Real-world experience of vedolizumab use in Colombian patients with inflammatory bowel disease-EXVEDOCOL.

BACKGROUND: Real-world studies about the effectiveness and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD) in Latin America are scarce. Our study describes the effectiveness and safety of VDZ in Colombian patients with IBD. METHODS: EXVEDOCOL (EXperience of VEDOlizumab in COLombia) was a retrospective, multicenter, observational study. Adults with IBD receiving a first dose of VDZ between July 2016 and October 2018 were included. The co-primary outcomes clinical response, and remission, were determined at week 14 and last visit during the maintenance phase (LVMP). The secondary outcomes, deep remission and loss of response were recorded at LVMP. RESULTS: Thirty-one patients (25 ulcerative colitis (UC), 6 Crohn's disease (CD)) were included. At week 14, clinical response was achieved by 87.1% (27/31) of the patients treated with VDZ, while loss of response was reported in 6.7% (2/30). The remission rate at week 14 was 65.5% (19/29) and 75.9% (22/29) at LVMP. Prior anti-TNF exposure was reported in 61.3% (19 patients) of whom 84.2% (16/19) achieved clinical response at week 14 and 89.5% (17/19) at LVMP. For anti-TNF naïve patients, clinical response was recorded in 91.7% (11/12) at week 14 and 100% (12/12) at LVMP. CONCLUSIONS: High clinical remission rates and safety profile highlight VDZ as a valuable treatment option for IBD patients. Anti-TNF naïve patients may derive greater benefit from therapy. Studies with larger cohorts could confirm these findings.

Dyssynergic Defecation Concerning Proctalgia Fugax: An Observational Study

Introduction: There is no clarity about manometric findings in patients with proctalgia fugax; evidence shows different results. This study aims to evaluate dyssynergic defecation through anorectal manometry in Colombian patients in two gastroenterology centers in Bogotá, Colombia. Materials and methods: A cross-sectional descriptive observational study in adult patients with proctalgia fugax undergoing anorectal manometry and treated in two gastroenterology centers in Bogotá between 2018 and 2020. Results: 316 patients were included, predominantly women (65%), with a median age of 45.2 (range: 18-78; standard deviation [SD]: 28.3). Four percent of patients had hypertonicity, 50% were normotonic, and 46% were hypotonic. Regarding manometric parameters, 50% had normal pressure, and 46% had anal sphincter hypotonia; 76% had a normal voluntary contraction test. Dyssynergic defecation was documented in 5% of patients, and the most frequent was type I, followed by type III. A rectoanal inhibitory reflex was identified in all patients, 42% with altered sensory threshold and 70% with abnormal balloon expulsion. There was an agreement between the results of the anorectal manometry and the subjective report of the digital rectal exam by the head nurse who performed the procedure. Conclusions: The data obtained in the present study suggest that proctalgia is not related to the elevated and sustained basal contracture of the sphincter but neither to the alteration in voluntary contraction since most patients have typical values.

Introducción: Actualmente, no hay claridad acerca de los hallazgos manométricos en pacientes con proctalgia fugaz, y la evidencia muestra diferentes resultados. Se plantea como objetivo en el presente estudio evaluar la presencia de disinergia defecatoria con manometría anorrectal en pacientes colombianos en dos centros de gastroenterología en Bogotá, Colombia. Metodología: Estudio observacional descriptivo de corte transversal en pacientes adultos sometidos a manometría anorrectal con proctalgia fugaz y atendidos en dos centros de gastroenterología de la ciudad de Bogotá entre el 2018 y el 2020. Resultados: Se incluyó a 316 pacientes, predominantemente mujeres (65%), con mediana de edad 45,2 (rango: 18-78; desviación estándar [DE]: 28,3). El 4% de los pacientes presentaban hipertonicidad, el 50% eran normotónicos y el 46%, hipotónicos. En cuanto a parámetros manométricos, el 50% tenía presión normal y el 46%, hipotonía de esfínter anal. El 76% tuvo una prueba de contracción voluntaria normal. En 5% pacientes se documentó disinergia defecatoria, y la más frecuente fue el tipo I, seguido del tipo III. En todos los pacientes se identificó reflejo recto anal inhibitorio, 42% con alteración en umbral sensitivo y 70% con expulsión de balón anormal, y hubo concordancia entre los resultados de la manometría anorrectal y el reporte subjetivo del tacto rectal de la jefe de enfermería que realizó el procedimiento. Conclusiones: Los datos obtenidos en el presente estudio sugieren que la proctalgia no está relacionada con la contractura basal elevada y sostenida del esfínter, pero tampoco con la alteración en la contracción voluntaria, ya que la mayoría de los pacientes presentan valores normales.

Using High-Resolution Anoscopy to Detect Anal Dysplasia Due to Papillomavirus in Patients with Inflammatory Bowel Disease

Introduction: Anal squamous cell carcinoma is rare, but its incidence and mortality have been increasing globally; 90% of cases are related to human papillomavirus (HPV) infection(1,2). Patients with inflammatory bowel disease (IBD) have a higher risk of infection with this virus; an incidence of 5.5 per 100,000 patients has been identified in the IBD group compared to 1.8 in the non-IBD group(3). Materials and methods: A descriptive case series study was conducted with 21 patients with IBD and no perianal symptoms between January and July 2022 at the Institute of Coloproctology in Medellín. They underwent anal cytology, HPV genotyping, and high-resolution anoscopy after explanation and acceptance of the procedure. If lesions were found, ablative treatment was performed. Results: 23% of this cohort had low-grade squamous lesions, while 14.2% had high-grade lesions with dysplasia changes during anoscopy. Besides, 90.4% had positive HPV genotyping, of which 76.1% were high-grade. Conclusions: Our study suggests that this series of patients with IBD behaves as a high-risk group for developing premalignant lesions in association with HPV. High-resolution anoscopy is a cost-effective, painless, and affordable method that, in expert hands, may impact the diagnosis and management of premalignant lesions and decrease the incidence of anal cancer in patients with IBD.

Introducción: El carcinoma anal de células escamosas es raro, pero su incidencia y mortalidad han ido en aumento globalmente. El 90% de los casos están relacionados con la infección por el virus del papiloma humano (VPH)1,2 y los pacientes con enfermedad inflamatoria intestinal (EII) tienen un mayor riesgo de infección por este virus; se ha identificado una incidencia de 5,5 por 100.000 pacientes en el grupo de EII frente a 1,8 en el grupo sin EII3. Metodología: Se realizó un estudio descriptivo de serie de casos en el que se incluyó a 21 pacientes con EII, sin síntomas perianales, entre enero y julio de 2022 en el Instituto de Coloproctología de Medellín, a quienes se les realizó citología anal, genotipificación del VPH y anoscopia de alta resolución, previa explicación y aceptación del procedimiento. Si se encontraban lesiones, se realizaba tratamiento ablativo. Resultados: El 23% de esta cohorte tenía lesiones escamosas de bajo grado, mientras que el 14,2% presentaba lesiones de alto grado con cambios de displasia al momento de la anoscopia. El 90,4% tenían genotipificación positiva para VPH, de los cuales el 76,1% eran de alto grado. Conclusiones: Nuestro estudio sugiere que esta serie de pacientes con EII se comporta como un grupo de alto riesgo para desarrollar lesiones premalignas en asociación con el VPH. La anoscopia de alta resolución es un método rentable, indoloro y asequible que, en manos expertas, puede impactar el diagnóstico y manejo de lesiones premalignas y disminuir la incidencia de cáncer anal en pacientes con EII.

Tofacitinib en el tratamiento de la colitis ulcerosa moderada a grave en Colombia: experiencia en mundo real / Tofacitinib in the treatment of moderate to severe ulcerative colitis in Colombia: Real world experience

Introducción: No hay estudios sobre eficacia de tofacitinib para colitis ulcerosa (CU) en Latinoamérica. Se plantea como objetivo describir la eficacia y seguridad, en mundo real, de pacientes con CU moderada-grave tratados con tofacitinib en nuestro medio. Materiales y métodos: Estudio observacional descriptivo multicéntrico, en pacientes con CU que recibieron tratamiento con tofacitinib en fase de inducción por 8 semanas y luego, terapia de mantenimiento, entre junio de 2019 y junio de 2022. Resultados: Treinta y cuatro pacientes adultos, 50% mujeres, edad media 38,1 (rango 22-72) años. El 76,5% presentó pancolitis y el 20,6% colitis izquierda; el 79,4% fallo a inhibidores del factor de necrosis tumoral (anti-TNF) y el 35,3% a vedolizumab; el 14,7% era naïve a terapia biológica; el 23,5% presentó previamente manifestaciones extraintestinales. Durante la inducción, el 58,8% de los pacientes alcanzaron remisión clínica, bioquímica y endoscópica. En el mantenimiento, el 76,9% de los pacientes a las 26 semanas, y el 66,6% a las 52 semanas, presentaron remisión clínica; 8 pacientes presentaron eventos adversos, ninguno cardiovascular ni tromboembólico. El 44,1% fueron dependientes de esteroides, y el 23,5% requirieron esteroides como terapia de rescate. El 38,3% requirió aumento de tofacitinib a 10mg cada 12h durante el mantenimiento. En el 17,6% se suspendió tofacitinib por ausencia de eficacia. Se incluyeron 3 pacientes en edad pediátrica, femeninas, edad media 15,3 (rango 14-17) años, 2/3 con pancolitis y 1/3 con colitis izquierda, todas con exposición previa a terapia biológica, quienes presentaron remisión clínica, biológica y endoscópica en la inducción. Conclusiones: En este primer estudio latinoamericano con tofacitinib en CU se demuestra eficacia y seguridad en el tratamiento de nuestros pacientes con actividad moderada a grave.(AU)

Introduction: There are no studies on efficacy of tofacitinib for ulcerative colitis (UC) in Latin America. The aim of this study was to describe the efficacy and safety, in the real world, of patients with moderate-severe UC treated with tofacitinib in our setting. Materials and methods: Multicenter descriptive observational study, in patients with UC who received treatment with tofacitinib in induction phase for 8 weeks and then, maintenance therapy, between June 2019 and June 2022. Results: Thirty-four adult patients, 50% female, mean age 38.1 (range 22–72) years. 76.5% pancolitis, and 20.6% left colitis. 79.4% failure to tumor necrosis factor inhibitors (anti-TNFs), and 35.3% to vedolizumab. 14.7% naïve to biologic therapy. 23.5% had previous extraintestinal manifestations. During induction, 58.8% of patients achieved clinical, biochemical and endoscopic remission. During maintenance, 76.9% of patients at 26 weeks and 66.6% at 52 weeks presented clinical remission. Eight patients presented adverse events, none of them cardiovascular or thromboembolic. 44.1% were steroid-dependent, and 23.5% required steroids as rescue therapy. 38.3% required an increase in tofacitinib to 10mg every 12h during maintenance. In 17.6% tofacitinib was discontinued due to lack of efficacy. We included three pediatric-aged female patients, mean age 15.3 (range 14–17) years, 2/3 with pancolitis and 1/3 with left colitis, all with prior exposure to biologic therapy, who had clinical, biologic and endoscopic remission at induction. Conclusions: In this first Latin American study with tofacitinib in UC, efficacy and safety are demonstrated in the treatment of our patients with moderate to severe activity.(AU)

[Health-related quality of life by IBDQ-32 in colombian patients with inflammatory bowel disease in remission: A cross-sectional study]. / Calidad de vida relacionada con la salud por IBDQ-32 en pacientes colombianos con enfermedad inflamatoria intestinal en remisión: Un estudio de corte transversal.

In Colombia there are no data about perception of quality of life (QoL) in inflammatory bowel disease (IBD). The aim of this study was to determine the perception of QoL by means of the IBDQ-32 questionnaire in patients with IBD from a sample of patients from different referral centers. We carried out a cross-sectional study in adults with IBD in clinical remission, in outpatient follow-up, in 3 institutions in different cities, between June 2022 and November 2022, eligible subjects were identified, information was collected on different dates, about socio-demographic and clinical aspects, and the IBDQ-32 questionnaire was evaluated on one occasion. Descriptive and analytical analysis of the variables evaluated was performed. 80 patients, 70% women, mean age 38.5(range 18-72; SD 13.25) years. 67.5% ulcerative colitis (UC), 32.5% Crohn's disease (CD). Moderate QoL involvement (median 150 points, interquartile range118.3-181.5) was found in IBD, in UC median 151 (interquartile range120-174.75) points, while in CD 133 (interquartile range106.25-186.25) points. There was greater involvement in the systemic domain, with median 21 (interquartile range 15.8-27) points, and 18.5 (interquartile range 12.8-25.3) points, for UC and CD, respectively. The least affected corresponded to the digestive domain and social function, in median UC 48.5 (interquartile range 40-58.3), and 27(interquartile range 20.8-33); in median CD 43 (interquartile range 35.5-61.75) and 24.5(interquartile range 18-32.5), respectively. No statistically significant differences were found. This study provides unique information about QoL of patients with IBD in Colombia. It is necessary to continue reinforcing the accompaniment, support, and education of patients with IBD.

Calidad de vida relacionada con la salud por IBDQ-32 en pacientes colombianos con enfermedad inflamatoria intestinal en remisión: Un estudio de corte transversal

En Colombia no hay datos acerca de la percepción de la calidad de vida (CdV) en enfermedad infamatoria intestinal (EII). Se plantea como objetivo determinar la percepción de la CdV mediante el cuestionario IBDQ-32 en pacientes con EII a partir de una muestra de pacientes de diferentes centros de referencia. Se realizó un estudio de corte transversal en adultos, con EII en remisión clínica, en seguimiento ambulatorio, en 3 instituciones en diferentes ciudades, entre junio 2022 a noviembre 2022, se identificaron sujetos elegibles, se recolectó información en fechas distintas, acerca aspectos sociodemográficos y clínicos, se evaluó el cuestionario IBDQ-32 en una ocasión y se realizó análisis descriptivo y analítico de las variables evaluadas. Como resultado, se obtuvieron 80 pacientes, 70% mujeres, edad media 38,5 (rango18-72; SD 13,25) años. 67,5% colitis ulcerosa (CU), 32,5% enfermedad de Crohn (EC). Se encontró compromiso moderado de la CdV (mediana 150 puntos, rango-intercuartílico 118,3-181,5) en EII, en CU mediana 151 (rango-intercuartílico 120-174,75) puntos, mientras en EC 133(rango-intercuartílico 106,25-186,25) puntos. Hubo mayor afección en dominio sistémico, con medianas 21 (rango-intercuartílico 15,8-27) puntos, y 18,5 (rango-intercuartílico 12,8-25,3) puntos, para CU y EC, respectivamente. Y, los menos afectados correspondieron al dominio digestivo y función social, en CU medianas 48,5 (rango-intercuartílico 40-58,3), y 27 (rango-intercuartílico 20,8-33); en EC medianas 43 (rango-intercuartílico 35,5-61,75) y 24,5 (rango-intercuartílico 18-32,5), respectivamente. No se encontraron diferencias estadísticamente significativas. Este estudio aporta información única acerca CdV de los pacientes con EII en Colombia. Se requiere seguir reforzando el acompañamiento, apoyo, y educación a los pacientes con EII.

In Colombia there are no data about perception of quality of life (QoL) in inflammatory bowel disease (IBD). The aim of this study was to determine the perception of QoL by means of the IBDQ-32 questionnaire in patients with IBD from a sample of patients from different referral centers. We carried out a cross-sectional study in adults with IBD in clinical remission, in outpatient follow-up, in 3 institutions in different cities, between June 2022 and November 2022, eligible subjects were identified, information was collected on different dates, about socio-demographic and clinical aspects, and the IBDQ-32 questionnaire was evaluated on one occasion. Descriptive and analytical analysis of the variables evaluated was performed. 80 patients, 70% women, mean age 38.5(range 18-72; SD 13.25) years. 67.5% ulcerative colitis (UC), 32.5% Crohn´s disease (CD). Moderate QoL involvement (median 150 points, interquartile range118.3-181.5) was found in IBD, in UC median 151 (interquartile range120-174.75) points, while in CD 133 (interquartile range106.25-186.25) points. There was greater involvement in the systemic domain, with median 21 (interquartile range 15.8-27) points, and 18.5 (interquartile range 12.8-25.3) points, for UC and CD, respectively. The least affected corresponded to the digestive domain and social function, in median UC 48.5 (interquartile range 40-58.3), and 27(interquartile range 20.8-33); in median CD 43 (interquartile range 35.5-61.75) and 24.5(interquartile range 18-32.5), respectively. No statistically significant differences were found. This study provides unique information about QoL of patients with IBD in Colombia. It is necessary to continue reinforcing the accompaniment, support, and education of patients with IBD.

Clinical and therapeutic characterisation of a multicentre cohort of patients with inflammatory bowel disease in Colombia. / Caracterización clínica y terapéutica de una cohorte multicéntrica de pacientes con enfermedad inflamatoria intestinal en Colombia.

INTRODUCTION: In Latin America and Colombia there are few studies about the clinical and therapeutic characteristics of patients with inflammatory bowel disease (IBD). The objective of this study is to obtain an approximation to these data from a sample of patients from different reference centres in Colombia. PATIENTS AND METHODS: Cross-sectional study in adult and paediatric patients, with IBD, attended ambulatory in 6 institutions in different cities, between 2017 and 2020 information was collected on different dates, about demographic, clinical, and therapeutic aspects. RESULTS: Six hundred and five subjects, 565 (93.4%) adults, mean age 43 years (SD 12.78), 64% with ulcerative colitis (UC). The age at diagnosis of UC was 41.9 years, while in Crohn's disease (CD) it was 47.9 years. In UC, there was greater left involvement (47.2%), and in CD, 42.8% ileocolonic (L3). More than 50% were in mild activity or clinical remission. In UC, the biologic requirement was 27.2%, while in CD, 78%. Overall hospitalisation requirement was 39.5%, and the need for surgery was 37.5% in UC and 62.5% in CD. Also, 40 pediatric patients, 90% female, with UC being more frequent (80%). In UC, 83.3% presented extensive colitis, and in CD, all with ileocolonic localization (L3). More than 95% were in mild activity or remission. Biologic therapy was required in 16.6% and 75% for UC and CD, respectively. The frequency of hospitalisations and surgery was 2.7%. CONCLUSIONS: This study shows some unique characteristics of patients with IBD in Colombia. An earlier diagnosis is required, with a better therapeutic approach.

Tofacitinib in the treatment of moderate to severe ulcerative colitis in Colombia: Real world experience. / Tofacitinib en el tratamiento de la colitis ulcerosa moderada a grave en Colombia: experiencia en mundo real.

INTRODUCTION: There are no studies on efficacy of tofacitinib for ulcerative colitis (UC) in Latin America. The aim of this study was to describe the efficacy and safety, in the real world, of patients with moderate-severe UC treated with tofacitinib in our setting. MATERIALS AND METHODS: Multicenter descriptive observational study, in patients with UC who received treatment with tofacitinib in induction phase for 8 weeks and then, maintenance therapy, between June 2019 and June 2022. RESULTS: Thirty-four adult patients, 50% female, mean age 38.1 (range 22-72) years. 76.5% pancolitis, and 20.6% left colitis. 79.4% failure to tumor necrosis factor inhibitors (anti-TNFs), and 35.3% to vedolizumab. 14.7% naïve to biologic therapy. 23.5% had previous extraintestinal manifestations. During induction, 58.8% of patients achieved clinical, biochemical and endoscopic remission. During maintenance, 76.9% of patients at 26 weeks and 66.6% at 52 weeks presented clinical remission. Eight patients presented adverse events, none of them cardiovascular or thromboembolic. 44.1% were steroid-dependent, and 23.5% required steroids as rescue therapy. 38.3% required an increase in tofacitinib to 10mg every 12h during maintenance. In 17.6% tofacitinib was discontinued due to lack of efficacy. We included three pediatric-aged female patients, mean age 15.3 (range 14-17) years, 2/3 with pancolitis and 1/3 with left colitis, all with prior exposure to biologic therapy, who had clinical, biologic and endoscopic remission at induction. CONCLUSIONS: In this first Latin American study with tofacitinib in UC, efficacy and safety are demonstrated in the treatment of our patients with moderate to severe activity.

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis.

OBJECTIVES: 5-aminosalicylate (mesalazine; 5-ASA) is an established first-line treatment for mild-to-moderate ulcerative colitis (UC). This study aimed to model the benefits of optimising 5-ASA therapy. METHODS: A decision tree model followed 10 000 newly diagnosed patients with mild-to-moderately active UC through induction and 1 year of maintenance treatment. Optimised treatment (maximising dose of 5-ASA and use of combined oral and rectal therapy before treatment escalation) was compared with standard treatment (standard doses of 5-ASA without optimisation). Modelled data were derived from published meta-analyses. The primary outcomes were patient numbers achieving and maintaining remission, with an analysis of treatment costs for each strategy conducted as a secondary outcome (using UK reference costs). RESULTS: During induction, there was a 39% increase in patients achieving remission through the optimised pathway without requiring systemic steroids and/or biologics (6565 vs 4725 for standard). Potential steroidal/biological adverse events avoided included: seven venous thromboembolisms and eight serious infections. Out of the 6565 patients entering maintenance following successful induction on 5-ASA, there was a 21% reduction in relapses when optimised (1830 vs 2311 for standard). This translated into 297 patients avoiding further systemic steroids and 214 biologics. Optimisation led to an average net saving of £272 per patient entering the model for the induction and maintenance of remission over 1 year. CONCLUSION: Modelling suggests that optimising 5-ASA therapy (both the inclusion of rectal 5-ASA into a combined oral and rectal regimen and maximisation of 5-ASA dose) has clinical and cost benefits that supports wider adoption in clinical practice.

Multinational evaluation of clinical decision-making in the treatment and management of mild-to-moderate ulcerative colitis.

OBJECTIVES: To understand current thinking and clinical decision-making in the treatment and management of patients with mild-to-moderate ulcerative colitis (UC). METHODS: This multinational, survey-based study was conducted in 2021. Two meetings were held, involving 11 IBD specialists, that used a series of questions and discussion to identify all factors possibly related to the management of UC. The importance of identified factors was assessed using an online questionnaire covering three scenarios - active disease, remission and patient empowerment. Each factor was scored on a scale of 0 (very-unimportant) to 100 (very-important) within each scenario, by a separate group of healthcare professionals working in IBD. RESULTS: A total of 157 individual factors were identified by the 11 IBD specialists and scored in the three scenarios by 56 respondents (52; 93% specialist gastroenterologists) from Europe and North America (25; 45%), South America (19; 34%) and the Middle East, Asia and Australia (12; 21%). For all scenarios, factors related to educating patients regarding UC and its treatment and understanding of patient goals ranked highest, ahead of clinical considerations regarding disease activity and treatment history. Setting realistic short-term treatment targets was a key consideration. 5-ASA optimisation and use of faecal calprotectin monitoring were core strategies across the three scenarios tested. Support for patients during longer-term management of their disease, starting from initial flare, was an important recurring theme. CONCLUSION: The current management approach for mild-to-moderate UC was found to be guided primarily by the patient's perspectives and goals, alongside assessment of their medical and disease history.

Guía para el manejo de colitis ulcerativa en población adulta (actualización) / Guidelines for the management of ulcerative colitis in the adult population (update)

Resumen Objetivo: desde 2015, la Asociación Colombiana de Gastroenterología, con el apoyo del Instituto de Investigaciones Clínicas de la Universidad Nacional de Colombia, realizó la guía de práctica clínica para el diagnóstico y tratamiento de colitis ulcerativa. Desde la publicación de esta guía, han aparecido nuevas alternativas terapéuticas y nuevos conceptos sobre los objetivos del tratamiento, por lo cual se consideró necesaria su actualización. Materiales y métodos: esta actualización fue realizada por un equipo multi-disciplinario con apoyo de la Asociación Colombiana de Gastroenterología y el Instituto de Investigaciones Clínicas de la Universidad Nacional de Colombia. Se desarrollaron preguntas relevantes a nuevos tratamientos y vigilancia endoscópica de los pacientes adultos con colitis ulcerativa y se realizó la búsqueda de guías nacionales e internacionales en bases de datos especializadas. Las guías fueron evaluadas en términos de calidad y aplicabilidad. El Grupo Cochrane llevó a cabo la búsqueda sistemática de la literatura. Las tablas de evidencia y recomendaciones fueron realizadas usando la metodología GRADE. Resultados: se realizó una actualización de la guía para el tratamiento de la colitis ulcerativa en adultos en Colombia y se diseñaron nuevos algoritmos de tratamiento, teniendo en cuenta la extensión y la actividad de la enfermedad y los diferentes niveles de atención. Conclusiones: se estableció la importancia para el tratamiento de la evaluación clínica y endoscópica y se especificaron las indicaciones para el adecuado tratamiento de los pacientes con colitis ulcerativa. Adicionalmente, se dieron recomendaciones de vigilancia endoscópica de cáncer colorrectal y la importancia de la cromoendoscopia.

Abstract Objective: In 2015, the Asociación Colombiana de Gastroenterología (Colombian Association of Gastroenterology), with the support of the Institute of Clinical Research of the Universidad Nacional de Colombia, created the Clinical Practice Guideline for the diagnosis and treatment of ulcerative colitis. Since then, new therapeutic alternatives and concepts about treatment goals have emerged, making it necessary to update its contents. Materials and methods: The present update was carried out by a multidisciplinary team with support from the Asociación Colombiana de Gastroenterología and the Clinical Research Institute of the Universidad Nacional de Colombia. Questions regarding new treatments and endoscopic surveillance of adult patients with ulcerative colitis were developed, and national and international guidelines were searched in specialized databases. The guidelines were evaluated in terms of quality and applicability. The Cochrane Group conducted a systematic search of the existing literature, and evidence tables and recommendations were made using the GRADE methodology. Results: The guideline for the treatment of ulcerative colitis in adults in Colombia was updated, and new treatment algorithms were designed, taking into account the extent and activity of the disease and the different levels of care. Conclusions: The relevance of clinical and endoscopic assessment for treatment was established, and the indications for the proper management of patients with ulcerative colitis were specified. Furthermore, recommendations were made for endoscopic surveillance of colorectal cancer, and the importance of chromoendoscopy was established.

El papel de los biosimilares en la enfermedad inflamatoria intestinal: una realidad en nuestro país / The Role of Biosimilars in Inflammatory Bowel Disease: A Reality in our Country

Resumen La enfermedad inflamatoria intestinal (EII) es un término con el que se conocen varias entidades, las 2 más importantes son: la colitis ulcerativa idiopática (CUI) y la enfermedad de Crohn (EC), cuyo origen es multifactorial y se caracterizan por un fenómeno inflamatorio, crónico, recurrente con diferentes grados de severidad del tubo digestivo; pero además con afectación potencial de otros órganos. En la última década ha habido un renovado interés en dichas entidades, debido a una incidencia creciente de estas, pero también debido al desarrollo de medicamentos que por primera vez están cambiando la historia natural de estas enfermedades: son los medicamentos llamados biológicos, que son aquellos producidos o derivados de organismos vivos y representan el sector de mayor crecimiento en la industria farmacéutica mundial. Debido al interés comercial, se han desarrollado y sometido a las autoridades reguladoras productos no originadores; similares, pero no idénticos a los productos de referencia. La Agencia Europea de Medicamentos (EMA) aprobó el primer biosimilar del infliximab para todas las indicaciones en las cuales este estaba aprobado, incluidas: colitis ulcerativa moderada a severa en todas las edades, EC moderada a severa en todas las edades, al igual que EC fistulizante, artritis psoriásica (AP), psoriasis, espondilitis anquilosante (EA) y artritis reumatoide (AR) (1). En esta revisión nos proponemos definir lo que son estos productos al igual que algunos conceptos relacionados (extrapolación, sustitución e intercambiabilidad), además hacer una revisión histórica de su desarrollo, sus indicaciones actuales, las posiciones de las diferentes asociaciones científicas al respecto y, lo más importante, brindar datos de la vida real en cuanto a su efectividad, seguridad y costos en los diferentes países donde se han estado usando.

Abstract The term Inflammatory Bowel Disease (IBD) is used to identify several entities, the two most important of which are Idiopathic Ulcerative Colitis (IUC) and Crohn's Disease (EC). Both are multifactorial in origin, are chronic and recurrent, are characterized by inflammation, have varying degrees of severity, and potentially involve other organs. In the last decade there has been renewed interest in these entities due to growing incidence and to the development of drugs called biologicals. For the first time, these drugs have changed the natural history of these diseases. They are produced or derived from living organisms and represent the fastest growing sector in the global pharmaceutical industry. Due to commercial interest, products similar but not identical to the original products have been developed and submitted to regulatory authorities. The European Medicines Agency has approved the first biosimilar for infliximab for all indications for which it has been approved. These include moderate to severe ulcerative colitis (UC) at all ages, moderate to severe Crohn's disease (CD) at all ages, fistulizing Crohn's disease, Psoriasic arthritis, Psoriasis, Ankylosing Spondylitis, and Rheumatoid Arthritis. 1 In this review, we define what these products are, as well as some concepts coined for their usage including extrapolation, substitution and interchangeability. We also make a historical review of their development, current indications, the positions of various scientific associations with respect to them, and - most importantly - provide real-life data regarding their effectiveness, safety and costs in countries where they have been used.

Clinical manifestations of colorectal cancer patients from a large multicenter study in Colombia.

Colorectal cancer (CRC) is a major public health problem, and its incidence is rising in developing countries. However, studies characterizing CRC clinicopathological features in cases from developing countries are still lacking. The goal of this study was to evaluate clinicopathological and demographic features in one of the largest CRC studies in Latin America.The study involved over 1525 CRC cases recruited in a multicenter study in Colombia between 2005 and 2014 as part of ongoing genetic and epidemiological studies. We gathered clinicopathological data such as age at diagnosis, sex, body mass index, tobacco and alcohol consumption, family history of cancer, and tumor features including location, histological type, and stage. Statistical analyses were performed to test the association between age of onset, sex, and clinical manifestations.The average age at CRC diagnosis was 57.4 years, with 26.5% of cases having early-onset CRC (diagnosed by age 50 years). Most cases were women (53.2%; P = 0.009), 49.2% were overweight or obese, 49.1% were regular alcohol drinkers, 52% were smokers/former smokers, and 12.2% reported relatives with cancer. Most tumors in the study were located in the rectum (42.7%), were adenocarcinomas (91.5%), and had advanced stage (T3-T4, 79.8%). Comparisons by sex found that male cases were more likely to be obese (36.5% vs 31.1%; P = 0.001), less likely to have a family history of cancer (9.7% vs 15.3%; P = 0.016), and more likely to have advanced-stage tumors (83.9% vs 76.1%; P = 0.036). Comparisons by age of onset found that early-onset cases were more likely to be women (59.3% vs 51.0%; P = 0.005) and report a family history of cancer (17.4% vs 10.2%; P = 0.001).To our knowledge, our study is the largest report of clinicopathological characterization of Hispanic CRC cases, and we suggest that further studies are needed to understand CRC etiology in diverse Hispanic populations.

Argón plasma versus formol al 4 por ciento en el manejo endoscópico de la proctitis actínica sangrante / Argon plasma coagulation versus aplication of 4 percent formalin for the treatment of radiation induced hemorrhagic proctitis

Antecedentes: la proctitis actínica es una complicación frecuente de la radioterapia para neoplasias pélvicas. En su forma más severa puede llevar a hemorragias masivas con necesidad de atención hospitalaria repetida y transfusiones de sangre. La terapia médica de la proctitis actínica es frecuentemente inefectiva, mientras que la cirugía cursa con una alta morbimortalidad.Objetivos: se pretende comparar los resultados terapéuticos con el argón plasma (AP) (ERBE USA, Inc., Marietta, GA, USA) en pacientes con hemorragia inducida por la proctitis actínica versus una cohorte histórica manejada con la instilación endoscópica de formol al 4 por ciento.Materiales y métodos: el AP se aplicó atendiendo a la técnica de "no tocar" con una potencia de 50-60 Watt y a un flujo de argón de 2 l/min. Se predeterminó una duración de los pulsos inferiores a 1 segundo. El tratamiento se hizo a intervalos de cada 2 a 4 semanas cuando se requirió. La terapia con formol al 4 por ciento se hizo por un operador usando 20 ml e instilándolo directamente al recto por 5 minutos mediante un endoscopio flexible. Se pretende con la técnica un contacto no muy prolongado con el formol. Resultados: los dos grupos son comparables en términos de edad, género y diagnóstico. En 26 pacientes (24 mujeres) con hemorragia por proctitis actínica se aplicó formol al 4 por ciento y 21 se trataron con AP (18 mujeres). Los pacientes que recibieron formol tuvieron la radioterapia en promedio 14 meses atrás (rango 7-28) y los tratados con AP de 9 meses (rango 6-18). El tiempo promedio de sangrado antes de la terapia fue de 7 meses (rango de 4-14) para el tratamiento con formol y de 5,5 meses (rango 3-11) para el grupo con AP. El promedio de administración de unidades de sangre fue de 2,6 unidades (rango 0-6) para el grupo con formol y de 1,8 (rango de 0-4) para los tratados con AP. En el grupo con formol tres pacientes requirieron más de una terapia y en el grupo con AP cuatro pacientes. No hubo necesidad...

Ulcera rectal solitaria / The solitary rectal ulcer syndrome

El Sindrome de Ulcera Rectal Solitaria (SURS) es un desorden poco frecuente no maligno y de etiologia obscura, caracterizado por cuatro componentes basicos para su diagnostico: historia de evacuacion dolorosa incompleta con sangrado y moco copioso, evidencia de prolapso rectal en la defecografia, ulceracion rectal unica, multiple o ausente con o sin eritema y engrosamiento de la lamina propia histologicamente. La asociacion entre el prolapso rectal y la (URS) es cada vez mas clara, aunque solo una tercera parte de los pacientes tienen sintomas lo suficientemente incapacitantes como para requerir cirugia y otra tercera parte han estado mal diagnosticados. Es por lo anterior que el exito de un diagnostico temprano y correcto es tener la (URS) siempre presente, tanto por parte del clinico como del radiologo y del patologo