Trends in Targeted Therapy Usage in Inflammatory Bowel Disease: TRENDY Study of ENEIDA.

Markers that allow for the selection of tailored treatments for individual patients with inflammatory bowel diseases (IBD) are yet to be identified. Our aim was to describe trends in real-life treatment usage. For this purpose, patients from the ENEIDA registry who received their first targeted IBD treatment (biologics or tofacitinib) between 2015 and 2021 were included. A subsequent analysis with Machine Learning models was performed. The study included 10,009 patients [71% with Crohn's disease (CD) and 29% with ulcerative colitis (UC)]. In CD, anti-TNF (predominantly adalimumab) were the main agents in the 1st line of treatment (LoT), although their use declined over time. In UC, anti-TNF (mainly infliximab) use was predominant in 1st LoT, remaining stable over time. Ustekinumab and vedolizumab were the most prescribed drugs in 2nd and 3rd LoT in CD and UC, respectively. Overall, the use of biosimilars increased over time. Machine Learning failed to identify a model capable of predicting treatment patterns. In conclusion, drug positioning is different in CD and UC. Anti-TNF were the most used drugs in IBD 1st LoT, being adalimumab predominant in CD and infliximab in UC. Ustekinumab and vedolizumab have gained importance in CD and UC, respectively. The approval of biosimilars had a significant impact on treatment.

Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.

Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders. Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders. Design: This was a retrospective and multicentre study. Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI). Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis (n = 37) or Crohn's disease of the pouch (n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy. Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option.

Evaluation of the effectiveness and safety of single-operator cholangiopancreatoscopy with the SpyGlass™ system / Evaluación de la eficacia y seguridad de la colangiopancreatoscopia de un solo operador con el sistema SpyGlass®

Background and study aims The single-operator cholangiopancreatoscopy (SOCP) with the SpyGlass™ system is a endoscopy technique whose use has grown exponentially in recent years. The aims of this study were to evaluate the efficacy and safety of SOCP with SpyGlass™ and determine the factors related to the onset of adverse events (AEs). Patients and methods Retrospective study at a single tertiary institution with inclusion of all consecutive patients undergoing SOCP with SpyGlass™ from February-2009 to December-2021. No exclusion criteria were considered. A descriptive statistical analysis was performed. The factors associated with the existence of AE were analyzed using Chi-square and Student's t-test. Results A total of 95 cases were included. The most common indications were biliary strictures (BS) evaluation (66.3%) or treatment of difficult common bile duct stones (27.4%). Technical and clinical success was attained in 98.9%. Single-session stone clearance was obtained in 84%. The AE rate was 7.4%. To detect malignancy in BS, optical diagnosis presents a sensitivity and specificity of 100% and 91.2%, respectively; while histology results were 36.4% and 100% respectively. A previous endoscopic sphincterotomy was associated with a lower rate of AEs (2.4% vs 41.7%; p < 0.001). Conclusions SOCP with SpyGlass™ is a safe and effective technique to diagnose and treat pancreatobiliary pathology. The presence of sphincterotomy performed prior to the procedure could improve the technique's safety (AU)

Antecedentes y objetivos del estudio La colangiopancreatoscopia de un solo operador (SOCP) con el sistema SpyGlass® es una técnica endoscópica cuyo uso ha crecido exponencialmente durante los últimos años. Los objetivos de este estudio fueron evaluar la eficacia y seguridad de la SOPC con SpyGlass® y determinar los factores relacionados con la aparición de eventos adversos (EA). Pacientes y métodos Estudio retrospectivo realizado en un único centro terciario, con inclusión consecutiva de todos los pacientes sometidos a SOCP con SpyGlass® desde febrero de 2009 hasta diciembre de 2021. No hubo criterios de exclusión. Se realizó un análisis estadístico descriptivo. Los factores asociados a la aparición de EA se analizaron mediante χ2 y la prueba t de Student. Resultados Se incluyeron un total de 95 casos. Las indicaciones más frecuentes fueron la evaluación de estenosis biliares (EB) (66,3%) o el tratamiento de coledocolitiasis difícil (27,4%). El éxito técnico y clínico se logró en 98,9%. La extracción de todas las litiasis en una sola sesión se obtuvo en 84%. La tasa de EA fue de 7,4%. Para la detección de malignidad en EB, el diagnóstico óptico presenta una sensibilidad y especificidad de 100% y 91,2%, respectivamente; mientras que los resultados de la histología fueron 36,4 y 100%, respectivamente. La esfinterotomía endoscópica previa se asocia con una menor tasa de EA (2,4 vs. 41,7%; p < 0,001). Conclusiones La SOCP con SpyGlass® es una técnica segura y eficaz para diagnosticar y tratar la patología biliopancreática. La presencia de esfinterotomía previa al procedimiento podría mejorar la seguridad de la técnica (AU)

Evaluation of the effectiveness and safety of single-operator cholangiopancreatoscopy with the SpyGlass™ system.

BACKGROUND AND STUDY AIMS: The single-operator cholangiopancreatoscopy (SOCP) with the SpyGlass™ system is a endoscopy technique whose use has grown exponentially in recent years. The aims of this study were to evaluate the efficacy and safety of SOCP with SpyGlass™ and determine the factors related to the onset of adverse events (AEs). PATIENTS AND METHODS: Retrospective study at a single tertiary institution with inclusion of all consecutive patients undergoing SOCP with SpyGlass™ from February-2009 to December-2021. No exclusion criteria were considered. A descriptive statistical analysis was performed. The factors associated with the existence of AE were analyzed using Chi-square and Student's t-test. RESULTS: A total of 95 cases were included. The most common indications were biliary strictures (BS) evaluation (66.3%) or treatment of difficult common bile duct stones (27.4%). Technical and clinical success was attained in 98.9%. Single-session stone clearance was obtained in 84%. The AE rate was 7.4%. To detect malignancy in BS, optical diagnosis presents a sensitivity and specificity of 100% and 91.2%, respectively; while histology results were 36.4% and 100% respectively. A previous endoscopic sphincterotomy was associated with a lower rate of AEs (2.4% vs 41.7%; p<0.001). CONCLUSIONS: SOCP with SpyGlass™ is a safe and effective technique to diagnose and treat pancreatobiliary pathology. The presence of sphincterotomy performed prior to the procedure could improve the technique's safety.

Impact of a colorectal cancer screening program implantation on delays and prognosis of non-screening detected colorectal cancer.

BACKGROUND: The implementation of a colorectal cancer (CRC) screening programme may increase the awareness of Primary Care Physicians, reduce the diagnostic delay in CRC detected outside the scope of the screening programme and thus improve prognosis. AIM: To determine the effect of implementation of a CRC screening programme on diagnostic delays and prognosis of CRC detected outside the scope of a screening programme. METHODS: We performed a retrospective intervention study with a pre-post design. We identified 322 patients with incident and confirmed CRC in the pre-implantation cohort (June 2014 - May 2015) and 285 in the post-implantation cohort (June 2017 - May 2018) in the Cancer Registry detected outside the scope of a CRC screening programme. In each patient we calculated the different healthcare diagnostics delays: global, primary and secondary healthcare, referral and colonoscopy-related delays. In addition, we collected the initial healthcare that evaluated the patient, the home location (urban/rural), and the CRC stage at diagnosis. We determined the two-year survival and we performed a multivariate proportional hazard regression analysis to determine the variables associated with survival. RESULTS: We did not detect any differences in the patient or CRC baseline-related variables. A total of 20.1% of patients was detected with metastatic disease. There was a significant increase in direct referral to colonoscopy from primary healthcare (25.5%, 35.8%; P = 0.04) in the post-implantation cohort. Diagnostic delay was reduced by 24 d (106.64 ± 148.84 days, 82.84 ± 109.31 d; P = 0.02) due to the reduction in secondary healthcare delay (46.01 ± 111.65 d; 29.20 ± 60.83 d; P = 0.02). However, we did not find any differences in CRC stage at diagnosis or in two-year survival (70.3%; P = 0.9). Variables independently associated with two-year risk of death were age (Hazard Ratio-HR: 1.06, 95%CI: 1.04-1.07), CRC stage (II HR: 2.17, 95%CI: 1.07-4.40; III HR: 3.07, 95%CI: 1.56-6.08; IV HR: 19.22, 95%CI: 9.86-37.44; unknown HR: 9.24, 95%CI: 4.27-19.99), initial healthcare consultation (secondary HR: 2.93, 95%CI: 1.01-8.55; emergency department HR: 2.06, 95%CI: 0.67-6.34), hospitalization during the diagnostic process (HR: 1.67, 95%CI: 1.17-2.38) and urban residence (HR: 1.44, 95%CI: 1.06-1.98). CONCLUSION: Although implementation of a CRC screening programme can reduce diagnostic delays for CRC detected in symptomatic patients, this has no effect on CRC stage or survival.