Estudio del riesgo de hemorragia gastrointestinal asociada al tratamiento de agentes anticoagulantes y antiplaquetarios en prevención cardiovascular

El tratamiento con antiinflamatorios no esteroideos o ácido acetilsalicilíco a dosis bajas se asocia al aumento de riesgo de hemorragia digestiva alta. Existe menos evidencia sobre el riesgo asociado a otros antiplaquetarios y anticoagulantes orales. El objetivo principal del estudio es cuantificar el riesgo de hemorragia digestiva no varicosa asociada a la toma de AINEs, AAS a bajas dosis, otros antiplaquetarios o anticoagulantes orales y su relación potencial con factores que pueden modificar dicho riesgo

Celiac patient satisfaction with nursing consultations in a gastroenterology department

The assessment of the personal care received is an indicator of the quality of the health care system. The diagnosis of celiac disease generates concern in the patient and limits the quality of life, and adherence to treatment determines symptomatic improvement. For this reason, a nursing consultation for health and nutritional education for celiac patients has been set up in our hospital. The objectives were to know the degree of patient´s satisfaction of this health program regarding technical and communicative aspects, as well as to assess the influence of adherence to the gluten-free diet (GFD) on health through clinical and analytical parameters. This is a descriptive cross-sectional observational study in patients diagnosed of celiac disease from January 2019 to June 2021 according to the Catassi criteria and who have attended the nursing consultation. Subsequently, the satisfaction survey was carried out and the clinical and analytical results were analyzed descriptively and statistically using the Student's t-test. The satisfaction of the nursing consultation was higher than 90%, highlighting aspects such as the clarity of the information, the interest and the kindness of the healthcare professionals. About 94.5% of the patients showed clinical improvement after the health education and the levels of hemoglobin, ferritin and vitamin B12 increased significantly in the analytical control after the GFD

Cytomegalovirus associated rectal ulcer as manifestation of primary HIV infection

We present the case of a 40-year-old male sent for fatigue, mild weight loss and rectal bleeding for 2 months, neither fever nor diarrhea. He referred unprotected intercourse. Blood test revealed mild elevation of transaminases. We requested serologies, with positive CMV IgG and CMV plasma levels of 47UI/ml (PCR), and a negative result of the rest of hepatotropic viruses. Abdominal ultrasound was normal and during colonoscopy we observed an ulcer in lower rectum, with negative biopsies for malignancy and a positive immunohistochemistry (IHC) for CMV. We amplified the serologic analysis and detected positive antibodies for the human immunodeficiency virus (HIV), with a viral load of 50500 copies/ml, negative p24 antigen and CD4+ cell count of 900 cells/mm3 (30%). Rest of serologies and triple-site testing were negative. We referred the patient to the infectious disease consultation and they started antiretroviral therapy (ART). We decided a watchful waiting approach for the rectal ulcer with close endoscopic follow-up, with early healing and complete resolution

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

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

Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry

Abstract Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice. Aims: 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. Thirty-six percent 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 both in 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 ustekinuma

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