Experiencia En Vida Real De La Eficacia, Seguridad Y Datos Farmacocineticos Del Cambio De Infliximab Intravenoso a Subcutaneo En Pacientes Con Enfermedad Inflamatoria Intestinal Inactiva. Resultados Del Registro Eneida

Poster con relevancia para la practica clinica Introduccion: Recientemente, se ha aprobado una formulacion subcutanea de infliximab biosimilar (CT-P13) (IFX- SC, dosis 120 mg) para la enfermedad inflamatoria intestinal (EII). Objetivos: Evaluar la eficacia, seguridad, farmacocinetica y experiencia de los pacientes tras el cambio a IFX-SC estando en remision clinica con tratamiento intravenoso. Metodos: Estudio multicentrico, descriptivo y observacional que incluyo a pacientes con enfermedad de Crohn (EC) y colitis ulcerosa (CU) que iban a ser cambiados de la via iv (IFX-IV) a la subcutanea (IFX-SC) a partir de datos obtenidos del registro ENEIDA (base de datos nacional, de recogida prospectiva por el Grupo Espanol de Trabajo en EII-GETECCU). Todos los pacientes estaban en remision clinica y biologica al menos 24 semanas antes del cambio. Se recogieron datos demograficos y de la enfermedad, actividad clinica (mediante indice de Harvey-Bradshaw para la EC e indice de mayo para la CU), datos analiticos (proteina C reactiva [PCR] y calprotectina fecal [CF]), asi como niveles valle al inicio, a las 12 y a las 24 semanas. Resultados: Se incluyeron 155 pacientes: 54 CU (35%) y 91 (65%) EC;44% mujeres;edad 45,5 anos (32-55). La indicacion del IFX-IV fue principalmente por enfermedad activa (72%) y perianal (7%), tratados durante 32 meses [14-56]. Pre- cambio, 78 (50,3%) recibian IFX-IV cada 8 semanas, 77 (49,7%) dosis intensificada. La mitad llevaban tratamiento inmunomodulador concomitante. El IFX-SC se cambio por mejorar adherencia durante la pandemia de COVID-19 (60%), para aumentar niveles (15%) o a peticion del paciente (25%). Permanecieron con dosis estandar 140 pacientes (90%), 8 (5%) requirieron intensificacion (120 mg semanal 4 y 240 mg cada 2 semanas 4) y en 7 (4,5%) se hizo una desescalada exitosa (120 mg cada 3 semanas en 4 y 120 mg cada 4 semanas en 3). Los indices clinicos, los niveles de PCR y la FC se mantuvieron sin cambios. Los niveles de IFXSC aumentaron significativamente de 4,5 μg/dl [2,6-9,2] basal a 14 μg/dl [9,5-16,2] a las 12 semanas y 13,2 μg/dl [10,4-19,7] a las 24 semanas. Ningun factor analizado (inmunosupresor concomitante, indice de masa corporal, localizacion de la enfermedad) se asocio con el aumento de niveles valle. Durante el seguimiento, suspendieron tratamiento inmunosupresor 16 de 78 (20,5%). Se registraron acontecimientos adversos en 9 pacientes (5,8%) y hubo 4 (2,6%) hospitalizaciones y 4 (2,6%) cirugias (1 de ellas perianal). Suspendieron tratamiento 9 pacientes (5,8%): 1 fracaso primario, 2 perdida de respuesta, 4 acontecimientos adversos, 1 voluntariamente y 1 cirugia. Conclusiones: El cambio de IFX IV a IFX SC mantiene la remision clinica de forma segura en la EII, ofrece mayores niveles de farmaco y una buena aceptacion por parte de los pacientes. El significado de los niveles mas altos con IFX-SC requiere una mayor exploracion.Copyright © 2023 Elsevier Espana, S.L.U. Todos los derechos reservados.

Managing the risks of the Coronavirus Pandemic: the case of the Mediterranean island of Menorca

The COVID-19 crisis could act as a catalyst for a series of social, economic, and political changes since it has sensitized governments and institutions on the need for a structural paradigm shift in their growth models from a triple economic, environmental and social perspective. This article offers a case study of the Spanish island of Menorca and its incidence rates in comparison with other territories of the European Union and Spain. Furthermore, we offer a brief description of the current context of the island and its function during the 19th century as a point of control and containment of infectious diseases in the Lazaretto of Maó. This study intends to interpret how the COVID-19 management has been carried out considering the actions made at the State, regional (autonomous community), insular and local levels. The paper is focused principally on the preventive actions at the insular level to know if some of these actions made during the crisis Covid and insular particularities before the start of the pandemic are conditions for the control of the COVID-19 and its incidence rates on the island. © 2022 Institution for Marine and Island Cultures, Mokpo National University.

Clinical impact of the suspension of the ERAS protocol on patients undergoing radical cystectomy during the COVID-19 pandemic Impacto clínico de no aplicar el protocolo ERAS en los pacientes sometidos a cistectomía durante la pandemia COVID-19

Introduction During the beginning of the COVID-19 pandemic in our center, neither prehabilitation nor multimodal rehabilitation could be applied due to the excessive patient load on the health system and to reduce SARS-CoV-2 transmission. The objective of our study was to analyze the evolution, complications, and survival up to one year of patients who underwent radical cystectomy in our hospital from March 1st to May 31st, 2020 (period of the first wave COVID-19 pandemic in Spain). We also compared the results with cystectomized patients outside the pandemic period and with application of the ERAS (Enhanced Recovery After Surgery) protocol. Material and methods Single-center, retrospective cohort study of patients scheduled for radical cystectomy from March 1st, 2020 to May 31st, 2020. They were matched with previously operated patients using a 1:2 propensity matching score. The matching variables were demographic data, preoperative and intraoperative clinical conditions. Results A total of 23 radical cystectomies with urinary diversion were performed in the period described. In none of the cases the prehabilitation or the follow-up of our ERAS protocol could be applied, and this was the only difference we found between the 2 groups. Although the minimally invasive approach was more frequent in the pandemic group, the difference was not statistically significant. Three patients were diagnosed with COVID-19 during their admission, presenting severe respiratory complications and high in-hospital mortality. Apart from respiratory complications secondary to SARS-CoV-2, we also found statistically significant differences in other postoperative complications. The hospital stay increased by 3 days in the pandemic group. Conclusions Patients who underwent radical cystectomy at our center during the first wave of the COVID-19 pandemic had a higher number and severity of respiratory and non-respiratory complications. Discontinuation of the ERAS protocol was the main difference in treatment between groups.

Clinical impact of the suspension of the ERAS protocol on patients undergoing radical cystectomy during the COVID-19 pandemic.

INTRODUCTION: During the beginning of the COVID-19 pandemic in our center, neither prehabilitation nor multimodal rehabilitation could be applied due to the excessive patient load on the health system and to reduce SARS-CoV-2 transmission. The objective of our study was to analyze the evolution, complications, and survival up to one year of patients who underwent radical cystectomy in our hospital from March 1st to May 31st, 2020 (period of the first wave COVID-19 pandemic in Spain). We also compared the results with cystectomized patients outside the pandemic period and with application of the ERAS (Enhanced Recovery After Surgery) protocol. MATERIAL AND METHODS: Single-center, retrospective cohort study of patients scheduled for radical cystectomy from March 1st, 2020 to May 31st, 2020. They were matched with previously operated patients using a 1:2 propensity matching score. The matching variables were demographic data, preoperative and intraoperative clinical conditions. RESULTS: A total of 23 radical cystectomies with urinary diversion were performed in the period described. In none of the cases the prehabilitation or the follow-up of our ERAS protocol could be applied, and this was the only difference we found between the 2 groups. Although the minimally invasive approach was more frequent in the pandemic group, the difference was not statistically significant. Three patients were diagnosed with COVID-19 during their admission, presenting severe respiratory complications and high in-hospital mortality. Apart from respiratory complications secondary to SARS-CoV-2, we also found statistically significant differences in other postoperative complications. The hospital stay increased by 3 days in the pandemic group. CONCLUSIONS: Patients who underwent radical cystectomy at our center during the first wave of the COVID-19 pandemic had a higher number and severity of respiratory and non-respiratory complications. Discontinuation of the ERAS protocol was the main difference in treatment between groups.

[CLINICAL IMPACT OF THE SUSPENSION OF THE ERAS PROTOCOL ON PATIENTS UNDERGOING RADICAL CYSTECTOMY DURING THE COVID-19 PANDEMIC.] / IMPACTO CLÍNICO DE NO APLICAR EL PROTOCOLO ERAS EN LOS PACIENTES SOMETIDOS A CISTECTOMÍA DURANTE LA PANDEMIA COVID-19.

INTRODUCTION: During the beginning of the COVID-19 pandemic in our center, neither prehabilitation nor multimodal rehabilitation could be applied due to the excessive patient load on the health system and to reduce SARS-CoV-2 transmission. The objective of our study was to analyze the evolution, complications, and survival up to one year of patients who underwent radical cystectomy in our hospital from March 1st to May 31st, 2020 (period of the first wave COVID-19 pandemic in Spain). We also compared the results with cystectomized patients outside the pandemic period and with application of the ERAS (Enhanced Recovery After Surgery) protocol. MATERIAL AND METHODS: Single-center, retrospective cohort study of patients scheduled for radical cystectomy from March 1st,2020 to May 31st, 2020. They were matched with previously operated patients using a 1:2 propensity matching score. The matching variables were demographic data, preoperative and intraoperative clinical conditions. RESULTS: A total of 23 radical cystectomies with urinary diversion were performed in the period described. In none of the cases the prehabilitation or the follow-up of our ERAS protocol could be applied, and this was the only difference we found between the 2 groups. Although the minimally invasive approach was more frequent in the pandemic group, the difference was not statistically significant. Three patients were diagnosed with COVID-19 during their admission, presenting severe respiratory complications and high in-hospital mortality. Apart from respiratory complications secondary to SARS-CoV-2, we also found statistically significant differences in other postoperative complications. The hospital stay increased by 3 days in the pandemic group. CONCLUSIONS: Patients who underwent radical cystectomy at our center during the first wave of the COVID-19 pandemic had a higher number and severity of respiratory and non-respiratory complications. Discontinuation of the ERAS protocol was the main difference in treatment between groups.

IMPACTO CLÍNICO DE NO APLICAR EL PROTOCOLO ERAS EN LOS PACIENTES SOMETIDOS A CISTECTOMÍA DURANTE LA PANDEMIA COVID-19 CLINICAL IMPACT OF THE SUSPENSION OF THE ERAS PROTOCOL ON PATIENTS UNDERGOING RADICAL CYSTECTOMY DURING THE COVID-19 PANDEMIC

Introducción: Al inicio de la pandemia COVID-19 no se pudo implementar ni prehabilitación ni rehabilitación multimodal por sobrecarga del sistema sanitario. Nuestro objetivo fue analizar evolución, complicaciones y supervivencia hasta el año de pacientes sometidos a cistectomía radical en nuestro centro desde 1 de Marzo hasta 31 de Mayo de 2020 (primera ola). Comparamos resultados con pacientes también cistectomizados fuera de pandemia donde sí estaba instaurado el protocolo ERAS. Material y Métodos: Estudio de cohortes retrospectivo, unicéntrico, de pacientes programados para cistectomía radical desde 1 de marzo de 2020 hasta 31 de mayo de 2020;se emparejaron con pacientes intervenidos anteriormente a través de score de emparejamiento por propensión 1:2. Las variables de emparejamiento fueron datos demográficos, condiciones clínicas preoperatorias e intraoperatorias. Resultados: Se realizaron 23 cistectomía en este periodo;en ningún caso se aplicó ni prehabilitación ni seguimiento del protocolo ERAS, y ésta fue la única diferencia en el tratamiento entre grupos. Tres pacientes se diagnosticaron de COVID-19 durante su ingreso presentando complicaciones respiratorias graves y alta mortalidad intrahospitalaria. La tasa de transfusión sanguínea fue mayor en el grupo pandemia. La estancia hospitalaria aumentó en 3 días en grupo pandemia. Conclusiones: Los pacientes sometidos a cistectomía en nuestro centro durante la primera ola de pandemia COVID-19 presentaron complicaciones respiratorias y no respiratorias en mayor número y más graves que los cistectomizados fuera de este periodo. La no aplicación del protocolo ERAS fue la principal diferencia en el tratamiento entre grupos.