Valoración de la eficacia de Infliximab biosimilar (CT-P13, remsima®) frente al Infliiximab original (Remicade®) en pacientes con enfermedad inflamatoria intestinal.

Introducción: las terapias biológicas, particularmente agentes anti-TNF alfa, han revolucionado el enfoque terapéutico de la Enfermedad Inflamatoria Intestinal (EII) en pacientes con enfermedad grave o refractaria. Sin embargo, con la expiración de algunas patentes, se ha llevado a cabo el desarrollo de biosimilares de estos fármacos, con el objetivo de proporcionar importantes ahorros de costes y una mayor accesibilidad al tratamiento. En 2013, la Agencia de Medicamentos Europea (EMA) aprobó el primer biosimilar del Infliximab (CT-P13) con las mismas indicaciones del medicamento de referencia, basados en los análisis obtenidos de dos estudios realizados en pacientes con enfermedades reumatológicas. Esta extrapolación de resultados, así como la sustitución del medicamento original por el biosimilar generaron preocupación y alarma entre los especialistas de digestivo, acerca de la eficacia y seguridad de esta terapia en la EII. Objetivos: comparar la eficacia global y la pérdida de eficacia de los pacientes con EII en remisión en tratamiento Infliximab original (Remicade®) frente a Infliximab biosimilar (CT-P13) durante 12 meses, así como los eventos adversos y los costes de los tratamientos. Material y métodos: se ha realizado un estudio observacional comparativo de dos cohortes y un estudio antes-después sin grupo control. Se han incluido pacientes con EII tratados con Infliximab original (Remicade®) y aquellos a los que se les realizó el intercambio por el fármaco biosimilar (CT-P13, Remsima®). Se ha analizado la eficacia global y la pérdida de eficacia en los pacientes en remisión al final de un año tras tratamiento con el fármaco original comparado con los resultados al año de tratamiento con el biosimilar. Resultados: - Estudio observacional de dos cohortes (n= 98 pacientes): la eficacia global del fármaco original al año de tratamiento fue del 71% vs 68,2% del fármaco biosimilar (p=0,80). Al analizar los resultados según el tipo de enfermedad tampoco se encuentran diferencias estadísticamente significativas. - Estudio antes-después (n=66 pacientes): la eficacia global del fármaco original al año de tratamiento fue del 74,2% vs 72,7% del fármaco biosimilar (p=0,45). La pérdida de remisión al año es del 7,5% con el fármaco original frente a un 24,8% al segundo año con el fármaco biosimilar (p=0,077). La tasa de eventos adversos es similar en ambos grupos (9,2 vs 11,2%) (p=0,81). El ahorro de costes fue de un 29,1% por paciente/año. Conclusiones: la eficacia global y la pérdida de respuesta del tratamiento con Infliximab original (Remicade®) es similar a la que se observa con Infliximab biosimilar (CT-P13) en los pacientes a quienes se les sustituyó el fármaco a doce meses de seguimiento. No hay diferencias en la tasa de eventos adversos. Además, el intercambio supone un ahorro importante por paciente/año

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results

Background: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. Materials and methods: This was a prospective single-center observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey–Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study. Results: A total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey–Bradshaw score showed a significant change at 12 months (P =0.007) but no significant change was observed in median CRP at this timepoint (P= 0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P =0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients. Conclusion: Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months

Prevalencia de deterioro cognitivo leve y sus factores asociados en pacientes con diabetes millitus tipo 2 aplicando la escala validada de MOCA (Montreal Cognitive Assessment) en el club de diabéticos del Centro de Atención Ambulatoria de Cotocollao del Instituto Ecuatoriano de Seguridad Social

El presente estudio transversal investigó la prevalencia de Deterioro Cognitivo Leve y factores asociados en pacientes con Diabetes Mellitus tipo II en el club de diabéticos del Centro de Atención Ambulatoria de Cotocollao del IESS de Quito-Ecuador, utilizando la escala validada de Moca para el español y corregida para la escolaridad. De los 100 pacientes que integran el club de diabéticos, se excluyeron por cumplir criterios de demencia y depresión a 10 y 24 pacientes respectivamente. De los 66 pacientes que fueron los que integraron el estudio 24 (36.4%) fueron hombres y 42 (63.6%) fueron mujeres, 9 (13.6%) estaban en el rango de edad entre 40-49 años, 10 (15,2%) entre 50-59 años, 27(40,9%) entre 60 – 69 años y 20 (30.3%) mayores a 70 años. 22 (33,3%) tenían años aprobados de escolaridad menor a 12 y 44 (66,7%) mayor a 12 años. 44 (66.7%) tenían hemoglobina glicosilada menor o igual a 7 mg/dl y 22 (33,3%) mayor a 7 mg/dl, 13 (19,7%) eran hipertensos y 53 (80.3%) no lo eran. 14(21.2%) tenían menor de 5 años de enfermedad, 23 (34.8%) de 5 – 10 años y 29 (43,9%) mayor de 10 años de duración de la misma. 13(19,7%) tenían valores de Colesterol LDL menor de 100 mg/dl, 21 (31,8%) 100-130mg/dl y 32 (48.5%) mayor de 130 mg/dl. Aplicando el test de Moca se obtuvo que 8 (12.1%) pacientes diabéticos tiene DCL y 58 (87.9%) no lo tienen con un punto de corte de 21. Utilizando un punto de corte de 23 se obtuvo el doble de DCL 24,2%. No se encontró significancia estadística que relacione a la duración de la enfermedad, valores de hemoglobina glicosilada, años de escolaridad, hipertensión, valores de colesterol LDL con el DCL en este grupo poblacional

Late migration of a metal stent after EUS-drainage of a pancreatic pseudocyst abscess.

Endoscopic ultrasound (EUS)-guided drainage of pancreatic collections has replaced surgery as the first line of treatment due its accuracy and safety profile. A higher success rate and fewer adverse events has been observed using fully covered metal stent for the drainage. However, complications of EUS-guided drainage can appear. We present a case of late migration of the stent

Ileocecal endometriosis as an infrequent cause of intussusception.

We present a case of ileocecal endometriosis as a cause of infrequent ileocolic intussusception in an adult patient. It is reviewed as published by the authors Sanchez Cifuentes, A et al. 2016, emphasizing the rarity of the location of endometriosis, and its association as a cause of intussusception

Dynamic Changes in Non-Invasive Markers of Liver Fibrosis Are Predictors of Liver Events after SVR in HCV Patients

Objectives: The course of progressive liver damage after achieving sustained virological response (SVR) with direct-acting antivirals (DAAs) remains undetermined. We aimed to determine risk factors associated with the development of liver-related events (LREs) after SVR, focusing on the utility of non-invasive markers. Methods: An observational, retrospective study that included patients with advanced chronic liver disease (ACLD) caused by hepatitis C virus (HCV), who achieved SVR with DAAs between 2014 and 2017. Patients were followed-up until December 2020. LREs were defined as the development of portal hypertension decompensation and the occurrence of hepatocellular carcinoma (HCC). Serological markers of fibrosis were calculated before treatment and one and two years after SVR. Results: The study included 321 patients, with a median follow-up of 48 months. LREs occurred in 13.7% of patients (10% portal hypertension decompensation and 3.7% HCC). Child–Pugh [HR 4.13 (CI 95% 1.74; 9.81)], baseline FIB-4 [HR 1.12 (CI 95% 1.03; 1.21)], FIB-4 one year post-SVR [HR 1.31 (CI 95% 1.15; 1.48)] and FIB-4 two years post-SVR [HR 1.42 (CI 95% 1.23; 1.64)] were associated with portal hypertension decompensation. Older age, genotype 3, diabetes mellitus and FIB-4 before and after SVR were associated with the development of HCC. FIB-4 cut-off values one and two years post-SVR to predict portal hypertension decompensation were 2.03 and 2.21, respectively, and to predict HCC were 2.42 and 2.70, respectively. Conclusions: HCV patients with ACLD remain at risk of developing liver complications after having achieved SVR. FIB-4 evaluation before and after SVR may help to predict this risk, selecting patients who will benefit from surveillance

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

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. 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. 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. in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission

Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data

Background: Several studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from followup periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease. Methods: This was a prospective single-center observational study involving patients with moderate-to-severe Crohn’s disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24months. Efficacy and loss of response were measured using the Harvey–Bradshaw (HB) index and partial Mayo score for patients with Crohn’s disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study. Results: A total of 64 patients with Crohn’s disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies. Conclusions: Most of the patients switching from original infliximab were maintained on CTP13 at 2years of follow up with a good profile of efficacy and safety