Clinical factors associated with severity in patients with inflammatory bowel disease in Brazil based on 2-year national registry data from GEDIIB.

The Brazilian Organization for Crohn's Disease and Colitis (GEDIIB) established a national registry of inflammatory bowel disease (IBD). The aim of the study was to identify clinical factors associated with disease severity in IBD patients in Brazil. A population-based risk model aimed at stratifying the severity of IBD based on previous hospitalization, use of biologics, and need for surgery for ulcerative colitis (UC) and Crohn's Disease (CD) and on previous complications for CD. A total of 1179 patients (34.4 ± 14.7y; females 59%) were included: 46.6% with UC, 44.2% with CD, and 0.9% with unclassified IBD (IBD-U). The time from the beginning of the symptoms to diagnosis was 3.85y. In CD, 41.2% of patients presented with ileocolic disease, 32% inflammatory behavior, and 15.5% perianal disease. In UC, 46.3% presented with extensive colitis. Regarding treatment, 68.1%, 67%, and 47.6% received biological therapy, salicylates and immunosuppressors, respectively. Severe disease was associated with the presence of extensive colitis, EIM, male, comorbidities, and familial history of colorectal cancer in patients with UC. The presence of Montreal B2 and B3 behaviors, colonic location, and EIM were associated with CD severity. In conclusion, disease severity was associated with younger age, greater disease extent, and the presence of rheumatic EIM.

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.

Thiols as a marker of inflammatory bowel disease activity: a systematic review.

BACKGROUND: Evidence indicates that inflammation in Inflammatory Bowel Disease (IBD) is associated with increased systemic levels of reactive oxygen species. Systemic oxidative stress has been associated with reduced levels of plasma thiols. Less invasive tests capable of reflecting and predicting IBD activity are increasingly sought after. We sought to systematically review the evidence inherent in serum thiol levels as a marker of Crohn's Disease and Ulcerative Colitis activity (PROSPERO: CRD42021255521). METHODS: The highest quality documents for systematic reviews standards were used as reference. Articles were searched on Medline via PubMed, VHL, LILACS, WOS, EMBASE, SCOPUS, COCHRANE, CINAHL, OVID, CTGOV, WHO/ICTRP, OPENGREY, BDTD and CAPES, between August, 03 and September, 03 on 2021. Descriptors were defined according to the Medical Subject Heading. Of the 11 articles selected for full reading, 8 were included in the review. It was not possible to perform a pooled analysis of the studies, as there were no combinable studies between subjects with active IBD and controls/inactive disease. RESULTS: Findings from the individual studies included in this review suggest an association between disease activity and systemic oxidation, as measured by serum thiol levels, however, there are limitations that preclude weighting the study results in a meta-analysis. CONCLUSIONS: We recommend conducting better-designed and controlled studies, that include individuals of both phenotypes and at different stages of IBD, involving a larger number of participants, using the standardization of the technique for measuring serum thiols, to confirm whether thiols can be a good parameter for monitoring the clinical course of these intestinal diseases and the degree of clinical applicability.

Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn's Disease: Results from an Early Access Program in Brazil.

This prospective, observational, open-label study aimed to provide access to ustekinumab prior to market authorization and assess its safety and effectiveness in patients with Crohn's disease (CD) refractory to anti-tumor necrosis factor-α and conventional drugs in Brazil. Patients with a diagnosis of moderate-to-severe active CD for ≥3 months before screening received ustekinumab in a single intravenous induction dose (~6 mg/kg) at week 0, and a 90 mg maintenance dose, subcutaneously, every 8 or 12 weeks, from week 8 through to 80. Serious adverse events (SAE), adverse drug reactions (ADR), clinical response (per CD Activity Index and Harvey Bradshaw Index (HBI) scores), remission (per HBI scores), biomarkers (C-reactive protein (CRP) and fecal calprotectin (FC)) and endoscopic improvement rate over 80 weeks were assessed. Patients with a mean age of 39.9 years were assessed. Discontinuation rate was low (23%) and most adverse events were mild (68.7%). The SAE rate was 21% (mostly infections/infestations or gastrointestinal disorder), and ADR rate was 44%. The CD Activity Index and HBI scores decreased (by 74% and 81%, respectively) with 50% of patients showing normalized CRP and FC, and 63% achieved endoscopic improvement. Ustekinumab was fairly safe, well tolerated and effective in a Brazilian cohort of CD patients.

COMPLEMENTARY AND ALTERNATIVE MEDICINE USE IN BRAZILIAN PATIENTS WITH INFLAMMATORY BOWEL DISEASE.

BACKGROUND: The conventional treatment of inflammatory bowel disease (IBD) is based on drug therapy, but different studies have shown a progressive increase in the use of complementary and alternative medicine (CAM). The most used CAM comprises of acupuncture, traditional Chinese medicine, Ayurvedic medicine, homeopathy, and herbal medicine, as well as more modern practices, including aromatherapy and reflexology. Data from CAM use in Brazil has previously been scarce and there are no studies among Brazilian patients with IBD. OBJECTIVE: The aim of the study was to evaluate the frequency of, and factors associated with the use of CAM among IBD patients in Brazil, in addition to estimating the satisfaction with CAM use. METHODS: A cross-sectional study was performed in adult IBD outpatients from two Southeastern Brazilian referral centers, with a total a sample of 227 individuals. A semi-structured questionnaire was used containing CAM products - tea, probiotics, omega 3 or glutamine, homeopathy, and herbal therapy, and factors associated with CAM use and patient satisfaction. We used descriptive statistics, association tests (P<0.05) and logistic regression for statistical analyses. RESULTS: In total, 126 patients with Crohn's disease and 101 with ulcerative colitis were included. The mean age was 41.19±14.49 years and 57.27% were female. The time since diagnosis was 10.58±7.5 years, and most patients were in clinical remission. Twenty-nine patients (12.8%) reported having used CAM for IBD treatment, such as tea (5.29%), probiotics (5.29%), omega-3 or glutamine (1.76%), homeopathy (0.88%), and herbal therapies (0.44%). Despite the low frequency, patients were satisfied (>50%). There was no difference between CAM use in Crohn's disease as compared to ulcerative colitis patients (P=0.1171). The factors associated with the use of CAM were regular or poor quality of life (odds ratio 2.084; 95% confidence interval 1.147-3.786, P=0.0159) and a shorter time since diagnosis (odds ratio 0.956; 95% confidence interval 0.918-0.995; P=0.0260). CONCLUSION: The prevalence of CAM use was low, but satisfactory among Brazilian IBD patients. The application of CAM has been associated with poor quality of life and shorter disease duration compared to patients with no use of CAM.

Uso de medicina complementar e alternativa em pacientes brasileiros com doença inflamatória intestinal / Complementary and alternative medicine use in brazilian patients with inflammatory bowel disease

ABSTRACT Background: The conventional treatment of inflammatory bowel disease (IBD) is based on drug therapy, but different studies have shown a progressive increase in the use of complementary and alternative medicine (CAM). The most used CAM comprises of acupuncture, traditional Chinese medicine, Ayurvedic medicine, homeopathy, and herbal medicine, as well as more modern practices, including aromatherapy and reflexology. Data from CAM use in Brazil has previously been scarce and there are no studies among Brazilian patients with IBD. Objective: The aim of the study was to evaluate the frequency of, and factors associated with the use of CAM among IBD patients in Brazil, in addition to estimating the satisfaction with CAM use. Methods: A cross-sectional study was performed in adult IBD outpatients from two Southeastern Brazilian referral centers, with a total a sample of 227 individuals. A semi-structured questionnaire was used containing CAM products - tea, probiotics, omega 3 or glutamine, homeopathy, and herbal therapy, and factors associated with CAM use and patient satisfaction. We used descriptive statistics, association tests (P<0.05) and logistic regression for statistical analyses. Results: In total, 126 patients with Crohn's disease and 101 with ulcerative colitis were included. The mean age was 41.19±14.49 years and 57.27% were female. The time since diagnosis was 10.58±7.5 years, and most patients were in clinical remission. Twenty-nine patients (12.8%) reported having used CAM for IBD treatment, such as tea (5.29%), probiotics (5.29%), omega-3 or glutamine (1.76%), homeopathy (0.88%), and herbal therapies (0.44%). Despite the low frequency, patients were satisfied (>50%). There was no difference between CAM use in Crohn's disease as compared to ulcerative colitis patients (P=0.1171). The factors associated with the use of CAM were regular or poor quality of life (odds ratio 2.084; 95% confidence interval 1.147-3.786, P=0.0159) and a shorter time since diagnosis (odds ratio 0.956; 95% confidence interval 0.918-0.995; P=0.0260). Conclusion: The prevalence of CAM use was low, but satisfactory among Brazilian IBD patients. The application of CAM has been associated with poor quality of life and shorter disease duration compared to patients with no use of CAM.

RESUMO Contexto: O tratamento convencional da doença inflamatória intestinal (DII) é baseado na terapia medicamentosa, mas diferentes estudos têm mostrado aumento progressivo do uso de medicina complementar e alternativa (MCA) na abordagem dos pacientes. As modalidades de MCA mais usadas compreendem: acupuntura, medicina tradicional chinesa, medicina ayurvédica, homeopatia e fitoterapia, bem como práticas mais modernas, como aromaterapia e reflexologia. Os dados do uso de MCA no Brasil são escassos e não há estudos entre pacientes brasileiros com DII. Objetivo: O objetivo do estudo foi avaliar a frequência e os fatores associados com o uso de MCA entre pacientes com DII, além de estimar a satisfação com o uso de MCA. Métodos: Foi realizado estudo transversal em pacientes adultos ambulatoriais com DII oriundos de dois centros de referência no sudeste do Brasil, com amostra de 227 indivíduos. Foi aplicado questionário semiestruturado contendo produtos como - chá, probióticos, ômega 3 ou glutamina, homeopatia e fitoterapia, além de fatores associados ao uso de MCA e a satisfação do paciente. Utilizamos estatística descritiva, testes de associação (P<0,05) e regressão logística para análise estatística. Resultados: No total, 126 pacientes com doença de Crohn e 101 com retocolite ulcerativa foram incluídos. A média de idade foi 41,19±14,49 anos e 57,27% eram do sexo feminino. O tempo desde o diagnóstico foi de 10,58±7,5 anos, e a maioria dos pacientes estava em remissão clínica. Vinte e nove pacientes (12,8%) relataram ter usado MCA para o tratamento de DII, como chá (5,29%), probióticos (5,29%), ômega-3 ou glutamina (1,76%), homeopatia (0,88%) e fitoterápicos (0,44%). Apesar da baixa frequência, os pacientes ficaram satisfeitos com o uso (>50%). Não houve diferença entre o uso de MCA entre os pacientes com doença de Crohn em comparação com pacientes com retocolite ulcerativa (P=0,1171). Os fatores associados com o uso de MCA foram qualidade de vida regular ou ruim (Odds ratio 2,084; intervalo de confiança de 95% 1,147-3,786, P=0,0159) e menor tempo desde o diagnóstico (Odds ratio 0,956; intervalo de confiança de 95% 0,918-0,995; P=0,0260). Conclusão: A prevalência do uso de MCA foi baixa, mas satisfatória entre os pacientes com DII. O uso de MCA tem sido associada a baixa qualidade de vida e menor duração da doença.

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.

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.

Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBDs) with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden, especially in patients with moderate-to-severe disease. The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil (RISE BR) study was a noninterventional study designed to evaluate disease control, treatment patterns, disease burden and health-related quality of life in patients with moderate-to-severe active IBD. We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD. AIM: To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil. METHODS: This was a prospective, noninterventional study of adult patients with active Crohn's disease (CD: Harvey-Bradshaw Index ≥ 8, CD Activity Index ≥ 220), inadequate CD control (i.e., calprotectin > 200 µg/g or colonoscopy previous results), or active ulcerative colitis (UC: Partial Mayo score ≥ 5). Enrollment occurred in 14 centers from October 2016 to February 2017. The proportion of active IBD patients after 9-12 mo of follow-up, Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation, discontinuation and dose changes were examined. RESULTS: The study included 118 CD and 36 UC patients, with mean ± SD ages of 43.3 ± 12.6 and 44.9 ± 16.5 years, respectively. The most frequent drug classes at index were biologics for CD (62.7%) and 5-aminosalicylate derivates for UC patients (91.7%). During follow-up, 65.3% of CD and 86.1% of UC patients initiated a new treatment at least once. Discontinuations/dose changes occurred in 68.1% of CD patients [median 2.0 (IQR: 2-5)] and 94.3% of UC patients [median 4.0 (IQR: 3-7)]. On average, CD and UC patients had 4.4 ± 2.6 and 5.0 ± 3.3 outpatient visits, respectively. The median time to first mild or no activity was 319 (IQR: 239-358) d for CD and 320 (IQR: 288-358) d for UC patients. At 9-12 mo, 22.0% of CD and 20.0% of UC patients had active disease. CONCLUSION: Although a marked proportion of active IBD patients achieved disease control within one year, the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting.

Hospitalization and surgery rates in patients with inflammatory bowel disease in Brazil: a time-trend analysis.

BACKGROUND: The prevalence of inflammatory bowel disease (IBD) is increasing globally, and the disease is frequently managed surgically. The aim of this study was to investigate the time trends and geographic distribution of IBD hospitalizations, surgeries and surgical-associated lethality. METHODS: Data from the Brazilian Health Public System were retrospectively collected regarding hospitalizations, in-hospital deaths, IBD-related surgical procedures and lethality from 2005 to 2015. RESULTS: This eleven-year period revealed decreases in the rates of hospitalization (24%), IBD-related surgeries (35%), and IBD-related surgical lethality (46%). Most surgeries were performed in Crohn's disease patients, and the predominant procedure was small bowel resection, mostly in young adults. A higher prevalence of ulcerative was observed throughout the country. The highest hospitalization and surgical rates were observed in the more industrialized regions of the South and the Southeast and in the municipalities integrated with metropolitan regions (MRs). The highest surgical-related lethality rates were seen in the less-developed regions and in municipalities not integrated with MRs. The length of hospital stay showed a slight increase throughout the period. CONCLUSIONS: Brazil follows the global trend of decreases in hospitalizations, lethality, surgeries, and surgical lethality associated with IBD. The unequal distribution of hospitalizations and surgeries, concentrated in the industrialized areas, but with a shift towards the Northeast and from urbanized to rural areas, indicates ongoing changes within the country. Reductions in the rates of IBD-related hospitalizations, surgeries and lethality suggest the effectiveness of decentralization and improvements in the quality of public health services and the advances in medical therapy during the study period.

Real-world disease activity and sociodemographic, clinical and treatment characteristics of moderate-to-severe inflammatory bowel disease in Brazil.

BACKGROUND: Understanding the treatment landscape of inflammatory bowel diseases (IBD) is essential for improving disease management and patient outcomes. Brazil is the largest Latin American country, and it presents socioeconomic and health care differences across its geographical regions. This country has the highest increase in IBD incidence and prevalence in Latin America, but information about the clinical and treatment characteristics of IBD is scarce. AIM: To describe the sociodemographic, clinical, and treatment characteristics of IBD outpatients in Brazil overall and in the Southeast, South and Northeast/Midwest regions. METHODS: Multicenter, cross-sectional study with a 3-year retrospective chart review component. Patients with moderate-to-severe Crohn's disease (CD) or ulcerative colitis (UC) were consecutively enrolled between October 2016 and February 2017. Active CD at enrollment was defined as a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or a calprotectin level > 200 µg/g or an active result based on colonoscopy suggestive of inadequate control during the previous year; active UC was defined as a partial Mayo score ≥ 5. Descriptive statistics were used to analyze all variables. RESULTS: In a total of 407 included patients, CD was more frequent than UC, both overall (264 CD/143 UC patients) and by region (CD:UC ratios of 2.1 in the Southeast, 1.6 in the South and 1.2 in the Northeast/Midwest). The majority of patients were female (54.2% of CD; 56.6% of UC), and the mean ages were 45.9 ± 13.8 years (CD) and 42.9 ± 13.0 years (UC). The median disease duration was 10.0 (range: 0.5-45) years for both IBD types. At enrollment, 44.7% [95% confidence interval (CI): 38.7-50.7] of CD patients and 25.2% (95%CI: 18.1-32.3) of UC patients presented with active disease. More than 95% of IBD patients were receiving treatment at enrollment; CD patients were commonly treated with biologics (71.6%) and immunosuppressors (67.4%), and UC patients were commonly treated with mesalazine [5-Aminosalicylic acid (5-ASA)] derivates (69.9%) and immunosuppressors (44.1%). More than 50% of the CD patients had ileocolonic disease, and 41.7% presented with stricturing disease. One-quarter of CD patients had undergone CD-related surgery in the past 3 years, and this proportion was lower in the Northeast/Midwest region (2.9%). CONCLUSION: In Brazil, there are regional variations in IBD management. CD outweighs UC in both frequency and disease activity. However, one-quarter of UC patients have active disease, and most are receiving 5-ASA treatment.

The Use of Curcumin as a Complementary Therapy in Ulcerative Colitis: A Systematic Review of Randomized Controlled Clinical Trials.

The objective of this study was to systematically review the literature to verify the efficacy and safety of curcumin as a complementary therapy for the maintenance or induction of remission in patients with inflammatory bowel disease (IBD). A comprehensive search was conducted by two independent authors in MEDLINE (PubMed), Scopus, Web of Science, the Cochrane Library, Lilacs, Food Science and Technology Abstracts, and ScienceDirect. The search terms "curcumin", "curcuma", "inflammatory bowel disease", "proctocolitis", "crohn disease", and "inflammation" were combined to create search protocols. This study considered randomized controlled trials (RCTs) published in any language before March 2020 that evaluated the effects of curcumin on inflammatory activity and the maintenance or remission of IBD patients. After duplicates were removed, 989 trials were identified, but only 11 met the eligibility criteria. Five of these were considered to be biased and were excluded. Therefore, six trials were considered in this review. All the studies included in the systematic review were placebo-controlled RCTs conducted on individuals with ulcerative colitis (UC). All the RCTs reported that curcumin was well tolerated and was not associated with any serious side effects. Studies show that curcumin may be a safe, effective therapy for maintaining remission in UC when administered with standard treatments. However, the same cannot be stated for Crohn's disease due to the lack of low bias risk studies. Further studies with larger sample sizes are needed before curcumin can be recommended as a complementary therapy for UC.

Review of the epidemiology and burden of ulcerative colitis in Latin America.

The incidence and prevalence of ulcerative colitis (UC) has been reported to be rising in newly industrialised regions, such as Latin America. Here, we review data from published studies reporting demographics and clinical aspects of UC in Latin America to further understand epidemiology and disease burden. The incidence and prevalence of UC in Latin America varied between regions and studies, ranging between 0.04 to 8.00/100,000 and 0.23 to 76.1/100,000, respectively, and generally increased over the period from 1986 to 2015. The majority of patients with UC were female (53.6-72.6%) and urban residents (77.8-97.4%). Extraintestinal manifestations were reported in approximately 26-89.4% of patients. Use of biologic therapies was generally low (0.8-16.2%), with the exception of Mato Grosso do Sul, Brazil, with a greater proportion of patients tending to receive 5-aminosalicylates, immunosuppressants or corticosteroids; colectomy rates varied between studies (1.5-22%). A high proportion of patients had moderate to severe UC (45.9-73.0%) and, in 11 of 19 studies, the greatest proportion of patients had extensive disease (pancolitis). Colorectal cancer (0-1.7%) and mortality rates (0-7.6%) were low. This evaluation of published studies may influence therapeutic approaches and the development of strategies to improve healthcare access and patient outcomes, although further high-quality studies are required in patients with UC in Latin America.

Quality of life, work productivity impairment and healthcare resources in inflammatory bowel diseases in Brazil.

BACKGROUND: Inflammatory bowel diseases (IBD) have been associated with a low quality of life (QoL) and a negative impact on work productivity compared to the general population. Information about disease control, patient-reported outcomes (PROs), treatment patterns and use of healthcare resources is relevant to optimizing IBD management. AIM: To describe QoL and work productivity and activity impairment (WPAI), treatment patterns and use of healthcare resources among IBD patients in Brazil. METHODS: A multicenter cross-sectional study included adult outpatients who were previously diagnosed with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). At enrolment, active CD and UC were defined as having a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or calprotectin > 200 µg/g or previous colonoscopy results suggestive of inadequate control (per investigator criteria) and a 9-point partial Mayo score ≥ 5, respectively. The PRO assessment included the QoL questionnaires SF-36 and EQ-5D-5L, the Inflammatory Bowel Disease Questionnaire (IBDQ), and the WPAI questionnaire. Information about healthcare resources and treatment during the previous 3 years was collected from medical records. Chi-square, Fisher's exact and Student's t-/Mann-Whitney U tests were used to compare PROs, treatment patterns and the use of healthcare resources by disease activity (α = 0.05). RESULTS: Of the 407 patients in this study (CD/UC: 64.9%/35.1%, mean age 42.9/45.9 years, 54.2%/56.6% female, 38.3%/37.1% employed), 44.7%/25.2% presented moderate-to-severe CD/UC activity, respectively, at baseline. Expressed in median values for CD/UC, respectively, the SF-36 physical component was 46.6/44.7 and the mental component was 45.2/44.2, the EQ-visual analog scale score was 80.0/70.0, and the IBDQ overall score was 164.0/165.0. Moderate to severe activity, female gender, being unemployed, a lower educational level and lower income were associated with lower QoL (P < 0.05). Median work productivity impairment was 20% and 5% for CD and UC patients, respectively, and activity impairment was 30%, the latter being higher among patients with moderate to severe disease activity compared to patients with mild or no disease activity (75.0% vs 10.0%, P < 0.001). For CD/UC patients, respectively, 25.4%/2.8% had at least one surgery, 38.3%/19.6% were hospitalized, and 70.7%/77.6% changed IBD treatment at least once during the last 3 years. The most common treatments at baseline were biologics (75.3%) and immunosuppressants (70.9%) for CD patients and 5-ASA compounds (77.5%) for UC patients. CONCLUSION: Moderate to severe IBD activity, especially among CD patients, is associated with a substantial impact on QoL, work productivity impairment and an increased number of IBD surgeries and hospitalizations in Brazil.

Crohn's disease - treatment with biological medication.

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.

Crohn's disease - treatment with biological medication

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.

Brazilian recommendations on the safety and effectiveness of the yellow fever vaccination in patients with chronic immune-mediated inflammatory diseases

Abstract Background: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Main body of the abstract: Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. Conclusion: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV.

Crohn's disease environmental factors in the developing world: A case-control study in a statewide catchment area in Brazil.

AIM: To identify environmental risk factors associated with the development of Crohn's disease (CD) in order to re-assess the hygiene hypothesis. METHODS: A hospital-based, case-control study was carried out with CD patients (n = 145) and controls (n = 163) representing a socioeconomically diverse statewide catchment area in Brazil. Controls were recruited from caregivers of patients seen in different outpatient clinics at the same hospital. A multi-item survey with 94 questions regarding family history of CD, perinatal and childhood circumstances, living conditions, tobacco use and familial socioeconomic status was carried out by interviewers. RESULTS: On the univariate analysis, predictive variables for CD included being male, under age of 40, a high education level, urban dweller, smaller family size, exposure to enteric pathogens and user of treated water (P < 0.005). On the multivariate analysis, variables significantly associated with CD were male gender (OR = 2.09), under age 40 (OR = 3.10), white (OR = 2.32), from a small family in childhood (OR = 2.34) and adulthood (OR = 3.02), absence of viral infections in childhood (OR = 2.23), exposure to enteric pathogens (OR = 2.41), having had an appendectomy (OR = 2.47) and prior or current smoker (OR = 2.83/1.12). CONCLUSION: Most variables supporting the "hygiene hypothesis" are associated with the development of CD but are not independent predictors of the diagnosis.