ABSTRACT
INTRODUCCIÓN: Ustekinumab, anticuerpo monoclonal que bloquea las interleucinas 12/23, ha demostrado en ensayos clínicos su eficacia para inducir y mantener la remisión clínica en la enfermedad de Crohn (EC). Su efectividad y su seguridad en la práctica clínica real es menos conocida y podría diferir respecto a los ensayos. OBJETIVO: Evaluar en la práctica clínica su efectividad y seguridad (pauta de inducción intravenosa esencialmente), como inducción y a largo plazo, en pacientes con EC refractarios a tratamiento biológico. MATERIAL Y MÉTODOS: Análisis retrospectivo multicéntrico (6 hospitales aragoneses), que incluye a todos los pacientes (N=69) con EC en tratamiento con ustekinumab (fuese con inducción intravenosa o subcutánea) que hubiesen alcanzado al menos 16 semanas de seguimiento. La respuesta o remisión clínica se ha evaluado en las semanas 16, 24, 32 y 48 mediante el índice de Harvey-Bradshaw. RESULTADOS: Se han incluido un total de 69 pacientes, edad media 42 años, 54% hombres. Un 89,86% (IC 95% [0,805, 0,949]) de los pacientes ha presentado mejoría clínica en la semana 16 (15,95% remisión, 73,92% respuesta). En el seguimiento posterior dicha respuesta se ha mantenido. Se han identificado mediante un modelo de regresión ordinal la edad (OR 0,95, p = 0.028) y el hábito tabáquico (OR 0,19, p = 0,027) como predictores de mala respuesta al tratamiento, mientras que la necesidad de cambio de biológico por efecto adverso (OR 96, p = 0,00017) y por pérdida de respuesta secundaria (OR 7,07, p = 0,034) han sido factores predictores de buena respuesta. No se han reportado efectos adversos graves que obligasen a interrumpir el tratamiento con ustekinumab. CONCLUSIÓN: Ustekinumab es efectivo y seguro en la práctica clínica real para lograr la inducción y el mantenimiento de la respuesta en pacientes con EC refractaria. El tabaco y la edad han mostrado ser predictores de mala respuesta, mientras que la indicación por efecto adverso a biológico previo y por pérdida de respuesta secundaria han mostrado ser predictores de buena respuesta
INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Ustekinumab/therapeutic use , Crohn Disease/drug therapy , Treatment Outcome , Cohort Studies , Biological Treatment/methods , Retrospective Studies , Patient Safety , Administration, IntravenousABSTRACT
INTRODUCTION: Ustekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials. OBJECTIVE: To evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment. MATERIAL AND METHODS: Multicentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N=69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index. RESULTS: A total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P=.028) and smoking habits (OR 0.19, P=.027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P=.00017) and due to loss of secondary response (OR 7.07, P=.034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab. CONCLUSION: Ustekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response.
Subject(s)
Crohn Disease/drug therapy , Ustekinumab/therapeutic use , Adrenal Cortex Hormones/therapeutic use , Adult , Drug Substitution , Drug Therapy, Combination , Female , Humans , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Remission Induction , Retrospective Studies , Risk Factors , Severity of Illness Index , Smoking/epidemiology , Treatment Outcome , Ustekinumab/adverse effectsABSTRACT
Ureteroenterostomy allows the replacement of the bladder role after radical cystectomy. Anastomotic stricture is a relatively common complication that may require surgical repair. We report a case of iatrogenic stricture in a Mainz-II ureterosigmoidostomy that was satisfactorily resolved using a combined endoscopic-urological approach.
Subject(s)
Anastomosis, Surgical/methods , Cystectomy/methods , Endoscopy/methods , Iatrogenic Disease , Ureter/surgery , Urologic Surgical Procedures/methods , Adenocarcinoma/surgery , Humans , Male , Middle Aged , Postoperative Complications/surgery , Treatment Outcome , Urinary Bladder Neoplasms/surgery , Urinary DiversionABSTRACT
No disponible
Subject(s)
Humans , Male , Middle Aged , Ureterostomy/instrumentation , Ureterostomy/trends , Enterostomy/instrumentation , Anastomosis, Surgical/methods , Endoscopy/methods , Urinary Bladder Neoplasms/complications , Urinary Bladder Neoplasms , Urinary Bladder, Neurogenic/pathology , Urinary Bladder, Neurogenic , Nephrostomy, Percutaneous/methods , Adenocarcinoma/complications , Adenocarcinoma/pathology , Adenocarcinoma , Wound Healing/radiation effectsABSTRACT
No disponible
