Low risk of new dysplastic lesions in an inflammatory bowel disease population study with dye chromoendoscopy.

Background and study aims Rates of new dysplastic lesions or cancer progression after first dye chromoendoscopy in the era of high-definition endoscopy have yet to be determined. Patients and methods A multicenter, population-based, retrospective cohort study was performed in seven hospitals in Spain. Patients with inflammatory bowel disease and fully resected (R0) dysplastic colon lesions under surveillance with high-definition dye-based chromoendoscopy were sequentially enrolled between February 2011 and June 2017, with a minimum endoscopic follow-up of 36 months. The aim was to assess the incidence of developing more advanced metachronous neoplasia by analyzing possible associated risk factors. Results The study sample included 99 patients and 148 index lesions (145 low-grade dysplasia lesions and three high-grade dysplasia [HGD] lesions with a mean follow-up of 48.76 months [IQR: 36.34-67.15]). The overall incidence of new dysplastic lesions was 0.23 per 100 patient-years, 1.15 per 100 patients at 5 years and 2.29 per 100 patients at 10 years. A history of dysplasia was associated with a higher risk of developing any grade of dysplasia during follow-up ( P  = 0.025), whereas left colon lesions were associated with a lower risk ( P  = 0.043). The incidence of more advanced lesions at 1 year and 10 years was 1 % and 14 % respectively, with lesion size > 1 cm being a risk factor ( P  = 0.041). One of the eight patients (13 %) with HGD lesions developed colorectal cancer during follow-up. Conclusions The risk of dysplasia progressing to advanced neoplasia and, specifically, the risk of new neoplastic lesions after endoscopic resection of colitis-associated dysplasia, are both very low.

Clinical Presentation, Management, and Evolution of Lymphomas in Patients with Inflammatory Bowel Disease: An ENEIDA Registry Study.

An increased risk of lymphoma has been described in patients with inflammatory bowel disease (IBD). The aims of our study were to determine the clinical presentation, the previous exposure to immunosuppressive and biologic therapies, and the evolution of lymphomas in patients with IBD. IBD patients with diagnosis of lymphoma from October 2006 to June 2021 were identified from the prospectively maintained ENEIDA registry of GETECCU. We identified 52 patients (2.4 cases of lymphoma/1000 patients with IBD; 95% CI 1.8-3.1). Thirty-five were men (67%), 52% had ulcerative colitis, 60% received thiopurines, and 38% an anti-TNF drug before lymphoma diagnosis. Age at lymphoma was lower in those patients treated with thiopurines (53 ± 17 years old) and anti-TNF drugs (47 ± 17) than in those patients not treated with these drugs (63 ± 12; p < 0.05). Five cases had relapse of lymphoma (1.7 cases/100 patient-years). Nine patients (17%) died after 19 months (IQR 0-48 months). Relapse and mortality were not related with the type of IBD or lymphoma, nor with thiopurines or biologic therapies. In conclusion, most IBD patients had been treated with thiopurines and/or anti-TNF agents before lymphoma diagnosis, and these patients were younger at diagnosis of lymphoma than those not treated with these drugs. Relapse and mortality of lymphoma were not related with these therapies.

Incidencia e historia natural de la enfermedad inflamatoria intestinal en Castilla y León: estudio prospectivo, multicéntrico y poblacional / Incidence, and natural history of inflammatory bowel disease in Castilla y León: Prospective and multicenter epidemiological study

Introducción: La incidencia de la enfermedad inflamatoria intestinal (EII) está aumentando en todo el mundo. Objetivos: Evaluar la incidencia de EII en la comunidad autónoma de Castilla y León y describir las características clínicas de los pacientes al diagnóstico, el tipo de tratamiento recibido y la evolución clínica durante el primer año. Material y métodos: Estudio prospectivo, multicéntrico y poblacional en el que se incluyeron pacientes adultos diagnosticados de EII (enfermedad de Crohn [EC], colitis ulcerosa [CU] o colitis indeterminada [CI]) durante el año 2017 procedentes de 8 centros de Castilla y León. Se incluyeron variables epidemiológicas, clínicas y terapéuticas. Se calculó la incidencia global y por enfermedades. Resultados: Doscientos noventa pacientes fueron diagnosticados de EII (54,5% de CU, 45.2% de EC y 0,3% de CI), con una mediana de seguimiento de 9 meses (rango 8-11). La tasa de incidencia fue de 16,6 casos/100.000 habitantes-año (9/105 casos de CU y 7,5/105 casos de EC), con una proporción CU/EC de 1,2:1. Los pacientes con EC recibieron significativamente más corticoides sistémicos (47% vs. 30%; p=0,002), más tratamiento inmunomodulador (81% vs. 19%; p=0,000), más tratamiento biológico (29% vs. 8%; p=0,000) y mayor necesidad de cirugía (11% vs. 2%; p=0,000). Conclusiones: La incidencia de pacientes con CU en nuestro medio se incrementa, mientras que la de EC se mantiene estable, con una historia natural de la enfermedad peor (uso de corticoides, inmunosupresores, biológicos y cirugía) para los pacientes con EC comparado con los pacientes con CU en el primer año de seguimiento.(AU)

Introduction: The incidence of inflammatory bowel disease (IBD) is increasing worldwide. Objectives: To evaluate the incidence of IBD in Castilla y León describing clinical characteristics of the patients at diagnosis, the type of treatment received and their clinical course during the first year. Materials and methods: Prospective, multicenter and population-based incidence cohort study. Patients aged >18 years diagnosed during 2017 with IBD (Crohn's disease [CD], ulcerative colitis [UC] and indeterminate colitis [IC]) were included from 8 hospitals in Castilla y León. Epidemiological, clinical, and therapeutic variables were registered. The global incidence and disease incidence were calculated.Results290 patients were diagnosed with IBD (54.5% UC, 45.2% CD, and 0.3% IC), with a median follow-up of 9 months (range 8−11). The incidence rate of IBD in Castilla y Leon in 2017 was 16.6 cases per 10,000 inhabitants-year (9/105 UC cases and 7.5/105 CD cases), with a UC/CD ratio of 1.2:1. Use of systemic corticosteroids (47% vs 30%; P=.002), immunomodulatory therapy (81% vs 19%; P=.000), biological therapy (29% vs 8%; P=.000), and surgery (11% vs 2%; p=.000) were significatively higher among patients with CD comparing with those with UC. Conclusions: The incidence of patients with UC in our population increases while the incidence of patients with CD remains stable. Patients with CD present a worse natural history of the disease (use of corticosteroids, immunomodulatory therapy, biological therapy and surgery) compared to patients with UC in the first year of follow-up.(AU)

Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety.

INTRODUCTION: The objective of this study was to assess the durability, short-term and long-term effectiveness, and safety of tofacitinib in ulcerative colitis (UC) in clinical practice. METHODS: This is a retrospective multicenter study including patients with UC who had received the first tofacitinib dose at least 8 weeks before the inclusion. Clinical effectiveness was based on partial Mayo score. RESULTS: A total of 408 patients were included. Of them, 184 (45%) withdrew tofacitinib during follow-up (mean = 18 months). The probability of maintaining tofacitinib was 67% at 6 m, 58% at 12 m, and 49% at 24 m. The main reason for tofacitinib withdrawal was primary nonresponse (44%). Older age at the start of tofacitinib and a higher severity of clinical activity were associated with tofacitinib withdrawal. The proportion of patients in remission was 38% at week 4, 45% at week 8, and 47% at week 16. Having moderate-to-severe vs mild disease activity at baseline and older age at tofacitinib start were associated with a lower and higher likelihood of remission at week 8, respectively. Of 171 patients in remission at week 8, 83 (49%) relapsed. The probability of maintaining response was 66% at 6 m and 54% at 12 m. There were 93 adverse events related to tofacitinib treatment (including 2 pulmonary thromboembolisms [in patients with risk factors] and 2 peripheral vascular thrombosis), and 29 led to tofacitinib discontinuation. DISCUSSION: Tofacitinib is effective in both short-term and long-term in patients with UC. The safety profile is similar to that previously reported.

Should Inflammatory Bowel Disease Clinicians Provide Their Patients with e-Health Resources? Patients' and Professionals' Perspectives.

Introduction: The internet is emerging as a source of information for patients with inflammatory bowel disease (IBD). However, it is not always reliable and may cause anxiety. We aim to assess patients' information habits and patients' and professionals' perceptions of a national website integrated as an educational resource for the IBD unit. Methods: Patients aged 18-65 years, comfortable with the internet, and attending follow-ups at participating IBD units (March-June 2019) and their professionals were invited to evaluate a recommended website through an online survey. Results: Three hundred eighty-nine patients and 95 professionals completed the survey. The internet (n = 109; 27.4%) was the second preferred source of information after the health care team (n = 229; 57.5%). Eighty percent of patients searched the internet for information on their disease and 28.6% did so at least once a week (n = 114), especially newly diagnosed ones (<2 years). Patients valued a website recommended by their professional (n = 379; 95.2%) and endorsed by the National Working Group (n = 377; 94.7%). They would attend online educational initiatives on the website (n = 279; 70.1%) and complete periodical surveys to improve its usefulness (n = 338; 84.9%). According to IBD professionals, this type of website is the best patient source of supplementary information (n = 76; 80%) and they "prescribe" it to most patients (67.0 ± 25.2%), especially the newly diagnosed patients (52.7 ± 26.5%). It effectively integrates routine face-to-face education (n = 95; 100%). Conclusions: Patients of IBD units, especially newly diagnosed ones, appreciate a trusted e-Health resource to back up professional information. The favorable opinion of patients and professionals will allow its use in training interventions.

Ustekinumab and vedolizumab for the prevention of postoperative recurrence of Crohn's disease: Results from the ENEIDA registry.

BACKGROUND: Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce. METHODS: All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered. RESULTS: Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection. CONCLUSIONS: Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies.

Incidence, and natural history of inflammatory bowel disease in Castilla y León: Prospective and multicenter epidemiological study. / Incidencia e historia natural de la enfermedad inflamatoria intestinal en Castilla y León: estudio prospectivo, multicéntrico y poblacional.

INTRODUCTION: The incidence of inflammatory bowel disease (IBD) is increasing worldwide. OBJECTIVES: To evaluate the incidence of IBD in Castilla y León describing clinical characteristics of the patients at diagnosis, the type of treatment received and their clinical course during the first year. MATERIALS AND METHODS: Prospective, multicenter and population-based incidence cohort study. Patients aged >18 years diagnosed during 2017 with IBD (Crohn's disease [CD], ulcerative colitis [UC] and indeterminate colitis [IC]) were included from 8 hospitals in Castilla y León. Epidemiological, clinical, and therapeutic variables were registered. The global incidence and disease incidence were calculated. RESULTS: 290 patients were diagnosed with IBD (54.5% UC, 45.2% CD, and 0.3% IC), with a median follow-up of 9 months (range 8-11). The incidence rate of IBD in Castilla y Leon in 2017 was 16.6 cases per 10,000 inhabitants-year (9/105 UC cases and 7.5/105 CD cases), with a UC/CD ratio of 1.2:1. Use of systemic corticosteroids (47% vs 30%; P=.002), immunomodulatory therapy (81% vs 19%; P=.000), biological therapy (29% vs 8%; P=.000), and surgery (11% vs 2%; p=.000) were significatively higher among patients with CD comparing with those with UC. CONCLUSIONS: The incidence of patients with UC in our population increases while the incidence of patients with CD remains stable. Patients with CD present a worse natural history of the disease (use of corticosteroids, immunomodulatory therapy, biological therapy and surgery) compared to patients with UC in the first year of follow-up.

Psychosocial impact of the COVID-19 pandemic on patients with inflammatory bowel disease in Spain. A post lockdown reflection / Impacto psicosocial de la pandemia de COVID-19 en pacientes con enfermedad inflamatoria intestinal en España. Una reflexión posterior al confinamiento

Objectives: This multicenter cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with inflammatory bowel disease (IBD) in Spain during lockdown and the first wave of the pandemic. Patients and methods: A self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale-21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of lockdown on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey between the 1st July and the 25th August 2020. Results: Of the 693 survey participants with IBD, 67% were women and the mean age was 43 (SD 12). Sixty-one percent had ulcerative colitis, 36% Crohn's disease and 3% indeterminate colitis. DASS-21 scores indicate that during lockdown the estimated prevalence of depression was 11% [95% CI 8.2–13%], anxiety 20% [95% CI 17 to 23%] and stress 18% [95% CI 8.2–13%]. Multivariate analysis showed that the perceived high risk of COVID-19 infection because of having IBD and maladaptation to government measures to reduce the spread of disease doubled the risk of anxiety and stress during lockdown. Conclusions: In the short-term, lockdown during the COVID-19 pandemic seemed to have an impact on the already affected mental health of our IBD patients in Spain.(AU)

Objetivos: Este estudio transversal multicéntrico se llevó a cabo para evaluar el impacto psicosocial de la COVID-19 en pacientes con enfermedad inflamatoria intestinal (EII) en España durante el confinamiento y la primera ola de la pandemia. Pacientes y métodos: Se diseñó un cuestionario de autoinforme que integraba la versión española de la Escala de Depresión, Ansiedad y Estrés-21 ítems (DASS-21) y el Cuestionario de Estrés Percibido (PSS) para recoger datos sociodemográficos e información relacionada con los efectos del confinamiento en la vida de los pacientes con EII. Doce unidades de EII invitaron a sus pacientes a responder a la encuesta anónima en línea entre el 1 de julio y el 25 de agosto de 2020. Resultados: De los 693 participantes en la encuesta con EII, el 67% eran mujeres y la edad media era de 43 años (DE 12). El 61% tenía colitis ulcerosa, el 36% enfermedad de Crohn y el 3% colitis indeterminada. Las puntuaciones del DASS-21 indican que durante el encierro la prevalencia estimada de depresión fue del 11% [IC 95%: 8,2-13%], de ansiedad del 20% [IC 95%: 17-23%] y de estrés del 18% [IC 95%: 8,2-13%]. El análisis multivariante mostró que la percepción de alto riesgo de infección por COVID-19 por tener EII y la inadaptación a las medidas gubernamentales para reducir la propagación de la enfermedad duplicaban el riesgo de ansiedad y estrés durante el encierro. Conclusiones: A corto plazo, el confinamiento durante la pandemia de COVID-19 pareció tener un impacto en la ya afectada salud mental de nuestros pacientes con EII en España.(AU)

Psychosocial impact of the COVID-19 pandemic on patients with inflammatory bowel disease in Spain. A post lockdown reflection.

OBJECTIVES: This multicenter cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with inflammatory bowel disease (IBD) in Spain during lockdown and the first wave of the pandemic. PATIENTS AND METHODS: A self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale-21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of lockdown on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey between the 1st July and the 25th August 2020. RESULTS: Of the 693 survey participants with IBD, 67% were women and the mean age was 43 (SD 12). Sixty-one percent had ulcerative colitis, 36% Crohn's disease and 3% indeterminate colitis. DASS-21 scores indicate that during lockdown the estimated prevalence of depression was 11% [95% CI 8.2-13%], anxiety 20% [95% CI 17 to 23%] and stress 18% [95% CI 8.2-13%]. Multivariate analysis showed that the perceived high risk of COVID-19 infection because of having IBD and maladaptation to government measures to reduce the spread of disease doubled the risk of anxiety and stress during lockdown. CONCLUSIONS: In the short-term, lockdown during the COVID-19 pandemic seemed to have an impact on the already affected mental health of our IBD patients in Spain.

Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry.

BACKGROUND AND AIMS: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life. METHODS: Patients included in the prospectively maintained ENEIDA registry, who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score [PMS]>2], were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at Week 16. RESULTS: A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at Week 16, 63% at Week 56, and 59% at Week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection. CONCLUSIONS: Ustekinumab is effective in both the short and the long term in real life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry.

AIM: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. METHODS: Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission was assessed at Weeks 4, 8, and 16. RESULTS: A total of 113 patients were included. They were exposed to tofacitinib for a median time of 44 weeks. Response and remission at Week 8 were 60% and 31%, respectively. In multivariate analysis, higher PMS at Week 4 (odds ratio [OR] = 0].2; 95% confidence interval [CI] = 0].1-0.4) was the only variable associated with lower likelihood of achieving remission at Week 8. Higher PMS at Week 4 [OR = 0.5; 95% CI = 0.3-0.7] and higher PMS at Week 8 [OR = 0.2; 95% CI = 0.1-0.5] were associated with lower probability of achieving remission at Week 16. A total of 45 patients [40%] discontinued tofacitinib over time. Higher PMS at Week 8 was the only factor associated with higher tofacitinib discontinuation [hazard ratio = 1.5; 95% CI = 1.3-1.6]. A total of 34 patients had remission at Week 8; of these, 65% had relapsed 52 weeks after achieving remission; the dose was increased to 10 mg/12 h in nine patients, and five of them reached remission again. Seventeen patients had adverse events. CONCLUSIONS: Tofacitinib is effective and safe in UC patients in real practice, even in a highly refractory cohort. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure.

Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry.

BACKGROUND: Data on the long-term administration of ustekinumab in recommended doses are limited. AIM: To assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn's disease (CD). METHODS: Multi-centre study of CD patients starting ustekinumab at the recommended dose, followed for 1 year. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs) and hospitalisations were documented. Potential predictors of remission were examined. RESULTS: A total of 407 patients were analysed. The initial maintenance dose of 90 mg SC was administered every 12, 8 and 4 weeks in 56 (14%), 347 (85%) and 4 (1%) patients, respectively. After 52 weeks, treatment was discontinued in 112 patients (27.5%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal in 44% and 54% of patients at weeks 26 and 52, and CRP returned to normal in 36% and 37% of patients at weeks 26 and 52, respectively. AEs were recorded in 60 patients. The use of fewer previous anti-TNFα agents and ileal localisation were associated with clinical remission, and endoscopic severity was associated with poor response. No factors correlated with endoscopic remission. CONCLUSION: After 52 weeks, ustekinumab demonstrated effectiveness in inducing clinical and endoscopic remission in patients with refractory CD.

Lesiones serradas en pacientes con enfermedad inflamatoria intestinal / Serrated Lesions in patients with Inflammatory Bowel Disease

Introducción: recientemente se ha descrito una nueva entidad histológica serrada en pacientes con enfermedad inflamatoria intestinal (EII) conocida como "cambio epitelial serrado" (CES). En los últimos estudios parece que hay una fuerte asociación entre la presencia de CES y displasia. Caso clínico: se presenta el caso clínico de un varón de 62 años en programa de cribado de displasia-cáncer colorrectal con cromoendoscopias periódicas con hallazgos compatibles con CES. Discusión: en aquellos pacientes que presentan varias lesiones serradas en las cromoendoscopias de cribado, sobre todo si son extensas y mal definidas, la realización de una colectomía profiláctica parece una opción razonable ante la posibilidad de aparición de displasia de alto grado o CCR en el seguimiento

Background: a new serrated histologic finding has recently been discovered in patients with inflammatory bowel disease (IBD), known as serrated epithelial change (SEC). Recent studies suggest that SEC is strongly associated with dysplasia. Case report: the case was a 62-year-old male in a dysplasia-colorectal cancer screening program with periodic chromoendoscopies, with CES findings in the previous chromoendoscopy studies. Discussion: a prophylactic colectomy seems a reasonable option for patients with several serrated lesions identified via chromoendoscopy screening. Particularly, if they are extensive and poorly defined, due to the possibility of developing high-grade dysplasia or colorectal cancer (CRC) during surveillance

Serrated Lesions in patients with Inflammatory Bowel Disease.

BACKGROUND: a new serrated histologic finding has recently been discovered in patients with inflammatory bowel disease (IBD), known as serrated epithelial change (SEC). Recent studies suggest that SEC is strongly associated with dysplasia. CASE REPORT: the case was a 62-year-old male in a dysplasia-colorectal cancer screening program with periodic chromoendoscopies, with CES findings in the previous chromoendoscopy studies. DISCUSSION: a prophylactic colectomy seems a reasonable option for patients with several serrated lesions identified via chromoendoscopy screening. Particularly, if they are extensive and poorly defined, due to the possibility of developing high-grade dysplasia or colorectal cancer (CRC) during surveillance.

Early dose optimization of golimumab induces late response and long-term clinical benefit in moderately to severely active ulcerative colitis.

Aim: To evaluate outcomes of early dose optimization of golimumab in ulcerative colitis (UC) patients with inadequate response to golimumab induction treatment. Methods: This observational, multicenter, cohort study included patients with moderate-to-severe active UC and with inadequate response to subcutaneous golimumab induction doses, in whom weight-based golimumab maintenance dose (European labeling) of 50 mg every 4 weeks (q4wk) was optimized before week 14 to 100 mg q4wk. At week 14, we assessed clinical response and remission using the partial Mayo score. In the long term we evaluate the cumulative probabilities of golimumab failure-free survival and colectomy-free survival. Results: A total of 209 patients who received golimumab induction doses were eligible. Of these, 151 patients (72.2%) weighing less than 80 kg were assigned to a golimumab maintenance dose of 50 mg q4wk. Twenty-four patients (15.9% [12.5% overall]), in whom scheduled doses of 50 mg q4wk were optimized to 100 mg q4wk before week 14, compose the study population. At week 14, 16 patients (66.7%, 95% CI 45.7-87.6) had clinical response, of these 12 were corticosteroid free. Four patients (16.7%) achieved corticosteroid-free remission. After a median follow-up of 12 months (IQR 10-22), 13 patients (54.2%) maintained clinical benefit. Thirteen of 16 patients (81.2%) with clinical response at week 14 maintained clinical benefit at last follow-up. All patients avoided colectomy. In none of the patients was golimumab dose de-escalated. There were no adverse events leading to golimumab withdrawal. Conclusion: Early optimization of golimumab dose induces clinical response at week 14 in two thirds of UC patients and leads to long-term clinical benefit in over half of patients.

Fiebre y hepatitis aguda por citomegalovirus en enfermedad de Crohn / Fever and acute cytomegalovirus hepatitis in Crohn’s disease

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