Long-Term Outcomes of Intravenous Ustekinumab Maintenance Treatment in Patients With Loss of Response to Subcutaneous Dosing.

BACKGROUND: Ustekinumab (UST) is commonly used to treat Crohn's disease and ulcerative colitis. However, some patients may experience diminishing response or require increased dosage. Intravenous (IV) UST maintenance is explored as a solution. OBJECTIVES: We sought to evaluate IV UST maintenance effectiveness and safety in inflammatory bowel disease patients with partial or lost subcutaneous UST response. METHODS: This was a multicenter retrospective study of inflammatory bowel disease patients on IV UST maintenance. Clinical response and remission at weeks 12 and 52, defined as Harvey-Bradshaw Index ≤4 for Crohn's disease or partial Mayo score ≤2 for ulcerative colitis. Objective markers reduction (fecal calprotectin, C-reactive protein), UST trough levels pre- and post-IV maintenance, and adverse events were assessed. RESULTS: A total of 59 patients were included. Clinical remission at weeks 12 and 52 achieved by 47.5% and 64.3% respectively. 96.6% continued IV UST at follow-up. UST serum levels quadrupled. No adverse events reported. CONCLUSIONS: IV UST maintenance effectively sustained remission in most patients at 52 weeks.

When patients lose response to subcutaneous ustekinumab, strategies include reinduction, interval shortening, and less explored intravenous maintenance. Its high rescue rate and safety profile make it a valuable option for managing active inflammatory bowel disease.

Índice de Mayo Endoscópico e Índice de Severidad Endoscópica de la Colitis Ulcerosa: ¿son igual de válidos? / No disponible

INTRODUCCIÓN: la endoscopia tiene un papel fundamental en el manejo de los pacientes con colitis ulcerosa (CU), ya que permite la visualización y evaluación de la gravedad de la enfermedad. No obstante, dicha evaluación no es siempre algo objetivo, por lo que se han desarrollado diferentes escalas que pretenden homogeneizar los hallazgos. Objetico: el objetivo del estudio fue evaluar la variabilidad interobservador entre el Índice de Mayo Endoscópico (IME) y el Índice de Severidad Endoscópica de la Colitis Ulcerosa (UCEIS), al analizar la gravedad de las lesiones endoscópicas en pacientes con CU. El objetivo secundario fue analizar si la preparación catártica afectaba al grado de concordancia entre los endoscopistas. MATERIAL Y MÉTODOS: se trata de un estudio observacional comparativo de una única cohorte a la cual se realiza una colonoscopia bajo guía de práctica clínica habitual a pacientes con CU y se estadifica según el IME y el UCEIS por tres endoscopistas expertos. Para valorar el grado de correlación interobservador se utilizaron el índice de Kappa para el IME y el coeficiente de correlación intraclase para el UCEIS. Se incluyeron 67 pacientes, con edad media de 51 años (DE ± 16,7) e índice de Mayo clínico medio de 3,07 (DE ± 2,54). RESULTADOS: el índice de Kappa ponderado entre los endoscopistas A y B para el IME fue de 0,8; entre el A y el C, de 0,52; y entre el B y el C, de 0,49. Para el UCEIS, el coeficiente de correlación intraclase fue del 0,922 entre los tres endoscopistas (IC 95 %: 0,832-0,959). Se encontró una mejor correlación interobservador cuando la preparación catártica era ≥ 8 según la escala de Boston. CONCLUSIÓN: existe, por tanto, una superior correlación entre los diferentes endoscopistas para el UCEIS que para el IME, por lo que debería ser considerado como el mejor índice a utilizar en la práctica clínica. Una buena preparación catártica es importante para mejorar la correlación interobservador

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Cut-off ranges of infliximab serum levels in Crohn's disease in the clinical practice

INTRODUCTION: between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined. The aim of this study was to determine the cut-off range of infliximab serum levels in Crohn's disease patients in remission in the clinical practice. METHODS: an observational retrospective study was performed from 2016 to 2017. Patients were included with established Crohn's disease, who had been on a maintenance dose schedule of infliximab. Infliximab levels and antibodies to infliximab were measured at least twice in all patients, after induction and after six months of treatment. Clinical remission was defined as ≤ 4 using the Harvey-Bradshaw index. Cluster analysis was used to analyze the results. RESULTS: one hundred and five Crohn's disease patients were included in the study; 57.1 % were male with a mean age of 39 years (SD ± 12.9). The median (range) time of the disease was eleven years (7-15) and the median (range) time of follow-up was 32 months (22-38). Patients who achieved remission had infliximab serum levels between 4.26-8.26 ug/ml versus 0.06-1.43 ug/ml in patients who did not achieve remission after induction. Infliximab serum levels were 2.84-7.75 ug/ml and 0.05-2.69 ug/ml in patients who achieved remission versus those who did not achieve remission after six months of treatment. Overall, 4.26-8.26 ug/ml was found to be the best cut-off range for remission. CONCLUSIONS: in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission

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Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months

Background and aims: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. Methods: this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade(R)) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study. Results: a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases. Conclusion: switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%

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Migración tardía de prótesis tras drenaje ecoendoscópico de pseudoquiste pancreático abscesificado / Late migration of a metal stent after EUS-drainage of a pancreatic pseudocyst abscess

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Evolution of the incidence of inflammatory bowel disease in Southern Spain

Background: The incidence of inflammatory bowel disease is increasing in Europe and in Spain. However, there is no recent data from Southern Spain. Objectives: To determine the evolution of the hospital incidence of inflammatory bowel disease in Southern Spain. Material and methods: A retrospective study was performed in two hospitals in Southern Spain. Data was collected from inflammatory bowel disease patients, divided into two periods (1995-2000 and 2001-2014) and compared. The reference population from both areas was 1,011,555 inhabitants. Results: A total of 430 patients were registered during the first period (1995-2000); 50% (215) had Crohn's disease that resulted in a cumulative incidence rate of 7.08 cases/100,000 inhabitants per year. The overall inflammatory bowel disease incidence was 3.54 cases/100,000 inhabitants per year. During the second period (2001-2014), 2,089 patients were collected; 51.7% had ulcerative colitis (1,081). The rate of cumulative incidence of inflammatory bowel disease was 14.7 cases/100,000 inhabitants per year (7.6 cases of ulcerative colitis/100,000 inhabitants/year and 7.1 cases of Crohn's disease/100,000 inhabitants/year). Conclusions: The incidence of inflammatory bowel disease in Southern Spain has doubled in the last decade and is similar to that of the rest of the country and Europe (AU)

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