Comparative Study of the Effectiveness of Vedolizumab Versus Ustekinumab After Anti-TNF Failure in Crohn's Disease (Versus-CD): Data from the ENEIDA Registry.

BACKGROUND: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited. AIMS: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD. METHODS: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors. RESULTS: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them. CONCLUSION: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.

Efficacy and safety of intravenous ustekinumab maintenance therapy in Crohn's disease.

Crohn's disease is a chronic multifactorial disease for which therapeutic options have expanded in the last decades. However there are still patients who lack or lose response to current standard treatment strategies. A unicentric, retrospective, study was performed in order to evaluate the clinical and biochemical response to intravenous ustekinumab manteinance therapy (IVUMT) in patients with refractory CD. We included 12 patients from our centre who started IVUMT between September 2018 and November 2021. 75% started IV treatment after previous subcutaneous (SC) treatment. At week 8 (n=8), 63% had clinical response, with 25% in clinical remission. At week 16 (n=10), 60% had clinical response, with 50% in clinical remission. At week 26 (n=10), 90% had clinical response, with 60% in clinical remission. At week 52 (n=11), 91% had clinical response, with 64% in clinical remission (Fig. 2). Basal faecal calprotectin (FCP) median level was 684µg/g, with a significant reduction at 52 weeks, with median FCP 97µg/g (p=0,017). Basal C-reactive protein (CRP) median level was 11,6mg/L. A significant reduction was observed at week 26, with median CRP 2,8mg/L (p=0,008); and 52 weeks, with median CRP 2,7 (p=0,013). Average follow-up was 117,1 weeks, average treatment survival was 105,9 weeks. There were no severe adverse events. Our results suggest IVUMT is a safe and effective treatment for most patients with refractory and complex CD and should be considered as an option in selected patients.

Correction: Chaparro et al. Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain: Large-Scale Epidemiological Study. J. Clin. Med. 2021, 10, 2885.

The authors wish to make the following corrections to this paper [...].

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.

Incidence, Clinical Characteristics and Management of Inflammatory Bowel Disease in Spain: Large-Scale Epidemiological Study.

(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD-Crohn's disease (CD), ulcerative colitis (UC) or IBD unclassified (IBD-U)-during 2017 in Spain were included and were followed-up for 1 year. (3) Results: We identified 3611 incident cases of IBD diagnosed during 2017 in 108 hospitals covering over 22 million inhabitants. The overall incidence (cases/100,000 person-years) was 16 for IBD, 7.5 for CD, 8 for UC, and 0.5 for IBD-U; 53% of patients were male and median age was 43 years (interquartile range = 31-56 years). During a median 12-month follow-up, 34% of patients were treated with systemic steroids, 25% with immunomodulators, 15% with biologics and 5.6% underwent surgery. The percentage of patients under these treatments was significantly higher in CD than UC and IBD-U. Use of systemic steroids and biologics was significantly higher in hospitals with high resources. In total, 28% of patients were hospitalized (35% CD and 22% UC patients, p < 0.01). (4) Conclusion: The incidence of IBD in Spain is rather high and similar to that reported in Northern Europe. IBD patients require substantial therapeutic resources, which are greater in CD and in hospitals with high resources, and much higher than previously reported. One third of patients are hospitalized in the first year after diagnosis and a relevant proportion undergo surgery.

Preliminary experience of maintenance treatment with intravenous ustekinumab as a rescue treatment for loss of response to subcutaneous doses.

It has been demonstrated that ustekinumab (UST) is effective as an induction and maintenance therapy in patients with Crohn's disease (CD). However, a significant number of patients experience an insufficient response or a secondary non-response. We report six cases from our center that underwent a rescue treatment by changing maintenance treatment to weight-adjusted intravenous UST, obtaining a subsequent clinical improvement.

Un raro trastorno linfoproliferativo asociado a terapia inmunomoduladora en la enfermedad de Crohn / A rare lymphoproliferative disorder associated with immunomodulating therapy in Crohn's disease

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Ictericia obstructiva secundaria a adenoma en conducto hepático común / Obstructive jaundice caused by an adenoma of the common hepatic duct

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A rare lymphoproliferative disorder associated with immunomodulating therapy in Crohn's disease.

Lymphomatoid granulomatosis is a rare lymphoproliferative disorder associated with immunosuppressive therapy in inflammatory bowel disease. We present the case of a patient with Crohn's disease and treated azathioprine that develops lymphomatoid granulomatosis, as well as its diagnostic process and the chosen treatment. Lymphomatoid granulomatosis is a serious disease barely described and whose suspicion is essential for its prognosis.

Trasplante fecal como tratamiento de infección por Clostridium difficile en paciente con colitis ulcerosa / Fecal transplantation as a treatment for Clostridium difficile infection in patients with ulcerative colitis

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Fecal transplantation as a treatment for Clostridium difficile infection in patients with ulcerative colitis.

Clostridium difficile (CD) infection is currently the most frequent etiology of nosocomial diarrhea. Besides, its incidence is progressively increasing in ambulatory patients. Inflammatory bowel disease (IBD) is a risk factor of CD infection itself, but also due to the regular immunosuppressive treatment used in these patients. At the present time, fecal transplantation (FT) is a safe and cost-effective alternative if the previous antibiotic treatments have failed. Similar outcomes between patients with IBD and general population have been reported. We present a case of a patient with ulcerative colitis and recurrent CD infection successfully treated with FT.

Reingresos por pancreatitis aguda biliar edematosa en pacientes sin colecistectomía / Readmissions due to acute biliary edematous pancreatitis in patients without cholecystectomy

Objetivos: analizar los reingresos de pacientes con pancreatitis aguda biliar edematosa (PABE) sin colecistectomía a pesar de un episodio previo de pancreatitis aguda biliar leve o colecistitis litiásica. Calcular el coste sanitario asociado a la no realización de colecistectomía. Material y métodos: estudio observacional prospectivo realizado en el Hospital de Cabueñes, entre julio y noviembre de 2014. Se incluyeron consecutivamente los pacientes ingresados en el Servicio de Digestivo con PABE que: a) habían presentado un episodio previo de pancreatitis aguda biliar leve o colecistitis al menos dos semanas antes del reingreso; y b) no se les había realizado colecistectomía pese a ausencia de contraindicaciones. Resultados: durante el periodo de estudio reingresaron 9 pacientes, 7 mujeres y 2 varones, con una edad media de 65,3 años (desviación estándar [DE] = 19,2). La mediana de días transcurridos desde el episodio previo de PABE o colecistitis hasta su reingreso fue de 114 días (recorrido intercuartílico [RIC] = 111,0). La estancia global mediana de los pacientes fue de 10 días (RIC = 2,0). Los pacientes realizaron una media de 2,8 (DE = 1,2) ecografías, 1,3 (DE = 0,9) TC abdómino-pélvicos, 0,8 (DE = 1,0) RM y 0,2 (DE = 0,4) CPRE. El coste medio de cada reingreso por paciente, incluyendo la estancia hospitalaria (143,0 €/día), en el servicio de Urgencias (332,31 €) y las pruebas realizadas, fue de 2.381,70 €/paciente. Conclusiones: la no realización de colecistectomía en las 2 semanas posteriores a un primer episodio de PABE leve o colecistitis contribuye a los reingresos por pancreatitis recurrentes con los consecuentes gastos evitables asociados

Aims: Analyzing the readmission of patients with acute biliary edematous pancreatitis (ABEP) without cholecystectomy despite a previous episode of mild acute gallstone pancreatitis or lithiasic cholecystitis. Calculating the health costs associated with the non-performance of cholecystectomy. Material and methods: Prospective observational study conducted at a tertiary hospital from July to November 2014. The study has consecutively included inpatients suffering from ABEP who: a) had suffered a previous episode of mild acute gallstone pancreatitis or cholecystitis at least 2 weeks before readmission; and b) had not undergone cholecystectomy despite the lack of contraindications. Results: During the research period, 9 patients (7 females and 2 males) with a mean age of 65.3 years (standard deviation [SD] 19.2) were readmitted. The median number of days between the previous episode of ABEP or cholecystitis and the readmission was 114 days (interquartile range [IQR] 111.0). Reported median overall length of hospital stay was 10 days (IQR = 2.0). Patients underwent a mean of 2.8 (SD = 1.2) ultrasound scans, 1.3 (SD = 0.9) abdominal and pelvic CT, 0.8 (SD = 1.0) MRCP and 0.2 (SD = 0.4) ERCP. The mean cost per patient for each readmission, including hospital stay (143.0 €/day), Emergency Service (332.31 €) and tests performed was 2,381.70 €/patient. Conclusions: Not performing a cholecystectomy within two weeks after a first episode of mild ABEP or cholecystitis contributes to patient readmission due to recurrent pancreatitis, resulting in avoidable treatment costs

Readmissions due to acute biliary edematous pancreatitis in patients without cholecystectomy.

AIMS: Analyzing the readmission of patients with acute biliary edematous pancreatitis (ABEP) without cholecystectomy despite a previous episode of mild acute gallstone pancreatitis or lithiasic cholecystitis. Calculating the health costs associated with the non-performance of cholecystectomy. MATERIAL AND METHODS: Prospective observational study conducted at a tertiary hospital from July to November 2014. The study has consecutively included inpatients suffering from ABEP who: a) had suffered a previous episode of mild acute gallstone pancreatitis or cholecystitis at least 2 weeks before readmission; and b) had not undergone cholecystectomy despite the lack of contraindications. RESULTS: During the research period, 9 patients (7 females and 2 males) with a mean age of 65.3 years (standard deviation [SD] 19.2) were readmitted. The median number of days between the previous episode of ABEP or cholecystitis and the readmission was 114 days (interquartile range [IQR] 111.0). Reported median overall length of hospital stay was 10 days (IQR = 2.0). Patients underwent a mean of 2.8 (SD = 1.2) ultrasound scans, 1.3 (SD = 0.9) abdominal and pelvic CT, 0.8 (SD = 1.0) MRCP and 0.2 (SD = 0.4) ERCP. The mean cost per patient for each readmission, including hospital stay (143.0 €/day), Emergency Service (332.31 €) and tests performed was 2,381.70 €/patient. CONCLUSIONS: Not performing a cholecystectomy within two weeks after a first episode of mild ABEP or cholecystitis contributes to patient readmission due to recurrent pancreatitis, resulting in avoidable treatment costs.