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Background: Real-world data on the effectiveness and safety of ustekinumab (UST) in ulcerative colitis (UC) are lacking in Latin America. In this study, we aimed to describe the effectiveness and safety of UST in a real-world multicenter cohort of Brazilian patients with UC. Methods: We conducted a multicenter retrospective observational cohort study, including patients with moderate-to-severe UC (total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who received UST. The co-primary endpoints were clinical remission, defined as a total Mayo score ≤2 at 1 year, with a combined rectal bleeding and stool frequency subscore of ≤1, and endoscopic remission (endoscopic Mayo subscore of 0) within 1 year from baseline. Secondary endpoints included clinical response between weeks 12 and 16, endoscopic response within 1 year of starting UST, steroid-free clinical remission at week 52, and biochemical remission at week 52. We also evaluated UST treatment persistence and safety. Results: A total of 50 patients were included (female, n = 36, 72.0%), with a median disease duration of 9.2 years (1-27). Most patients had extensive colitis (n = 38, 76.0%), and 43 (86.0%) were steroid dependent at baseline. Forty patients (80.0%) were previously exposed to biologics (anti-TNF drugs, n = 31; vedolizumab [VDZ], n = 27). The co-primary endpoints of clinical remission at 1 year and endoscopic remission within 1 year were achieved by 50.0% and 36.0% of patients, respectively. Clinical response at weeks 12-16 was 56.0%, and endoscopic response, steroid-free clinical remission, and biochemical remission at week 52 were 68.0%, 46.5%, and 50.0%, respectively. The UST treatment persistence rate at 24 months was 73.7%. During the follow-up, 10 patients (20.0%) were hospitalized, mostly due to disease progression, and 3 patients required colectomy. Nine patients (18.0%) discontinued the drug mainly due to a lack of effectiveness. Twenty-seven adverse events (AEs) were reported, 16 of which were considered as serious AEs. Conclusions: In this real-world cohort of difficult-to-treat UC patients, UST was associated with improvements in clinical, biochemical, and endoscopic outcomes. The safety profile was favorable, consistent with the known profile of UST.

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Objective: To describe the pro file of surgeons who treat patients with inflammatory bowel disease as well as the characteristics of inflammatory bowel disease care, unmet demands, and difficulties. Methods: The research participants answered a Google Forms questionnaire. Results: Of the 99 surgeons who participated in the survey, 84.5% were coloproctologists, 40% were from the southeastern region of Brazil, and 77.7% were male and had been working for more than 19 years. Regarding the healthcare sector, 63.6% of surgeons worked in both public and private clinics, and most clinically cared for up to 50 patients with inflammatory bowel disease and operated on up to 5 cases per year. Conclusion: This is the first national study that aimed to identify the profile of surgeons working with inflammatory bowel disease in Brazil. The vast majority are experienced male coloproctologists, located in the southern and southeastern regions, who perform clinical and surgical treatment of these pathologies, with major surgeries being performed in large centers by a small number of surgeons. (AU)

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BACKGROUND: Despite optimized medical therapy, contemporary risk of surgery in inflammatory bowel diseases (IBD) after 10 years of diagnosis is 9.2% in patients with ulcerative colitis (UC) and 26.2% in Crohn's disease, (CD) in the biological era. OBJECTIVE: This consensus aims to detail guidance to the most appropriate surgical procedures in different IBD scenarios. In addition, it details surgical indications and perioperative management of adult patients with CD and UC. METHODS: Our consensus was developed by colorectal surgeons and gastroenterologists representing the Brazilian Study Group of Inflammatory Bowel Diseases (GEDIIB), with the Rapid Review methodology being conducted to support the recommendations/statements. Surgical recommendations were structured and mapped according to the disease phenotypes, surgical indications, and techniques. After structuring the recommendations/statements, the modified Delphi Panel methodology was used to conduct the voting by experts in IBD surgery and gastroenterology. This consisted of three rounds: two using a personalized and anonymous online voting platform and one face-to-face presential meeting. Whenever participants did not agree with specific statements or recommendations, an option to outline possible reasons was offered to enable free-text responses and provide the opportunity for the experts to elaborate or explain disagreement. The consensus of recommendations/statements in each round was considered to have been reached if there was ≥80% agreement. RESULTS AND CONCLUSION: This consensus addressed the most relevant information to guide the decision-making process for adequate surgical management of CD and UC. It synthesizes recommendations developed from evidence-based statements and state-of-art knowledge. Surgical recommendations were structured and mapped according to the different disease phenotypes, indications for surgery and perioperative management. Specific focus of our consensus was given to elective and emergency surgical procedures, determining when to indicate surgery and which procedures may be the more appropriate. The consensus is targeted to gastroenterologists and surgeons interested in the treatment and management of adult patients with CD or UC and supports decision-making of healthcare payors, institutional leaders, and/or administrators.

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BACKGROUND: Inflammatory bowel diseases are immune-mediated disorders that include Crohn's disease (CD) and ulcerative colitis (UC). UC is a progressive disease that affects the colorectal mucosa causing debilitating symptoms leading to high morbidity and work disability. As a consequence of chronic colonic inflammation, UC is also associated with an increased risk of colorectal cancer. OBJECTIVE: This consensus aims to provide guidance on the most effective medical management of adult patients with UC. METHODS: A consensus statement was developed by stakeholders representing Brazilian gastroenterologists and colorectal surgeons (Brazilian Organization for Crohn's Disease and Colitis [GEDIIB]). A systematic review including the most recent evidence was conducted to support the recommendations and statements. All recommendations/statements were endorsed using a modified Delphi Panel by the stakeholders/experts in inflammatory bowel disease with at least 80% or greater consensus. RESULTS AND CONCLUSION: The medical recommendations (pharmacological and non-pharmacological) were mapped according to the stage of treatment and severity of the disease onto three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/patient monitoring after initial treatment. The consensus targeted general practitioners, gastroenterologists and surgeons who manage patients with UC, and supports decision-making processes by health insurance companies, regulatory agencies, health institutional leaders, and administrators.

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BACKGROUND: Inflammatory bowel disease (IBD) is an immune-mediated disorder that includes Crohn's disease (CD) and ulcerative colitis. CD is characterized by a transmural intestinal involvement from the mouth to the anus with recurrent and remitting symptoms that can lead to progressive bowel damage and disability over time. OBJECTIVE: To guide the safest and effective medical treatments of adults with CD. METHODS: This consensus was developed by stakeholders representing Brazilian gastroenterologists and colorectal surgeons (Brazilian Organization for Crohn's disease and Colitis (GEDIIB)). A systematic review of the most recent evidence was conducted to support the recommendations/statements. All included recommendations and statements were endorsed in a modified Delphi panel by the stakeholders and experts in IBD with an agreement of at least 80% or greater consensus rate. RESULTS AND CONCLUSION: The medical recommendations (pharmacological and non-pharmacological interventions) were mapped according to the stage of treatment and severity of the disease in three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/patient monitoring after initial treatment. The consensus is targeted towards general practitioners, gastroenterologists, and surgeons interested in treating and managing adults with CD and supports the decision-making of health insurance companies, regulatory agencies, and health institutional leaders or administrators.

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BACKGROUND: Approximately 25% of patients with inflammatory bowel disease (IBD) develop the disease during childhood or adolescence and treatment aims to control active symptoms and prevent long-term complications. The management of Crohn's disease (CD) and ulcerative colitis (UC) can be especially challenging in children and adolescents, related to particularities that may affect growth, development, and puberty. OBJECTIVE: This consensus aims to provide guidance on the most effective medical and surgical management of pediatric patients with CD or UC. METHODS: Experts in Pediatric IBD representing Brazilian gastroenterologists (Brazilian Organization for Crohn's Disease and Colitis [GEDIIB]) developed this consensus. A rapid review was performed to support the recommendations/statements. Medical and surgical recommendations were structured and mapped according to the disease type, disease activity, and indications and contraindications for medical and surgical treatment. After structuring the statements, the modified Delphi Panel methodology was used to conduct the voting. The process took place in three rounds: two using a personalized and anonymous online voting platform and one face-to-face. Whenever participants did not agree with a specific recommendation, an option to explain why was offered to enable free-text responses and provide the opportunity for the experts to elaborate or explain disagreement. The consensus of recommendations in each round was accepted when reached ≥80% agreement. RESULTS AND CONCLUSION: The recommendations are presented according to the stage of treatment and severity of the disease in three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/ patient monitoring after initial treatment, follow-up/ patient monitoring after initial treatment. Surgical recommendations were grouped according to disease type and recommended surgery. The target audience for this consensus was general practitioners, gastroenterologists, and surgeons interested in the treatment and management of pediatric CD and UC. Additionally, the consensus aimed to support the decision-making of health insurance companies, regulatory agencies, and health institutional leaders and/or administrators.

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Crohn's disease (CD) is a relapse-remitting inflammatory bowel disease that can affect any part of the digestive system. This heterogeneous disease has multiple factors that contribute to an abnormal immune response to intestinal microorganisms. Treatment is based on the use of anti-inflammatories, corticosteroids, immunosuppressants and biologic biologic agents either alone or in combination. Surgical treatment is usual and, ten years after diagnosis, more than 80% of patients report having undergone surgical procedures related to the disease. Unfortunately, none of the treatments described offer a cure, and many cases become refractory or without therapeutic options. In this scenario, hematopoietic stem cell transplantation has been suggested because clinical remission was obtained in patients who had CD associated with malignant hematological diseases and an alternative since the first reports in 2010. In this report, the Transplantation Committee of the Brazilian Group for the Study of Inflammatory Bowel Diseases reviews the history and results of the procedure in patients with CD, detailing and discussing the various relevant points that permeate hematopoietic stem cell transplantation and cell therapy in this disease.

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ABSTRACT Crohn's disease (CD) is a relapse-remitting inflammatory bowel disease that can affect any part of the digestive system. This heterogeneous disease has multiple factors that contribute to an abnormal immune response to intestinal microorganisms. Treatment is based on the use of anti-inflammatories, corticosteroids, immunosuppressants and biologic biologic agents either alone or in combination. Surgical treatment is usual and, ten years after diagnosis, more than 80% of patients report having undergone surgical procedures related to the disease. Unfortunately, none of the treatments described offer a cure, and many cases become refractory or without therapeutic options. In this scenario, hematopoietic stem cell transplantation has been suggested because clinical remission was obtained in patients who had CD associated with malignant hematological diseases and an alternative since the first reports in 2010. In this report, the Transplantation Committee of the Brazilian Group for the Study of Inflammatory Bowel Diseases reviews the history and results of the procedure in patients with CD, detailing and discussing the various relevant points that permeate hematopoietic stem cell transplantation and cell therapy in this disease.

RESUMO A doença de Crohn (DC) é uma doença inflamatória intestinal (DII) recidivante recorrente que pode afetar qualquer parte do sistema digestivo. É doença heterogênea e possui múltiplos fatores que contribuem para uma resposta imune anormal aos microrganismos intestinais. O tratamento baseia-se no uso de anti-inflamatórios, corticosteroides e imunossupressores e imunobiológicos que são utilizados isoladamente ou em combinação. O tratamento cirúrgico é frequente e 10 anos após o diagnóstico, mais de 50% dos pacientes relatam terem sido submetidos a procedimentos cirúrgicos relacionados à doença. Infelizmente, nenhum dos tratamentos descritos oferece cura, e inúmeros casos tornam-se refratários ou sem opções terapêuticas. Nesse cenário, o transplante de células-tronco hematopoéticas (TCTH) em decorrência da remissão clínica de pacientes que apresentavam DC associada a doenças hematológicas malignas, passou a ser alternativa desde os primeiros resultados em 2010. Neste relato, a Comissão de Transplantes do Grupo Brasileiro de Estudo das Doenças Inflamatórias Intestinais revisa a história e os resultados do procedimento em pacientes com DC, detalhando e discutindo os diversos pontos relevantes que permeiam o TCTH e a terapia celular no tratamento da moléstia.

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BACKGROUND: This is the first study on the epidemiology of inflammatory bowel diseases (IBDs) in Rio Grande do Sul (RS), the southernmost state of Brazil with the country's fifth largest population. Crohn's disease (CD) and ulcerative colitis (UC) are collectively termed IBDs. They have high incidence and prevalence rates in high-income countries, although in recent years there has been a change in the classic geographical distribution of IBDs, with growing rates in traditionally low-incidence regions. AIM: To estimate the incidence and prevalence of IBDs in the RS state, Brazil, between 2014 and 2019. METHODS: This is a cross-sectional descriptive observational study. Patients with IBD who had initiated treatment and met the inclusion criteria of the RS state free drug distribution program were included. Data were obtained from registration or renewal records of the RS state specialty pharmacy. The male, female, and total populations were estimated according to mid-year data from the Brazilian Institute of Geography and Statistics, which served as a reference for calculating the incidence and prevalence rates of IBDs during the study period. Results were described using mean, standard deviation, and range. RESULTS: We included 1082 patients with IBD, of whom 57.5% were female and 42.5% were male. Patients with CD accounted for 72.45% of the sample, and those with UC accounted for 27.54%. IBD prevalence during the study period was 9.51 per 100000 population, of which 6.89 corresponded to people with CD and 2.62, to people with UC. Incidence rates per 100000 population/year were 2.54 in 2014, 2.61 in 2015, 1.91 in 2016, 0.80 in 2017, 0.83 in 2018, and 0.96 in 2019. The mean IBD incidence rate per 100000 population was 1.61, of which 1.17 corresponded to CD and 0.44, to UC. The mean age was 41 years, and patients were mostly aged 30-40 years. Prevalence by region was higher in the state capital metropolitan area: 12.69 per 100000 population. CONCLUSION: Our results demonstrated an IBD prevalence of 9.51% and incidence of 1.61 per 100000 population. The patients were predominantly female, and CD was more prevalent than UC.

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ABSTRACT Background: Approximately 25% of patients with inflammatory bowel disease (IBD) develop the disease during childhood or adolescence and treatment aims to control active symptoms and prevent long-term complications. The management of Crohn's disease (CD) and ulcerative colitis (UC) can be especially challenging in children and adolescents, related to particularities that may affect growth, development, and puberty. Objective: This consensus aims to provide guidance on the most effective medical and surgical management of pediatric patients with CD or UC. Methods: Experts in Pediatric IBD representing Brazilian gastroenterologists (Brazilian Organization for Crohn's Disease and Colitis [GEDIIB]) developed this consensus. A rapid review was performed to support the recommendations/statements. Medical and surgical recommendations were structured and mapped according to the disease type, disease activity, and indications and contraindications for medical and surgical treatment. After structuring the statements, the modified Delphi Panel methodology was used to conduct the voting. The process took place in three rounds: two using a personalized and anonymous online voting platform and one face-to-face. Whenever participants did not agree with a specific recommendation, an option to explain why was offered to enable free-text responses and provide the opportunity for the experts to elaborate or explain disagreement. The consensus of recommendations in each round was accepted when reached ≥80% agreement. Results and conclusion: The recommendations are presented according to the stage of treatment and severity of the disease in three domains: management and treatment (drug and surgical interventions), criteria for evaluating the effectiveness of medical treatment, and follow-up/ patient monitoring after initial treatment, follow-up/ patient monitoring after initial treatment. Surgical recommendations were grouped according to disease type and recommended surgery. The target audience for this consensus was general practitioners, gastroenterologists, and surgeons interested in the treatment and management of pediatric CD and UC. Additionally, the consensus aimed to support the decision-making of health insurance companies, regulatory agencies, and health institutional leaders and/or administrators.

RESUMO Contexto: Aproximadamente 25% dos pacientes desenvolvem doença inflamatória intestinal (DII) durante a infância ou adolescência, e o tratamento visa controlar os sintomas ativos e prevenir complicações a longo prazo. O tratamento da doença de Crohn (DC) e retocolite ulcerativa (RCU) pode ser especialmente desafiador em crianças e adolescentes, relacionado a particularidades que podem afetar o crescimento, o desenvolvimento e a puberdade. Objetivo: Este consenso visa fornecer orientações sobre o tratamento clínico e cirúrgico mais eficaz de pacientes pediátricos com DC ou RCU. Métodos: Gastroenterologistas brasileiros especialistas em DII Pediátrico membro da Organização Brasileira para Doença de Crohn e Colite (GEDIIB) desenvolveram este consenso. Uma revisão rápida foi realizada para apoiar as recomendações/declarações. As recomendações médicas e cirúrgicas foram estruturadas e mapeadas de acordo com o tipo de doença, atividade da doença e indicações e contraindicações para tratamento médico e cirúrgico. Após a estruturação das declarações, foi utilizada a metodologia modificada do Painel Delphi para conduzir a votação. O processo ocorreu em três rodadas: duas por meio de uma plataforma de votação online personalizada e anônima e uma presencial. Sempre que os participantes não concordavam com a recomendação específica, uma opção para explicar o motivo era oferecida para permitir respostas em texto livre e dar a oportunidade para os especialistas elaborarem ou explicarem a discordância. O consenso das recomendações em cada rodada foi aceito quando houve concordância ≥80%. Resultados e conclusão: As recomendações são apresentadas de acordo com o estágio de tratamento e gravidade da doença em três domínios: manejo e tratamento (intervenções medicamentosas e cirúrgicas), critérios para avaliar a eficácia do tratamento médico, acompanhamento/monitoramento do paciente após tratamento. As recomendações cirúrgicas foram agrupadas de acordo com o tipo de doença e cirurgia recomendada. O público-alvo deste consenso foram clínicos gerais, gastroenterologistas e cirurgiões interessados no tratamento e manejo da RCU e DC pediátrica. Além disso, o consenso visava apoiar a tomada de decisão das operadoras de planos de saúde, agências reguladoras e líderes e/ou administradores de instituições de saúde.