacuna frente a SARS-CoV-2 en pacientes con EII, el 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, solo el 43% aceptaban la vacunación frente a SARS-CoV-2, frente al 43% que no estaban seguros. El sexo masculino (p<0,001) y el uso de mesalazina (p=0,021) se asoció de forma positiva con la aceptación de la vacuna. En el análisis multivariante, solo el sexo masculino fue asociado significativamente con la intención de vacunarse (OR=1,6; IC95%=1,2-2,0; p=0,001). Conclusiones: La perspectiva de gastroenterólogos y pacientes con EII con respecto a la vacunación frente a SARS-CoV-2 es diferente. Es necesario realizar esfuerzos para incrementar el uso de la vacuna y disminuir falsas creencias.(AU)

Psychosocial impact of the COVID-19 pandemic on patients with inflammatory bowel disease in Spain. A post lockdown reflection / Impacto psicosocial de la pandemia de COVID-19 en pacientes con enfermedad inflamatoria intestinal en España. Una reflexión posterior al confinamiento

Objectives: This multicenter cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with inflammatory bowel disease (IBD) in Spain during lockdown and the first wave of the pandemic. Patients and methods: A self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale-21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of lockdown on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey between the 1st July and the 25th August 2020. Results: Of the 693 survey participants with IBD, 67% were women and the mean age was 43 (SD 12). Sixty-one percent had ulcerative colitis, 36% Crohn's disease and 3% indeterminate colitis. DASS-21 scores indicate that during lockdown the estimated prevalence of depression was 11% [95% CI 8.2–13%], anxiety 20% [95% CI 17 to 23%] and stress 18% [95% CI 8.2–13%]. Multivariate analysis showed that the perceived high risk of COVID-19 infection because of having IBD and maladaptation to government measures to reduce the spread of disease doubled the risk of anxiety and stress during lockdown. Conclusions: In the short-term, lockdown during the COVID-19 pandemic seemed to have an impact on the already affected mental health of our IBD patients in Spain.(AU)

Objetivos: Este estudio transversal multicéntrico se llevó a cabo para evaluar el impacto psicosocial de la COVID-19 en pacientes con enfermedad inflamatoria intestinal (EII) en España durante el confinamiento y la primera ola de la pandemia. Pacientes y métodos: Se diseñó un cuestionario de autoinforme que integraba la versión española de la Escala de Depresión, Ansiedad y Estrés-21 ítems (DASS-21) y el Cuestionario de Estrés Percibido (PSS) para recoger datos sociodemográficos e información relacionada con los efectos del confinamiento en la vida de los pacientes con EII. Doce unidades de EII invitaron a sus pacientes a responder a la encuesta anónima en línea entre el 1 de julio y el 25 de agosto de 2020. Resultados: De los 693 participantes en la encuesta con EII, el 67% eran mujeres y la edad media era de 43 años (DE 12). El 61% tenía colitis ulcerosa, el 36% enfermedad de Crohn y el 3% colitis indeterminada. Las puntuaciones del DASS-21 indican que durante el encierro la prevalencia estimada de depresión fue del 11% [IC 95%: 8,2-13%], de ansiedad del 20% [IC 95%: 17-23%] y de estrés del 18% [IC 95%: 8,2-13%]. El análisis multivariante mostró que la percepción de alto riesgo de infección por COVID-19 por tener EII y la inadaptación a las medidas gubernamentales para reducir la propagación de la enfermedad duplicaban el riesgo de ansiedad y estrés durante el encierro. Conclusiones: A corto plazo, el confinamiento durante la pandemia de COVID-19 pareció tener un impacto en la ya afectada salud mental de nuestros pacientes con EII en España.(AU)

Using Interpretable Machine Learning to Identify Baseline Predictive Factors of Remission and Drug Durability in Crohn's Disease Patients on Ustekinumab.

Ustekinumab has shown efficacy in Crohn's Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are predictive of remission and the drug durability of ustekinumab, and whether its positioning with respect to prior use of biologics has a significant effect after correcting for disease severity and phenotype at baseline using interpretable machine learning. Patients' data from SUSTAIN, a retrospective multicenter single-arm cohort study, were used. Disease phenotype, baseline laboratory data, and prior treatment characteristics were documented. Clinical remission was defined as the Harvey Bradshaw Index ≤ 4 and was tracked longitudinally. Drug durability was defined as the time until a patient discontinued treatment. A total of 439 participants from 60 centers were included and a total of 20 baseline covariates considered. Less exposure to previous biologics had a positive effect on remission, even after controlling for baseline disease severity using a non-linear, additive, multivariable model. Additionally, age, body mass index, and fecal calprotectin at baseline were found to be statistically significant as independent negative risk factors for both remission and drug survival, with further risk factors identified for remission.

Apolipoprotein C3 Is Downregulated in Patients With Inflammatory Bowel Disease.

INTRODUCTION: Inflammatory bowel disease (IBD) has been associated with an abnormal lipid profile. Apolipoprotein C-III (ApoC3) is a key molecule of triglyceride metabolism that is known to be related to inflammation and cardiovascular disease. In this study, we aim to study whether ApoC3 serum levels differ between patients with IBD and controls and whether the hypothetical disturbance of ApoC3 can be explained by IBD characteristics. METHODS: This is a cross-sectional study that included 405 individuals, 197 patients with IBD and 208 age-matched and sex-matched controls. ApoC3 and standard lipid profiles were assessed in patients and controls. A multivariable analysis was performed to analyze whether ApoC3 serum levels were altered in IBD and to study their relationship to IBD characteristics. RESULTS: After fully multivariable analysis including cardiovascular risk factors, use of statins, and changes in lipid profile caused by the disease itself, patients with IBD showed significant lower serum levels of ApoC3 (beta coef. -1.6 [95% confidence interval -2.5 to -0.7] mg/dL, P = 0.001). Despite this, inflammatory markers, disease phenotypes, or disease activity of IBD was not found to be responsible for this downregulation. DISCUSSION: Apolipoprotein C3 is downregulated in patients with IBD.

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study.

BACKGROUND: Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice. METHODS: A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. RESULTS: A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). CONCLUSIONS: Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.

This large retrospective study demonstrated the short- and long-term effectiveness and safety of ustekinumab in patients with Crohn's disease in real-world clinical practice, including those with refractory disease.

SARS-CoV-2 vaccine acceptance among gastroenterologists and inflammatory bowel disease patients: VACUNEII project.

INTRODUCTION: Several vaccines against SARS-CoV-2 are currently in use and are recommended in inflammatory bowel disease (IBD) patients. Data are scarce about the gastroenterologists and IBD patient's acceptance of SARS-CoV-2 vaccines. The aim of the study was to evaluate the intention to get vaccination with SARS-CoV-2 vaccine among IBD patients from gastroenterologists and patient's perspective. METHODS: An online anonymous survey was sent to 8000 patients from ACCU-Spain and 1000 members of the GETECCU. Three invitations were sent between October-December 2020. Descriptive analyses were performed, comparing physicians and patients responses by standard statistical analyses. RESULTS: 144 gastroenterologists [63% female, mean age 43 years (SD 9.5)], and 1302 patients [72% female, mean age 43 years (SD 12)] responded to the survey. 95% of the physicians recommended SARS-CoV-2 vaccine for IBD patients and 87% consider that their vaccination strategies has not changed after the pandemic compared to 12% who considered that they currently refer more patients to vaccination. Regarding to IBD patients, only 43% of patients were willing to receive the vaccine and 43% were not sure. Male sex (p<0.001) and mesalazine treatment (p=0.021) were positively associated with SARS-CoV-2 vaccine acceptance. After multivariate analysis, only male sex was significantly associated with vaccination intent (OR=1.6; 95% confidence interval=1.2-2.0; p=0.001). CONCLUSIONS: Gastroenterologists and patient's perspective about SARS-CoV-2 are different. Future efforts to increase COVID-19 vaccine and decrease unfounded beliefs among IBD patients are needed.

Psychosocial impact of the COVID-19 pandemic on patients with inflammatory bowel disease in Spain. A post lockdown reflection.

OBJECTIVES: This multicenter cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with inflammatory bowel disease (IBD) in Spain during lockdown and the first wave of the pandemic. PATIENTS AND METHODS: A self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale-21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of lockdown on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey between the 1st July and the 25th August 2020. RESULTS: Of the 693 survey participants with IBD, 67% were women and the mean age was 43 (SD 12). Sixty-one percent had ulcerative colitis, 36% Crohn's disease and 3% indeterminate colitis. DASS-21 scores indicate that during lockdown the estimated prevalence of depression was 11% [95% CI 8.2-13%], anxiety 20% [95% CI 17 to 23%] and stress 18% [95% CI 8.2-13%]. Multivariate analysis showed that the perceived high risk of COVID-19 infection because of having IBD and maladaptation to government measures to reduce the spread of disease doubled the risk of anxiety and stress during lockdown. CONCLUSIONS: In the short-term, lockdown during the COVID-19 pandemic seemed to have an impact on the already affected mental health of our IBD patients in Spain.

QRISK3 Performance in the Assessment of Cardiovascular Risk in Patients with Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) has been described as an independent risk factor for the development of cardiovascular (CV) disease. Since the QRESEARCH risk estimator version 3 (QRISK3) calculator was recently proposed to assess CV in the general population, our objective was to compare the predictive ability of QRISK3 with that of a well-established European CV risk calculator, the Systematic Coronary Risk Assessment (SCORE), to identify the presence of subclinical carotid atherosclerosis in patients with IBD. In all, 186 patients with IBD and 178 controls were recruited. The presence of subclinical atherosclerosis was evaluated by carotid ultrasound to identify carotid plaque and the thickness of the carotid intima-media (cIMT). QRISK3 and SCORE were calculated. The relationship of QRISK3 and SCORE with each other and with the presence of subclinical carotid atherosclerosis (both carotid plaque and cIMT) was studied in patients and controls. SCORE (0.2 (interquartile range 0.1-0.9) vs. 0.4 (0.1-1.4), p = 0.55) and QRISK3 1.7 ((0.6-4.6) vs. 3.0 (1.0-7.8), p = 0.16) absolute values did not differ between patients and controls. QRISK3 and SCORE correlated equally with cIMT within both populations. However, SCORE correlation with cIMT was found to be significantly lower in patients with IBD when compared to controls (Spearman's Rho 0.715 vs. 0.587, p = 0.034). Discrimination analysis of both calculators with carotid plaque was similar within both populations. Nevertheless, in patients with IBD, QRISK3 showed a trend toward a higher discrimination (QRISK3 area under the curve 0.812 (95%CI 0.748-0.875) vs. SCORE 0.790 (95%CI 0.723-0.856), p = 0.051). In conclusion, QRISK3 discrimination for subclinical atherosclerosis is optimal and equivalent to that of SCORE in IBD patients. However, our findings highlight the role of QRISK3 as an appropriate tool for the assessment of CV risk in patients with IBD.

Insulin Resistance Is Not Increased in Inflammatory Bowel Disease Patients but Is Related to Non-Alcoholic Fatty Liver Disease.

BACKGROUND: Insulin resistance (IR) has been linked to inflammatory states. The aim of this study was to determine whether IR is increased in a cohort of inflammatory bowel disease (IBD) patients with low disease activity. We additionally intended to establish which factors were the determinants of IR in this population, including the presence of nonalcoholic fatty liver disease (NAFLD). METHODS: Cross-sectional study encompassing 151 IBD patients and 174 non-diabetic controls. Insulin and C-peptide serum levels and IR and beta cell function (%B) indices based on homoeostatic model assessment (HOMA2) were assessed in patients and controls. Liver stiffness as measured by transient elastography, and the presence of NAFLD detected via ultrasound were additionally assessed. A multivariable regression analysis was performed to evaluate the differences in IR indexes between patients and controls, and to determine which predictor factors were associated with IR in IBD patients. RESULTS: Neither HOMA2-IR (beta coef. -0.26 {95%CI -0.64-0.13}, p = 0.19) nor HOMA2-%B (beta coef. 15 {95%CI -14-44}, p = 0.31) indexes differed between patients and controls after fully multivariable analysis. Among classic IR risk factors, obesity, abdominal circumference, and triglycerides significantly and positively correlated with IR indexes in IBD patients. However, most features related to IBD, such as disease patterns, disease activity, and inflammatory markers, were not associated with IR. The presence of NAFLD was independently and significantly associated with beta cell dysfunction in patients with IBD (HOMA2-B grade 4, 251 ± 40 vs. grade 1, 107 ± 37, p = <0.001). CONCLUSIONS: IR is not increased in IBD patients with low disease activity compared to controls. However, the presence of NAFLD favors the development of IR in patients with IBD.

Carotid Plaque Assessment Reclassifies Patients with Inflammatory Bowel Disease into Very-High Cardiovascular Risk.

The addition of carotid ultrasound into cardiovascular (CV) risk scores has been found to be effective in identifying patients with chronic inflammatory diseases at high-CV risk. We aimed to determine if its use would facilitate the reclassification of patients with inflammatory bowel disease (IBD) into the very high-CV-risk category and whether this may be related to disease features. In this cross-sectional study encompassing 186 IBD patients and 175 controls, Systematic Coronary Risk Evaluation (SCORE), disease activity measurements, and the presence of carotid plaques by ultrasonography were assessed. Reclassification was compared between patients and controls. A multivariable regression analysis was performed to evaluate if the risk of reclassification could be explained by disease-related features and to assess the influence of traditional CV risk factors on this reclassification. After evaluation of carotid ultrasound, a significantly higher frequency of reclassification was found in patients with IBD compared to controls (35% vs. 24%, p = 0.030). When this analysis was performed only on subjects included in the SCORE low-CV-risk category, 21% IBD patients compared to 11% controls (p = 0.034) were reclassified into the very high-CV-risk category. Disease-related data, including disease activity, were not associated with reclassification after fully multivariable regression analysis. Traditional CV risk factors showed a similar influence over reclassification in patients and controls. However, LDL-cholesterol disclosed a higher effect in controls compared to patients (beta coef. 1.03 (95%CI 1.02-1.04) vs. 1.01 (95%CI 1.00-1.02), interaction p = 0.035) after adjustment for confounders. In conclusion, carotid plaque assessment is useful to identify high-CV risk IBD patients.

Pre-procedural antibody testing for SARS-CoV-2 in the routine endoscopic practice.

METHODS: a retrospective multicenter cohort study was performed of all endoscopic procedures performed between April 27 and June 15, 2020. A screening questionnaire (SQ) was performed with patients three days prior to the procedure and 14 days after. Furthermore, a serologic SARS-CoV-2 test was performed 48 hours before. RESULTS: two hundred and eleven consecutive patients with endoscopic procedures were included. No patients had a positive SQ, either on entry to the study or 14 days later. Only four patients (1.9 % [95 % CI: 0.07-4.8 %]) were positive for antibodies. CONCLUSION: the pre-endoscopy seroprevalence of SARS-CoV-2 is low in this cohort. Pre-procedural SARS-CoV-2 antibody testing does not add any benefit over clinical SQ to identify active COVID-19 patients.

Usefulness of magnetic resonance enterography in the clinical decision-making process for patients with inflammatory bowel disease / Utilidad de la enterografía por resonancia magnética en la toma de decisiones clínicas en pacientes con enfermedad inflamatoria intestinal

OBJECTIVE: To evaluate the impact of magnetic resonance enterography (MRE) diagnosis on clinical decision-making regarding treatment choice and maintenance of treatment over time in patients with inflammatory bowel disease (IBD). METHODS: A cohort of patients who underwent MRE for IBD assessment between 2011 and 2014 was analyzed. From clinical records, we retrospectively retrieved their demographic data and clinical data on their IBD at the time of MRE, the results of MRE and the patient's clinical course. Medical management decisions made during the three months following MRE and at the 15-month follow-up were assessed. RESULTS: In total, 474 MREs were reviewed. In the first three-month period, MRE results led to changes in the medical management of 266 patients (56.1%). Of those, maintenance therapy was altered in 140 patients (68.3%) (90.7% step-up and 9.3% top-down strategy), 65 (24.4%) were prescribed a course of steroids and 61 (22.9%) underwent surgery. MRE confirmed a CD diagnosis in 14/41 patients (34.1%) previously diagnosed with indeterminate colitis or ulcerative colitis and in 4/18 patients (22.2%) with suspected IBD. At the 15-month follow-up, treatment remained unchanged in 289 patients (65.8%). CONCLUSIONS: These results suggest that MRE is a diagnostic tool that provides valid information for the clinical-decision making process for patients with CD

OBJETIVO: Evaluar el impacto del diagnóstico de la enterografía por resonancia magnética (ERM) en la toma de decisiones clínicas con respecto a la elección del tratamiento y el mantenimiento del mismo a lo largo del tiempo en pacientes con enfermedad inflamatoria intestinal (EII). MÉTODOS: Se analizó una cohorte de pacientes que se sometieron a ERM para la evaluación de EII entre 2011 y 2014. De los registros clínicos recuperamos retrospectivamente sus datos demográficos y datos clínicos sobre su EII en el momento de la ERM, los resultados de la ERM y la evolución clínica del paciente. Se evaluaron las decisiones de manejo médico tomadas durante los 3 meses posteriores a la ERM y a los 15 meses de seguimiento. RESULTADOS: Se revisaron 474 ERM. En el primer período de 3 meses, los resultados de la ERM llevaron a cambios en el manejo médico en 266 pacientes (56,1%). De ellos, se modificó el tratamiento de mantenimiento en 140 (68,3%) pacientes (se escaló en el 90,7% y top-down en el 9,3%), 65 (24,4%) recibieron un curso de esteroides y 61 (22,9%) se sometieron a cirugía. La ERM confirmó un diagnóstico de enfermedad de Crohn (EC) en 14/41 pacientes (34,1%) diagnosticados previamente con colitis indeterminada o colitis ulcerosa y en 4/18 pacientes (22,2%) con sospecha de EII. A los 15 meses de seguimiento, el tratamiento se mantuvo sin cambios en 289 (65,8%) pacientes. CONCLUSIONES: Estos resultados sugieren que la ERM es una herramienta de diagnóstico que proporciona información válida para el proceso de toma de decisiones clínicas para pacientes con EC