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The prevalence of penetrating complications in Crohn's disease (CD) increases progressively over time, but evidence on the medical treatment in this setting is limited. The aim of this study was to evaluate the effectiveness of biologic agents in CD complicated with internal fistulizing disease.Adult patients with CD-related fistulae who received at least one biologic agent for this condition from the prospectively-maintained ENEIDA registry were included. Exclusion criteria involved those receiving biologics for perianal disease, enterocutaneous, rectovaginal, anastomotic or periostomal fistulae. The primary endpoint was fistula-related surgery. Predictive factors associated with surgery and fistula closure were evaluated by multivariate logistic regression and survival analyses.A total of 760 patients from 53 hospitals (673 receiving anti-TNFs, 69 ustekinumab, and 18 vedolizumab) were included. After a median follow-up of 56 months (IQR, 26-102), 240 patients required surgery, with surgery rates of 32%, 41%, 24% among those under anti-TNF, vedolizumab, or ustekinumab, respectively. Fistula closure was observed in 24% of patients. Older patients, ileocolonic disease, entero-urinary fistulae, or an intestinal stricture distal to the origin of the fistula were associated with a higher risk of surgery, while non-smokers, and combination therapy with an immunomodulator reduced this risk.Biologic therapy is beneficial in approximately three quarters of patients with fistulizing CD, achieving fistula closure in 24%. However, around one third still undergo surgery due to refractory disease. Some patient and lesion-related factors can identify patients who will obtain more benefit from these drugs.

Background The effectiveness of the switch to another anti–tumor necrosis factor (anti-TNF) agent is not known. The aim of this study was to analyze the effectiveness and safety of treatment with a second and third anti-TNF drug after intolerance to or failure of a previous anti-TNF agent in inflammatory bowel disease (IBD) patients. Methods We included patients diagnosed with IBD from the ENEIDA registry who received another anti-TNF after intolerance to or failure of a prior anti-TNF agent. Results A total of 1122 patients were included. In the short term, remission was achieved in 55% of the patients with the second anti-TNF. The incidence of loss of response was 19% per patient-year with the second anti-TNF. Combination therapy (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.8–3; P < 0.0001) and ulcerative colitis vs Crohn’s disease (HR, 1.6; 95% CI, 1.1–2.1; P = 0.005) were associated with a higher probability of loss of response. Fifteen percent of the patients had adverse events, and 10% had to discontinue the second anti-TNF. Of the 71 patients who received a third anti-TNF, 55% achieved remission. The incidence of loss of response was 22% per patient-year with a third anti-TNF. Adverse events occurred in 7 patients (11%), but only 1 stopped the drug. Conclusions Approximately half of the patients who received a second anti-TNF achieved remission; nevertheless, a significant proportion of them subsequently lost response. Combination therapy and type of IBD were associated with loss of response. Remission was achieved in almost 50% of patients who received a third anti-TNF; nevertheless, a significant proportion of them subsequently lost response.

RESUMEN Introducción: la sedación profunda con propofol controlada por endoscopista en las diferentes unidades de endoscopia ha sido un tema de continua controversia a lo largo de los últimos años, origen de conflictos de intereses entre las distintas sociedades científicas de Anestesiología y Gastroenterología. Numerosos estudios han demostrado ya la eficacia, eficiencia y escasa aparición de complicaciones en la sedación controlada por un endoscopista formado frente al anestesiólogo. Material y métodos: hemos revisado en nuestra base de datos el porcentaje de complicaciones cardio-respiratorias graves en nuestra unidad, en el periodo comprendido entre 2011 y 2016, en las distintas exploraciones endoscópicas que realizamos (gastroscopia, colonoscopia, colangiopancreatografía retrógrada endoscópica [CPRE] y ecoendoscopia [USE]) y cuya sedación es controlada por un endoscopista. Resultados: se llevó a cabo el análisis de 33.195 exploraciones durante el periodo de estudio. Obtuvimos un 0,13% de complicaciones cardio-respiratorias, la mayor parte de ellas desaturaciones graves (la mayoría respondieron a la apertura de la vía aérea asociada a la interrupción de la infusión del fármaco, precisando la necesidad de ambú en contadas ocasiones). No existieron diferencias estadísticamente significativas entre los diferentes grupos excepto en edad media, riesgo por tipo de exploración y riesgo ASA, donde la CPRE presentó una p < 0,01 frente al resto de exploraciones. Conclusión: con los datos de los que disponemos hasta la actualidad, existen numerosas evidencias en la literatura científica para divulgar que la sedación de las endoscopias controlada por un endoscopista formado es segura, eficaz y eficiente. No obstante, deben realizarse más estudios prospectivos que confirmen estas suposiciones, ya que hasta el momento la mayoría de los estudios son retrospectivos.