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.

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.

Thiopurines are an independent risk factor for active tuberculosis in inflammatory bowel disease patients.

The use of thiopurines is an independent risk factor for active tuberculosis in patients with inflammatory bowel disease.

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.

Anorectal Function and Clinical Characteristics Associated with Faecal Incontinence in Patients with Crohn's Disease.

BACKGROUND AND AIMS: Faecal incontinence is an important complaint reported by patients with Crohn's disease [CD] and it is associated with several disease-related mechanisms, including anorectal functional disorders. This study aimed to assess the anorectal function and clinical characteristics to identify parameters associated with faecal incontinence in CD patients. METHODS: This is a cross-sectional study of 104 patients with CD, aged 18 years or older, from a referral centre between August 2019 and May 2021. Patients responded to a specific questionnaire, and underwent medical record review, proctological examination and anorectal functional assessment with anorectal manometry. RESULTS: Of the 104 patients, 49% were incontinent. Patients with incontinence had a lower mean resting pressure [43.5 vs 53.1 mmHg; p = 0.038], lower mean squeeze pressure [62.1 vs 94.1 mmHg; p = 0.036] and lower maximum rectal capacity [140 vs 180 mL; p < 0.001]. Faecal incontinence was also associated with disease activity [p < 0.001], loose stools [p = 0.02], perianal disease [p = 0.006], previous anoperineal surgery [p = 0.048] and number of anorectal surgeries [p = 0.036]. CONCLUSIONS: This is the largest reported study describing manometric findings of Crohn's disease patients with and without faecal incontinence. Our results identified an association between faecal incontinence and functional disorders, in addition to clinical features in these patients. Functional assessment with anorectal manometry may help choose the best treatment for faecal incontinence in patients with CD.

Variables associated with progression of moderate-to-severe Crohn's disease.

OBJECTIVE: Determine the variables associated with hospitalisations in patients with Crohn's disease and those associated with surgery, intestinal resection, hospital readmission, need for multiple operations and immunobiological agent use. DESIGN: A cross-sectional study was conducted from 2019 to 2021, using two centres for inflammatory bowel diseases in the Brazilian Public Health System. RESULTS: This study included 220 patients. Only perianal disease was associated with hospitalisation (31.6% vs 13.0%, p=0.012). Stricturing or penetrating behaviour (35.8% vs 12.6%, p<0.001) and perianal disease (45.9% vs 9.9%, p<0.001) were associated with surgery. Ileal or ileocolonic location (80.0% vs 46.5%, p=0.044) and stricturing or penetrating behaviour (68.0% vs 11.2%, p<0.001) were associated with intestinal resection. Steroids use at first Crohn's disease occurrence and postoperative complications were associated with hospital readmission and need for multiple operations, respectively. Age below 40 years at diagnosis (81.3% vs 62.0%, p=0.004), upper gastrointestinal tract involvement (21.8% vs 10.3%, p=0.040) and perianal disease (35.9% vs 16.3%, p<0.001) were associated with immunobiological agent use. CONCLUSION: Perianal disease and stricturing or penetrating behaviour were associated with more than one significant outcome. Other variables related to Crohn's disease progression were age below 40 years at diagnosis, an ileal or ileocolonic disease localisation, an upper gastrointestinal tract involvement, the use of steroids at the first Crohn's disease occurrence and history of postoperative complications. These findings are similar to those in the countries with a high prevalence of Crohn's disease.

Overweight and abdominal fat are associated with normal bone mineral density in patients with ulcerative colitis.

BACKGROUND: Low bone mineral density (BMD) is common in patients with inflammatory bowel disease. However, nutritional risk factors for low BMD in the ulcerative colitis (UC) population are still poorly understood. AIM: To investigate the association of anthropometric indicators and body composition with BMD in patients with UC. METHODS: This is a cross-sectional study on adult UC patients of both genders who were followed on an outpatient basis. A control group consisting of healthy volunteers, family members, and close people was also included. The nutritional indicators evaluated were body mass index (BMI), total body mass (TBM), waist circumference (WC), body fat in kg (BFkg), body fat in percentage (BF%), trunk BF (TBF), and also lean mass. Body composition and BMD assessments were performed by dual-energy X-ray absorptiometry. RESULTS: The sociodemographic characteristics of patients with UC (n = 68) were similar to those of healthy volunteers (n = 66) (P > 0.05). Most patients (97.0%) were in remission of the disease, 58.8% were eutrophic, 33.8% were overweight, 39.0% had high WC, and 67.6% had excess BF%. However, mean BMI, WC, BFkg, and TBF of UC patients were lower when compared to those of the control group (P < 0.05). Reduced BMD was present in 41.2% of patients with UC (38.2% with osteopenia and 2.9% with osteoporosis) and 3.0% in the control group (P < 0.001). UC patients with low BMD had lower BMI, TBM, and BFkg values than those with normal BMD (P < 0.05). Male patients were more likely to have low BMD (prevalence ratio [PR] = 1.86; 95% confidence interval [CI]: 1.07-3.26). Those with excess weight (PR = 0.43; 95%CI: 0.19-0.97) and high WC (PR = 0.44; 95%CI: 0.21-0.94) were less likely to have low BMD. CONCLUSION: Patients with UC in remission have a high prevalence of metabolic bone diseases. Body fat appears to protect against the development of low BMD in these patients.

Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB).

BACKGROUND: Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. METHODS: A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. RESULTS: Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan-Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. CONCLUSIONS: IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.

Hospitalizations and in-hospital mortality for inflammatory bowel disease in Brazil.

BACKGROUND: Inflammatory bowel disease (IBD) is associated with complications, frequent hospitalizations, surgery and death. The introduction of biologic drugs into the therapeutic arsenal in the last two decades, combined with an expansion of immunosuppressant therapy, has changed IBD management and may have altered the profile of hospitalizations and in-hospital mortality (IHM) due to IBD. AIM: To describe hospitalizations from 2008 to 2018 and to analyze IHM from 1998 to 2017 for IBD in Brazil. METHODS: This observational, retrospective, ecological study used secondary data on hospitalizations for IBD in Brazil for 2008-2018 to describe hospitalizations and for 1998-2017 to analyze IHM. Hospitalization data were obtained from the Hospital Information System of the Brazilian Unified Health System and population data from demographic censuses. The following variables were analyzed: Number of deaths and hospitalizations, length of hospital stay, financial costs of hospitalization, sex, age, ethnicity and type of hospital admission. RESULTS: There was a reduction in the number of IBD hospitalizations, from 6975 admissions in 1998 to 4113 in 2017 (trend: y = -0.1682x + 342.8; R2 = 0.8197; P < 0.0001). The hospitalization rate also decreased, from 3.60/100000 in 2000 to 2.17 in 2010. IHM rates varied during the 20-year period, between 2.06 in 2017 and 3.64 in 2007, and did not follow a linear trend (y = -0.0005049x + 2.617; R2 = 0,00006; P = 0.9741). IHM rates also varied between regions, increasing in all but the southeast, which showed a decreasing trend (y = -0.1122x + 4.427; R2 = 0,728; P < 0.0001). The Southeast region accounted for 44.29% of all hospitalizations. The Northeast region had the highest IHM rate (2.86 deaths/100 admissions), with an increasing trend (y = 0.1105x + 1.110; R2 = 0.6265; P < 0.0001), but the lowest hospitalization rate (1.15). The Midwest and South regions had the highest hospitalization rates (3.27 and 3.17, respectively). A higher IHM rate was observed for nonelective admissions (2.88), which accounted for 81% of IBD hospitalizations. The total cost of IBD hospitalizations in 2017 exhibited an increase of 37.5% compared to 2008. CONCLUSION: There has been a notable reduction in the number of hospitalizations for IBD in Brazil over 20 years. IHM rates varied and did not follow a linear trend.

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.

Endoscopic and Histopathological Findings of the Esophagus, Stomach, and Duodenum in Patients with Crohn's Disease from a Reference Center in Bahia, Brazil.

(1) The aim of the present study was to describe the endoscopic and histopathological findings in the esophagus, stomach, and duodenum in patients with Crohn's disease. (2) Methods: This was a cross-sectional study that included patients receiving treatment from the inflammatory bowel disease outpatient clinic. Esophagogastroduodenoscopies with biopsies of the stomach and proximal duodenum were performed. Presence of Helicobacter pylori bacteria was assessed by Giemsa staining. (3) Results: We included 58 patients. Erosive esophagitis was identified in 25 patients (43.1%), gastritis was diagnosed in 32 patients (55.2%) and erosive duodenitis was found in eight (13.8%). The most frequent histopathological finding in the H. pylori-positive group was increased inflammatory activity in the gastric body and antrum, with a predominance of mononuclear and polymorphonuclear cells. In turn, the most frequent finding in the H. pylori-negative group was chronic inflammation with predominance of mononuclear cells. Focally enhanced gastritis was identified in four patients (6.9%), all of whom were negative for H. pylori. Granulomas were not observed. H. pylori infection was present in 19 patients (32.8%). (4) Conclusions: Nonspecific endoscopic and histological findings were frequent in patients with Crohn's disease. Focally enhanced gastritis was uncommon and observed only in H. pylori-negative patients. The time from the diagnosis, patient age, and therapy in use may have influenced the nondetection of epithelioid granuloma.

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.

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.

Active tuberculosis in inflammatory bowel disease patients under treatment from an endemic area in Latin America.

BACKGROUND: There has been an increase in cases of inflammatory bowel disease (IBD) in recent years. There is also greater access and availability of immunosuppressive and biological agents, which increase the risk of opportunistic infection despite improving the quality of life and promoting mucosal healing. Tuberculosis (TB) remains a public health problem, and it has a high incidence in several countries. Therefore, knowledge of the risk of developing TB in patients with IBD is important. AIM: To evaluate the risk of active TB in patients with IBD under treatment from an endemic area in Latin America. METHODS: A standard questionnaire included demographic variables, clinical aspects of IBD disease, history of active TB during treatment, active TB characteristics and evolution, initial screening and results and time from the start of anti-tumor necrosis factor alpha (TNFα) to TB development. RESULTS: Azathioprine, anti-TNFα and the combination of these two drugs were associated with a higher risk of active TB incidence. The TNFα blockers increased the relative risk of developing active TB compared to other treatments. All four multivariable models showed that the use of TNFα blockers alone or in combination with azathioprine was an important risk factor for the incidence of active TB. After adjustment for sex, age, type of IBD and latent TB, anti-TNFα with azathioprine increased the relative risk to 17.8 times more than conventional treatment. Late TB, which was diagnosed 3 mo after the start of anti-TNFα, was the most frequent. CONCLUSION: Treatment with anti-TNFα increased the risk of active TB in IBD patients from an endemic area in Latin America. This risk was increased when anti-TNFα was combined with azathioprine. The time from the beginning of the treatment to the active TB diagnosis suggests a new TB infection.

INFLAMMATORY BOWEL DISEASE CARE IN BRAZIL: HOW IT IS PERFORMED, OBSTACLES AND DEMANDS FROM THE PHYSICIANS' PERSPECTIVE.

BACKGROUND: Inflammatory bowel diseases (IBD) are chronic inflammatory affections of recurrent nature whose incidence and prevalence rates have increased, including in Brazil. In long term, they are responsible for structural damage that impacts quality of life, morbidity and mortality of patients. OBJECTIVE: To describe the profile of physicians who treat IBD patients as well as the characteristics of IBD care, unmet demands and difficulties. METHODS: A questionnaire containing 17 items was prepared and sent to 286 physicians from 101 Brazilian cities across 21 states and the Federal District, selected from the register of the State Commission of the "Study Group of Inflammatory Bowel Disease of Brazil" (GEDIIB). RESULTS: The majority of the physicians who answered the questionnaire were gastroenterologists and colorectal surgeons. More than 60% had up to 20 years of experience in the specialty and 53.14% worked at three or more locations. Difficulties in accessing or releasing medicines were evident in this questionnaire, as was referrals to allied healthy professionals working in IBD-related fields. More than 75% of physicians reported difficulties in performing double-balloon enteroscopy and capsule endoscopy, and 67.8% reported difficulties in measuring calprotectin. With regard to the number of patients seen by each physician, it was shown that patients do not concentrate under the responsibility of few doctors. Infliximab and adalimumab were the most commonly used biological medicines and there was a higher prescription of 5-ASA derivatives for ulcerative colitis than for Crohn's disease. Steroids were prescribed to a smaller proportion of patients in both diseases. The topics "biological therapy failure" and "new drugs" were reported as those with higher priority for discussion in medical congresses. In relation to possible differences among the country's regions, physicians from the North region reported greater difficulty in accessing complementary exams while those from the Northeast region indicated greater difficulty in accessing or releasing medicines. CONCLUSION: The data obtained through this study demonstrate the profile of specialized medical care in IBD and are a useful tool for the implementation of government policies and for the Brazilian society as a whole.

Atendimento da doença inflamatória intestinal no Brasil: como é feito, os entraves e as demandas sob a ótica dos médicos / Inflammatory bowel disease care in brazil: how it is performed, obstacles and demands from the physicians' perspective

ABSTRACT BACKGROUND: Inflammatory bowel diseases (IBD) are chronic inflammatory affections of recurrent nature whose incidence and prevalence rates have increased, including in Brazil. In long term, they are responsible for structural damage that impacts quality of life, morbidity and mortality of patients. OBJECTIVE: To describe the profile of physicians who treat IBD patients as well as the characteristics of IBD care, unmet demands and difficulties. METHODS: A questionnaire containing 17 items was prepared and sent to 286 physicians from 101 Brazilian cities across 21 states and the Federal District, selected from the register of the State Commission of the "Study Group of Inflammatory Bowel Disease of Brazil" (GEDIIB). RESULTS: The majority of the physicians who answered the questionnaire were gastroenterologists and colorectal surgeons. More than 60% had up to 20 years of experience in the specialty and 53.14% worked at three or more locations. Difficulties in accessing or releasing medicines were evident in this questionnaire, as was referrals to allied healthy professionals working in IBD-related fields. More than 75% of physicians reported difficulties in performing double-balloon enteroscopy and capsule endoscopy, and 67.8% reported difficulties in measuring calprotectin. With regard to the number of patients seen by each physician, it was shown that patients do not concentrate under the responsibility of few doctors. Infliximab and adalimumab were the most commonly used biological medicines and there was a higher prescription of 5-ASA derivatives for ulcerative colitis than for Crohn's disease. Steroids were prescribed to a smaller proportion of patients in both diseases. The topics "biological therapy failure" and "new drugs" were reported as those with higher priority for discussion in medical congresses. In relation to possible differences among the country's regions, physicians from the North region reported greater difficulty in accessing complementary exams while those from the Northeast region indicated greater difficulty in accessing or releasing medicines. CONCLUSION: The data obtained through this study demonstrate the profile of specialized medical care in IBD and are a useful tool for the implementation of government policies and for the Brazilian society as a whole.

RESUMO CONTEXTO: As doenças inflamatórias intestinais (DII) são afecções inflamatórias crônicas de caráter recorrente, cujas taxas de incidência e prevalência têm aumentado, inclusive no Brasil. A longo prazo, são responsáveis por danos estruturais que impactam na qualidade de vida, morbidade e mortalidade dos pacientes. OBJETIVO: Avaliar o perfil dos médicos que atendem pacientes com DII, assim como as características deste atendimento, demandas não atendidas e dificuldades. MÉTODOS: Um questionário contendo 17 variáveis foi elaborado e enviado para médicos, selecionados a partir do cadastro da Comissão das Estaduais do Grupo de Estudos da Doença Inflamatória Intestinal do Brasil (GEDIIB), totalizando 286 médicos de 101 cidades brasileiras distribuídas por 21 estados e Distrito Federal. RESULTADOS: A maioria dos médicos que respondeu o questionário foram Gastroenterologistas e Coloproctologistas. Mais de 60% tinham até 20 anos de atuação na especialidade e 53,14% trabalhavam em três locais ou mais. A dificuldade no acesso ou liberação de medicamentos ficou evidenciada neste questionário, assim como a dificuldade no encaminhamento para profissionais não médicos que atuam em DII. Mais de 75% dos médicos relataram dificuldades para realização de enteroscopia por duplo balão e cápsula endoscópica, e 67,8% para realização da calprotectina. Em relação ao número de pacientes atendidos por cada médico, foi evidenciado que não há uma concentração de pacientes sob a responsabilidade de poucos médicos. O infliximabe e o adalimumabe foram os biológicos mais utilizados e ficou evidenciada prescrição maior de derivados de 5-ASA para retocolite ulcerativa quando comparada à doença de Crohn. Os corticoides foram prescritos para uma parcela menor de pacientes em ambas doenças. Os temas "falha a terapia biológica" e "novas drogas" foram referidos como aqueles com maior prioridade para discussão em eventos científicos. Em relação às possíveis diferenças entre cada região e o restante do país, os médicos da região Norte relataram maior dificuldade no acesso a exames complementares e os médicos da região Nordeste, maior dificuldade no acesso ou liberação de medicamentos. CONCLUSÃO: Os dados obtidos por meio deste estudo mostram o perfil do atendimento médico especializado em DII e podem se constituir em ferramenta útil para para elaboração de políticas governamentais e para sociedade brasileira como um todo.

Crohn's disease of esophagus, stomach and duodenum.

Crohn's disease with involvement of the esophagus, stomach and duodenum has a prevalence of 0.5% to 4% in symptomatic adult patients, but some studies have shown that these results may be underestimated, since upper gastrointestinal endoscopy is not performed routinely in the initial evaluation of the disease in adult patients, as it is in the pediatric population. In general, involvement of the upper gastrointestinal tract in Crohn's disease occurs concomitantly with involvement of the lower gastrointestinal tract. The diagnosis depends on clinical, endoscopic, histological and radiological evaluation. The presence of aphthoid ulcers, longitudinal ulcers, bamboo-joint-like appearance, stenoses and fistulas are endoscopic findings suggestive of the disease, and it is important to exclude the presence of Helicobacter pylori infection. The primary histological findings, which facilitate the diagnosis, are the presence of a chronic inflammatory process with a predominance of lymphoplasmacytic cells and active focal gastritis. The presence of epithelioid granuloma, although less frequent, is highly suggestive of the disease in the absence of chronic granulomatous disease. Treatment should include the use of proton pump inhibitors associated with corticosteroids, immunomodulators and biological therapy according to the severity of the disease.