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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.
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Objective: To evaluate the prevalence of dry socket as a postoperative complication in cases where there was intense local pain in the preoperative state, during the preventive mandatory social isolation (PMSI) for the COVID-19 pandemic in Argentina. Method(s): This was a descriptive study, which included 1209 walk-in patients at the emergency and orientational service at Buenos Aires University School of Dentistry during the PMSI from March 20 to June 20, 2020, with indication for dental extraction as well as intense acute pain at the surgical site. The presence of dry socket was exploratoryly associated with the variables age, sex, smoking and chronic medication use. Result(s): 1209 patients were operated, resulting in a total 1372 dental extractions. Average patient age was 41 years. The prevalence found in this study was 1.06%. Conclusion(s): The prevalence of dry socket was 1%, not being higher than other experiences where pain was not considered a condition prior to extraction.Copyright © 2023 Duke University Press. All Rights Reserved.
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Background: Recently, a subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) has been approved for inflammatory bowel disease (IBD). The aims of this study were to evaluate efficacy, safety, pharmacokinetics and patient experience following a switching to SC-IFX in patients who are in clinical remission on IV-IFX maintenance treatment. Method(s): Multicentre, descriptive, and observational study including Crohn's disease (CD) and ulcerative colitis (UC) patients who were going to be changed from IV-IFX to SC-IFX on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD-GETECCU). All patients were on clinical and biological remission at least 24 weeks before changing. Demographic and disease data, clinical activity (Harvey-Bradshaw index for CD and mayo index for UC), analytical data (C reactive protein (CRP) and fecal calprotectin (FC), as well as trough levels were collected at baseline, at 12 and 24 weeks. Result(s): One hundred and fifty-five patients were included: 54 UC (35%) and 91 (65%) CD;44% women and 56% men;age 45.5 years (32-55). IV-IFX was mainly administered due to active disease (72%) and perianal disease (7%) and during 32 months [range 14-56]. Preswitch, 78 (50.3%) were on 8-weekly dosing of IV-IFX, 77 (49.7%) were with intensification dose and the half (50.3%) were on concomitant immunomodulatory therapy. SC-IFX was mainly switching by COVID-19 pandemic (60%), to increase through levels (15%) or patient request (25%). The majority of patients (140, 90%) remained with standard dose, 8 (5%) required dose intensification (120 mg weekly in 4 and 240 mg every 2 weeks in 4) and 7 (4.5%) had successful de-escalation (120 mg every 3 weeks in 4 and 120 mg every 4 weeks in 3). Clinical indices, CRP levels and FC remained unchanged (Figure). Median SC-IFX levels significantly increased from baseline of 4.5 mug/ dl [range 2.6-9.2] to 14 mug/dl [range 9.5-16.2] at week 12 and 13.2 mug/ dl [range 10.4-19.7] at week 24. No factors (immunossupresor, body mass index, disease location) were associated with the increase of IFX trough levels. During 24 weeks of follow-up, 16 of the 78 patients (20.5%) stopped immunosuppressant treatment. The adverse events were recorded in 9 patients (5.8%), 4 (2.6%) were hospitalized and 4 (2.6%) had surgery (one of them for perianal disease). Nine patients (5.8%) stopped SC-IFX (1 primary failure, 2 loss of response, 4 adverse events, 1 voluntarily, and 1 surgery). Conclusion(s): The switch from IV to SC IFX maintains clinical remission safely in IBD patients, offers higher drug levels and a good patient acceptance. However, the significance of higher drug levels with SC-IFX requires further exploration.
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Objective The Covid-19 pandemic has had consequences on the mental health of health personnel, a vulnerable population that is on the front lines of attention. Long working hours, as well as the fear of getting sick and transmitting the virus to their families, generate high levels of anxiety and burnout. The objective of the present study is to evaluate the presence of burnout and anxiety in health personnel during the Covid-19 pandemic. Methods The Maslach Burnout Inventory and the Hamilton anxiety scale were distributed electronically and prospectively to 566 health workers in Colombia from March to April 2020. Additionally, age, level of schooling, marital status, occupation, source of income, type of contract, and the number of jobs and working hours were evaluated. Results A total of 566 health professionals were evaluated, 60.8% of whom were women, and 39.2% of whom were men. The sample was composed of 85.3% of doctors, 9.2% of nurses, and the other 5.5% corresponded to administrative staff, dentists, and paramedics. Of the aforementioned, 19.3% had 3 or more jobs. The survey reported high levels of emotional exhaustion and depersonalization, with low levels of personal fulfillment. Additionally, mild anxiety was evident. Conclusions One of the most important consequences of the Covid-19 pandemic is the effects of burnout and anxiety in health personnel. Given our results, it is essential to highlight the importance of psychological support for health personnel in these times of fear and uncertainty.