HLA-DQA1*05 Was Not Associated With Primary Nonresponse or Loss of Response to First Anti-TNF in Real-World Inflammatory Bowel Disease Patients.

BACKGROUND: We lack predictors of response to biologics in the management of patients with inflammatory bowel disease (IBD). A recent study has shown a significant association between HLA-DQA1*05 carriers and the development of loss of response to anti-tumor necrosis factor (TNF) mediated by immunogenicity. METHODS: Retrospective single-center cohort study including IBD patients who had received anti-TNF therapy as a first biologic and whose HLA-DQA1*05 had been determined. Primary nonresponse and secondary failure (assessed by survival analysis) have been evaluated as well as safety outcomes. RESULTS: A total of 199 IBD patients (161 [81%] with Crohn's disease and 38 [19%] with ulcerative colitis) were included. A total of 42.4% were HLA-DQA1*05 carriers and 60% received combination therapy at the start of anti-TNF treatment. Median follow-up was 24 (interquartile range, 11-66) months. No statistically significant differences were found in primary nonresponse to anti-TNF (89.3% vs 87.8%; P = .825), depending on HLA carriers and noncarriers. No differences in secondary loss of response according to HLA variant in any of the analyses performed (full cohort, according to IBD or anti-TNF type) were observed. Again, no differences were observed in patients treated with combination therapy. In terms of safety, no significant differences were found in the rate of infusion reactions or serious adverse events. CONCLUSION: In our real-life cohort of IBD patients treated for the first time with anti-TNF, being an HLA-DQA1*05 carrier did not act as a predictor of response failure, either primary or secondary. The safety of anti-TNF treatment has also not been influenced by the variant.

The HLA variant DQA1*05 has been identified as a risk factor for the development of antibodies to anti-tumor necrosis factor drugs. We observed that its presence has no impact on clinical outcomes, such as secondary loss of response. These data suggest that caution is required before making decisions based on this HLA variant.

Traducción al español y validación de un cuestionario breve de medida del control de la enfermedad inflamatoria intestinal desde la perspectiva del paciente: IBD-Control, EII-Control / Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control

Objetivo: La medida de los resultados percibidos por el paciente en la asistencia de la enfermedad inflamatoria intestinal (EII) adquiere cada vez más importancia. Existe una herramienta sencilla y validada en inglés para este fin: el «IBD-Control». Nuestro objetivo es traducirlo al español, adaptarlo y validarlo.Pacientes y métodos: Se tradujo el IBD-Control, generando el instrumento en español «EII-Control», y se validó prospectivamente. Los pacientes cumplimentaban el EII-Control y otros cuestionarios que servían de comparadores de referencia. El gastroenterólogo realizaba una valoración global de la enfermedad, calculaba índices de actividad y registraba el tratamiento. Un subgrupo de pacientes repitió toda la valoración en una segunda visita. Se analizó también la utilidad de escalas resumidas del EII-Control (el EII-Control-8 y el EII-Control-EVA). Resultados: Se incluyeron 249 pacientes con EII (101 repitieron la segunda visita). Estándares psicométricos del test: consistencia interna: α de Cronbach para EII-Control 0,83 con fuerte correlación entre EII-Control-8 y EII-Control-EVA (r=0,5); reproducibilidad: correlación intraclase 0,70 para EII-Control; validez de constructo: correlaciones de moderadas a fuertes entre EII-Control, EII-Control-8 y EII-Control-EVA frente a comparadores; validez discriminante: p <0,001; sensibilidad al cambio: misma respuesta que índice de calidad de vida. Sensibilidad y especificidad en el punto de corte 14 de 0,696 y 0,903, respectivamente, para determinar el estado quiescente. Conclusiones: El EII-Control es un instrumento válido para medir el control de la EII desde la perspectiva del paciente en nuestro medio y cultura. Su simplicidad lo convierte en una herramienta útil para apoyar la asistencia.(AU)

Objective: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the “IBD-Control”. Our aim is to translate it into Spanish, adapt and validate it. Patients and methods: The IBD-Control was translated into the Spanish instrument “EII-Control” and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. Results: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. Conclusions: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.(AU)

Uso de prótesis esofágicas cubiertas de doble malla en fístulas esofágicas postquirúrgicas y perforaciones esofágicas: experiencia en nuestro centro / Use of double-layered covered esophageal stents in post-surgical esophageal leaks and esophageal perforation: Our experience

Introducción: El uso de prótesis esofágicas para el manejo endoscópico de fístulas y perforaciones se ha convertido en un procedimiento habitual. Una de sus limitaciones es su alta tasa de migración. Para resolver esta situación, se ha propuesto el uso de prótesis cubiertas de doble malla.Objetivos: Analizar nuestra experiencia práctica en el empleo de prótesis esofágicas cubiertas de doble malla (PECDM) (modelo Niti S™ DOUBLE™ Esophageal Metal Stent) en pacientes con fístula o perforación esofágica.Material y métodos: Estudio retrospectivo, descriptivo y unicéntrico, donde se incluyen pacientes con diagnóstico de fístula o perforación esofágica, desde noviembre 2010 hasta octubre 2018. Como objetivo primario, se evaluará su eficacia en términos de éxito técnico. Como objetivo secundario, se analizará su perfil de seguridad.Resultados: Se incluyeron inicialmente un total de 31 pacientes, siendo 8 de ellos excluidos por fallecimiento por causas ajenas a la técnica. Se detectó un éxito técnico del 100%, con un éxito primario del 75% tras la recolocación de la prótesis. Entre sus complicaciones, la migración ocurrió en un 21,7% de los pacientes (n=5), resolviéndose vía endoscópica en el 100% de los casos.Conclusiones: Según nuestros hallazgos, las PECDM suponen una alternativa en el tratamiento de fístulas y perforaciones esofágicas, con una alta tasa de éxito en la resolución de fístulas y baja de complicaciones, en contraste con lo expuesto en las series publicadas. En todos los casos, la migración de la prótesis se resolvió mediante recolocación endoscópica, sin requerir nueva prótesis ni cirugía.(AU)

Introduction: The use of esophageal stents for the endoscopic management of esophageal leaks and perforations has become a usual procedure. One of its limitations is its high migration rate. To solve this incovenience, the double-layered covered esophageal stents have become an option.Objectives: To analyse our daily practice according to the usage of double-layered covered esophageal metal stents (DLCEMS) (Niti S™ DOUBLE™ Esophageal Metal Stent Model) among patients diagnosed of esophageal leak or perforation.Methods: Retrospective, descriptive and unicentric study, with inclusion of patients diagnosed of esophageal leak or perforation, from November 2010 until October 2018. The main aim is to evaluate the efficacy of DLCEMS, in terms of primary success and technical success. The secondary aim is to evaluate their (the DLCEMS) safety profile.Results: Thirty-one patients were firstly included. Among those, 8 were excluded due to mortality not related to the procedure. Following stent placement, technical success was reached in 100% of the cases, and primary success, in 75% (n=17). Among the complications, stent migration was present in 21.7% of the patients (n=5), in whom the incident was solved by endoscopic means.Conclusions: According to our findings, DLCEMS represent an alternative for esophageal leak and perforation management, with a high success rate in leak and perforation resolutions and low complication rate, in contrast to the published data. The whole number of migrations were corrected by endoscopic replacement, without the need of a new stent or surgery.(AU)

NSAID-induced ischemic colitis.

We present the case of a 38-year-old man with no previous medical history who went to the emergency department due to abdominal pain and diarrheal stools with blood of 24 hours of evolution. The patient reports consumption of anti-inflammatories the previous days due to back pain.

Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control. / Traducción al español y validación de un cuestionario breve de medida del control de la enfermedad inflamatoria intestinal desde la perspectiva del paciente: IBD-Control, EII-Control.

OBJECTIVE: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it. PATIENTS AND METHODS: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. RESULTS: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. CONCLUSIONS: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.

Use of double-layered covered esophageal stents in post-surgical esophageal leaks and esophageal perforation: Our experience. / Uso de prótesis esofágicas cubiertas de doble malla en fístulas esofágicas postquirúrgicas y perforaciones esofágicas: experiencia en nuestro centro.

INTRODUCTION: The use of esophageal stents for the endoscopic management of esophageal leaks and perforations has become a usual procedure. One of its limitations is its high migration rate. To solve this incovenience, the double-layered covered esophageal stents have become an option. OBJECTIVES: To analyse our daily practice according to the usage of double-layered covered esophageal metal stents (DLCEMS) (Niti S™ DOUBLE™ Esophageal Metal Stent Model) among patients diagnosed of esophageal leak or perforation. METHODS: Retrospective, descriptive and unicentric study, with inclusion of patients diagnosed of esophageal leak or perforation, from November 2010 until October 2018. The main aim is to evaluate the efficacy of DLCEMS, in terms of primary success and technical success. The secondary aim is to evaluate their (the DLCEMS) safety profile. RESULTS: Thirty-one patients were firstly included. Among those, 8 were excluded due to mortality not related to the procedure. Following stent placement, technical success was reached in 100% of the cases, and primary success, in 75% (n=17). Among the complications, stent migration was present in 21.7% of the patients (n=5), in whom the incident was solved by endoscopic means. CONCLUSIONS: According to our findings, DLCEMS represent an alternative for esophageal leak and perforation management, with a high success rate in leak and perforation resolutions and low complication rate, in contrast to the published data. The whole number of migrations were corrected by endoscopic replacement, without the need of a new stent or surgery.

Pseudotumor asociado a citomegalovirus simulando un carcinoma de ciego en un paciente inmunocompetente / Cytomegalovirus-associated pseudotumor mimicking ceccum carcinoma in a non inmunocompromised patient

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Seguridad de la sedación profunda con propofol controlada por el endoscopista en la colangiopancreatografía retrógrada endoscópica (CPRE). Estudio prospectivo en un hospital terciario / The safety of deep sedation with propofol controlled by the endoscopist in endoscopic retrograde cholangiopancreatography (ERCP): a prospective study in a tertiary hospital

Introducción: el propofol, administrado por el endoscopista con una enfermera entrenada, ha evolucionado como alternativa a la monitorización anestésica y es cada vez más frecuente en la práctica clínica habitual, incluso en endoscopia avanzada. Objetivo: evaluar la seguridad de la sedación profunda con propofol controlada por el endoscopista en pacientes sometidos a colangiopancreatografía retrógrada endoscópica (CPRE). Material y métodos: estudio prospectivo en los pacientes a los que se les realizó CPRE bajo sedación profunda con propofol. Se incluyeron diferentes variables relacionadas con el paciente y se registraron los datos iniciales y finales de la saturación de oxígeno (SatO2), la tensión arterial (TA), y la frecuencia cardiaca (FC) para determinar la presencia de eventos adversos a la sedación (hipoxemia, hipotensión o bradicardia). Resultados: un total de 661 pacientes fueron sometidos a CPRE bajo sedación con propofol durante un periodo de 24 meses. La tasa de eventos adversos registrada fue del 9,7%. La más frecuente fue la hipoxemia (5,7%), seguida de la radicardia (2,4%) y de la hipotensión (1,6%). En el análisis univariante, la aparición de eventos adversos a la sedación (EAS) se asoció a una clasificación de ASA ≥ III (p = 0,026), a pacientes de edad más avanzada (p = 0,009), mayor IMC (p = 0,002) y a un tiempo de exploración más prolongado (p = 0,034). La dosis de inducción de propofol también se relacionó con mayor probabilidad de eventos adversos (p = 0,045), pero no la dosis total de propofol administrado (p = 0,153). En el análisis de regresión logística multivariante, la edad, el índice de masa corporal (IMC) y la duración de la exploración se registran como predictores independientes de EAS (p < 0,05). Conclusión: la sedación profunda con propofol controlada por personal de endoscopia entrenado es un método seguro en procedimientos endoscópicos complejos como la CPRE

Introduction: propofol administered by an endoscopist with a trained nurse has evolved as an alternative to anesthesia monitoring and is increasingly common in the routine clinical practice, even in advanced endoscopy. Objective: to evaluate the safety of deep sedation with endoscopist-controlled propofol in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Material and methods: this was a prospective study in patients undergoing ERCP under deep sedation with propofol. Different patient-related variables were included and the initial and final data on oxygen saturation (SatO2), blood pressure (BP) and heart rate (HR) were recorded in order to determine the presence of adverse events due to sedation (hypoxemia, hypotension, or bradycardia). Results: a total of 661 patients underwent ERCP under sedation with propofol over a 24-month period. The rate of recorded adverse events was 9.7%. The most frequent adverse event was hypoxemia (5.7%), followed by bradycardia (2.4%) and hypotension (1.6%). According to the univariate analysis, the occurrence of adverse events due to sedation (AES) was associated with an ASA score ≥ III (p = 0.026), older patients (p = 0.009), higher body mass index (BMI) (p = 0.002) and a longer exploration time (p = 0.034). The induction dose of propofol was also associated with a greater likelihood of adverse events (p = 0.045) but not the total dose of propofol administered (p = 0.153). According to the multivariate logistic regression analysis, age, body mass index (BMI) and the duration of the exploration were independent predictors of SAE (p < 0.05). Conclusion: deep sedation with propofol controlled by trained endoscopy staff is a safe method in complex endoscopic procedures such as ERCP

The safety of deep sedation with propofol controlled by the endoscopist in endoscopic retrograde cholangiopancreatography (ERCP): a prospective study in a tertiary hospital.

INTRODUCTION: propofol administered by an endoscopist with a trained nurse has evolved as an alternative to anesthesia monitoring and is increasingly common in the routine clinical practice, even in advanced endoscopy. OBJECTIVE: to evaluate the safety of deep sedation with endoscopist-controlled propofol in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). MATERIAL AND METHODS: this was a prospective study in patients undergoing ERCP under deep sedation with propofol. Different patient-related variables were included and the initial and final data on oxygen saturation (SatO2), blood pressure (BP) and heart rate (HR) were recorded in order to determine the presence of adverse events due to sedation (hypoxemia, hypotension, or bradycardia). RESULTS: a total of 661 patients underwent ERCP under sedation with propofol over a 24-month period. The rate of recorded adverse events was 9.7%. The most frequent adverse event was hypoxemia (5.7%), followed by bradycardia (2.4%) and hypotension (1.6%). According to the univariate analysis, the occurrence of adverse events due to sedation (AES) was associated with an ASA score ≥ III (p = 0.026), older patients (p = 0.009), higher body mass index (BMI) (p = 0.002) and a longer exploration time (p = 0.034). The induction dose of propofol was also associated with a greater likelihood of adverse events (p = 0.045) but not the total dose of propofol administered (p = 0.153). According to the multivariate logistic regression analysis, age, body mass index (BMI) and the duration of the exploration were independent predictors of SAE (p < 0.05). CONCLUSION: deep sedation with propofol controlled by trained endoscopy staff is a safe method in complex endoscopic procedures such as ERCP.