Clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in patients with ulcerative colitis treated with two consecutive anti-TNF agents: data from the ENEIDA registry.

Background: Infliximab seems to be the most efficacious of the three available anti-TNF agents for ulcerative colitis (UC) but little is known when it is used as the second anti-TNF. Objectives: To compare the clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in UC patients. Design: Retrospective observational study. Methods: Patients from the ENEIDA registry treated consecutively with infliximab and a subcutaneous anti-TNF (or vice versa), naïve to other biological agents, were identified and grouped according to the administration route of the first anti-TNF into IVi (intravenous initially) or SCi (subcutaneous initially). Results: Overall, 473 UC patients were included (330 IVi and 143 SCi). Clinical response at week 14 was 42.7% and 48.3% in the IVi and SCi groups (non-statistically significant), respectively. Clinical remission rates at week 52 were 32.8% and 31.4% in the IVi and SCi groups (nonsignificant differences), respectively. A propensity-matched score analysis showed a higher clinical response rate at week 14 in the SCi group and higher treatment persistence in the IVi group. Regarding long-term outcomes, dose escalation and discontinuation due to the primary failure of the first anti-TNF and more severe disease activity at the beginning of the second anti-TNF were inversely associated with clinical remission. Conclusion: The use of a second anti-TNF for UC seems to be reasonable in terms of efficacy, although it is particularly reduced in the case of the primary failure of the first anti-TNF. Whether the second anti-TNF is infliximab or subcutaneous does not seem to affect efficacy.

OBJECTIVES: To compare the clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in UC patients. DESIGN: Retrospective observational study. METHODS: Patients from the ENEIDA registry treated consecutively with infliximab and a subcutaneous anti-TNF (or vice versa), naïve to other biological agents, were identified and grouped according to the administration route of the first anti-TNF into IVi (intravenous initially) or SCi (subcutaneous initially). RESULTS: Overall, 473 UC patients were included (330 IVi, 143 SCi). Clinical response at week 14 was 42.7% and 48.3% in the IVi and SCi groups (non-statistically significant), respectively. Clinical remission rates at week 52 were 32.8% and 31.4%, in the IVi and SCi groups (nonsignificant differences), respectively. A propensity-matched score analysis showed a higher clinical response rate at week 14 in the SCi group and higher treatment persistence in the IVi group. Regarding long-term outcomes, dose escalation and discontinuation due to the primary failure of the first anti-TNF and more severe disease activity at the beginning of the second anti-TNF were inversely associated with clinical remission. CONCLUSION: The use of a second anti-TNF for UC seems to be reasonable in terms of efficacy, although it is particularly reduced in the case of the primary failure of the first anti-TNF. Whether the second anti-TNF is infliximab or subcutaneous does not seem to affect efficacy.

Clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in patients with ulcerative colitis treated with two consecutive anti-TNF agents. Data from the ENEIDA registry Background: Infliximab seems to be the most efficacious of the three available anti-TNF agents for ulcerative colitis (UC), but little is known when it is used as the second anti-TNF.

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.

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.

BACKGROUND: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.

Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn's Disease: Real World Evidence From the ENEIDA Registry.

BACKGROUND AND AIMS: Clinical trials and real-life studies with ustekinumab in Crohn's disease [CD] have revealed a good efficacy and safety profile. However, these data are scarcely available in elderly patients. Therefore, we aim to assess the effectiveness and safety of ustekinumab in elderly patients with CD. METHODS: Elderly patients [>60 years old] from the prospectively maintained ENEIDA registry treated with ustekinumab due to CD were included. Every patient was matched with two controls under 60 years of age, according to anti-tumour necrosis factor use and smoking habit. Values for the Harvey-Bradshaw Index [HBI], endoscopic activity, C-reactive protein [CRP] and faecal calprotectin [FC] were recorded at baseline and at weeks 16, 32 and 54. RESULTS: In total, 648 patients were included, 212 of whom were elderly. Effectiveness was similar between young and elderly patients during the follow-up. Steroid-free remission was similar at week 16 [54.6 vs 51.4%, p = 0.20], 32 [53.0% vs 54.5%, p = 0.26] and 54 [57.8% vs 51.1%, p = 0.21]. Persistence of ustekinumab as maintenance therapy was similar in both age groups [log-rank test; p = 0.91]. There was no difference in the rate of adverse effects [14.2% vs 11.2%, p = 0.350], including severe infections [7.1% vs 7.3%, p = 1.00], except for the occurrence of de novo neoplasms, which was higher in older patients [0.7% vs 4.3%, p = 0.003]. CONCLUSIONS: Ustekinumab is as effective in elderly patients with CD as it is in non-elderly patients. The safety profile also seems to be similar except for a higher rate of de novo neoplasms, probably related to the age of the elderly patients.

Alergia alimentaria en el centro educativo / Food allergy in a school

Se ha constatado que la alergia a los alimentos como motivo de consulta se ha duplicado en los últimos años. Los investigadores coinciden en la existencia de una compleja interacción entre los genes y los factores ambientales (diferentes áreas geográficas implican distintos hábitos dietéticos)que regularían la aparición y manifestación de la sintomatología alérgica.En España, los alimentos que producen alergia con más frecuencia en niños son la leche, el huevo y el pescado, mientras que en adultos son lasfrutas y los frutos secos, seguidos por el pescado y el marisco. En los centros educativos aumenta el número de escolares que padece algún tipo de alergia alimentaria, por ello, la figura de la enfermera escolares cada vez más necesaria.Evitar el alimento alergénico es el único método de prevención disponible en la actualidad y en caso de contacto, inhalación y/o ingestión del mismo, es necesario disponer de un protocolo de actuación que facilitela toma de decisiones en función de los síntomas presentados.En el caso concreto de los comedores escolares es de suma importancia que todos los que rodean al alumno con alergia (cuidadores, profesores,compañeros), tengan conocimientos sobre el manejo de las alergias alimentarias.En este trabajo se proporciona información focalizada sobre la reacción alérgica a los alimentos, sus manifestaciones, los alimentos más frecuentemente implicados y se describe el protocolo de actuación en caso de que se produzca la ingesta de un alimento alergénico (AU)

It has been shown that food allergy as a motive for consultation has doubled in the last years. Researchers coincide in the existence of a complexinteraction between genes and environmental factors (different geographic areas entail different dietary habits) that would regulate the development and manifestation of the allergic symptoms.In Spain, the foods that most often cause allergy in children are milk, eggs and fish while in adults offending foods are fruits and nuts, followed byfish and seafood.At schools there are increasing numbers of students who suffer from some sort of food allergy. Because of that, the role of the school nurseis more and more necessary. Avoiding the allergic food is the only prevention method available at present and in the case of contact, inhalation and/or ingestion of suchproduct, it is necessary to have a clinical protocol that establishes the decisions to be taken based on presenting symptoms.In the specific case of school canteens, it is of outmost importance that all those that come into contact with the allergic student (caregivers, teachers,classmates) are familiar with the management of food allergies.This paper provides the information relating to allergic reactions to foods, their manifestations, the most frequently involved foods (offendingfoods) and describes the steps to take according to protocol in case ingestion of an allergenic food (AU)

Low complement levels and opsonic activity in hepatic hydrothorax: its relationship with spontaneous bacterial empyema.

GOALS: To analyze the pleural fluid factors that might cause spontaneous bacterial empyema (SBEM) in patients with cirrhotic hydrothorax. BACKGROUND: Pathogenic mechanism of SBEM of cirrhotic patients is probably similar to that of spontaneous bacterial peritonitis, but local factors affecting pleural fluid have not been studied. STUDY: Determination of C3, C4, and opsonic activity levels of pleural fluid in a cohort of patients with pleural effusions of different causes. RESULTS: Forty-eight patients had hepatic hydrothorax; 8, heart failure and 45, exudates (9, tuberculosis; 21, malignancies; 10, other). Of the 48 cirrhotic patients, 15 developed SBEM on admission. The pleural fluid of cirrhotic patients showed significantly lower levels of total protein, complement, and opsonic activity than did the fluids of patients with other causes of SBEM. Patients who developed SBEM had lower concentrations of pleural fluid total protein and C3 and had a higher Child-Pugh score than patients who did not develop the infection. CONCLUSION: Cirrhotic patients with hepatic hydrothorax have lower pleural fluid opsonic activity and C3 levels than those found in the pleural fluid of patients with other causes. Patients who develop SBEM have lower levels of pleural fluid C3, pleural fluid total protein, and a higher Child-Pugh score than those who do not develop SBEM.

Hepatitis tóxica inducida por valsartán / Acute hepatitis induced by valsartan

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