Oral budesonide versus prednisolone in patients with active extensive and left-sided ulcerative colitis
Abstract
BACKGROUND & AIMS: Systemic glucocorticosteroids (GCSs) have proven efficacy in active ulcerative colitis but cause undesired systemic side effects. Therefore, new GCSs with high topical activity and a high rate of metabolism may be of clinical value in this condition. The aim of this study was to explore the efficacy and safety of the topically acting GCS budesonide in an oral controlled-release formulation in extensive or left-sided, mild to moderately active ulcerative colitis. METHODS: A 9-week, randomized, double-blind, controlled trial was performed, and treatments with 10 mg budesonide or 40 mg prednisolone daily, both gradually tapered, were compared. Endoscopic improvement and effect on endogenous plasma cortisol were assessed. RESULTS: Thirty- four patients were administered budesonide, and 38 patients were administered prednisolone. Mean endoscopic scores improved significantly in both groups but without difference between the groups. Five patients in the budesonide group and 7 patients in the prednisolone group deteriorated and were withdrawn from the study. Morning plasma cortisol levels were suppressed in the prednisolone group (entry, 449 nmol/L; 2 weeks, 116 nmol/L; 4 weeks, 195 nmol/L) but were unchanged in the budesonide group. CONCLUSIONS: The GCS budesonide administered in an oral controlled-release formulation seems to give an overall treatment result in active ulcerative colitis approaching that of prednisolone but without suppression of plasma cortisol levels. This concept merits further evaluation. (Gastroenterology 1996 Jun;110(6):1713-8)
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GADECCU 2022 Guideline for the treatment of Ulcerative Colitis. Adaptation and updating of the GETECCU 2020 Guideline
2023, Gastroenterologia y HepatologiaLa colitis ulcerosa (CU) es una enfermedad inflamatoria crónica que compromete el colon, afectando la calidad de vida de individuos de cualquier edad. Existe un amplio espectro de situaciones clínicas. Los avances realizados en fisiopatogenia de la CU han permitido desarrollar nuevos agentes terapéuticos más efectivos y seguros.
Actualizar y ampliar la evaluación de la eficacia y seguridad de los tratamientos relevantes para la inducción de la remisión y el mantenimiento luego de un brote leve, moderado o grave de CU.
Gastroenterólogos, coloproctólogos, médicos clínicos, médicos de familia y otros profesionales de la salud, interesados en el tratamiento de la CU.
Las autoridades de GADECCU obtuvieron la autorización de GETECCU para la adaptación y actualización de la «Guía GETECCU 2020 para el tratamiento de la CU. Elaborada con metodología GRADE». Se conformó un equipo que incluyó a autores, panel de expertos, enfermera y un paciente, expertos en metodología y revisores externos. Se utilizó metodología GRADE con la nueva información.
Se elaboró un documento de 118 páginas con las 44 recomendaciones GADECCU 2022, para distintas situaciones clínicas y opciones terapéuticas, según niveles de evidencia. Se agregó un apartado con las nuevas moléculas próximas a estar disponibles.
Esta guía ha sido realizada con el fin de facilitar la toma de decisiones relativas al tratamiento de la CU, adaptando y actualizando la guía elaborada por GETECCU en el año 2020.
Ulcerative colitis (UC) is a chronic inflammatory disease that compromises the colon, affecting the quality of life of individuals of any age. In practice, there is a wide spectrum of clinical situations. The advances made in the physio pathogenesis of UC have allowed the development of new, more effective and safer therapeutic agents.
To update and expand the evaluation of the efficacy and safety of relevant treatments for remission induction and maintenance after a mild, moderate or severe flare of UC.
Gastroenterologists, coloproctologists, general practitioners, family physicians and others health professionals, interested in the treatment of UC.
GADECCU authorities obtained authorization from GETECCU to adapt and update the GETECCU 2020 Guide for the treatment of UC. Prepared with GRADE methodology. A team was formed that included authors, a panel of experts, a nurse and a patient, methodological experts, and external reviewers. GRADE methodology was used with the new information.
A 118-page document was prepared with the 44 GADECCU 2022 recommendations, for different clinical situations and therapeutic options, according to levels of evidence. A section was added with the new molecules that are about to be available.
This guideline has been made in order to facilitate decision-making regarding the treatment of UC, adapting and updating the guide prepared by GETECCU in the year 2020.
Inflammatory Bowel Disease – Non-biological treatment
2020, Pharmacological ResearchNowadays, non-biological treatments remain valuable approaches among the therapeutic armamentarium of inflammatory bowel disease (IBD). Mesalamine is the core treatment of mild‑to‑moderate ulcerative colitis (UC) and corticosteroids are crucial for the induction of remission of moderate‑to‑severe flares in both UC and Crohn’s disease (CD). Even approaches as cyclosporine, tacrolimus, azathioprine, methotrexate, and surgery still have a nuclear position as strategies to induce and/or maintain remission in IBD. Due to their particularities and to the accumulated evidence, each of these strategies conquered peculiar roles in the overall IBD strategy, all of them contributing to better outcomes.
This review emphasizes the particular roles that non-biological treatments gained over time: recent mesalamine formulations to increase adhesion rates, higher doses of 5-ASA for high-risk patients, MMX technology to improve drug release and attain higher bowel concentrations, cyclosporine as a bridge to vedolizumab, tacrolimus as a potential alternative to thiopurines or infliximab, azathioprine in combination therapy with infliximab and dubious in monotherapy, and surgery as a mean to a “better end”.
GETECCU 2020 guidelines for the treatment of ulcerative colitis. Developed using the GRADE approach
2020, Gastroenterologia y HepatologiaDesde la publicación de la primera edición de la Guía en 2013, se ha generado mucha información en torno al tratamiento de la colitis ulcerosa, y se han introducido nuevos fármacos y protocolos de actuación. La práctica clínica ha variado substancialmente, lo que justifica nuevas aproximaciones y una revisión exhaustiva, así como la actualización de la evidencia.
Se utiliza nuevamente metodología GRADE, apoyados en una herramienta electrónica (https://gradepro.org). Los escenarios clínicos son los mismos que en la versión previa (inducción y mantenimiento en brote grave y en brote leve-moderado), así como las variables y su evaluación. En la guía actualizada, en relación a la versión previa, se eliminan tres preguntas, se añaden 14 y se mantienen 30, con un total de 44 preguntas clínicas. Tras una exhaustiva revisión de la evidencia, se actualizan las recomendaciones.
De las 44 preguntas analizadas, en dos de ellas no se ha podido establecer ninguna recomendación por muy baja calidad de la evidencia, mientras que en las 42 restantes, basados en diferentes grados de calidad de evidencia, se ha formulado una recomendación de acuerdo con el sistema GRADE. En 25 de estas preguntas la recomendación final es fuerte a favor; en seis, fuerte en contra; mientras que en siete es débil a favor, y en cuatro débil en contra. Siguiendo los escenarios y las recomendaciones, se proponen seis algoritmos como guía sencilla en la toma de decisiones prácticas.
Esta actualización de la guía previa publicada en 2013 intenta dar respuesta basada en la metodología GRADE a las diferentes preguntas que nos hacemos diariamente a la hora de decidir el tratamiento más adecuado de nuestros pacientes con colitis ulcerosa en los diferentes escenarios clínicos.
Since the first edition of the Guidelines was published in 2013, much information has been generated around the treatment of ulcerative colitis, and new drugs and action protocols have been introduced. Clinical practice has changed substantially, warranting new approaches and a comprehensive review and update of the evidence.
Once again, we used the GRADE approach, supported by an electronic tool (https://gradepro.org). The clinical scenarios are the same as in the previous version (induction and maintenance in severe and mild-moderate flare-ups), as are the variables and their evaluation. However, in the updated guidelines, three questions have been deleted, 14 added and 30 maintained, making a total of 44 clinical questions. After an exhaustive review of the evidence, the recommendations are now updated.
Of the 44 questions analysed, no recommendation could be established in two due to the very low quality of the evidence, while in the other 42, based on different degrees of quality of evidence, recommendations were made according to the GRADE system. In 25 of these questions the final recommendation is strongly in favour, in six strongly against, in seven weakly in favour and in four weakly against. According to the scenarios and recommendations, six algorithms are proposed as a simple guide for practical decision-making.
The aim of this update of the 2013 guidelines is to provide answers, based on the GRADE approach, to the different questions we ask ourselves daily when deciding the most appropriate treatment for our patients with ulcerative colitis in the different clinical scenarios.
British Society of Gastroenterology endorsed guidance for the management of immune checkpoint inhibitor-induced enterocolitis
2020, The Lancet Gastroenterology and HepatologyCitation Excerpt :Although early clinical response to oral prednisolone at 40 mg once daily was observed in historical ulcerative colitis studies, clinical outcomes were typically reported at later timepoints (weeks to months).70–73 Response rates exceeding 75% were shown in patients with ulcerative colitis treated with corticosteroids, including robust endpoints such as mucosal healing, although the earliest timepoints at which patients have been evaluated is typically at 2 weeks after initiation of corticosteroids.69,74–76 In one of these studies,69 clinical remission was observed in 25% of patients with ulcerative colitis after 1 week of treatment with oral prednisolone at 40 mg once daily.
Immune checkpoint inhibitors are a novel class of cancer treatment that have improved outcomes for a subset of cancer patients. They work by antagonising inhibitory immune pathways, thereby augmenting immune-mediated antitumour responses. However, immune activation is not cancer-specific and often results in the activation of immune cells in non-cancer tissues, resulting in off-target immune-mediated injury and organ dysfunction. Diarrhoea and gastrointestinal tract inflammation are common and sometimes serious side-effects of this type of therapy. Prompt recognition of gastrointestinal toxicity and, in many cases, rapid institution of anti-inflammatory or biologic therapy (or both) is required to reverse these complications. Management of organ-specific complications benefits from multidisciplinary input, including engagement with gastroenterologists for optimal management of immune checkpoint inhibitor-induced enterocolitis. In this British Society of Gastroenterology endorsed guidance document, we have developed a consensus framework for the investigation and management of immune checkpoint inhibitor-induced enterocolitis.
AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis
2019, GastroenterologyAGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis
2019, GastroenterologyMost patients with ulcerative colitis (UC) have mild-to-moderate disease activity, with low risk of colectomy, and are managed by primary care physicians or gastroenterologists. Optimal management of these patients decreases the risk of relapse and proximal disease extension, and may prevent disease progression, complications, and need for immunosuppressive therapy. With several medications (eg, sulfasalazine, diazo-bonded 5-aminosalicylates [ASA], mesalamines, and corticosteroids, including budesonide) and complex dosing formulations, regimens, and routes, to treat a disease with variable anatomic extent, there is considerable practice variability in the management of patients with mild–moderate UC. Hence, the American Gastroenterological Association prioritized clinical guidelines on this topic. To inform clinical guidelines, this technical review was developed in accordance with the Grading of Recommendations Assessment, Development and Evaluation framework for interventional studies. Focused questions included the following: (1) comparative effectiveness and tolerability of different oral 5-ASA therapies (sulfalsalazine vs diazo-bonded 5-ASAs vs mesalamine; low- (<2 g) vs standard (2–3 g/d) vs high-dose (>3 g/d) mesalamine); (2) comparison of different dosing regimens (once-daily vs multiple times per day dosing) and routes (oral vs rectal vs both oral and rectal); (3) role of oral budesonide in patients mild–moderate UC; (4) comparative effectiveness and tolerability of rectal 5-ASA and corticosteroid formulations in patients with distal colitis; and (5) role of alternative therapies like probiotics, curcumin, and fecal microbiota transplantation in the management of mild–moderate UC.