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Objective: The aim of this study was to evaluate the prevalence and risk factors related to metabolic dysfunction-associated steatotic liver disease in inflammatory bowel disease patients., Methods: This is a cross-sectional study conducted on adults with inflammatory bowel disease from 2019 to 2021. Metabolic dysfunction-associated steatotic liver disease encompasses patients with steatosis and at least one cardiometabolic risk factor. Patients with alcohol consumption ≥20 g/day, chronic liver diseases, or methotrexate use were excluded., Results: Almost 140 patients were included: 67.1% were female, with a mean age of 49.7±13.7 years, and 63.6% had Crohn's disease. The mean duration of inflammatory bowel disease was 9.7±7.9 years. Metabolic dysfunction-associated steatotic liver disease was observed in 44.3% and advanced liver fibrosis was excluded in 63.5% by Fibrosis-4. Patients with metabolic dysfunction-associated steatotic liver disease were older (p = 0.003) and had a higher number of metabolic syndrome components (2.9±1.1 versus 1.6±1.0; p<0.001), greater abdominal circumference (p<0.001), and body mass index (p<0.001). The only factor related to inflammatory bowel disease associated with metabolic dysfunction-associated steatotic liver disease was disease duration (11.6±9.5 versus 8.3±6.2; p = 0.017). A higher number of metabolic syndrome components and obesity increase by 2.2 times and an altered waist circumference by 2.6 times the occurrence of metabolic dysfunction-associated steatotic liver disease., Conclusion: A high prevalence of metabolic dysfunction-associated steatotic liver disease was observed in patients with inflammatory bowel disease, with the main risk factors being associated with metabolic syndrome predicting it, but not with inflammatory bowel disease features and/or its treatment.

Background: Inflammatory bowel disease (IBD), represented by Crohn's disease (CD) and ulcerative colitis (UC), is a chronic condition that affects all age groups, predominantly in young individuals. Currently, an increase in the prevalence of IBD has been documented, in parallel with the increase in the elderly population. The scarce number of studies that better characterize the impact of IBD on Quality of Life (QoL) in the elderly motivated the present study., Objective: To evaluate the impact of IBD on the QoL of elderly people treated at a Tertiary IBD Center., Methods: Prospective cross-sectional study that included elderly patients (age ≥60 years) with quiescent or mildly active IBD treated at the HU-UFJF IBD Center between March 2019 and December 2022. Elderly companions without severe comorbidities who attended the consultation with the patients were included as a control group. Sociodemographic and IBD-related characteristics were recorded. QoL was assessed using previously validated questionnaires (WHOQOL-BREF and IBDQ). Patients with IBD with moderate to severe activity, history of recent or imminent hospitalization, serious or opportunistic infections in the last 6 months, previous neoplasia, dementia, and difficulty understanding/fulfilling the questionnaires were excluded., Results: A total of 123 patients were included (74 with IBD and 49 in the control group), with a mean age of 67±6.2 years, 52.7% with CD, and 47.3% with UC. Mild disease activity was observed in 31.1%. Both groups (IBD patients and control) were comparable based on age, sex, BMI, and the Charlson Comorbidity Index. Patients with IBD and controls had similar QoL scores in the different domains assessed by the WHOQOL-BREF. On the other hand, when evaluating the general facet of QoL, IBD patients had significantly lower scores in General QoL (3.71±0.87 versus 4.02±0.62, respectively; P=0.021) and General Health (3.32±1.05 versus 3.69±0.94, respectively; P=0.035). The presence of mildly active IBD negatively impacted the general health score (2.91±0.99 versus 3.47±1.04, respectively; P=0.035) and the physical domain of the WHOQOL-BREF (12.27±2.63 versus 13.86±2.61, respectively; P=0.019) when compared to patients in remission. Conversely, no impact on QoL was observed with the Application of the IBDQ questionnaire regarding the type of the disease (161±38.5 versus 163.1±42.6 for CD and UC, respectively; P=0.84) or the presence of activity (152.5±38.8 versus 166.4±40.5, respectively; P=0.17)., Conclusion: No statistically significant differences were found between elderly patients with mildly active or quiescent IBD and elderly patients without IBD when observing global QoL scores. However, IBD negatively impacted the general facet of QoL, just as mild activity was associated with lower scores in general health and the physical domain assessed by the WHOQOL-BREF. Patients with IBD treated with biological therapy had better Qol than those on conventional therapy. Future studies are needed to choose the most appropriate tool for assessing QoL in this population.

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., Competing Interests: R.S.P. has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, and Pfizer. J.M.F.C. has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, AbbVie, Abbott, and Sandoz. M.F.C.A. has received fees for serving as a speaker and/or an advisory board member for Takeda, Abbvie, Pfizer, and Janssen. L.A.C. has received fees for serving as a speaker and/or an advisory board member for Takeda and Janssen. G.P.Z. has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, and Takeda. O.S.C. has received fees for serving as a speaker and/or an advisory board member for Nestle, Abbvie, Janssen, Takeda, and Buhlmann. R.S.B.F. is a speaker for Janssen, Abbvie, Takeda, Ferring, Pfizer, and CSL Vifor. G.O.S. is a speaker for Abbvie, Celtrion, Janssen, and Takeda; conducts clinical research for Janssen, Lilly, Takeda, Polpharma, and Roche; and serves as an advisory board member for Janssen and Pfizer. M.I. has received fees for serving as a speaker and/or an advisory board member for Abbvie, Janssen, Pfizer, and Takeda. A.C.S.M. has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, and Takeda. F.V.T. is a speaker and an advisory board member of Takeda. A.J.T.A.J. has received fees for serving as a speaker and/or an advisory board member for Janssen, Takeda, UCB, and Abbvie. N.L.T.G.J. is a speaker and an advisory board member of Janssen and Takeda. S.C.F. has received fees for serving as a speaker and/or an advisory board member for Janssen, Takeda, and Pfizer. S.F.Q.N. has received fees for serving as a speaker and/or an advisory board member for Takeda, Janssen, Abbvie, and Pfizer. P.G.K. has received fees for serving as a speaker and/or an advisory board member for Janssen, Abbvie, Pfizer, and Takeda. He also has received scientific grants from Pfizer and Takeda. M.L., D.O.M., and F.O. report no conflicts of interest. P.G.K. holds the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. N.S.F.Q. is a Deputy Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

This study focuses on the use of thiopurines for treating inflammatory bowel diseases (IBD). These drugs undergo enzymatic changes within the body, resulting in active and inactive metabolites that influence their therapeutic effects. The research examines the role of genetic polymorphisms in the enzyme thiopurine S-methyltransferase (TPMT) in predicting the therapeutic response and adverse effects of thiopurine treatment. The TPMT genotype variations impact the individual responses to thiopurines. Patients with reduced TPMT activity are more susceptible to adverse reactions (AEs), such leukopenia, hepatotoxicity, pancreatitis, and nausea, which are common adverse effects of thiopurine therapy. The therapeutic monitoring of the metabolites 6-thioguanine nucleotides (6-TGN) and 6-methyl mercaptopurine (6-MMP) is proposed to optimize treatment and minimize AEs. Patients with higher 6-TGN levels tend to have better clinical responses, while elevated 6-MMP levels are linked to hepatotoxicity. Genotyping for TPMT before or during treatment initiation is suggested to tailor dosing strategies and enhance treatment efficacy while reducing the risk of myelosuppression. In conclusion, this study highlights the importance of considering genetic variations and metabolite levels in optimizing thiopurine therapy for IBD patients, focusing on balance therapeutic efficacy with the prevention of adverse effects and contributing to personalized treatment and better patient outcomes.

Background: In real-world experience, the number of patients using vedolizumab as first-line biological therapy was low. We aimed to evaluate the effectiveness and safety of vedolizumab in mild-to-moderate Crohn's disease (CD) biologic-naïve patients., Methods: We performed a retrospective multicentric cohort study with patients who 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., Results: From a total of 66 patients, 53% (35/66) reached clinical remission at week 12. This percentage increased to 69.7% (46/66) at week 26, and 78.8% (52/66) at week 52. Mucosal healing was achieved in 62.3% (33/53) of patients. Vedolizumab was well tolerated, and most adverse events were minor. During vedolizumab treatment, 3/66 patients underwent surgery., Conclusions: This study demonstrates the effectiveness and safety of vedolizumab as a first-line biological agent in patients with mild-to-moderate CD., Competing Interests: P.G.K. and N.S.F.Q. hold the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. A.Z.D. received a funding to a Master’s Degree scholarship for 2 years. D.O.M., E.G.V., M.M.L., R.L.P., R.L.K.J., and M.A.G.F. have nothing to declare. J.M.F.C. served as speaker for Abbott, Abbvie, Janssen and Takeda. LAC e ARA served as speaker for Janssen, Takeda, Abbvie. F.S. served as Advisory board member of Eurofarma, Janssen, Pfizer, Takeda, and speaker for AbbVie, Amgen, Ferring, Janssen, Pfizer, Sandoz, and Takeda. M.A. served as speaker from Janssen, Takeda, Abbvie, and Pfizer. NSC served as speaker from Janssen, Abbvie, and Sandoz. J.M.L.P. and J.C.L. served as speaker for Takeda. R.S.P. received lecture fee[s] from AbbVie, Janssen, Takeda, Pfizer; is an advisory committee member for Janssen and AbbVie; and he also does clinical research for Janssen and Abbvie. C.F. served as speaker from Takeda, Abbvie, Janssen, Sandoz, Pfizer. E.M.M. served as speaker from Takeda, Janssen, and Ferring. S.C.F. and G.M.N. served as speaker for Takeda and Janssen. N.S.F.Q. served a speaker and advisory board member for Janssen, Takeda, and Abbvie. P.G.K. served as speaker and consultancy for Janssen, Takeda, Abbvie, and Pfizer., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Therapeutic drug monitoring (TDM) during induction therapy with anti-tumor necrosis factor drugs has emerged as a strategy to optimize response to these biologics and avoid undesired outcomes related to inadequate drug exposure. This study aimed to describe clinical, biological, and endoscopic remission rates at six months in Brazilian inflammatory bowel disease (IBD) patients following a proactive TDM algorithm guided by IFX trough levels (ITL) and antibodies to IFX (ATI) levels during induction, at week six. A total of 111 IBD patients were prospectively enrolled, excluding those previously exposed to the drug. ITL ≥ 10 μg/mL was considered optimal. Patients with suboptimal ITL (<10 µg/mL) were guided according to ATI levels. Those who presented ATI ≤ 200 ng/mL underwent dose intensification in the maintenance phase, and patients with ATI > 200 ng/mL discontinued IFX. In our study, proactive TDM was associated with persistence in the IFX rate at six months of 82.9%. At that time, rates of clinical, biological, and endoscopic remission in patients under IFX treatment were 80.2%, 73.9%, and 48.1%, respectively. Applying a simplified TDM-guided algorithm during induction seems feasible and can help improve patients' outcomes in clinical practice.

Background: Vasculitis is an uncommon complication of biologics used to treat inflammatory bowel disease (IBD). This study describes a case series of vasculitis induced by anti-tumor necrosis factor (TNF) therapy in IBD patients., Methods: Retrospective assessments were performed using the medical records of adult IBD patients who underwent outpatient clinical follow-ups between January 2010 and December 2019 in order to identify patients with vasculitis caused by anti-TNF therapy., Results: There were 2442 patients altogether. Of these, 862 (35%) took anti-TNF medication. Five patients (0.6% of the overall patients; n = 3 (60%) Crohn's disease; n = 2 (40%), ulcerative colitis) were identified as having leukocytoclastic vasculitis (LCV) due to anti-TNF therapy; these patients were white, female, and non-smokers. The mean age of LCV diagnosis was 32.2 years, and the mean IBD duration was 7.2 years. The mean time between the start of biologic therapy and LCV onset was 30.8 months. Most of the patients were using adalimumab (80%; n = 4). All the patients were in remission at the time of the LCV diagnosis, and the vasculitis affected the skin in all cases. Anti-TNF therapy was discontinued in the five abovementioned patients, and the response of LCV to the oral steroids was significantly positive. Remarkably, all five patients experienced complete remission from LCV within 4-12 weeks after starting prednisone therapy, and none of them had LCV recurrence in the follow-up period (a mean duration of 28 months)., Conclusions: LCV is an unusual complication of anti-TNF therapy in the IBD setting. In this context, clinicians should have a high degree of suspicion of LCV in patients who develop an unexplained cutaneous rash.

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.

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.

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.

The conversion of azathioprine (AZA) to active 6-thioguanine nucleotides (6-TGN) is essential for its clinical efficacy; however, another metabolite formed, 6-methylmercaptopurine (6-MMP), is related to hepatotoxicity. Blood samples were collected from 37 patients under AZA's treatment, and a new HPLC-UV method was validated and applied for simultaneous quantification of 6-TGN and 6-MMP in erythrocytes of Crohn's disease (CD) patients. The concentration of 6-TGN and 6-MMP found ranged from 4.5 to 2,456 ρmol/8 × 108 red blood cells (RBCs) for 6-TGN and from 170 to 53,951 ρmol/8 × 108 RBCs for 6-MMP. Reduced levels of 6-MMP in patients into combo therapy with AZA and allopurinol (2,031 ρmol/8 × 108 RBCs) have been observed when compared to patients undergoing monotherapy with AZA (9,098 ρmol/8 × 108 RBCs). Additionally, there was a negative correlation (r = -83.7%, P < 0.05) between lymphocyte count and 6-TGN levels. The method developed is reliable, accurate and reproducible and can be used as an important tool in the monitoring routine of patients with CD under AZA treatment, allowing the individualization of the dose, monitoring adherence to the treatment and the evaluation of the clinical outcome of these patients., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: The effectiveness of ustekinumab (UST) in the treatment of Crohn's disease (CD) has been demonstrated in the pivotal Phase 3 UNITI 1 and 2 and IM-UNITI studies in both anti-TNF-naïve and anti-TNF-exposed patients. Given the selective nature of pivotal trial designs, real-world effectiveness and safety studies are warranted. We report our experience with UST treatment in a large, real-world multicenter cohort of Brazilian patients with CD., Methods: We performed a retrospective multicenter study including patients with CD, predominantly biologically refractory CD, who received UST. The primary endpoint was the proportion of patients in clinical remission at weeks 8, 24 and 56. Possible predictors of clinical and biological response/remission and safety outcomes were also assessed., Results: Overall, 245 CD (mean age 39.9 [15-87]) patients were enrolled. Most patients (86.5%) had been previously exposed to biologics. According to nonresponder imputation analysis, the proportions of patients in clinical remission at weeks 8, 24 and 56 were 41.0% (n = 98/239), 64.0% (n = 153/239) and 39.3% (n = 94/239), respectively. A biological response was achieved in 55.4% of patients at week 8, and 59.3% were in steroid-free remission at the end of follow-up. No significant differences in either clinical or biological remission were noted between bio-naïve and bio-experienced patients. Forty-eight patients (19.6%) presented 60 adverse events during the follow-up, of which 8 (13.3%) were considered serious adverse events (3.2% of 245 patients). Overall, a proximal disease location, younger age, perianal involvement, and smoking were associated with lower rates of clinical remission over time., Conclusions: UST therapy was effective and safe in the long term in this large real-life cohort of Brazilian patients with refractory CD, regardless of previous exposure to other biological agents., (© 2022. The Author(s).)

Background: Ulcerative colitis (UC) is a chronic inflammatory disease whose manifestations can drastically affect the individual's quality of life, and therefore adherence to treatment is important in order to keep it in remission., Objective: To verify the prevalence of non-adherence and the influence of sociodemographic, clinical and pharmacotherapeutic characteristics associated with non-adherence to treatment of UC in remission., Methods: Cross-sectional study conducted with 90 individuals diagnosed with UC in remission. The information was collected through interviews during medical consultations at Medical Clinic of Gastroenterology of Hospital Universitário da Universidade Federal de Juiz de Fora. To verify the association of the variables under study with the outcome of interest and its measure of association, Student's t-test or Pearson's chi-square non-parametric test (P<0.05) was used and prevalence ratio and confidence interval were calculated., Results: A high prevalence of non-adherence (77.8%) was found among patients with UC in remission. The individuals most likely to not adhere to the treatment were those aged less than 50 years, who were not engaged in paid work, with high scores for anxiety and who used more than one medication as part of the treatment of UC., Conclusion: These findings reinforce that acknowledging the factors that influence the non-adherence behavior is of paramount importance for the development of strategies by health care professionals, assuring that those will be really effective to prolong, as much as possible, one of the most successful ways to maintain the UC remission period: the use of medications.

Background: Rectovaginal fistulas (RVFs) are abnormal tracts that connect the lower gastrointestinal tract with the vagina. They can result from obstetric trauma, infection, local surgeries, cancer, radiation damage, and Crohn's disease. Despite the advances in surgical and clinical treatment, there is no consensus regarding the best line of treatment. Objective: To report five cases of patients with RVF submitted to intravaginal CO 2 fractional laser treatment, as a complementary and additional therapeutic option in this scenery. Materials and methods: Five laser sessions with monthly intervals followed by complete evaluation through clinical examination and magnetic resonance imaging of the pelvis were performed for all patients. Results: Three patients had complete resolution of symptoms after the end of planned vaginal laser sessions, whereas two patients reported significant improvement in symptoms. Four patients who had stopped having sex due to their condition admitted to resuming regular sexual activity. In addition, all five patients had closure of the fistulous track confirmed by pelvic MRI. No adverse events from vaginal laser therapy were reported by any of the patients. Conclusions: We believe this method to be a complementary, promising, and safe therapeutic alternative for the management of RVF. It may potentially enable return to regular sexual activity. Future studies using this therapeutic strategy are needed to confirm the efficacy and safety of this method in this clinical setting. Clinical trial registration no.: CAAE 93673618.4.0000.5133.

Managing inflammatory bowel disease (IBD) during the coronavirus disease 2019 (COVID-19) pandemic has been a challenge faced by clinicians and their patients, especially concerning whether to proceed with biologics and immunosuppressive agents in the background of a global outbreak of a highly contagious new coronavirus (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2). The knowledge about the impact of this virus on patients with IBD, although it is still scarce, is rapidly evolving. In particular, concerns surrounding medications' impact for IBD on the risk of acquiring SARS-CoV-2 infection or developing COVID-19, and potentially exacerbate viral replication and the COVID-19 course, are a current thinking of both practicing clinicians and providers caring for patients with IBD. Managing patients with IBD infected with SARS-CoV-2 depends on both the clinical activity of the IBD and the occasional development and severity of COVID-19. In this review, we summarize the current data regarding gastrointestinal involvement by SARS-CoV-2 and pharmacologic and surgical management for IBD concerning this infection, and the COVID-19 impact on both the patient's psychological functioning and endoscopy services, and we concisely summarize the telemedicine roles during the COVID-19 pandemic., Competing Interests: Conflict-of-interest statement: Parra RS has received fees for serving as a speaker and/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, and Takeda. Chebli JMF has received fees for serving as a speaker and/or an advisory board member for Abbott, AbbVie, Janssen, and Takeda. Chebli LA has received fees for serving as a speaker for Janssen and Takeda. Queiroz NSF reports receiving consulting and lecture fees from Janssen, Takeda, and Abbvie. Damião AOMC has received fees for serving as a speaker and/or an advisory board member for Takeda, Abbvie, Pfizer, Janssen, Ferring, and Natulab., (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background and Aims: The 6-minute walk test (6MWT) is a measure of the overall functional capacity and is associated with the risk of mortality in patients with liver cirrhosis and in those listed for liver transplantation. Nevertheless, physical performance has not yet been established as a predictor of the risk of clinical decompensation in patients with cirrhosis. We aimed to determine the capacity of the 6MWT to predict the clinical decompensation in patients with cirrhosis after 1 year of follow-up., Methods: This prospective cohort study included patients with compensated cirrhosis of several etiologies. All participants had stable clinical conditions for at least 6 months prior to baseline. At baseline, patients performed the 6MWT and were followed up for 1 year to detect the decompensation outcomes., Results: A total of 55 participants completed the evaluation and follow-up. The mean age was 56.3±10.5 years, and 65% were men. Around 65.4% were classified as Child-Pugh class A. In the receiver operating characteristic analysis, a walking distance ≤ 401.8 m during the 6MWT was set as the threshold for predicting clinical decompensation with 64% sensitivity and 82% specificity. Kaplan-Meier curve analysis revealed that patients who covered a distance of < 401.8 m during the test had a decompensation-free outcome rate of 30% as compared to the rate of 75% of those who walked > 401.8 m (p<0.001)., Conclusions: The 6MWT was a significant predictor of clinical decompensation in patients with cirrhosis. A cutoff of 401.8 m was related to an increased risk of clinical decompensation in cirrhotic patients with a stable clinical condition at baseline. The 6MWT should be added to the clinical assessment of the cirrhotic population.

Background and Aims: Studies on inflammatory bowel disease [IBD] have shown that religiousness and spirituality [R/S] were associated with better mental health and quality of life [QOL]. However, longitudinal studies assessing the impact of R/S on long-term clinical outcomes of Crohn's disease [CD] are scarce. The aim of this study was to assess the influence of R/S on the course of CD after a 2-year follow-up and to determine whether these R/S beliefs were associated with mental health and QOL., Methods: A longitudinal 2-year follow-up study was conducted at a referral centre for IBD, including patients with moderately to severely active CD. Clinical data, disease activity [Harvey-Bradshaw Index], QOL [Inflammatory Bowel Disease Questionnaire-IBDQ], depression and anxiety [Hospital Anxiety and Depression Scale-HADS], and R/S [Duke Religion Index-DUREL, Spirituality Self-Rating Scale-SSRS, and Spiritual/Religious Coping-SRCOPE scale] were assessed at baseline and at the end of the 2-year follow-up. Linear and logistic regression models were employed., Results: A total of 90 patients [88.2%] were followed up for 2 years. On logistic regression, baseline levels of spirituality (odds ratio [OR] = 1.309; 95% confidence interval [CI]= 1.104-1.552, p = 0.002) and intrinsic religiousness [OR = 1.682; 95% CI = 1.221-2.317, p = 0.001] were predictors of remission at 2 years. On linear regression, the different dimensions of R/S did not significantly predict IBDQ or anxiety and depression scores after 2 years., Conclusions: R/S predicted remission of CD patients after a 2-year follow-up. However, these beliefs failed to predict mental health or QOL. Health professionals who treat CD should be aware of the religious and spiritual beliefs of their patients, given these beliefs may impact on the disease course., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Aim: To compare the level of physical activity (PA), exercise capacity, and body composition before and after infliximab-induced clinical remission in patients with Crohn's disease (CD)., Methods: This prospective longitudinal study evaluated 44 adult outpatients with active CD before infliximab administration and 24 weeks after infliximab therapy. The patients were evaluated for PA in daily life, exercise capacity, muscle strength, and body composition., Results: 38 (86.4%) patients achieved infliximab-induced remission at 24 weeks and presented an increment in the number of steps taken of 1092 (7440±2980 vs. 6348±3177, respectively; p=0.006). The inactive time was reduced when compared to the baseline value (454.2±106.3 vs. 427.9±97.8, respectively; p=0.033). There was no difference in the distance walked before and after infliximab therapy, while there was an increase in the fat mass index in responders to infliximab compared to the baseline (19.1±7.6 vs. 14.9±5.8; p=0.001)., Conclusions: Infliximab-induced remission was shown to be effective for increasing physical activity by improving the number of steps and reducing inactive time. The maintenance of clinical remission associated with incentives to regular PA may contribute to making these patients reach an ideal level of PA.

Background and Aims: Non-alcoholic steatohepatitis (NASH) has multifactorial etiopathogenesis, and intestinal microbiota is co-responsible in this process. The aim of this study was to evaluate the intestinal microbiota in NASH patients with different metabolic profiles., Methods: Patients with biopsy-proven NASH were evaluated. Subjects were divided into two groups according to their metabolic profile, with or without metabolic syndrome (MS). Their characteristics in relation to liver disease and intestinal microbiota were analyzed. To evaluate the microbiota, breath tests to investigate small intestinal bacterial overgrowth (SIBO) and fecal microbiota analysis by fluorescence in situ hybridization (FISH) were performed., Results: There was a high prevalence of SIBO in both groups, with no significant difference between them. Breathing tests were positive in 43.8% of patients with MS and 50% of those without MS. There was a significant difference regarding the quantification of Verrucomicrobiales, less abundant in patients with NASH without MS. Its lower concentration also correlated with higher serum ferritin levels and higher hepatocyte ballooning. This order of bacteria, through its representative in human microbiota, Akkermansia muciniphila, is associated with mucosal protection and metabolic processes with liver aggression., Conclusions: Our results suggested that lower Verrucomicrobiales concentration is associated with higher inflammatory activity in patients with NASH without MS, where the disease etiopathogenesis does not have its classic metabolic substrate.

Background: Small intestinal bacterial overgrowth (SIBO) appears to be common in patients with Crohn's disease (CD). The rate of SIBO has been estimated at 25%-88% in this setting. However, different demographic, socioeconomic, and disease-related factors may exist between South American and North American or European populations that may limit the generalization of these findings, as the data are mainly derived from North American or European studies., Objective: We studied the prevalence and predictors of SIBO in CD outpatients., Methods: In this retrospective study, between June 2011 and June 2016, the medical records of 110 CD patients were assessed for presence of SIBO using the H2/CH4 glucose breath test. Univariate analysis was performed to investigate the potential association between SIBO and demographic, disease-related data, systemic markers of inflammation (C-reactive protein and erythrocyte sedimentation rate)., Results: The SIBO rate was high in CD patients (30%). Patients with and without SIBO were comparable according to demographics, systemic inflammatory biomarkers, and disease characteristics, except to the stricturing phenotype more common in the SIBO-positive CD patients (48.5% vs 19.5%, P=0.001)., Conclusion: In Brazilian CD patients, SIBO is a highly prevalent condition. Stricturing phenotype demonstrated association with SIBO. An individualized screening plan followed by the timely treatment for SIBO should be carried out as part of quality of care improvement in CD individuals.

We aim to investigate the association among religious/spiritual coping (RSC), quality of life (QOL), and mental health in patients with active Crohn's disease (CD). This cross-sectional study included 102 patients with active CD. Religious and spiritual beliefs were common among patients, being positive RSC higher than negative RSC. Negative coping was associated with mood disorders (depressive or anxiety symptoms) through the Hospital Anxiety and Depression Scale (β = 0.260, p < 0.01) but not with QOL (Inflammatory Bowel Disease Questionnaire) (β = - 0.105, p = NS) after adjustments. Positive coping and other religious/spiritual beliefs and behaviors were not associated with either QOL or mental health. This study suggests that a negative RSC is associated with worse mental health outcomes. This may detrimentally impact adaptations to deal with CD in the active phase, although patients generally tend to use more common positive strategies. These findings may increase the awareness of health professionals while dealing with spiritual beliefs in patients with CD.

Background: Fatigue is a common symptom in patients with inflammatory bowel diseases (IBD). A translated and culturally adapted, instrument with robust psychometric for measuring fatigue in Brazilian patients with IBD is needed., Objective: To translate and cross-culturally adapt the inflammatory Bowel Disease Fatigue Scale (IBD-F) into Brazilian-Portuguese and to test its measurement properties in Brazilian patients with IBD., Methods: Data from 123 patients with IBD were collected. In addition to IBD-F, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) was used. The measurement properties tested were: internal consistency, reproducibility (reliability and agreement), construct validity, internal and external responsiveness, and ceiling and floor effects., Results: The Brazilian-Portuguese version of the IBD-F showed excellent internal consistency (Cronbach's alpha of 0.95), excellent reproducibility (ICC=0.97) and a minimal detectable change of 6.0 points. The construct validity was demonstrated with a good correlation between the IBD-F and FACIT-F (r=- 0.46). Effect sizes used for measuring internal responsiveness were moderate among those with Crohn's (0.66) disease and low in patients with ulcerative colitis (0.24). The Brazilian-Portuguese version of the IBD-F presented with high external responsiveness for Crohn's disease (0.84) and with low external responsiveness for ulcerative colitis (0.33). The area under the curve considered for responsiveness was 0.84. Twenty-five percent of floor effects and no ceiling effect were recorded., Conclusion: The Brazilian-Portuguese version of IBD-F has adequate measurement properties and its use can be recommended in clinical practice and research.

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., Competing Interests: Conflict-of-interest statement: Parra RS has received fees for serving as a speaker and/or an advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma and Takeda. Saad-Hossne R has received fees for serving as a speaker for AbbVie, Janssen, Pfizer and Takeda. Miszputen S has received fees for serving as a speaker and/or a consultant for Farmoquimica, Janssen and Marjan. He has received research funding from Ache, Roche and Takeda. Fernandes M is an employee of Eurotrials, now part of CTI, a CRO that provides services for pharmaceutical laboratories. Catapani WR has received fees for serving as a speaker and/or an advisory board member for Janssen and Takeda. Sassaki LY has received fees for serving as a speaker for AbbVie and Takeda. Gomes TNF has received research funding from Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior (CAPES) and Takeda. She has received fees for serving as a speaker for Janssen. Chebli JMF has received fees for serving as a speaker for AbbVie, Janssen, UCB Pharma and Takeda. Senra JT and Caratin RF are employees of Takeda Pharmaceuticals Brazil. Nones RB has received fees for serving as a speaker for AbbVie, Ferring Pharmaceuticals, Janssen, Nestle, Novartis, Pfizer, UCB Pharma and Takeda. Parente JML has received fees for serving as a speaker for Takeda. Ferrari MLA has received fees for serving as a speaker and/or advisory board member for AbbVie, Ferring Pharmaceuticals, Janssen, UCB Pharma, and Takeda. Santana GO has received fees for serving as a speaker for Takeda, AbbVie, Janssen, and UCB Pharma. She has received research funding from Celgene and Roche. She has received fees for serving as an advisory board member for Janssen. Rocha JJR has received fees for serving as a speaker for Nestle. Feitosa MR has received fees for serving as a speaker for AbbVie and Janssen. Scotton AS has received fees for serving as a speaker for Janssen, Novartis, AbbVie, MSD, and EMS. He has received research funding from Janssen, Novartis, AbbVie, Roche, Pfizer, Bristol, Lilly, Novo Nordisk, Anthera, AstraZeneca, GSK, UCB, Sanofi, Takeda, Parexel, IQVIA, PPD, PRA, ICON, INP Research, Covance, and In Trials. Flores C has received fees for serving as a speaker for Janssen, Takeda, and AbbVie. She has received fees for serving as an advisory board member for Janssen. Zaltman C has received fees for serving as a speaker for UCB, Janssen, Takeda, and AbbVie. She has received research funding from AbbVie, Takeda, and Janssen. Bafutto M has received fees for serving as a speaker for Takeda, AbbVie, Janssen, UCB and Farmoquimica. He has received fees for serving as an advisory board member for AbbVie and Janssen. No conflict-of-interest: Omar Feres, Murilo Moura Lima, Roberto Luiz Kaiser Junior, Carolina Dias Gonçalves, Stella Cristina Silva de Souza, Anderson Antonio de Faria, Isabella de Miranda Guimaraes, Heda Maria Barska dos Santos Amarante, Mikaell Alexandre Gouvea Faria, Odery Ramos Junior., (©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Physical activity in daily life and exercise capacity have not been assessed in patients with Crohn's disease to date., Objective: To evaluate the physical activity in daily life, exercise capacity, quality of life, and prevalence of mood disorders in patients with moderate-to-severe Crohn's disease on infliximab-induced remission and the possible associations among variables., Methods: A cross-sectional preliminary study was conducted. Twenty-six patients with Crohn's disease and 20 controls were selected. Participants underwent evaluation of physical activity in daily life (triaxial accelerometer), exercise capacity (shuttle walk test), handgrip strength, quality of life, and presence of mood disorders., Results: The number of steps taken (7446±3081 vs 7898±2487), active time (80.6±42 vs 89.7±24.3min), shuttle walk test distance [665 (405) vs 710 (409) m] and handgrip strength [31 (15) vs 29 (20) kgf did not show any difference between the patients with Crohn's disease and the controls. The time spent lying down [95.8 (68.8) vs 60.9 (74.7) min] was greater and some domains of the quality of life were superior in the patients with Crohn's disease. No correlation was observed between the physical activity in daily life and quality of life or presence of mood disorders in patients with Crohn's disease., Conclusion: Patients with Crohn's disease on infliximab-induced remission, despite to more time spent lying down, they have the same level of physical activity in daily life and exercise capacity min compared with the controls.

Background: Rectovaginal fistulas (RVFs) are defined as any connection between the anorectum and the vagina. They can have several causes, being Crohn's disease, the second leading cause of RVFs, responsible for ∼10% of the RVFs. Despite the advances in surgical and clinical treatment, there is no consensus regarding the best line of treatment. Objective: To report another therapeutic option, we describe the case of a patient with Crohn's disease and RVF refractory to anti-tumor necrosis factor (TNF) therapy, submitted to intravaginal CO 2 fractional laser treatment. Materials and methods: Three laser sessions with monthly interval and analysis by clinical examination, sexual evaluation questionnaire, and magnetic resonance of the pelvis were performed. Results: We obtained an important improvement of the symptoms and of the dimension of the fistulous path. Conclusions: We believe this method to be a complementary, promising, and safe therapeutic alternative for the management of vaginal fistula. Future studies using this therapeutic strategy are needed to confirm the efficacy of this method in this clinical setting.

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.

Purpose: The prospective assessment of Clostridium difficile infection (CDI) impact in inflammatory bowel disease (IBD) flare in outpatient setting has been poorly investigated. We aimed to evaluate the prevalence and the associated factors with CDI in IBD outpatients presenting colitis flares as well as the outcomes following treatment., Methods: In this prospective cohort study, conducted from October, 2014, to July, 2016, 120 IBD patients (55% presenting colitis flare) and 40 non-IBD controls were assessed for CDI. Multivariate regression analysis was performed to identify predictors of CDI. Outcome analysis was estimated for recurrent CDI, hospitalization, colectomy, and CDI-associated mortality., Results: The number of patients with CDI was significantly higher in IBD patients experiencing flares than in both inactive IBD and non-IBD groups (28.8 vs. 5.6 vs. 0%, respectively; p = 0.001). Females (OR = 1.39, 95% CI, 1.13-17.18), younger age (OR = 0.77, 95% CI, 0.65-0.92), steroid treatment (OR = 7.42, 95% CI, 5.17-40.20), and infliximab therapy (OR = 2.97, 95% CI, 1.99-24.63) were found to be independently associated with CDI. There was a dose-related increase in the risks of CDI on patients which had taken prednisone. Those treated with vancomycin had a satisfactory response to therapy, but 21% presented recurrent CDI and 16% were hospitalized. Neither necessity of colectomy nor mortality was noticed in any patient during the investigation., Conclusions: In IBD outpatients presenting colitis flares, CDI is highly prevalent. Females, younger age, infliximab, and notably steroid therapy were independently associated with CDI. Most patients with CDI experienced mild-to-moderate disease, and prompt treatment with vancomycin was highly effective, which seems to reduce the serious complication risks.

Goals: We studied the prevalence and predictors of small-intestinal bacterial overgrowth (SIBO) in Crohn's disease (CD) outpatients and the relationship between SIBO and intestinal and/or systemic inflammation., Background: The relationship of SIBO with systemic and intestinal inflammation in CD patients is unclear., Study: In this cross-sectional study, conducted between June, 2013 and January, 2015, 92 CD patients and 97 controls with nonchronic gastrointestinal complaints were assessed for the presence of SIBO using the H2/CH4 glucose breath test. Multivariate logistic regression was performed to investigate the potential association between SIBO and demographic, disease-related data, systemic markers of inflammation (C-reactive protein, and erythrocyte sedimentation rate), and biomarker of intestinal inflammation [fecal calprotectin concentration (FCC)]., Results: The SIBO rate was significantly higher in CD patients than in controls (32.6% vs. 12.4%, respectively, P=0.0008). Patients with and without SIBO were comparable with regard to demographics, systemic inflammatory biomarkers, and disease characteristics, except for the stricturing phenotype being more common in SIBO-positive CD patients (43.3% vs. 19.3%, P=0.015). Notably, FCC was significantly higher in SIBO-positive patients (median of 485.8 vs.132.7 μg/g; P=0.004). Patients presenting increased FCC and stricturing disease had an odds of 9.43 (95% confidence interval, 3.04-11.31; P<0.0001) and 3.83 (95% confidence interval, 1.54-6.75; P=0.025) respectively, for SIBO diagnosis., Conclusions: In CD patients, SIBO is a highly prevalent condition. Stricturing phenotype and increased FCC were strongly and independently associated with the presence of SIBO. SIBO diagnostic work-up followed by directed treatment is recommended in CD patients who present stricturing disease, especially in those with concurrent intestinal inflammation.

Introduction:: Protein-energy malnutrition in Crohn's disease (CD) has been reported in 20 to 92% of patients, and is associated with increased morbidity and mortality and higher costs for the health system. Anti-TNF drugs are a landmark in the clinical management, promoting prolonged remission in patients with CD. It is believed that the remission of this disease leads to nutritional recovery. The effect of biological therapy on body composition and nutritional status is unclear., Method:: Prospective study of body assessment by bioelectrical impedance method in patients with moderate to severe CD undergoing treatment with infliximab. The main outcome was the body composition before and after 6 months of anti-TNF therapy., Results:: There was a predominance of females (52%) with a mean age of 42±12 years. Most patients were eutrophic at baseline and remained so. There was an increase in all parameters of body composition after anti-TNF treatment: BMI (22.9±3.2 versus 25±3.8; p=0.005), waist circumference (88.1±6.7 versus 93.9±7.7; p=0.002), lean mass index (17.5±2.2 versus 18.2±2.3; p=0.000) and fat mass index (5.5±2.3 versus 6.8±2.3; p=0.000). Phase angle remained unchanged (6.2 versus 6.8; p=0.94)., Conclusion:: After therapy with IFX, all components of body composition increased, except for phase angle. The substantial increase in fat mass index and waist circumference led to concern regarding cardiovascular risk and, thus, to the need for further studies.