Search

Purpose: biosimilar infliximab (CTP-13) has been recently approved for the treatment of several immune-mediated inflammatory disorders, including inflammatory bowel disease (IBD). Comparative studies between this biosimilar and original infliximab in the real clinical practice are scarce. The objective of this study was to compare short and long-term safety and efficacy of original (O) and biosimilar infliximab (B-IFX) in biologic-naive, IBD patients in the real life clinical practice. Methods: a retrospective, multicentric study was performed in five Spanish hospitals. Consecutive IBD, biologic-naive patients from an historic cohort who initiated O-IFX from January 2013 were compared with biologic-naive patients, who started treatment with B-IFX since its approval in January 2015. The evaluation of efficacy was assessed after the induction phase, at week 14 and week 54 of treatment. Time to dose escalation or treatment persistence of both O-IFX and B-IFX was also considered. The appearance of serious adverse events was recorded. Results: two hundred and thirty-nine IBD biologic-naive patients who started with O-IFX or B-IFX were included: 153 patients were diagnosed with Crohn’s disease (95 treated with O- and 58 treated with B-IFX) and 86 with ulcerative colitis (40 received O- and 46 received B-IFX). At weeks 14 and 54, both O-IFX and B-IFX groups reached a similar clinical response and remission rates. Time to dose escalation, treatment persistence and safety profile were comparable between both groups. Conclusions: this long-term real-life experience provides additional evidence of the similarity of O- and B-IFX CTP-13 in terms of efficacy and safety in IBD patients.

Decision making in hospitals, and especially in their own healthcare services, is hardly referenced in the literature. During the pandemic period, healthcare services have put in place contingency plans to minimize the consequences of the coronavirus on professionals and patients. However, the deployment of contingency plans and results are hardly shared, depriving other services of references to refute, compare or emulate the aforementioned plans. The objective of this work was the description of the implementation and evaluation of Contingency Plans in the Covid-19 pandemic in a unit of inflammatory bowel disease of a Digestive Service in the Sanitary Area of Pontevedra and O Salnés.A team of managers and professionals adapted the 10 measures recommended by Deloitte to face a pandemic to the healthcare environment. The measures were then formulated as a checklist. From the Plan-Do-Check-Act improvement cycle, they were grouped into categories: risk management, organizational management and decision-making. Finally, an external team carried out a qualitative evaluation of the implementation of the contingency plan carried out.The Intestinal Inflammatory Disease Unit of the Digestive Service has obtained an assessment of compliance with the 10 recommended measures to confidently face a pandemic.Sharing the deployment of the contingency plan and its results is useful to identify good practices. This article shows a method to evaluate decision-making in pandemic situations. The outcomes faces the The Intestinal Inflammatory Disease Unit in an excelent position.La toma de decisiones en los hospitales y en sus propios servicios asistenciales apenas está referenciada en la literatura. Durante el período de pandemia por Covid-19, los servicios asistenciales han puesto en marcha planes de contingencia para minimizar las consecuencias del coronavirus en los profesionales y pacientes. Sin embargo, apenas se comparte el despliegue de esos planes de contingencia, ni sus resultados, privando de referencias para refutar, comparar o emular los citados planes a otros servicios asistenciales u hospitales. El objetivo del trabajo fue la descripción de la puesta en marcha de dichos planes ante la pandemia de Covid-19 en la Unidad de Enfermedad Inflamatoria Intestinal de un Servicio de Digestivo en el Área Sanitaria de Pontevedra e O Salnés (Galicia).Un equipo de directivos y profesionales adaptaron al entorno sanitario las 10 medidas recomendadas por Deloitte para afrontar una pandemia. A continuación, se formularon las medidas como listado de comprobación. A partir del ciclo de mejora Plan-Do-Check-Act, se agruparon las 10 medidas en las siguientes categorías: gestión del riesgo, gestión organizacional y toma de decisiones. Por último, un equipo externo realizó una evaluación cualitativa de la puesta en marcha del plan de contingencia realizado.La Unidad de Enfermedad Inflamatoria Intestinal del Servicio de Digestivo realizó un plan de contingencia que presenta un cumplimiento de las 10 medidas recomendadas para hacer frente a la pandemia de Covid-19 con garantías.Compartir el despliegue del plan de contingencia y sus resultados es útil para identificar buenas prácticas. Este trabajo ofrece un método para evaluar las tomas de decisiones en los plantes de contingencia en situaciones de pandemia. Los resultados sitúan a la Unidad de Enfermedad Inflamatoria Intestinal en el rango de la excelencia.

Background Tacrolimus is a calcineurin inhibitor commonly used for prophylaxis of rejection in renal and liver transplantation. There are limited but favourable data regarding its possible use in patients with inflammatory bowel disease (IBD). Aims To evaluate the efficacy and safety of tacrolimus in patients with IBD in clinical practice. Methods We performed a retrospective, multicentre study in 22 centres in Spain. All adult patients who received oral tacrolimus for luminal or perianal IBD were included. Clinical response was assessed by Harvey-Bradshaw index and partial Mayo score after 3 months. Perianal disease was evaluated by fistula drainage assessment. Results One hundred and forty-three patients were included (mean age 38 years; 51% male; median disease duration 110 months). In ulcerative colitis (UC) (n = 58), the partial Mayo score decreased after 3 months from median 6 to 3 (P = 0.0001), whereas in Crohn's disease (CD) (n = 85), the Harvey-Bradshaw index decreased after 3 months from median 9 to 7 (P = 0.011). In CD patients, blood tacrolimus concentrations during induction (>10 ng/mL vs