Crohn´s disease is an independent risk factor for liver fibrosis in patients with inflammatory bowel disease and non-alcoholic fatty liver disease.

BACKGROUND AND AIMS: Controversial data have been reported regarding the prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) in Inflammatory Bowel Disease (IBD) population and IBD-related risk factors. The aim of the study was to assess the prevalence and risk factors associated with NAFLD and liver fibrosis in IBD participants compared with non-IBD controls. METHODS: Cross-sectional, case-control study including 741 IBD cases and 170 non-IBD controls, matched by sex and age. All participants underwent liver ultrasound, transient elastography and laboratory tests. A logistic regression multivariable analysis was performed adjusting for classic metabolic risk factors and history of systemic steroid use. RESULTS: The prevalence of NAFLD and significant liver fibrosis was 45 % and 10 % in IBD group, and 40 % and 2.9 % in non-IBD group (p = 0.255 and 0.062, respectively). Longer IBD duration (aOR 1.02 95% CI (1.001-1.04)) and older age at IBD diagnosis (aOR 1.02 95 % CI (1.001-1.04)) were independent risk factors for NAFLD in IBD group. Crohn´s Disease was an independent risk factor for significant liver fibrosis in participants with IBD and NAFLD (aOR 3.97 95 % CI (1.78-8.96)). NAFLD occurred at lower BMI levels in IBD group with NAFLD compared to non-IBD group with NAFLD (aOR 0.92 95 % CI (0.87-0.98)). CONCLUSIONS: Although we found no differences in the prevalence of NAFLD and liver fibrosis between IBD group and non-IBD group, our findings suggest that liver fibrosis progression should be closely monitored in patients with concomitant CD and NAFLD, more in particular in those with long standing active disease.

Unravelling the cellular response to the SARS-COV-2 vaccine in inflammatory bowel disease patients on biologic drugs.

Suboptimal vaccine response is a significant concern in patients with Inflammatory Bowel Disease (IBD) receiving biologic drugs. This single-center observational study involved 754 patients with IBD. In Phase I (October 2020-April 2021), 754 IBD participants who had not previously received the SARS-CoV-2 vaccine, underwent blood extraction to assess the seroprevalence of SARS-CoV-2 infection and IBD-related factors. Phase II (May 2021-October 2021) included a subgroup of 52 IBD participants with confirmed previous SARS-CoV-2 infection, who were studied for humoral and cellular response to the SARS-CoV-2 vaccine. In Phase I, treatment with anti-TNF was associated with lower rates of seroconversion (aOR 0.25 95% CI [0.10-0.61]). In Phase II, a significant increase in post-vaccination IgG levels was observed regardless of biologic treatment. However, patients treated with anti-TNF exhibited significantly lower IgG levels compared to those without IBD therapy (5.32 ± 2.47 vs. 7.99 ± 2.59 U/ml, p = 0.042). Following vaccination, a lymphocyte, monocyte, and NK cell activation pattern was observed, with no significant differences between patients receiving biologic drugs and those without IBD treatment. Despite lower seroprevalence and humoral response to the SARS-CoV-2 vaccine in patients treated with anti-TNF, the cellular response to the vaccine did not differ significantly from that patients without IBD therapy.

Lifestyle Can Exert a Significant Impact on the Development of Metabolic Complications and Quality Life in Patients with Inflammatory Bowel Disease.

Inflammatory bowel diseases (IBDs) are associated with an increased risk of metabolic comorbidities. There is a lack of data regarding the relationship between lifestyle and metabolic diseases in IBD patients. A cross-sectional study on consecutive IBD outpatients was conducted. Adherence to the Mediterranean diet (MD) was assessed using a 14-item questionnaire from the PREDIMED study, and physical activity was evaluated using the GODIN-Leisure score. Body composition was studied based on body mass index and waist-hip ratio (WHR), while quality of life was assessed using a nine-item short questionnaire. Among the 688 evaluated IBD patients, 66% were overweight or obese, 72.7% did not lead an active lifestyle and 70.1% did not adhere to the MD. Metabolic syndrome was associated with age (OR = 1.07, p = 0.019), overweight/obesity (OR = 12.987, p < 0.001) and the inflammatory behavior of Crohn's disease (OR = 6.172, p = 0.001). Type 2 diabetes mellitus or prediabetes was associated with age (OR = 1.063 p = 0.016), overweight/obesity (OR = 3.861, p < 0.001) and the inflammatory behavior of Crohn's disease (OR = 4.716, p = 0.001). Overweight /obesity (OR = 5.494, p < 0.001), a high WHR (OR = 2.564, p = 0.005) and a non-active lifestyle (OR = 2.202, p = 0.0003) were associated with metabolic dysfunction-associated steatotic liver disease. Lifestyle, body composition and not solely systemic inflammation might exert a significant influence on the emergence of metabolic comorbidities such as MASLD, type 2 diabetes mellitus and metabolic syndrome in patients with IBD.

Inflammatory Bowel Disease Is an Independent Risk Factor for Metabolic Dysfunction-Associated Steatotic Liver Disease in Lean Individuals.

BACKGROUND: Despite classical association between metabolic dysfunction-associated steatotic liver disease (MASLD) and obesity, there is increasing evidence on the development of MASLD in lean individuals. The aim of the study was to assess the prevalence and risk factors of MASLD and significant liver fibrosis in lean participants with inflammatory bowel disease (IBD). METHODS: This was a cross-sectional, case-control study including 300 lean cases with IBD and 80 lean controls without IBD, matched by sex and age. All participants underwent a liver ultrasound, transient elastography, and laboratory tests. RESULTS: The lean IBD group showed a significantly higher prevalence of MASLD compared with lean non-IBD group (21.3% vs 10%; P = .022), but no differences were observed in the prevalence of significant liver fibrosis (4.7% vs 0.0%; P = 1.000). No differences were found between the prevalence of MASLD in IBD and non-IBD participants who were overweight/obese (66.8% vs 70.8%; P = .442). In addition, the prevalence of MASLD was significantly higher in the overweight/obese IBD group compared with the lean IBD group (P < .001). IBD was an independent risk factor for MASLD in lean participants (odds ratio [OR], 2.71; 95% confidence interval [CI], 1.05-7.01; P = .04), after adjusting for classic metabolic risk factors and prior history of systemic steroid use. Nevertheless, no association between IBD related factors and MASLD was identified in lean IBD participants. When the overweight/obese and lean IBD groups with MASLD were compared, the overweight/obese IBD group with MASLD showed higher levels of the homeostatic model assessment of insulin resistance (OR, 1.49; 95% CI, 1.11-1.98; P = .007) and history of smoking (OR, 4.66; 95% CI, 1.17-18.49; P = .029). CONCLUSIONS: MASLD prevalence was higher in the lean IBD group compared with lean non-IBD group, independent of classic metabolic risk factors.

Impact of the lockdown period due to the COVID-19 pandemic in patients with inflammatory bowel disease / Impacto del confinamiento debido a la pandemia por COVID-19 en pacientes con enfermedad inflamatoria intestinal

Introduction: The lockdown period due to the coronavirus disease 2019 (COVID-19) in Spain probably had a significant emotional impact on chronic patients and hence on those who are suffering from inflammatory bowel disease (IBD) due to their high risk of emotional disorders. The aim of this study was to learn how COVID-19 influenced patients suffering from IBD during the quarantine period, focusing in particular on psychological distress through the Perceived Stress Scale-10 (PSS-10) and also the impact of the pandemic on therapeutic adherence using the Visual Analogue Scale (VAS).Patients and methods: A prospective, single-centre and analytical observational study was carried out in the IBD unit in August 2020. Patients were contacted and interviewed by phone. A descriptive analysis was carried out and subsequently the factors associated with the loss of therapeutic adherence and higher-moderate levels of stress were analyzed through logistic regression multivariate analyses.Results: A total of 426 patients were included with a median PSS-10 score of 12 (10–16). A higher level of stress was reported by those who were not married, women and those who experienced an increase in IBD-related symptoms. Adherence to treatment was not associated with stress based on the PSS-10 questionnaire.Conclusions: Although the lockdown period due to the COVID-19 pandemic has probably had a significant emotional impact on Spaniards with IBD, IBD patients in general had lower PSS-10 scores.

Introducción: El confinamiento debido a la pandemia por COVID-19 en España tuvo probablemente un importante impacto emocional en los pacientes crónicos, y por tanto en aquellos que sufren enfermedad inflamatoria intestinal (EII) debido a su riesgo incrementado de padecer desórdenes emocionales. El objetivo de este estudio es el de conocer como la COVID-19 ha influido a los pacientes con EII durante el período de cuarentena, haciendo hincapié en el nivel de estrés a través de la Escala de Estrés Percibido (PSS-10) así como en la adherencia a los tratamientos por medio de la escala visual analógica (VAS).Pacientes y métodos: Estudio prospectivo, unicéntrico y observacional realizado en la Unidad de EII durante el mes de agosto de 2020. Los pacientes fueron entrevistados por teléfono. Se llevó a cabo un análisis descriptivo inicial, posteriormente se identificaron los factores relacionados con la pérdida de adherencia, así como con los niveles altos-moderados de estrés a través de análisis de regresión logística multivariante.Resultados: Fueron incluidos un total de 426 pacientes con una puntuación media en la escala PSS-10 de 12 (10-16). Los niveles más altos de estrés se reportaron en aquellos pacientes que no estaban casados, las mujeres o aquellos que habían incrementado sintomatología relacionada con su EII. La adherencia al tratamiento no se asoció con el nivel de estrés basado en el cuestionario PSS-10.Conclusiones: A pesar de que el período de cuarentena por COVID-19 haya podido tener un importante papel en el impacto emocional de la población española con EII, los pacientes con EII tuvieron en general niveles bajos según el cuestionario PSS-10.

Impact of the lockdown period due to the COVID-19 pandemic in patients with inflammatory bowel disease.

INTRODUCTION: The lockdown period due to the coronavirus disease 2019 (COVID-19) in Spain probably had a significant emotional impact on chronic patients and hence on those who are suffering from inflammatory bowel disease (IBD) due to their high risk of emotional disorders. The aim of this study was to learn how COVID-19 influenced patients suffering from IBD during the quarantine period, focusing in particular on psychological distress through the Perceived Stress Scale-10 (PSS-10) and also the impact of the pandemic on therapeutic adherence using the Visual Analogue Scale (VAS). PATIENTS AND METHODS: A prospective, single-centre and analytical observational study was carried out in the IBD unit in August 2020. Patients were contacted and interviewed by phone. A descriptive analysis was carried out and subsequently the factors associated with the loss of therapeutic adherence and higher-moderate levels of stress were analyzed through logistic regression multivariate analyses. RESULTS: A total of 426 patients were included with a median PSS-10 score of 12 (10-16). A higher level of stress was reported by those who were not married, women and those who experienced an increase in IBD-related symptoms. Adherence to treatment was not associated with stress based on the PSS-10 questionnaire. CONCLUSIONS: Although the lockdown period due to the COVID-19 pandemic has probably had a significant emotional impact on Spaniards with IBD, IBD patients in general had lower PSS-10 scores.

Utilidad clínica de la determinación de niveles de CT-P13, biosimilar de infliximab, en el control de la enfermedad inflamatoria intestinal / Clinical value of CT-P13 trough levels, an infliximab biosimilar, in the management of inflammatory bowel disease

INTRODUCCIÓN: CT-P13 es un fármaco biosimilar de infliximab (IFX), efectivo en pacientes con enfermedad inflamatoria intestinal (EII). La medición de niveles de IFX y anticuerpos anti-IFX forma parte del tratamiento integral de dicha enfermedad. OBJETIVO: Comparar la respuesta clínica en función de un abordaje estrictamente clínico (CLN) o proactivo (PRO) basado en la medición de niveles en la semana 14, en la práctica clínica. MÉTODOS: Estudio prospectivo en pacientes que inician CT-P13 por EII. En el grupo PRO se midieron sistemáticamente los niveles de IFX y de anticuerpos postinducción (semana 14) y se intensificaron aquellos con niveles infraterapéuticos (<3μg/ml), independientemente de la respuesta clínica. RESULTADOS: Se incluyeron 77 pacientes (23 colitis ulcerosa y 54 enfermedad de Crohn). Ambos grupos, PRO (n=41) y CLN (n=36) presentaron una eficacia inicial y a largo plazo sin diferencias significativas. En la semana 14 hubo un 61% de remisión clínica (RC) (58,5% PRO, 63,9% CLN) y un 80,5% de al menos respuesta parcial (RP) (80,5% PRO, 80,6% CLN). En la semana 54 hubo un 68,8% de RC (61% PRO, 77,8% CLN) y un 76,6% de al menos RP (73,2% PRO, 80,6% CLN). De los pacientes en RC en la semana 14 (24 PRO, 23 CLN), 13 del grupo PRO fueron intensificados por niveles infraterapéuticos. En este subgrupo no se observaron diferencias significativas en la pérdida de respuesta secundaria (PRO 0%, CLN 8,7%). CONCLUSIÓN: Un manejo proactivo no mejoró las tasas de respuesta ni la remisión en el primer año. La intensificación de pacientes en RC y niveles infraterapéuticos postinducción no parece prevenir de forma significativa la pérdida de respuesta secundaria en el primer año

INTRODUCTION: CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. OBJECTIVE: To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on the monitoring of levels in week 14, in clinical practice. METHODS: We conducted a prospective study in IBD patients starting CT-P13. In the PRO group, levels of IFX and post-induction antibodies were systematically measured (week 14) and those with infraterapeutic levels (<3μg/ml) were intensified, irrespective of the clinical response. RESULTS: We included 77 patients (23 ulcerative colitis and 54 Crohn's disease). Both PRO (n=41) and CLN (n=36) groups showed initial and long-term efficacy without significant differences. At week 14, 61% clinical remission (CR) (58.5% PRO, 63.9% CLN) and 80.5% at least partial response (PR) (80.5% PRO, 80.6% CLN). In week 54, 68.8% CR (61% PRO, 77.8% CLN) and 76.6% at least PR (73.2% PRO, 80.6% CLN). Of the patients in CR in week 14 (24 PRO, 23 CLN), 13 of the PRO group were intensified due to infra-therapeutic levels. In this subgroup no significant differences were observed in secondary loss of response (PRO 0%, CLN 8.7%). CONCLUSION: Proactive management does not improve response or remission rates in the first year. The intensification of clinical remission patients with post-induction infratherapeutic levels does not seem to significantly prevent secondary loss of response in the first year

Clinical value of CT-P13 trough levels, an infliximab biosimilar, in the management of inflammatory bowel disease. / Utilidad clínica de la determinación de niveles de CT-P13, biosimilar de infliximab, en el control de la enfermedad inflamatoria intestinal.

INTRODUCTION: CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. OBJECTIVE: To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on the monitoring of levels in week 14, in clinical practice. METHODS: We conducted a prospective study in IBD patients starting CT-P13. In the PRO group, levels of IFX and post-induction antibodies were systematically measured (week 14) and those with infraterapeutic levels (<3µg/ml) were intensified, irrespective of the clinical response. RESULTS: We included 77 patients (23 ulcerative colitis and 54 Crohn's disease). Both PRO (n=41) and CLN (n=36) groups showed initial and long-term efficacy without significant differences. At week 14, 61% clinical remission (CR) (58.5% PRO, 63.9% CLN) and 80.5% at least partial response (PR) (80.5% PRO, 80.6% CLN). In week 54, 68.8% CR (61% PRO, 77.8% CLN) and 76.6% at least PR (73.2% PRO, 80.6% CLN). Of the patients in CR in week 14 (24 PRO, 23 CLN), 13 of the PRO group were intensified due to infra-therapeutic levels. In this subgroup no significant differences were observed in secondary loss of response (PRO 0%, CLN 8.7%). CONCLUSION: Proactive management does not improve response or remission rates in the first year. The intensification of clinical remission patients with post-induction infratherapeutic levels does not seem to significantly prevent secondary loss of response in the first year.

Outcomes of peptic ulcer bleeding following treatment with proton pump inhibitors in routine clinical practice: 935 patients with high- or low-risk stigmata.

OBJECTIVE: To assess rates of further bleeding, surgery and mortality in patients hospitalized owing to peptic ulcer bleeding. MATERIALS AND METHODS: Consecutive patients hospitalized for peptic ulcer bleeding and treated with a proton pump inhibitor (PPI) (esomeprazole or pantoprazole) were identified retrospectively in 12 centers in Spain. Patients were included if they had high-risk stigmata (Forrest class Ia-IIb, underwent therapeutic endoscopy and received intravenous PPI ≥120 mg/day for ≥24 h) or low-risk stigmata (Forrest class IIc-III, underwent no therapeutic endoscopy and received intravenous or oral PPI [any dose]). RESULTS: Of 935 identified patients, 58.3% had high-risk stigmata and 41.7% had low-risk stigmata. After endoscopy, 88.3% of high-risk patients and 22.1% of low-risk patients received intravenous PPI therapy at doses of at least 160 mg/day. Further bleeding within 72 h occurred in 9.4% and 2.1% of high- and low-risk patients, respectively (p < 0.001). Surgery to stop bleeding was required within 30 days in 3.5% and 0.8% of high- and low-risk patients, respectively (p = 0.007). Mortality at 30 days was similar in both groups (3.3% in high-risk and 2.3% in low-risk patients). CONCLUSION: Among patients hospitalized owing to peptic ulcer bleeding and treated with PPIs, patients with high-risk stigmata have a higher risk of further bleeding and surgery, but not of death, than those with low-risk stigmata.

Effect of proton pump inhibitors on the outcomes of peptic ulcer bleeding: comparison of event rates in routine clinical practice and a clinical trial.

OBJECTIVE: To assess clinical outcomes in patients treated with proton pump inhibitors (PPIs) after endoscopic hemostasis in routine clinical care, and to compare these outcomes to those seen in a randomized controlled trial (RCT) of i.v. esomeprazole. MATERIALS AND METHODS: Patients with peptic ulcer bleeding and endoscopic stigmata of recent hemorrhage, who were treated with i.v. esomeprazole or pantoprazole ≥120 mg/day following therapeutic endoscopy, were identified from 12 hospitals in Spain (n = 539). Outcomes assessed included further bleeding, all-cause mortality and surgery. The results were compared to those of the RCT. RESULTS: Overall, 9.1% (95% confidence interval [CI]: 6.7-11.5) of patients experienced further bleeding within 72 h following initial endoscopy, 14.3% (95% CI: 11.3-17.2) of patients had further bleeding within 30 days and 3.3% (95% CI: 1.8-4.9) of patients died within 30 days. In the RCT, the rate of rebleeding within 72 h was significantly lower in the esomeprazole arm (5.9%) than in the placebo arm (10.3%; p = 0.026). The further bleeding rate in patients treated with esomeprazole in routine clinical practice (7.8%; 95% CI: 4.6-11.1) was between these two values. Similar results were seen with the other outcomes studied. CONCLUSIONS: The proportion of patients treated with i.v. esomeprazole in routine clinical practice who experienced further bleeding following endoscopic treatment for peptic ulcer bleeding was between the rates observed in the esomeprazole group and the placebo group in the RCT.