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.

Complicaciones asociadas al reservorio ileal en colitis ulcerativa versus poliposis familiar adenomatosa: Impacto en la calidad de vida del paciente / Ileal reservoir-associated complications in ulcerative colitis versus familial adenomatous polyposis: Impact on patient quality of life

Antecedentes: La proctocolectomía con reservorio es el procedimiento quirúrgico de elección para los pacientes con colitis ulcerosa y poliposis adenomatosa familiar. Objetivos: Evaluar las complicaciones posoperatorias a largo plazo (1994-2019) en pacientes operados por poliposis familiar adenomatosa (PFA) y colitis ulcerativa (CU) y el grado de satisfacción con la intervención. Métodos: Estudio observacional basado en el análisis de una base de datos retrospectiva con seguimiento prospectivo en 115 pacientes consecutivos: 79 con CU y 36 con PFA. Se ha realizado el seguimiento de un total de 88 pacientes, 60 con CU y 28 con PFA. Resultados: Se evaluaron 48 varones (54,4%) con una edad media de 44,8 ± 10,6 años. Las indicaciones para la cirugía fueron enfermedad intratable en 54 pacientes (47%), displasia/cáncer en 43 (37%), sangrado severo en cuatro (4%) y perforación en tres (3%). Se realizó una proctectomía y mucosectomía del muñón rectal en 67 (76,1%), y una técnica de doble grapado en 21. Se realizó una ileostomía protectora en todos los pacientes con CU y PFA. No se encontraron diferencias en las complicaciones tempranas entre los dos grupos. Las complicaciones tardías mostraron una mayor tasa de reservoritis en los pacientes de la CU respecto a la PFA (44,9 vs. 14,3%, p = 0,001), con más reservoritis refractaria en el grupo de la CU (13,3 vs. 0%, p = 0,04) sin diferencias en cuanto a obstrucción intestinal, estenosis o fístulas anastomóticas. La satisfacción general y la adaptación se consideraron buenas en el 87% de los pacientes con CU y solo en el 57% del grupo de PFA (p < 0,01). Conclusiones: La proctocolectomía con reservorio ileal tiene una morbilidad y mortalidad comparables, excepto por la mayor tasa de reservoritis en los pacientes con antecedentes de CU, a pesar de esta contingencia hay una mejor calidad de vida y mayor aceptación de la cirugía en los pacientes con CU que en los pacientes con PFA.(AU)

Background: Proctocolectomy with ileal reservoir is the surgical procedure of choice for patients with ulcerative colitis and familial adenomatous polyposis. Objectives: To evaluate long-term postoperative complications (1994-2019) in patients operated for familial adenomatous polyposis (FAP) and ulcerative colitis (UC) and the degree of satisfaction with the procedure. Methods: Observational study based on the analysis of a retrospective database with prospective follow-up in 115 consecutive patients: 79 with UC and 36 with FAP. A total of 88 patients were followed up, 60 with UC and 28 with PFA. Results: 48 males (54.4%) with a mean age of 44.8 ± 10.6 years were evaluated. Indications for surgery were intractable disease in 54 patients (47%), dysplasia/cancer in 43 (37%), severe bleeding in 4 (4%) and perforation in 3 (3%). A proctectomy and mucosectomy of the rectal stump was performed in 67 (76.1%), and a double stapling technique in 21. A protective ileostomy was performed in all patients with UC and FAP. No differences were found in early complications between the two groups. Late complications showed a higher rate of reservoritis in UC patients compared to FAP (44.9 vs. 14.3%, p = 0.001), with more refractory reservoritis in the UC group (13.3 vs. 0%, p = 0.04) with no differences in bowel obstruction, strictures, or anastomotic fistulas. Overall satisfaction and adaptation were considered good in 87% of UC patients and only 57% in the FAP group (p < 0.01). Conclusions: Proctocolectomy with ileal reservoir has comparable morbidity and mortality, except for the higher rate of reservoritis in patients with a history of UC, despite this contingency there is a better quality of life and greater acceptance of surgery in UC patients than in FAP patients.(AU)

Changes in the management of IBD patients since the onset of COVID-19 pandemic. A path toward the implementation of telemedicine in Spain? / Cambios en el manejo de la EII desde la pandemia por COVID-19. ¿Un nuevo inicio de la telemedicina en España?

Background: COVID-19 pandemic increased medical services demand aside from interrupting daily clinical practice for other diseases such as inflammatory bowel disease (IBD). Here we present the results of a survey to gain the perception of IBD specialists in their patient-management using telemedicine in their daily practice. Methods: This was an observational survey study among physicians focused on IBD (gastroenterologist, surgeons, and pediatricians) members of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU), the Spanish Association of Gastroenterology (AEG), and the Spanish Association of Coloproctology (AECP), regarding changes of management of IBD patients. Results: We received a total of 269 responses to the survey (from May to June 2020). Before the pandemic, nearly all the respondents reported performing very frequently their visits face-to-face (n=251, 93.3%) while, during the pandemic, the telephone visits were the most frequent visits performed (n=138, 51.3%). Regarding communication difficulties, 157 (58.4%) respondents reported the impossibility of performing a proper examination as the most relevant issue. Also, 114 (42.4%) respondents considered remote visits more time-consuming than face-to-face visits. Most gastroenterologists (n=188, 83.2%) considered patients with active perianal disease in special need of face-to-face consultation and more than half of the surgeons (n=35, 50.7%) reported having performed an immediate postoperative follow-up remotely. Conclusions: Most IBD units have implemented remote visits during the pandemic, but most professionals found them more time-consuming and unsuitable for some disease profiles. Therefore, there is a need for the development of better telemedicine systems that can meet professionals’ and patients’ requirements.(AU)

Introducción: La pandemia por COVID-19ha supuesto un incremento en la demanda de atención sanitaria y ha modificado el modelo asistencial de algunas patologías como la enfermedad inflamatoria intestinal (EII). Presentamos los resultados de una encuesta sobre el papel de la telemedicina en el manejo de pacientes con EII. Material y métodos: Estudio observacional mediante encuesta dirigida a gastroenterólogos, cirujanos y pediatras especializados en EII, miembros del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa, la Asociación Española de Gastroenterología y/o la Asociación Española de Coloproctología. Resultados: Recibimos un total de 269 respuestas (mayo a junio de 2020). Antes de la pandemia, el 93,3% de los participantes afirmó llevar a cabo la mayor parte de sus consultas de manera presencial. Durante la pandemia, la consulta telefónica se ha convertido en la modalidad preferida por el 51,3%. El principal inconveniente de la asistencia telemática fue la imposibilidad de llevar a cabo una exploración física según el 58,4%. Además, el 42,4% aseguró emplear más tiempo en este tipo de consultas. Entre gastroenterólogos, el 83,2% consideró que el paciente que más puede beneficiarse de la visita presencial es aquel con enfermedad perianal activa. Y, por último, el 50,7% de los cirujanos afirmó haber realizado controles remotos en el postoperatorio inmediato. Conclusiones: Si bien las unidades de EII han implementado durante la pandemia herramientas de telemedicina, muchos de los encuestados encontraron dificultades en su implementación. Es necesario adecuar y mejorar estos nuevos canales de asistencia remota para satisfacer las necesidades de profesionales y pacientes.(AU)

Rapidity of clinical response to adalimumab and improvement of quality of life in luminal Crohn's disease: RAPIDA study.

OBJECTIVE: No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. PATIENTS AND METHODS: RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation. RESULTS: Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI<5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p<0.0001). CONCLUSION: Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.

Relationship between IGF-1 and body weight in inflammatory bowel diseases: Cellular and molecular mechanisms involved.

Inflammatory bowel diseases (IBD), represented by ulcerative colitis (UC) and Crohn's disease (CD), are characterized by chronic inflammation of the gastrointestinal tract, what leads to diarrhea, malnutrition, and weight loss. Depression of the growth hormone-insulin-like growth factor-1 axis (GH-IGF-1 axis) could be responsible of these symptoms. We demonstrate that long-term treatment (54 weeks) of adult CD patients with adalimumab (ADA) results in a decrease in serum IGF-1 without changes in serum IGF-1 binding protein (IGF1BP4). These results prompted us to conduct a preclinical study to test the efficiency of IGF-1 in the medication for experimental colitis. IGF-1 treatment of rats with DSS-induced colitis has a beneficial effect on the following circulating biochemical parameters: glucose, albumin, and total protein levels. In this experimental group we also observed healthy maintenance of colon size, body weight, and lean mass in comparison with the DSS-only group. Histological analysis revealed restoration of the mucosal barrier with the IGF-1 treatment, which was characterized by healthy quantities of mucin production, structural maintenance of adherers junctions (AJs), recuperation of E-cadherin and ß-catenin levels and decrease in infiltrating immune cells and in metalloproteinase-2 levels. The experimentally induced colitis caused activation of apoptosis markers, including cleaved caspase 3, caspase 8, and PARP and decreases cell-cycle checkpoint activators including phosphorylated Rb, cyclin E, and E2F1. The IGF-1 treatment inhibited cyclin E depletion and partially protects PARP levels. The beneficial effects of IGF-1 in experimental colitis could be explained by a re-sensitization of the IGF-1/IRS-1/AKT cascade to exogenous IGF-1. Given these results, we postulate that IGF-1 treatment of IBD patients could prove to be successful in reducing disease pathology.

Riesgo de infección asociado a los inhibidores de las quinasas Janus (JAK) y las terapias biológicas en enfermedad inflamatoria intestinal y artritis reumatoide. Estrategias de prevención / Risk of infection associated with Janus Kinase (JAK) inhibitors and biological therapies in inflammatory intestinal disease and rheumatoid arthritis. Prevention strategies

Los pacientes con ciertas enfermedades inflamatorias mediadas inmunológicamente, como la artritis reumatoide (AR) y la enfermedad inflamatoria intestinal (EII), presentan una mayor incidencia y gravedad de enfermedades infecciosas que la población general, asociadas especialmente a los tratamientos inmunosupresores que reciben.Dichos tratamientos actúan sobre el sistema inmunitario a través de diferentes mecanismos, causando diferentes grados de inmunosupresión y un riesgo variable dependiendo de si el patógeno es un virus, una bacteria o un hongo. Este artículo es una revisión de la bibliografía más relevante sobre el tema, seleccionada y debatida por un panel de expertos. El objetivo de este artículo es revisar el riesgo de infecciones en pacientes con EII y AR y las potenciales medidas preventivas.(AU)

Patients with certain immune-mediated inflammatory diseases, such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), have an increased risk of severe infectious diseases than the general population, which are mainly associated with the immunosuppressive treatments that they receive.These treatments act on the immune system through different mechanisms, causing different degrees of immunosuppression and a variable risk depending on whether the pathogen is a virus, bacteria or fungus. This article reviews the most relevant literature on the subject, which was selected and discussed by a panel of experts. The aim of this article is to review the risk of infections in patients with IBD and RA, and the potential preventive measures.(AU)

Oral budesonide in gastrointestinal and liver disease: A practical guide for the clinician.

Oral budesonide is a second-generation steroid that allows local, selective treatment of the gastrointestinal tract and the liver, minimizing systemic exposure. The results of randomized trials comparing budesonide versus placebo or active comparators have led to expert recommendations that budesonide be used to treat mild or moderate active ileocecal Crohn's disease, microscopic colitis (including both collagenous and lymphocytic colitis), ulcerative colitis, and non-cirrhotic autoimmune hepatitis. The mechanism of budesonide action obviates the need for dose tapering due to safety reasons after induction therapy. Where low-dose budesonide is used to maintain remission, usually in microscopic colitis, it does not appear to have adverse safety implications other than slight reductions in cortisol levels on rare occasions. As a gut-selective and liver-selective corticosteroid, budesonide offers an appealing alternative to conventional systemic glucocorticoids in diseases of these organs.

Epidemiology and hospital resources use in the treatment of ulcerative colitis at gastroenterology units in Spain (EPICURE study).

BACKGROUND AND AIM: Nationwide epidemiological data on ulcerative colitis (UC) in Spain are lacking. The primary objective was to assess the epidemiology of UC at hospital gastroenterology units and the use of hospital resources (characteristics and facilities) for the management of UC in Spain. METHODS: A retrospective, multicenter, epidemiological, cross-sectional study (EPICURE study) analyzed data from hospital registries and records from UC patients admitted and treated in 2011 at a representative selection of Spanish sites. The prevalence of UC in gastroenterology units was calculated as the total UC patients divided by the total inhabitants covered by those sites. Incidence was defined as the number of new UC cases during 2011 divided by the total inhabitants covered by those sites. RESULTS: In 2011, a total of 42,000 patients were attended for UC in gastroenterology units in Spain with a prevalence rate of 88.7 UC cases (95% CI: 69.6-106.0) per 100,000 inhabitants. The incidence rate was of 5.7 cases (95% CI: 1.2-10.8)/100,000 inhabitants. Six percent of patients being attended for UC were hospitalized in the 58 units analyzed in 2011. There were 1075 hospitalizations related to UC in total (approximately 14 per gastroenterology unit; median hospital stay length: 8 days). Six out of 1000 UC patients underwent colectomy in 2011. Near one third (32.7%) were emergency colectomies. Most hospitals had specific IBD units (87.9%) and colorectal surgeons (93.1%). CONCLUSIONS: Our study provides the first national data on the prevalence and incidence of UC in gastroenterology units in Spain. Hospitalization and surgical burden associated with UC was low.