Background Background: Population-based data on incidence and prevalence of Inflammatory Bowel Diseases (IBD) in newly industrialized countries such as Brazil are scarce. This study aims to define temporal trends of estimated incidence and prevalence rates of Crohn’s disease (CD) and ulcerative colitis (UC) in Brazil using unique public healthcare datasets. Methods Methods: All IBD patients (UC and CD) from the unique public healthcare national system (DATASUS) were included from January 2012 to December 2020 and identified according to ICD codes, medication use or IBD-relates procedures. Data extraction was performed with the platform “TT Disease Explorer” (Techtrials Healthcare Data Science, Brazil) and checked by 2 independent reviewers. The platform collects publicly available data from the ministry of health via electronic algorithms (ETLs and Webcrawlers) with automatic updates. The population of Brazil was calculated according to the national Brazilian Geographics and Statistics Institute (IBGE). Average Annual Percent Change (AAPC) and 95% confidence intervals (CI) were calculated using poisson (or negative binomial) regression for incidence and log binomial regression for prevalence. Results Results: A total of 212,026 IBD patients (UC: n=140,705; CD: n=92,326) were included, There was a higher proportion of females as opposed to males, and age at health system entry was similar to developed countries (figure 1). Estimated incidence rates of IBD were 9.41 per 100,000 in 2012 and 9.57 per 100,000 in 2020 (AAPC=0.80%; CI -0.37–1.99; p=0.18); for UC, incidence increased from 5.69 per 100,000 to 6.89 per 100,000 (AAPC=3.04; CI 1.51–4.58; p<0.001) and for CD incidence dropped from 3.71 per 100,000 to 2.68 per 100,000 (AAPC=-3.24%; CI -4.45- -2.02; p<0.001) in the same time period (figure 2). Estimated prevalence rates of IBD increased significantly from 30.01 per 100,000 in 2012 to 100.13 per 100,000 in 2020 (AAPC=14.87%; CI 14.78–14.95; p<0.001); For UC, from 17.4 per 100,000 to 66.45 per 100,000 (AAPC=16.51%; CI 16.41–16.62; p<0.001) and for CD from 14.24 per 100,000 to 43.6 per 100,000 (AAPC=13.49%; CI13.37-13.61; p<0.001) in the same time period (figure 3). Conclusion Conclusions: Estimated incidence rates of IBD have remained stable from 2012–2020. Incidence of CD is significantly decreasing whereas of UC is significantly increasing. There was a significant increase in estimated prevalence rates of CD and UC. This massive rise in prevalence can support planning for future strategies for public healthcare providers in our country towards better IBD care. This is the largest IBD epidemiological study from newly industrialized countries to date.

Background Gut microbiota profiles are closely related to cardiovascular diseases through mechanisms that include the reported deleterious effects of metabolites, such as trimethylamine N-oxide (TMAO), which have been studied as diagnostic and therapeutic targets. Moderate red wine (RW) consumption is reportedly cardioprotective, possibly by affecting the gut microbiota. Objective To investigate the effects of RW consumption on the gut microbiota, plasma TMAO, and the plasma metabolome in males with documented coronary artery disease (CAD) using a multiomics assessment in a crossover trial. Methods We conducted a randomized, crossover, controlled trial involving 42 males (average age, 60 years) with documented CAD comparing 3-week RW consumption (250 mL/day, 5 days/week) with an equal period of alcohol abstention, both preceded by a 2-week washout period. The gut microbiota was analyzed via 16S rRNA high-throughput sequencing. Plasma TMAO was evaluated by liquid chromatography coupled with mass spectrometry (LC-MS/MS). The plasma metabolome of 20 randomly selected participants was evaluated by ultra-high-performance LC-MS/MS. The effect of RW consumption was assessed by individual comparisons using paired tests during the abstention and RW periods. Results Plasma TMAO did not differ between RW intervention and alcohol abstention, and TMAO levels showed low intraindividual concordance over time, with an intraclass correlation coefficient of 0.049 during the control period. After RW consumption, there was significant remodeling of the gut microbiota, with a difference in beta diversity and predominance of Parasutterella, Ruminococcaceae, several Bacteroides species and Prevotella. Plasma metabolomic analysis revealed significant changes in metabolites after RW consumption, consistent with improved redox homeostasis. Conclusions Modulation of the gut microbiota may contribute to the putative cardiovascular benefits of moderate RW consumption. The low intraindividual concordance of TMAO presents challenges regarding its role as a cardiovascular risk biomarker at the individual level. This study was registered at clinical trials.gov, NCT03232099.

Background The impact of current medical options in Crohn’s disease (CD) on hospitalization and surgical rates may be conflicting, and there is lack of data in newly industrialized countries. This study aims to describe temporal trends of proportional hospitalization and CD-related abdominal surgery rates according to drug-dispensing in Brazil, using public healthcare datasets. Methods All CD patients from the unique public healthcare national system (DATASUS) were included from January 2012 to December 2020 and identified according to ICD codes, medication or CD-related procedures. Data extraction was performed with the platform “TT Disease Explorer” (Techtrials Healthcare Data Science), which collects publicly available data via electronic algorithms with automatic updates. Annual rates of all-cause hospitalization and CD-related abdominal surgical procedures were captured and stratified by type of drug dispended. Average Annual Percent Change (AAPC) and 95% confidence intervals (CI) were calculated using poisson (or negative binomial) regression. Results The absolute number of registries of overall drug-dispensing for CD was 178,209, being 32.03% for Azathioprine (AZA), 10.91% for infliximab (IFX) and 10.52% for Adalimumab (ADA). AZA dispensing increased from 28.60% to 30.83% (AAPC 1.15; CI 0.23–2.09; p=0.015), ADA increased from 5.98% to 12.03% (AAPC 8.79; CI 6.33–11.30; p<0.001) and IFX increased from 7.09% to 12.03% (AAPC 7.52; CI 6.94–8.10; p<0.001) (figure 1). A total of 39,161 hospitalizations (all-cause) were captured in the same period. Hospitalization rates with AZA varied from 37.09% to 36.35% (AAPC -0.42, CI -1.08-0.24; p=0.209); for ADA remained stable (13.16% to 13.12%, AAPC -0.03; CI -1.10-1.05; p=0.962) and for IFX increased from 17.93% to 22.49% (AAPC 3.21; CI 1.66–4.79, p<0.001) (figure 2). Regarding CD-related abdominal surgical procedures (n=1181), rates were stable for AZA (AAPC 1.34; CI -8.41–12.12; p=0.797). Considering the use of anti-TNF agents, rates were stable with ADA, varying from 26,7% to 20,0% (AAPC -1.64; CI -13.84-12.29; p=0.807) and decreased from 33,3% to 4,5% for IFX (AAPC -17.05; CI -28.19- -4.17; p=0.011) (figure 3). Conclusion In this large national study, there was an increase in the number of dispensings of AZA, IFX and ADA for CD from 2012–2020 in the public healthcare system in Brazil, due in part to the increasing prevalence of CD. All-cause hospitalization rates remained stable for AZA and ADA, and increased in IFX patients. A reduction in CD-related abdominal surgical procedures was observed in patients who used IFX and were stable with AZA and ADA. These data can be used for future strategic planning in the national public healthcare system (SUS) in CD management in Brazil.

Background Vedolizumab, a human monoclonal antibody that blocks integrin α4-β7, was approved for the management of Inflammatory Bowel Diseases. In real-world experience the number of patients using vedolizumab as first-line biological therapy was low, mainly in Crohn′s Disease (CD). This study aimed to evaluate the efficacy of vedolizumab exclusively in CD patients who were naïve to previous biologics, with mild to moderate disease. Additionally, we aimed to analyze the safety profile of vedolizumab, rates of mucosal healing, need for abdominal surgery and drug discontinuation over time in this specific population. Methods We performed a retrospective multicentric cohort study with patients with mild to moderate CD treated with VDZ who were naïve to previous biologics agents. These patients had clinical activity scores (Harvey-Bradshaw Index [HBI]) measured at baseline and weeks 12, 26, 52 as well as at the last follow-up. Clinical response was defined as a reduction ≥3 in HBI whereas clinical remission as HBI ≤4. Mucosal healing was defined as the complete absence of ulcers in control colonoscopies. Kaplan-Meier survival analysis was used to assess the persistence with vedolizumab over time. Results From a total of 72 patients (6 excluded) 53% (35/66) reached clinical remission at week 12. This percentage increased to 71.9% (46/64) at week 26, 88.1% (52/59) at week 52 and 81.8% (54/66) at the last follow-up visit. Clinical response was achieved in 72.7% (48/66), 92.2% (59/64), 95,1% (58/61) and 83.3% (55/66) in the same periods, respectively. Mucosal healing was achieved in 62.3% (33/57) of patients. Vedolizumab was well-tolerated and most adverse events were minor; 89.3% remained on vedolizumab after 52 weeks. During vedolizumab treatment, 3/66 patients underwent surgery. Conclusion Vedolizumab was effective in the management of patients with mild to moderate CD as first biological agent, with a remission rate of 88.1% after one year. Mucosal healing was observed in 62.3% of patients and major abdominal surgery was needed in only 4.5% of patients. This is one of the first international studies focused on the use of vedolizumab as a first-line biological treatment option in clinical practice in mild to moderate CD.

Background Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), characterized by chronic inflammation of the intestine, have a rising incidence and prevalence globally. The potential impact of socioeconomic inequality on health and mortality is well documented. In chronic diseases, the effect of inequality in assessment to healthcare can be associated with a higher frequency of complications and worse organ functionality in patients with social deprivation. In IBD, there are scarce studies comparing the differences between patients according to their socioeconomic status. Our aim was to comparatively evaluate hospitalizations, use of biologics and rates of surgery in patients with IBD between public and private healthcare systems. Methods single-center retrospective cohort study in patients with IBD from a tertiary referral unit from Latin America, between 2015 and 2021. CD and UC patients were classified into two subgroups: public and private healthcare systems. Main analyzed variables were age at diagnosis, gender, Montreal classification, new diagnoses or referred patients, smoking status, previous medications, need for IBD-related hospitalizations and abdominal surgery. Demographic characteristics, hospitalizations, need for surgery and biologics were compared between two subgroups: private and public healthcare systems. Results 500 patients were included, 322 with CD and 178 with UC. CD-related hospitalizations were frequently observed in both healthcare systems (76.28% in private and 67.46% in public). More than half of the patients had been submitted to one or more CD-related abdominal surgical procedure, with no significant difference between the subgroups. Although there was no difference in the rates of use of biological therapy in CD subgroups, infliximab was more used in the public setting (57.69% vs. 43.97%, p=0.014). There was no difference in UC-related hospitalizations between the subgroups (public 30.69% and private 37.66%, p=0.33) as well as the rates of colectomy (public: 16.83%, private: 19.48%, p=0.65). Biologics were used almost twice as often in private as compared to the public system (45.45% vs. 22.77%, p=0.001). Conclusion Patient demographics were overall similar between healthcare systems in IBD patients. There were no differences in the rates of hospitalization and abdominal surgery between the two subgroups in both diseases. In patients with UC, there was greater use of biological therapy in the private healthcare setting. Global data regarding the possible impact of social deprivation in IBD-related outcomes are warranted.

Background There is lack of epidemiological data in regard to the accurate situation of Inflammatory Bowel Disease (IBD): Crohn’s disease (CD) and ulcerative colitis (UC) in Brazil. It is known that both diseases' progression is variable and the chronic iinflammation results in structural bowel damage. Comparative data between adult and pediatric patients in the IBD field, regarding different outcomes, is lacking globally. We aimed to analyze the proportion of use of biologicals, need for major abdominal surgery and hospitalizations in CD and UC , between adult and pediatric patients. Methods Cross-sectional and multicenter study. Data was collected from all consecutive IBD patients seen as outpatients or admitted to hospital, from 2015 – 2021, in two IBD tertiary centers from a capital from south Brazil. We included all patients with clinical, endoscopic, radiological or histological diagnosis of CD and UC. Patients with unclassified colitis or without available data in medical records for investigating variables of interest were excluded. Patients were classified in two main groups (CD and UC) and in two subgroups each, according to age range: adults and pediatrics. Analyses were made by frequency, proportion, Fisher’s exact test and Chi-squared test, through software IBM SPSS Statistics 28. Results Eight hundred and twenty-nine patients were included: 509 with CD (378 adults/131 pediatrics) and 320 with UC (225/95). There was significantly difference between diseases in the proportion of biological use 75.0% in CD and 31.6% in UC (p<0.001), surgeries 49.7%/14,1% (p<0.001) and hospitalizations 58.9%/30.9% (p<0.001), respectively. In CD, there was no difference regarding biological use (80.2% in pediatric group vs. 73.3% in adults; p=0.129), surgeries (46.6% vs. 50.8%; p=0.419) and hospitalizations (64.9% vs. 56.9%; p=0.122). There was significantly difference in biological use (40.0% vs. 28.0%; p=0.048) and hospitalizations (47.4% vs. 24.0%; p< 0.001) in UC and there was no difference regarding surgery necessity between age ranges (17.9% vs. 12.4%; p=0.219). Conclusion There was a higher proportion of biological use, surgery and need for hospitalizations in CD as compared to UC. Comparing age ranges, pediatric patients with UC used more biologicals and required more hospitalizations than adults, but there was no difference in the need for abdominal surgery. In CD, there was no significant difference in the three main outcomes, between the age groups.