Effectiveness and Safety of Ustekinumab for Ulcerative Colitis: A Brazilian Multicentric Observational Study.

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.

STRUCTURAL EVALUATION OF INFLAMMATORY BOWEL DISEASE COMPREHENSIVE CARE UNITS IN BRAZIL.

BACKGROUND: The most efficient way to prevent complications from inflammatory bowel disease (IBD) is to provide patients with optimized care. Nonetheless, in Brazil, there is no validated methodology for evaluating health services recognized as comprehensive care units (CCU), making it difficult to assess the quality of care provided. OBJECTIVE: To understand the current scenario, map the distribution of centers and identify strengths and weaknesses, considering local and regional characteristics. METHODS: The study was carried out in three phases. Initially, the Brazilian Organization for Crohn's disease and colitis (GEDIIB) developed 22 questions to characterize CCU in Brazil. In the second phase, all GEDIIB members were invited to respond to the survey with the 11 questions considered most relevant. In the last phase, an interim analysis of the results was performed, using the IBM SPSS Statistics v 29.0.1.0 software. Descriptive statistics were used to characterize the center's profile. The chi-square test was used to compare categorical variables. RESULTS: There were 53 responses from public centers (11 excluded). Most centers were concentrated in the Southeastern (n=22/52.4%) and only 1 (2.4%) in the Northern region of Brazil. Thirty-nine centers (92.9%) perform endoscopic procedures, but only 9 (21.4%) have access to enteroscopy and/or small bowel capsule endoscopy. Thirty-three centers (78.6%) offer infusion therapy locally, 26 (61.9%) maintain IBD patient records, 13 (31.0%) reported having an IBD nurse, 34 (81.0%) have specific evidence-based protocols and only 7 (16.7%) have a patient satisfaction methodology. In the private scenario there were 56 responses (10 excluded). There is also a concentration in the Southeastern and Southern regions. Thirty-nine centers (84.8%) have access to endoscopic procedures and 19 perform enteroscopy and/or small bowel capsule endoscopy, more than what is observed in the public environment. Infusion therapy is available in 24 centers (52.2%). Thirty-nine centers (84.8%) maintain a specific IBD patient database, 17 (37%) have an IBD nurse, 36 (78.3%) have specific evidence-based protocols, and 22 (47. 8%) apply a patient satisfaction methodology. CONCLUSION: IBD CCU in Brazil were mainly located in the Southeastern and Southern regions of the country. Most centers have dedicated multidisciplinary teams and IBD specialists. There is still a current need to improve the proportion of IBD nurses in IBD care in Brazil. BACKGROUND: •In Brazil, there is no validated methodology for evaluating health services recognized as comprehensive care units (CCU), making it difficult to assess the quality of care provided. BACKGROUND: •Most CCU were concentrated in the Southeast region and only one (2.4%) in the Northeast region of Brazil. This pattern follows the epidemiological trends of IBD in the country. BACKGROUND: •There is still difficulty in accessing enteroscopy and/or small bowel capsule endoscopy in the public health system. BACKGROUND: •Most centers have dedicated multidisciplinary teams and IBD specialist doctors. BACKGROUND: •There is still a current need to improve the proportion of nurses treating IBD in Brazil.

Avaliação estrutural das unidades de atenção integral às doenças inflamatórias intestinais no Brasil / Structural evaluation of inflammatory bowel disease comprehensive care units in brazil

ABSTRACT Background: The most efficient way to prevent complications from inflammatory bowel disease (IBD) is to provide patients with optimized care. Nonetheless, in Brazil, there is no validated methodology for evaluating health services recognized as comprehensive care units (CCU), making it difficult to assess the quality of care provided. Objective: To understand the current scenario, map the distribution of centers and identify strengths and weaknesses, considering local and regional characteristics. Methods: The study was carried out in three phases. Initially, the Brazilian Organization for Crohn's disease and colitis (GEDIIB) developed 22 questions to characterize CCU in Brazil. In the second phase, all GEDIIB members were invited to respond to the survey with the 11 questions considered most relevant. In the last phase, an interim analysis of the results was performed, using the IBM SPSS Statistics v 29.0.1.0 software. Descriptive statistics were used to characterize the center's profile. The chi-square test was used to compare categorical variables. Results: There were 53 responses from public centers (11 excluded). Most centers were concentrated in the Southeastern (n=22/52.4%) and only 1 (2.4%) in the Northern region of Brazil. Thirty-nine centers (92.9%) perform endoscopic procedures, but only 9 (21.4%) have access to enteroscopy and/or small bowel capsule endoscopy. Thirty-three centers (78.6%) offer infusion therapy locally, 26 (61.9%) maintain IBD patient records, 13 (31.0%) reported having an IBD nurse, 34 (81.0%) have specific evidence-based protocols and only 7 (16.7%) have a patient satisfaction methodology. In the private scenario there were 56 responses (10 excluded). There is also a concentration in the Southeastern and Southern regions. Thirty-nine centers (84.8%) have access to endoscopic procedures and 19 perform enteroscopy and/or small bowel capsule endoscopy, more than what is observed in the public environment. Infusion therapy is available in 24 centers (52.2%). Thirty-nine centers (84.8%) maintain a specific IBD patient database, 17 (37%) have an IBD nurse, 36 (78.3%) have specific evidence-based protocols, and 22 (47. 8%) apply a patient satisfaction methodology. Conclusion: IBD CCU in Brazil were mainly located in the Southeastern and Southern regions of the country. Most centers have dedicated multidisciplinary teams and IBD specialists. There is still a current need to improve the proportion of IBD nurses in IBD care in Brazil.

RESUMO Contexto: A forma mais eficiente de prevenir complicações da doença inflamatória intestinal (DII) é proporcionar aos pacientes cuidados otimizados. Contudo, no Brasil não existe uma metodologia validada para avaliação de serviços de saúde reconhecidos como unidades de atenção integral (UAI), dificultando a avaliação da qualidade da assistência prestada. Objetivo: Compreender o cenário atual, mapear a distribuição dos polos e identificar pontos fortes e fracos, considerando as características locais e regionais. Métodos: O estudo foi realizado em três fases. Inicialmente, a Organização Brasileira para Doença de Crohn e Colite (GEDIIB) desenvolveu 22 questões para caracterizar as UAI no Brasil. Na segunda fase, todos os membros do GEDIIB foram convidados a responder ao inquérito com as 11 questões consideradas mais relevantes. Na última fase foi realizada uma análise dos resultados, utilizando o software IBM SPSS Statistics v 29.0.1.0. Estatísticas descritivas foram utilizadas para caracterizar o perfil do centro. O teste qui-quadrado foi utilizado para comparar variáveis categóricas. Resultados: Houve 53 respostas de centros públicos (11 excluídas). A maioria das UAI concentrou-se na região sudeste (n=22/52,4%) e apenas 1 (2,4%) na região norte do Brasil. Trinta e nove centros (92,9%) realizam procedimentos endoscópicos, mas apenas 9 (21,4%) têm acesso à enteroscopia e/ou cápsula endoscópica. Trinta e três centros (78,6%) oferecem terapia de infusão localmente, 26 (61,9%) mantêm registros de pacientes com DII, 13 (31,0%) relataram ter uma enfermeira para DII, 34 (81,0%) têm protocolos específicos baseados em evidências e apenas 7 (16,7%) %) possuem uma metodologia de satisfação do paciente. No cenário privado houve 56 respostas (10 excluídas). Há também concentração nas regiões sudeste e sul. Trinta e nove centros (84,8%) têm acesso a procedimentos endoscópicos e 19 realizam enteroscopia e/ou cápsula endoscópica, mais do que o observado no ambiente público. A terapia infusional está disponível em 24 centros (52,2%). Trinta e nove centros (84,8%) mantêm um banco de dados específico de pacientes com DII, 17 (37%) têm uma enfermeira para DII, 36 (78,3%) têm protocolos específicos baseados em evidências e 22 (47,8%) aplicam uma metodologia de satisfação do paciente. Conclusão: As UAI do DII no Brasil estavam localizadas principalmente nas regiões sudeste e sul do país. A maioria dos centros possui equipes multidisciplinares dedicadas e médicos com experiencia em DII. Ainda há uma necessidade atual de melhorar a proporção de enfermeiros no tratamento de DII no Brasil.

Pharmacological Therapy in Inflammatory Bowel Diseases: A Narrative Review of the Past 90 Years.

Inflammatory Bowel Diseases had their first peak in incidence in countries in North America, Europe, and Oceania and are currently experiencing a new acceleration in incidence, especially in Latin America and Asia. Despite technological advances, 90 years after the development of the first molecule for the treatment of IBD, we still do not have drugs that promote disease remission in a generalized way. We carried out a narrative review on therapeutic advances in the treatment of IBD, the mechanisms of action, and the challenges facing the therapeutic goals in the treatment of IBD. Salicylates are still used in the treatment of Ulcerative Colitis. Corticosteroids have an indication restricted to the period of therapeutic induction due to frequent adverse events, while technologies with less systemic action have been developed. Most immunomodulators showed a late onset of action, requiring a differentiated initial strategy to control the disease. New therapeutic perspectives emerged with biological therapy, initially with anti-TNF, followed by anti-integrins and anti-interleukins. Despite the different mechanisms of action, there are similarities between the general rates of effectiveness. These similar results were also evidenced in JAK inhibitors and S1p modulators, the last therapeutic classes approved for the treatment of IBD.

SURGICAL MANAGEMENT OF ADULT CROHN'S DISEASE AND ULCERATIVE COLITIS PATIENTS: A CONSENSUS FROM THE BRAZILIAN ORGANIZATION OF CROHN'S DISEASE AND COLITIS (GEDIIB).

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.

SECOND BRAZILIAN CONSENSUS ON THE MANAGEMENT OF ULCERATIVE COLITIS IN ADULTS: A CONSENSUS OF THE BRAZILIAN ORGANIZATION FOR CROHN'S DISEASE AND COLITIS (GEDIIB).

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.

SECOND BRAZILIAN CONSENSUS ON THE MANAGEMENT OF CROHN'S DISEASE IN ADULTS: A CONSENSUS OF THE BRAZILIAN ORGANIZATION FOR CROHN'S DISEASE AND COLITIS (GEDIIB).

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.

BRAZILIAN CONSENSUS ON THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASES IN PEDIATRIC PATIENTS: A CONSENSUS OF THE BRAZILIAN ORGANIZATION FOR CROHN'S DISEASE AND COLITIS (GEDIIB).

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.

EncephalApp Stroop Test validation for the screening of minimal hepatic encephalopathy in Brazil.

INTRODUCTION AND OBJECTIVES: The EncephalApp Stroop Test was developed to more easily diagnose minimal hepatic encephalopathy (MHE). A cut-off of >274.9sec (ONtime+OFFtime) reached a 78% sensitivity and 90% specificity in the validation study, but it has been poorly studied in Brazil. We aim to analyze the usefulness of this diagnostic method and to describe a cut-off value to screen MHE in Brazil. METHODS: In this cross-sectional and single-center study, three positive psychometric tests defined the diagnosis of MHE as the gold standard. We evaluated gender, age, education, familiarity with smartphones, etiology of cirrhosis, Child-Pugh/MELD scores, and previous hepatic encephalopathy (HE). Healthy controls and patients without HE were compared for the task validation. The Chi-square and Mann-Whitney tests, logistic regression analysis, and ROC curves were used for statistical evaluation. RESULTS: We included 132 patients with cirrhosis (61% male) and 42 controls (62% male) around 51y. Sixty-three were diagnosed with MHE on psychometric tests and 23 had clinical HE. Viral hepatitis (38%) was the major etiology of cirrhosis. The median MELD was 10 and Child-Pugh A was more frequent (70%). There was no significant difference in test results between controls and patients without HE. There was also no influence of gender, age, education, and familiarity with smartphones in the test results. Child-Pugh A was associated with MHE (p=0.0106). A cut-off of >269.8sec (ONtime+OFFtime) had an 87% sensitivity and 77% specificity to detect MHE (p=0.002). CONCLUSION: This is a valid and reliable tool for screening MHE. However, optimal cut-off values need to be validated locally.

Consenso brasileiro de manejo das doenças inflamatórias intestinais em pacientes pediátricos: Consenso da Organização Brasileira para doença de Crohn e colite (GEDIIB) / Brazilian consensus on the management of inflammatory bowel diseases in pediatric patients: a consensus of the brazilian organization for crohn's disease and colitis (gediib)

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.

Segundo Consenso Brasileiro de Manejo da Doença de Crohn em adultos: um consenso da Organização Brasileira de Doença de Crohn e Colite (GEDIIB) / Second brazilian consensus on the management of crohn's disease in adults: a consensus of the brazilian organization for crohn's disease and colitis (gediib)

ABSTRACT 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.

RESUMO Contexto: A doença inflamatória intestinal (DII) é uma doença imunomediada que inclui a doença de Crohn (DC) e a retocolite ulcerativa. A DC é caracterizada por um envolvimento intestinal transmural da boca ao ânus com sintomas recorrentes e remitentes que podem levar a danos intestinais progressivos e incapacidade ao longo do tempo. Objetivo: Orientar os tratamentos médicos mais seguros e eficazes de adultos com DC. Métodos: Este consenso foi desenvolvido por autores que representam gastroenterologistas e cirurgiões brasileiros especialistas em doenças colorretais (GEDIIB, Organização Brasileira de Doença de Crohn e Colite). Uma revisão sistemática das evidências mais recentes foi realizada para apoiar as recomendações/declarações. Todas as recomendações e declarações incluídas foram endossadas em um painel Delphi modificado pelas partes interessadas e especialistas em DII com uma concordância de pelo menos 80% ou mais. Resultados e conclusão: As recomendações médicas (intervenções farmacológicas e não farmacológicas) foram mapeadas 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, e acompanhamento/monitoramento do paciente após o tratamento inicial. O consenso é direcionado a clínicos gerais, gastroenterologistas e cirurgiões interessados em tratar e gerenciar adultos com DC e apoia a tomada de decisões de companhias de seguro de saúde, agências reguladoras e líderes ou administradores de instituições de saúde.

Tratamento cirúrgico de pacientes adultos com doença de Crohn e retocolite ulcerativa: um consenso da Organização Brasileira de Doença de Crohn e Colite (GEDIIB) / Surgical management of adult crohn's disease and ulcerative colitis patients: a consensus from the brazilian organization of crohn's disease and colitis (gediib)

ABSTRACT 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.

RESUMO Contexto: Apesar da terapia medicamentosa otimizada, o risco contemporâneo de cirurgia nas doenças inflamatórias intestinais (DII) após 10 anos do diagnóstico é de 9,2% em pacientes com retocolite ulcerativa (RCU) e de 26,2% na doença de Crohn (DC) na era biológica. Objetivo: Este consenso visa detalhar as orientações para os procedimentos cirúrgicos mais adequados em diferentes cenários da DII. Além disso, detalha as indicações cirúrgicas e o manejo perioperatório de pacientes adultos com DC e RCU. Métodos: Nosso consenso foi desenvolvido por cirurgiões colorretais e gastroenterologistas representantes da Organização Brasileira de Doença de Crohn e Colite (GEDIIB), com a metodologia de revisão rápida sendo conduzida para respaldar as recomendações. As recomendações cirúrgicas foram estruturadas e mapeadas de acordo com os fenótipos da doença, indicações cirúrgicas e técnicas. Após a estruturação das recomendações, a metodologia modificada do Painel Delphi foi utilizada para conduzir a votação por especialistas em cirurgia de DII e gastroenterologia. Esta consistiu em três rondas: duas com recurso a uma plataforma de votação online personalizada e anônima e uma reunião presencial. Sempre que os participantes não concordavam com afirmações ou recomendações específicas, era oferecida uma opção de delinear possíveis razões para permitir respostas em texto livre e dar a oportunidade para os especialistas elaborarem ou explicarem a discordância. O consenso de recomendações/declarações em cada rodada foi considerado alcançado se houve concordância ≥80%. Resultados e conclusão Este consenso abordou as informações mais relevantes para orientar o processo de tomada de decisão para o manejo cirúrgico adequado de DC e RCU. Ele sintetiza recomendações desenvolvidas a partir de evidências e conhecimento de alto nível. As recomendações cirúrgicas foram estruturadas e mapeadas de acordo com os diferentes fenótipos da doença, indicações para cirurgia e manejo perioperatório. O foco específico do nosso consenso foi dado aos procedimentos cirúrgicos eletivos e de emergência, determinando quando indicar a cirurgia e quais procedimentos podem ser os mais adequados. O consenso é direcionado a gastroenterologistas e cirurgiões interessados no tratamento e manejo de pacientes adultos com DC ou RCU e apoia a tomada de decisões de pagadores de saúde, líderes institucionais e/ou administradores.

Segundo Consenso Brasileiro no manejo da retocolite ulcerativa em adultos: um consenso da Organização Brasileira para Doença de Crohn e Colite (GEDIIB) / Second brazilian consensus on the management of ulcerative colitis in adults: a consensus of the brazilian organization for crohn's disease and colitis (gediib)

ABSTRACT 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.

RESUMO Contexto: As doenças inflamatórias intestinais são doenças imunomediadas que incluem a doença de Crohn (DC) e a retocolite ulcerativa (RCU). A RCU é uma doença progressiva que acomete a mucosa colorretal causando sintomas debilitantes levando a alta morbidade e incapacidade laboral. Como consequência da inflamação crônica do cólon, a RCU também está associada a um risco aumentado de câncer colorretal. Objetivo: Este consenso visa fornecer orientações sobre o manejo médico mais eficaz de pacientes adultos com RCU. Métodos: As recomendações do consenso foram desenvolvidas por gastroenterologistas e cirurgiões colorretais referências no Brasil (membros da Organização Brasileira para Doença de Crohn e Colite [GEDIIB]). Uma revisão sistemática, incluindo as evidências mais recentes, foi conduzida para apoiar as recomendações. Todas as recomendações foram endossadas pelas partes interessadas/especialistas em doença inflamatória intestinal usando um Painel Delphi modificado. O nível de concordância para alcançar consenso foi de 80% ou mais. Resultados e conclus ão: As recomendações médicas (farmacológicas e não farmacológicas) foram mapeadas 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, e acompanhamento/monitoramento do paciente após o tratamento inicial. O consenso foi direcionado a clínicos gerais, gastroenterologistas e cirurgiões que tratam pacientes com RCU e apoia os processos de tomada de decisão por companhias de seguro de saúde, agências reguladoras, líderes institucionais de saúde e administradores.

Nutritional Global Status and Its Impact in Crohn's Disease.

BACKGROUND: Malnutrition among inflammatory bowel disease (IBD) subjects is well documented in literature and may emerge from factors including inadequate dietary intake, malabsorption and disease activity. The aim of this study was to complete a comprehensive nutrition assessment and explore what possibilities may help bring a better quality of life for IBD subjects. METHODS: Nutritional status based on biochemical tests, body composition and body mass index (BMI). Food intake was assessed by an alternate 3-day food record and the adequacy of intake was evaluated according to national and international references. Clinical disease activity was evaluated by the Harvey-Bradshaw index and CRP levels. RESULTS: The study included 217 patients and 65 controls, where 54.4% of these patients were classified as normal weight with a mean BMI lower than controls (23.8 ± 4.9 versus 26.9 ± 4.8 kg/m2, P = 0.02). Patients with disease activity showed more overweight and obesity than patients with controlled disease. Vitamin B12 deficiency was present in 19% of Crohn's disease (CD), mainly in patients with ileal commitment and small bowel resections. Anemia was present in 21.7% of patients, being more common in patients with active disease (25%) and bowel resection (23%). Regarding calorie intake (EI), CD group ingested more than controls (1986.3 ± 595.9 kcal versus 1701.8 ± 478.9 kcal; P = 0.003). CONCLUSIONS: CD patients presented micronutrient deficiency when compared with controls, explained for other reasons than intake restrictions. Also, fat excess might have contributed to disease burden as continuously reported in the literature.

P064 Association Between Crohn's Disease (CD) and Transient IgM and IgG Immunodeficiency-Diagnostic and Management Challenges.

CASE: Background: CD is an inflammatory disease that predominantly affects the gastrointestinal tract and has a progressive course. Immunodeficiencies can occur by altering different components of innate or adaptive immune responses. Such changes put the patient at greater risk for infectious diseases or non-infectious complications. Among the non-infectious complications are cancer, autoimmune diseases and gastrointestinal diseases, which should be suspected in patients with recurrent infections, with clinical, radiological or histological features of the disease are atypical or in the occurrence of an unsatisfactory response to conventional therapy. OBJECTIVE: To describe a case report of a CD patient complicated with enteric alterations related to immunodeficiency. RESULTS: A 31-year-old male patient started presenting abdominal pain, diarrhea, and weight loss in October 2020. He underwent a colonoscopy that showed diffuse involvement of the colon suggestive of CD. He didn`t respond to therapy with prednisone and azathioprine and lost 40kg until January 2021, when he was referred to an IBD center. He had signs of malnutrition (eg, BMI = 15.4, Albumin = 1.8g/dL). The MRI showed diffuse thickening of the walls of the entire length of the ileum, colon and rectum, associated with submucosal edema and more intense enhancement in the inner layer. Findings compatible with nonspecific diffuse ileocolitis. After negative infectious screening, hydrocortisone, azathioprine and infliximab were prescribed, but the patient remained clinical worsening. During the 6 weeks of therapy use, the patient presented oral candidiasis, septic pyoarthritis, DNA testing for Clostridium difficile and PCR for Cytomegalovius were positive. Despite the treatment of infectious diseases, the patient continued to worsen and was considered a primary non-response to anti-TNF, opting for the initiation of Ustekinumab. There was improvement in endoscopic and fecal calprotectin, but continued progression of ileal disease and diarrhea, with no response to enteral or parenteral nutritional therapies. An investigation for immunodeficiencies was carried out and IgM/IgG deficiency was noted, and parenteral immunoglobulin was started. He presented an intestinal subocclusion, requiring a loop ileostomy. In this surgery, it was decided to send a sample of ileal tissue for diagnostic differentiation, where ileitis was observed with intense plasma cell reaction and lymphoid nodular hyperplasia, uncharacteristic of DC, which may correspond to enteropathy secondary to immunodeficiency. Despite the treatment, the patient presented fungal endocarditis, esophageal moniliasis and septic condition of undetermined origin. He remained in hospital for 120 days until complete improvement of the infectious complications. With the slow improvement in nutritional parameters, there was a reduction in the incidence of infections as well as an increase in immunoglobulins. After five months of combined nutrition and anti-interleukin therapy, the patient presented clinical improvement, weight gain and complete normalization of IgG and IgM. Ileal disease is in regression and in the colon, in endoscopic remission. CONCLUSION: We present a case report of the initial presentation of DC complicated with severe malnutrition where there was depletion of part of immunoglobulins, resulting in infectious and non-infectious complications, where ileal involvement intensified the manifestation of colonic DC.

Hypoalbuminemia as a risk factor for thromboembolic events in inflammatory bowel disease inpatients.

BACKGROUND/AIMS: Inflammatory bowel disease (IBD) are chronic entities characterized by local and systemic inflammation and may be associated with thrombosis. The aim of this study was to identify the prevalence of thromboembolic events (TEE) in hospitalized IBD patients and identify risk factors for their occurrence. METHODS: This retrospective, single-center study included patients treated at a Brazilian IBD referral unit between 2004 and 2014. Patients hospitalized for more than 48 hours due to active IBD and who did not receive prophylaxis for TEE during hospitalization were included. Patients were allocated to 2 groups: those with TEE up to 30 days or at the time of hospitalization (TEE-group) and patients without TEE (control-group). Clinical and laboratory characteristics were evaluated. RESULTS: Of 53 patients evaluated, 69,8% with Crohn's disease (CD) and 30.2% with ulcerative colitis (UC). The prevalence of TEE 30 days before or during hospitalization was 15.1%, with 10.8% in CD and 25% in UC. In the TEE group, mean serum albumin was 2.06 g/dL versus 3.30 g/dL in the control group. Patients with albumin levels below 2.95 g/dL (43.18%) had a higher risk of developing TEE (relative risk, 1.72; 95% confidence interval, 1.17-2.53) (P<0.001). CONCLUSIONS: Albumin levels were significantly lower in patients with TEE, and hypoalbuminemia was considered a risk factor for the development of TEE in this population.

Serum sodium, model for end-stage liver disease, and a recent invasive procedure are risk factors for severe acute-on-chronic liver failure and death in cirrhotic patients hospitalized with bacterial infection.

INTRODUCTION: Bacterial infection is present in up to 30% of hospitalized cirrhotic patients. It can lead, even after its resolution, to organ dysfunction and even acute-on-chronic liver failure (ACLF). It is the precipitating factor of ACLF in one third of the cases and is the main cause of mortality in patients with liver cirrhosis. OBJECTIVES: The aim of this study was to evaluate the prevalence and identify early risk factors for severe ACLF and death in hospitalized patients with liver cirrhosis with bacterial infection. PATIENTS AND METHODS: This was a prospective observational study. Hospitalized patients with liver cirrhosis and bacterial infection were included. Clinical and laboratory data and their evolution to organ dysfunction and death were assessed. A statistical analysis were carried out to identify predictors of severe ACLF and in-hospital mortality. RESULTS: This study included 88 patients. ACLF was observed in 62 (70%) patients, with 48 (55%) grade 2 or higher. Of the 27 deaths (31% of all patients), 26 had severe ACLF (54% mortality) (P<0.0001). The independent risk factors for ACLF of at least 2 and death were baseline serum sodium [odds ratio (OR): 0.874; P=0.01, and OR: 0.9, P=0.04], initial MELD (OR: 1.255, P=0.0001, and OR: 1.162, P=0.005), and a recent invasive procedure (OR: 3.169, P=0.01, and OR: 6.648, P=0.003). CONCLUSION: Lower serum sodium values, higher MELD scores at diagnosis of infection, and a recent history of invasive procedures were independent risk factors for severe ACLF and death in patients with cirrhosis and bacterial infection.

Multiple hepatic metastases of cardiac angiosarcoma.

The differential diagnosis of hepatic focal lesions is challenging because the etiology can be inflammatory, infectious, and even neoplastic. A rare cause of metastatic liver nodules is cardiac angiosarcoma. We report a case of this tumor, which was diagnosed only after autopsy. A 26-year-old Caucasian man was admitted for progressive dyspnea and cough over the past 3 weeks. Physical examination showed only hypophonetic heart sounds. Laboratory analysis demonstrated anemia and elevated inflammatory markers, despite normal biochemical parameters and liver function. Transthoracic echocardiography revealed massive pericardial effusion. Abdomen computed tomography (CT) showed multiple hepatic nodules, the largest of which measured 3 cm, but the percutaneous biopsy revealed only lobular necrosis and perisinusoidal fibrosis without granulomas or neoplastic cells. During hospitalization, the patient had fever and night sweats with weight loss, and empiric treatment for extrapulmonary tuberculosis associated with corticosteroids was initiated. The outpatient follow-up revealed complete improvement of the pericardial effusion, but maintenance of the liver lesions. After 2 months of hospital discharge, the patient was readmitted with hemorrhagic shock due to bleeding liver lesions, which were evidenced by CT. Embolization of the right hepatic artery was performed, but the patient soon died. The autopsy revealed a primary cardiac angiosarcoma with multiple hepatic metastases, rupture of the Glisson's capsule and laceration of the liver. The case shows how important and difficult the diagnosis of focal liver lesions is, since it may result in an unexpected fatal outcome.