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

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

BODY FAT COMPOSITION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASES: A COMPARATIVE STUDY BETWEEN SKINFOLDS AND ULTRASONOGRAPHY.

BACKGROUND: Inflammatory bowel diseases (IBD) are associated with important changes in nutritional status. OBJECTIVE: The aim of the study was to compare body fat composition between two anthropometric methods: skinfolds and ultrasonography, in patients with IBD. METHODS: Single-center cross-sectional study with IBD patients in remission or active disease. For the agreement analysis between the body fat assessment methods, the Bland Altman method was used. RESULTS: A total of 101 patients with IBD were included, 75 with Crohn's disease and 26 with ulcerative colitis. Approximately 56% of the patients with Crohn's disease and 65.4% of those with ulcerative colitis had a body fat composition above normal levels, with no significant difference between the diseases (P=0.63). The Bland-Altman concordance analysis showed that the methods for assessing the percentage of fat by the adipometer and ultrasound were not in full agreement (P=0.001), despite both presented good correlation (CC 0.961; P=0.000). CONCLUSION: The analysis of body fat percentage in patients with IBD was different between the skinfolds and ultrasound. Both methods can be used to assess the of body fat percentage of patients with IBD. However, monitoring of body fat sequentially and longitudinally should always be performed using the same method throughout the disease course. Prospective longitudinal studies are warranted to precisely define the role of these two methods of measuring body composition in patients with IBD. BACKGROUND: • Inflammatory bowel diseases are associated with changes in nutritional status. BACKGROUND: • Skinfolds measurements and ultrasound are valid methods for assessing body composition and body fat. BACKGROUND: • These methods despite comparable are not identical and are useful in clinical nutritional practices in IBD.

HOSPITALIZATION, USE OF BIOLOGICS AND SURGERY RATES IN INFLAMMATORY BOWEL DISEASES: A SINGLE-CENTRE COMPARATIVE ANALYSIS BETWEEN PUBLIC AND PRIVATE HEALTHCARE SYSTEMS IN A TERTIARY UNIT FROM LATIN AMERICA.

BACKGROUND: Inflammatory bowel diseases (IBD) have rising incidence and prevalence rates globally. In IBD, there are scarce stu-dies comparing differences between patients according to 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 systems. Demographic characteristics, hospitalizations, need for surgery and biologics were compared. RESULTS: A total of 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 surgery, 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%). There was no difference in UC-related hospitalizations between the subgroups (public 30.69% and private 37.66%) as well as the rates of colectomy (public: 16.83%, private: 19.48%). Biologics were prescribed almost twice as often in private as compared to public (45.45 vs 22.77%). CONCLUSION: There were no differences in the rates of hospitalization and abdominal surgery between the systems. In patients with UC, there was greater use of biological therapy in the private healthcare setting. BACKGROUND: • In a tertiary IBD center in Latin America. BACKGROUND: • More than half of the patients had been submitted to one or more CD-related abdominal surgical procedure. BACKGROUND: • Between the two healthcare systems, there was no difference in the rates of use of biological therapy in patients with CD, and in UC-related hospitalizations. BACKGROUND: • Biologics were prescribed almost twice as often in the private system as compared to the public in patients with UC.

WARNING TO DELAY IN DIAGNOSING MICROSCOPIC COLITIS IN OLDER ADULTS. A SERIES OF CASES.

BACKGROUND: Microscopic colitis (MC) is a chronic inflammatory bowel disease causing non-bloody diarrhea, and several cases are undiagnosed as a hidden cause of chronic diarrhea. OBJECTIVE: We aimed to report the symptoms, delay diagnosis and the treatment of MC in a case series. METHODS: All patients were treated at a Gastroenterology reference office from May 2022 to June 2023. Personal history including preexisting disorders, use of medications and smoking habits were collected. The delay between the onset of symptoms and the correct diagnosis was informed. All patients consented to use budesonide MMX (Corament®) off label. RESULTS: During the study period, six Caucasoid patients were diagnosed with MC, five females and one male, between the ages of 65 and 74. All patients had comorbities and were taking multiple prescription drugs. Laboratory findings showed negative serology for celiac disease for all patients, normal levels of albumin and vitamin B12. The delay between the symptoms and the MC diagnosis varied from 2 months to 6 years. All patients had a previous diagnosis of irritable bowel syndrome. All patients were in complete clinical remission during the treatment and referred no side effects of the drug. CONCLUSION: Older females using high-risk medications are suggestive of MC. Preventing delay in the diagnosis of MC is crucial to improvement in patients´ quality of life. Budesonide MMX appears to be effective, safe and well-tolerated. BACKGROUND: • Microscopic Colitis is a chronic inflammatory bowel disease causing non-bloody diarrhea. BACKGROUND: • Several cases are undiagnosed and can be a hidden cause of chronic diarrhea. BACKGROUND: • Treatment with budesonide MMX (Corament®, off label) was effective and safe.

Challenges in the diagnosis and treatment of inflammatory bowel disease in Latin America.

The incidence and prevalence of inflammatory bowel disease (IBD), namely Crohn's disease and ulcerative colitis, have increased in Latin America over the past few decades. Although incidence is accelerating in some countries in the region, other areas in Latin America are already transitioning into the next epidemiological stage-ie, compounding prevalence-with a similar epidemiological profile to the western world. Consequently, more attention must be given to the diagnosis and management of IBD in Latin America. In this Review, we provide an overview of epidemiology, potential local environmental risk factors, challenges in the management of IBD, and limitations due to the heterogenity of health-care systems, both public and private, in Latin America. Unresolved issues in the region include inadequate access to diagnostic resources, biological therapies, tight disease monitoring (including treat to target therapy, surveillance and prevention of complications, drug monitoring), and specialised IBD surgery. Local guidelines are an important effort to overcome barriers in IBD management. Advancements in long-term health-care policies will be important to promote early diagnosis, access to new treatments, and improvements in research in Latin America. These improvements will not only affect overall health care but will also lead to optimal prioritisation of IBD-related costs and resources and enhance the quality of life of people with IBD in Latin America.

Alerta de atraso no diagnóstico de colite microscópica em idosos. Uma série de casos / Warning to delay in diagnosing microscopic colitis in older adults. a series of cases

ABSTRACT Background: Microscopic colitis (MC) is a chronic inflammatory bowel disease causing non-bloody diarrhea, and several cases are undiagnosed as a hidden cause of chronic diarrhea. Objective: We aimed to report the symptoms, delay diagnosis and the treatment of MC in a case series. Methods: All patients were treated at a Gastroenterology reference office from May 2022 to June 2023. Personal history including preexisting disorders, use of medications and smoking habits were collected. The delay between the onset of symptoms and the correct diagnosis was informed. All patients consented to use budesonide MMX (Corament®) off label. Results: During the study period, six Caucasoid patients were diagnosed with MC, five females and one male, between the ages of 65 and 74. All patients had comorbities and were taking multiple prescription drugs. Laboratory findings showed negative serology for celiac disease for all patients, normal levels of albumin and vitamin B12. The delay between the symptoms and the MC diagnosis varied from 2 months to 6 years. All patients had a previous diagnosis of irritable bowel syndrome. All patients were in complete clinical remission during the treatment and referred no side effects of the drug. Conclusion: Older females using high-risk medications are suggestive of MC. Preventing delay in the diagnosis of MC is crucial to improvement in patients´ quality of life. Budesonide MMX appears to be effective, safe and well-tolerated.

RESUMO Contexto: A colite microscópica (CM) é uma doença inflamatória intestinal crônica que causa diarreia não sanguinolenta, e vários casos não são diagnosticados como uma causa oculta de diarreia crônica. Objetivo: Esse estudo visou relatar os sintomas, qual o atraso diagnóstico e o tratamento da CM em uma série de casos. Métodos: Todos os pacientes foram atendidos em um consultório de referência em Gastroenterologia no período de maio de 2022 a junho de 2023. Foram coletados antecedentes pessoais, incluindo distúrbios preexistentes, uso de medicamentos e tabagismo. Foi buscado o período entre o início dos sintomas e o diagnóstico correto. Todos os pacientes consentiram em usar budesonida MMX (Corament®) off label. Resultados: Durante o período do estudo, seis pacientes caucasóides foram diagnosticados com CM, cinco mulheres e um homem, com idades entre 65 e 74 anos. Todos os pacientes apresentavam comorbidades e faziam uso de vários medicamentos prescritos. Os achados laboratoriais mostraram sorologia negativa para doença celíaca em todos os pacientes, níveis normais de albumina e vitamina B12. O atraso entre os sintomas e o diagnóstico de CM variou de 2 meses a 6 anos. Todos os pacientes tinham diagnóstico prévio de síndrome do intestino irritável. Todos os pacientes apresentaram remissão clínica completa durante o tratamento e não referiram efeitos colaterais da droga. Conclusão: As mulheres mais velhas que usam medicamentos de alto risco são sugestivas de CM. Evitar o atraso no diagnóstico de CM é fundamental para melhorar a qualidade de vida dos pacientes. A budesonida MMX foi eficaz, segura e bem tolerada.

Taxas de hospitalização, uso de biológicos e cirurgias em doenças inflamatórias intestinais: uma análise comparativa entre os sistemas público e privado de saúde em centro de referência da América Latina / Hospitalization, use of biologics and surgery rates in inflammatory bowel diseases: a single-centre comparative analysis between public and private healthcare systems in a tertiary unit from latin america

ABSTRACT Background: Inflammatory bowel diseases (IBD) have rising incidence and prevalence rates globally. In IBD, there are scarce stu­dies comparing differences between patients according to 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 systems. Demographic characteristics, hospitalizations, need for surgery and biologics were compared. Results: A total of 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 surgery, 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%). There was no difference in UC-related hospitalizations between the subgroups (public 30.69% and private 37.66%) as well as the rates of colectomy (public: 16.83%, private: 19.48%). Biologics were prescribed almost twice as often in private as compared to public (45.45 vs 22.77%). Conclusion: There were no differences in the rates of hospitalization and abdominal surgery between the systems. In patients with UC, there was greater use of biological therapy in the private healthcare setting.

RESUMO Contexto: As doenças inflamatórias intestinais (DII) têm taxas crescentes de incidência e prevalência em todo o mundo. Na DII, são escassos os estudos comparando as diferenças entre os pacientes de acordo com o nível socioeconômico. Objetivo: Nosso objetivo foi avaliar comparativamente as hospitalizações, o uso de biológicos e as taxas de cirurgia em pacientes com DII entre os sistemas público e privado de saúde. Métodos: Estudo de coorte retrospectivo unicêntrico em pacientes com DII de uma unidade terciária de referência da América Latina, entre 2015 e 2021. Os pacientes com DC (doença de Crohn) e retocolite ulcerativa foram classificados em dois subgrupos: sistema público e privado. Características demográficas, hospitalizações, necessidade de cirurgia e biológicos foram comparadas. Resultados: Foram inclusos 500 pacientes, sendo 322 com DC e 178 com retocolite ulcerativa. Internações por DC foram frequentes em ambos os sistemas de saúde (76,28% na rede privada e 67,46% na rede pública). Mais da metade dos pacientes havia sido submetida a uma ou mais cirurgias abdominais relacionadas à DC, sem diferença significativa entre os subgrupos. Embora não tenha havido diferença nas taxas de uso de terapia biológica nos subgrupos de DC, o infliximabe foi mais utilizado no ambiente público (57,69% vs 43,97%). Não houve diferença nas internações relacionadas a retocolite ulcerativa entre os subgrupos (público 30,69% e privado 37,66%) e nas taxas de colectomia (público: 16,83%, privado: 19,48%). Os biológicos foram prescritos quase duas vezes mais no privado do que no público (45,45 vs 22,77%). Conclusão: Não houve diferença nas taxas de internação hospitalar e de cirurgia abdominal entre os sistemas. Nos pacientes com retocolite ulcerativa, houve maior utilização da terapia biológica no setor privado de saúde.

Composição da gordura corporal em pacientes com doenças inflamatórias intestinais: um estudo comparativo entre dobras cutâneas e ultrassonografia / Body fat composition in patients with inflammatory bowel diseases: a comparative study between skinfolds and ultrasonography

ABSTRACT Background: Inflammatory bowel diseases (IBD) are associated with important changes in nutritional status. Objective: The aim of the study was to compare body fat composition between two anthropometric methods: skinfolds and ultrasonography, in patients with IBD. Methods: Single-center cross-sectional study with IBD patients in remission or active disease. For the agreement analysis between the body fat assessment methods, the Bland Altman method was used. Results: A total of 101 patients with IBD were included, 75 with Crohn's disease and 26 with ulcerative colitis. Approximately 56% of the patients with Crohn's disease and 65.4% of those with ulcerative colitis had a body fat composition above normal levels, with no significant difference between the diseases (P=0.63). The Bland-Altman concordance analysis showed that the methods for assessing the percentage of fat by the adipometer and ultrasound were not in full agreement (P=0.001), despite both presented good correlation (CC 0.961; P=0.000). Conclusion: The analysis of body fat percentage in patients with IBD was different between the skinfolds and ultrasound. Both methods can be used to assess the of body fat percentage of patients with IBD. However, monitoring of body fat sequentially and longitudinally should always be performed using the same method throughout the disease course. Prospective longitudinal studies are warranted to precisely define the role of these two methods of measuring body composition in patients with IBD.

RESUMO Contexto: As doenças inflamatórias intestinais (DII) estão associadas a alterações importantes no estado nutricional. Objetivo: O objetivo do estudo foi comparar a composição da gordura corporal entre dois métodos antropométricos: dobras cutâneas e ultrassonografia, em pacientes com DII. Métodos: Estudo transversal de centro único com pacientes com DII em remissão ou doença ativa. Para a análise de concordância entre os métodos de avaliação da gordura corporal foi utilizado o método de Bland-Altman. Resultados: Foram incluídos 101 pacientes com DII, 75 com doença de Crohn e 26 com colite ulcerativa. Aproximadamente 56% dos pacientes com doença de Crohn e 65,4% daqueles com colite ulcerativa apresentaram composição de gordura corporal acima dos níveis normais, sem diferença significativa entre as doenças (P=0,63). A análise de concordância de Bland-Altman mostrou que os métodos de avaliação do percentual de gordura pelo adipômetro e ultrassonografia não foram totalmente concordantes (P=0,001), apesar de ambos apresentarem boa correlação (CC 0,961; P=0,000). Conclusão: A análise do percentual de gordura corporal em pacientes com DII foi diferente entre as dobras cutâneas e a ultrassonografia. Ambos os métodos podem ser usados para avaliar o percentual de gordura corporal de pacientes com DII. Entretanto, o monitoramento da gordura corporal de forma sequencial e longitudinal deve ser sempre realizado utilizando o mesmo método durante todo o curso da doença. Estudos longitudinais prospectivos são necessários para definir com precisão o papel desses dois métodos de medição da composição corporal em pacientes com DII.

Short and long-term outcomes of surgery for inflammatory (uncomplicated) ileocecal Crohn's disease: Multicentric retrospective analysis of 211 patients.

BACKGROUND: Surgical management for patients with inflammatory ileocecal Crohn's disease (CD) could be a reasonable alternative to second-line medical treatment. AIM: To assess short and long-term outcomes of patients operated on for inflammatory, ileocecal Crohn's disease. METHODS: A retrospective analysis of patients intervened at four referral hospitals during 2012-2021 was performed. RESULTS: 211 patients were included. 43% of patients underwent surgery more than 5 years after diagnosis, and 49% had been exposed to at least one biologic agent preoperatively. 89% were operated by laparoscopy, with 1.6% conversion rate. The median length of the resected bowel was 25 cm (7-92) and three patients (1.43%) received a stoma. Median follow-up was 36 (17-70) months. The endoscopic recurrence-free survival proportion at 24, 48, 72, 96, and 120 months was 56%, 52%, 45%, 38%, and 33%, respectively. The clinical recurrence-free survival proportion at 24, 48, 72, 96, and 120 months was 83%, 79%, 76%, 74%, and 74%, respectively. In multivariate analysis, previous biological treatment (HR=2.01; p = 0.001) was associated with a higher risk of overall recurrence. CONCLUSION: Surgery in patients with primary inflammatory ileocecal CD is associated with good postoperative outcomes, low postoperative morbidity with reasonable recurrence rates.

Outcomes and endpoints of postoperative recurrence in Crohn's Disease: systematic review and consensus conference.

BACKGROUND: Outcomes after ileocolonic resection in Crohn's Disease (CD) are heterogeneous and a clear definition of postoperative recurrence remains to be determined. Our Endpoints Working Group of the International Organization for the study of Inflammatory Bowel Disease (IOIBD) aimed to standardize postoperative outcomes, to discuss which endpoints should be used for postoperative clinical trials and to define those which could be used in trials or registries. METHODS: Based on a systematic review of the literature, recommendations and statements were drafted and sent to all IOIBD members for a first round of voting. Recommendations and statements were revised based on the voters' comments during a consensus hybrid conference open to all IOIBD members. If no agreement was reached after 2 rounds of voting, the statement was excluded. RESULTS: In the systematic review, 3,071 manuscripts were screened, of which 434 were included. Sixteen recommendations were identified, of which 11 were endorsed. Recommendations and statements include that endoscopy remains the gold standard and should be used as a short-term primary endpoint in both observational cohorts and randomized controlled trials. Clinical symptoms classically used in clinical trials for luminal CD are not reliable in this specific situation. For that reason, longer term endpoints should be based on the evidence of macroscopic inflammation assessed by imaging techniques, endoscopy or reflected by the presence of complications. CONCLUSIONS: Agencies recommend the use of clinical evaluations, as in the case of luminal CD, and do not recognize primary endpoints based solely on endoscopy. This consensus has led to agreement on the need to define postoperative endoscopy- and/or imaging-based endpoints.

Implementation of regulatory guidance for JAK inhibitors use in patients with immune-mediated inflammatory diseases: An international appropriateness study.

BACKGROUND AND AIMS: The Pharmacovigilance Risk Assessment Committee (PRAC) proposed measures to address severe side effects linked to Janus kinase inhibitors (JAKi) in immune-mediated inflammatory diseases (IMID). Use of these medications in individuals aged 65 and older, those at high cardiovascular risk, active or former long-term smokers, and those with increased cancer risk should be considered only if no alternatives exist. Caution is advised when administering JAKi to patients at risk of venous thromboembolism. We aim to implement recommendations from regulatory guidelines based on areas of uncertainty identified. METHODS: A two-round modified Research and Development/University of California Los Angeles appropriateness methodology study was conducted. A panel of 21 gastroenterologists, dermatologists and rheumatologists used a 9-point Likert scale to rate the appropriateness of administering a JAKi for each proposed clinical scenario. Scores for appropriateness were categorized as appropriate, uncertain, or inappropriate. Two rounds were performed, each with online surveys and a virtual meeting to enable discussion and rating of each best practice. RESULTS: Round 1 involved participants rating JAKi appropriateness and suggesting descriptors to reduce uncertainty. Survey results were discussed in a virtual meeting, identifying areas of disagreement. In round 2, participants rated their agreement with descriptors from round 1, and the level of uncertainty and disagreement reduced. Age flexibility is recommended in the absence of other risk factors. Active counseling on modifiable risks (e.g., overweight, mild hyperlipidemia and hypertension) and smoking cessation is advised. Uncertainty persists regarding cancer risk due to various factors. CONCLUSIONS: We outlined regulatory guidance without a personalized evaluation of the patient's risk profile might lead to uncertainty and become an arid technicality. Therefore, we identified gaps and implemented PRAC recommendations to help health professionals in clinical practice.

Infliximab serum concentrations in luminal Crohn's disease and its relationship with disease activity: A multicentric cross-sectional study.

OBJECTIVES: In Latin America, experience with monitoring serum Infliximab (IFX) concentrations is scarce. Our study aimed to compare IFX serum concentrations between patients with active disease or in remission. PATIENTS AND METHODS: A cross-sectional study was performed in patients with luminal Crohn's disease (CD) during maintenance treatment with IFX. Patients were classified as in remission or disease activity according to clinical scores and endoscopic, radiological, and laboratory markers. A comparison of IFX trough levels between the two groups was performed. RESULTS: 80 CD patients were included [41 (51%) in remission and 39 (49%) with active disease]. In the analysis of general disease activity, the median serum levels of IFX in patients with remission and with active CD were 5.63 [0.03-14.40] vs. 3.84 [0.03-14.40] (p=0.287). Furthermore, there was no difference in serum IFX concentrations in endoscopic, radiological, and laboratory activities. Only in the clinical evaluation there was a significant difference in the median serum IFX levels between patients in remission and disease activity, 5.63 [0.03-14.40] vs. 2.14 [0.32-10.54] (p=0.042). CONCLUSIONS: IFX serum concentrations during maintenance treatment were similar in patients with luminal CD in remission and general, endoscopic, radiological, and laboratory disease activity. Patients with clinically active disease had lower IFX concentrations than patients in remission.

Vedolizumab in Mild-to-Moderate Crohn's Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study.

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.

Biological therapy, surgery, and hospitalization rates for inflammatory bowel disease: An observational Latin American comparative study between adults and pediatric patients.

OBJECTIVE: Compare the proportions of use of biological therapy, surgeries, and hospitalizations between adults and pediatric inflammatory bowel disease (IBD)-Crohn's disease (CD) and ulcerative colitis (UC)-patients. PATIENTS AND METHODS: Observational, retrospective, and multicenter study. Data were collected from all consecutive IBD patients seen as outpatients or admitted to hospital, during 2015-2021, in two IBD tertiary centers in a South Brazilian capital. Patients with unclassified colitis diagnosis were excluded from this study. Patients were classified as having CD or UC and sub-categorized as adult or pediatric according to age. Data were analyzed using frequency, proportion, Fisher's exact test, and Chi-square test. RESULTS: A total of 829 patients were included: 509 with CD (378 adults/131 pediatric) and 320 with UC (225/95). Among patients with CD, no differences were observed for proportions of use of biological therapy (80.2% in pediatric vs. 73.3% in adults; P=0.129), surgery (46.6% vs. 50.8%; P=0.419), or hospitalization (64.9% vs. 56.9%; P=0.122). In UC, significant differences were observed for biological therapy (40.0% vs. 28.0%; P=0.048) and hospitalization (47.4% vs. 24.0%; P<0.001). No significant difference was observed in surgery rates (17.9% vs. 12.4%; P=0.219). CONCLUSIONS: Biological therapy and incidence of hospitalization were greater among pediatric patients with UC, compared with adults; no difference was observed in the need for abdominal surgery. In CD, no significant difference was observed in the three main outcomes between the age groups.

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus.

As the patents for biologic originator drugs expire, biosimilars are emerging as cost-effective alternatives within healthcare systems. Addressing various challenges in the clinical management of inflammatory bowel disease (IBD) remains crucial. To shed light on physicians' current knowledge, beliefs, practical approaches, and concerns related to biosimilar adoption-whether initiating a biosimilar, transitioning from an originator to a biosimilar, or switching between biosimilars (including multiple switches and reverse switching)-a global survey was conducted. Fifteen physicians with expertise in the field of IBD from 13 countries attended a virtual international consensus meeting to develop practical guidance regarding biosimilar adoption worldwide, considering the survey results. This consensus centered on 10 key statements covering biosimilar effectiveness, safety, indications, rationale, multiple switches, therapeutic drug monitoring of biosimilars, non-medical switching, and future perspectives. Ultimately, the consensus affirmed that biosimilars are equally effective and safe when compared to originator drugs. They are considered suitable for both biologic-naïve patients and those who have previously been treated with originator drugs, with cost reduction being the primary motivation for transitioning from an originator drug to a biosimilar.

Disease Clearance as a New Outcome in Ulcerative Colitis: a Systematic Review and Expert Consensus.

The concept of disease clearance has been proposed as a potential target in ulcerative colitis (UC). We conducted a systematic review to investigate the role of disease clearance, defined as a composite outcome including simultaneous clinical, endoscopic, and histologic remission of disease in the management of patients with UC. Based on the literature data, statements regarding disease clearance were developed and voted on by the members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) according to a Delphi methodology. A definition of disease clearance was proposed to standardize its use in clinical practice and clinical trials and to provide practical recommendations for its implementation as a therapeutic target in UC.

MICROSCOPIC COLITIS: CONSIDERATIONS FOR GASTROENTEROLOGISTS, ENDOSCOPISTS, AND PATHOLOGISTS.

•Diagnosis of microscopic colitis necessitates effective communication among gastroenterologists, endoscopists, and pathologists. •The gastroenterologist should refer every patient with chronic watery diarrhea to perform a colonoscopy in spite of the benign course of the disease and the absence of alarm symptoms. •The endoscopist should take 2 or 3 biopsy samples of the colonic mucosa from the right and left colon, put in separate recipients, despite that the mucosa looked macroscopically normal. •The pathologist should be encouraged to use objective histological criteria to make the diagnosis. Microscopic colitis is a chronic inflammatory bowel disease characterized by non-bloody diarrhea that can range from mild to severe. It is difficult to attribute up to 10-20% of chronic diarrhea to microscopic colitis. The three determinants factors of the diagnosis are characteristic clinical symptoms, normal endoscopic picture of the colon, and pathognomonic histological picture. This manuscript aimed to update considerations and recommendations for professionals involved (gastroenterologist, endoscopists and pathologist) in the diagnosis of MC. In addition, a short recommendation about treatment.

Stemming the tide with ileocecal Crohn's disease: when is pharmacotherapy enough?

INTRODUCTION: Crohn's disease (CD) mostly affects the terminal ileum and ileocecal region and up to 80% of patients end up requiring surgery. Previously reserved for complicated or refractory forms, surgery is now considered as an alternative to medical treatment in localized ileocecal disease. AREAS COVERED: This review examines factors associated with response to medical treatment and those associated with the need for surgery in ileocecal CD to identify the patients' profile for whom pharmacotherapy might be enough. Factors associated with the recurrence and the postoperative complications are also reviewed to help the clinician identify patients for whom medical therapy might be preferred. EXPERT'S OPINION: LIR!C study long-term follow-up data show that 38% of infliximab-treated patients were still treated with infliximab at the end of their follow-up, while 14% had switched to another biologic or had received immunomodulator or corticosteroid and 48% had CD-related surgery. Only the combination with an immunomodulator was associated with a greater likelihood of continuing infliximab. Patients with ileocecal CD for whom pharmacotherapy might be sufficient are probably those with no risk factors for CD-related surgery.In addition, patients with high risk of recurrence or of post-operative complications may benefit more from medical treatment than from surgery.