Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU.

BACKGROUND: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context. METHODS: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment. RESULTS: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab. CONCLUSION: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.

Cuando la ileítis de Crohn no es solo ileítis / When Crohn's ileitis is not just ileitis

RESUMEN En una minoría de pacientes con ileítis de Crohn (EC) de larga evolución, la recrudescencia de los síntomas puede representar una neoplasia ileal, con una clínica indistinguible de la enfermedad basal y por ende poco sospechada. Frecuentemente la patología tumoral se diagnostica en la pieza quirúrgica, tras una intervención por hemorragia u obstrucción intestinal. El objetivo de este trabajo es destacar la importancia de un diagnóstico diferencial ante una ileítis terminal en un paciente con EC con mala respuesta a tratamiento médico.

ABSTRACT In a minority of patients with long-standing Crohn's ileitis, the recrudescence of symptoms may represent a neoplasm involving the ileum that is clinically indistinguishable from the baseline disease and therefore poorly suspected. Tumors are often diagnosed in the surgical specimen, after an intervention due to bleeding or bowel obstruction. The aim of this study is to emphasize the importance of the differential diagnoses of terminal ileitis in a patient with CD with poor response to medical treatment.

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.

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.