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

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

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.

Banded RYGB Ring Slippage Endoscopic Removal with Self-expandable Stents: a Comparative Study Between Metallic and Plastic One.

PURPOSE: Banded Roux-en-Y gastric bypass (RYGB) was a common bariatric procedure in the 2000s, and the ring slippage is one of its late adverse events. Both plastic and metallic stents have been reported as adjunct methods to induce erosion and facilitate endoscopic removal of the ring. OBJECTIVE: To compare the safety and effectiveness of self-expanding metallic stents (SEMS) and plastic stents (SEPS) to treat ring slippage. MATERIALS AND METHODS: We conducted a retrospective longitudinal study analyzing consecutive patients with ring dysfunction treated with stents plus endoscopic removal. RESULTS: Ninety patients were enrolled (36 SEMS vs. 54 SEPS). The mean age was 48.56 ± 13.07 and 45.6 ± 12.1 in the SEMS and SEPS groups, respectively. All patients had band slippage, but 24 from SEMS group and 23 from SEPS group had further complications. There were more complications in metallic stent concerning mean absolute number of therapy-related adverse events (1.33 ± 0.48 vs. 1.72 ± 0.5, p > 0.05) and time until erosion (14.9 ± 1.6 vs. 13.8 ± 1.4 days, p > 0.05). Female sex and age > 41 years old correlated with longer time to band erosion and higher incidence of adverse events in SEMS patients. In SEPS group, only female sex was a risk factor for adverse events. CONCLUSION: Both procedures were efficient at inducing band erosion with similar safety profiles. Older and female patients are at a higher risk of treatment-related adverse events, especially those receiving SEMS.

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

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

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

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

P052 National Registration of Patients With Inflammatory Bowel Disease in Brazil on Behalf of GEDIIB.

BACKGROUND: The IBD National Patient Registry is an initiative of the GEDIIB (Brazilian Study Group of Inflammatory Bowel Disease) who aims to survey the epidemiological profile of IBD patients through the creation of a centralized registry with data on patients monitored in public and private health services which will allow the planning of actions by the GEDIIB to facilitate the diagnosis and access to treatment of IBD, enabling the implementation of actions of the GEDIIB and the partnership with government agencies to improve care and, consequently, the quality of life of patients with IBD. This study aims to show the results of the IBD National Patient Registry. METHODS: A cohort study was performed. Data were collected from July 2020 to August 2021. Data were obtained from medical records and/or from patients during the regular follow-up visit and stored in pre-established records for further analysis. Only patients with an established diagnosis of CD and UC were included. The study was approved by the local ethical committees and all patients signed the consent form. RESULTS: In total, 797 patients were included, 60% with UC and 40% with CD; 52.9% from University Hospitals. The mean age was 44.75 ± 16.11 (12 - 92y), 59.9% female, 59.3% married, 76.4% Caucasian, 85.1% non-smokers, 30.5% completed higher education, 14.9% presented familial history of IBD. The age of onset of symptoms ranged from 3 - 79 years (32.94 ± 14.22) and 33.2% presented diarrhea as an initial manifestation. The age of diagnosis ranged from 4 - 81 years (35.07 ± 14.60) and the time from symptoms to diagnosis ranged from 1 to 2 years. The Montreal classification of CD patients were A1: 6.3%, A2: 59.9%, A3: 33.8%; L1: 38%, L2: 16.7%, L3: 43.9%, B1: 51.5%, B2: 27.8%, B3: 7.8%; perianal 12.8%. In UC, 47.8% presented pancolitis, 30.3% left-sided and 21.8% distal colitis. EIMs were present in 45.7% of patients, the most frequent being rheumatological 21.8%. Comorbidities were present in 72%, the most frequent were high blood pressure (15.3%) and diabetes (6.3%); 50% were with BMI > 25 Kg/m2. Most of the patients were in use of medical therapy (95.5%), of which 81.3% salicylate, 70.3% biological therapy, 49% immunosuppressor, 25.6% corticosteroid and 1.2% tofacitinib. Regarding biological therapy, the following medications were used: infliximab 47.6%, adalimumab 28.4%, vedolizumab 9.5%, ustekinumab 7.5%, certolizumab 2.2% and golimumab 1.3%. Eleven women used the medication during pregnancy. IBD surgery-related was performed in 69.7%, 77.2% abdominal and 22.8% perianal. Almost 30% performed more than one surgery. In 62% of patients, at least one complication was reported; most of them were infective disorders, demanding prolonged hospitalizations. CONCLUSION: To date, there is no IBD epidemiologic study covering the entire Brazilian territory. The results found with the registry will be fundamental to show the epidemiology of a country with continental dimensions such as Brazil. The greater the number of researchers included and from different regions of the country, the greater the representativeness of the data and may even help direct government actions on behalf of IBD patients.

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

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

Ectopic spleen mimicking hepatocellular carcinoma in the late post-operative period of bariatric surgery.

An ectopic spleen occurs with less than 600 cases reported and has a large series of splenectomies less than 0.3%. Its highest prevalence occurs between 20 and 40 years of age, being more frequent in female patients. To present an original case report on the occurrence of ectopic spleen, mimicking hepatocellular carcinoma (HCC) after bariatric surgery. Occurrence of migratory spleen after late bariatric surgery, mimicking an HCC discovered in a routine evaluation. JCA patient, male, 66 years old, previously with sleep apnea, hypertensive and diabetic patients on medication regularly, who weighed 112.8 kg, with a BMI of 43.4 kg / m2. After 2 years of by-pass, a routine evaluation identified hepatobiliary surface on hepatic ultrasound performing MRI imaging suggestive of HCC. The team opted for a new laparoscopy with the possibility of cavity inventory beyond the biopsy of the tumor lesion already identified, to track intra-abdominal metastases and to review anatomy. The operation revealed that the suggestive lesion was subcapsular implanted only in the falciform and hepatic surface in segment amenable to total resection. The anatomopathological results of the lesions were described as congenital splenic cells compatible with ectopic spleen. The emergence of the ectopic spleen after laparoscopic bypass has not been reported so far because it is a non-traumatic surgery. The lesion in question had a benign behavior, with hepatic subcapsular implantation restricted to the falciform ligament, capable of total resection. Patient evolved well following follow up with gastroenterologist.

NEW BOWEL PREPARATION TECHNIQUE FOR COLONOSCOPY: CLINICAL TRIAL COMPARING AQUANET AND MANNITOL.

BACKGROUND: Fifty-five percent of Americans aged 50-65 are submitted to colonoscopy. For over 65-year, this number increases to 64%. In Brazil, it is forecast that the population submitted to colonoscopy will grow, even though inadequate preparation is still a major problem. AIM: To analyze the quality of a new intestinal preparation technique, Aquanet EC-2000®, compared to oral Mannitol solution. METHODS: This prospective longitudinal study enrolled 200 patients with indication for colonoscopy. The sample was randomly allocated to two groups of 100; one group received Aquanet EC-2000® to prepare for colonoscopy and the other Mannitol solution. The Boston scale was used to analyze the results. RESULTS: As expected both preparations produced similar results with the bowel cleansing of the different regions of the colon being classified as Boston scale 3 (excellent) in most patients (p>0.05). CONCLUSION: The results of bowel preparation using Aquanet EC-2000® were similar to using Mannitol solution.

Aquanet Bowel Cleansing Device Versus Oral Sodium Picosulfate for Pre-Endoscopy Bowel Preparation: Propensity Score Analysis for Interventional Effectiveness Evaluation.

BACKGROUND: Colonoscopy procedures are commonly performed and have high success rates. However, poor or inadequate bowel preparation is one of the most common reasons for a repeated or failed colonoscopy. We therefore performed an observational study followed by propensity score modeling to evaluate and compare the quality of bowel preparation with the use of Aquanet bowel cleansing devices (BCDs) versus the use of oral sodium picosulfate solution. METHODS: We performed a prospective cross-sectional study to compare the quality of pre-endoscopic bowel preparation using a BCD with oral solution. Our major outcome of interest was the quality of bowel preparation as measured through the Boston bowel preparation (BBP) scale. Our main predictor was the method of bowel preparation. The bowel was prepared using either sodium picosulfate or the BCD. RESULTS: A total of 314 participants were part of this study. The average age of the participants was 54 years and most of the participants were females (81%). Sodium picosulfate was associated with better scores at each segment. After propensity scoring with a 1:1 match and further adjusting for the unbalanced variable (age), we found that despite the apparent superior cleansing performance of sodium picosulfate over the BCD, the difference was not statistically significant. CONCLUSION: This study reinforces previous reports regarding the quality, safety and comfort of BCDs, indicating that this technique should be considered for colonoscopy preparation. In the future, randomized controlled trials should be performed to validate these preliminary findings.

A Case of Adolescent Cronkhite-Canada Syndrome.

The Cronkhite-Canada syndrome (CCS) was first reported in 1955, since then more than 500 cases have been reported, indicating an estimated incidence of one case per 1 million inhabitants. The syndrome occurs predominantly in male, with a ratio of three males to two females. Because of the rarity of the syndrome, there are no evidence-based therapies and the treatments described include a combination of therapies, but none is consistently effective. Surgery is usually reserved for the treatment of complications. Herein, we present a case of adolescent CCS. The patient was a 15-year-old boy who presented with watery diarrhea with 20 episodes a day, vomiting and abdominal pain for 4 weeks, with a weight loss of 8.0 kg (15.0% of initial weight). Endoscopic examination revealed polyposis in the stomach, duodenum, and colon. CCS was diagnosed and the patient was treated with a combined corticosteroid and metronidazole. Followed up at 8 month after the diagnosis, the patient was asymptomatic.

New bowel preparation technique for colonoscopy: clinical trial comparing aquanet and mannitol / Nova técnica de preparo intestinal para colonoscopia: estudo clínico comparativo entre aquanet e manitol

ABSTRACT Background: Fifty-five percent of Americans aged 50-65 are submitted to colonoscopy. For over 65-year, this number increases to 64%. In Brazil, it is forecast that the population submitted to colonoscopy will grow, even though inadequate preparation is still a major problem. Aim: To analyze the quality of a new intestinal preparation technique, Aquanet EC-2000®, compared to oral Mannitol solution. Methods: This prospective longitudinal study enrolled 200 patients with indication for colonoscopy. The sample was randomly allocated to two groups of 100; one group received Aquanet EC-2000® to prepare for colonoscopy and the other Mannitol solution. The Boston scale was used to analyze the results. Results: As expected both preparations produced similar results with the bowel cleansing of the different regions of the colon being classified as Boston scale 3 (excellent) in most patients (p>0.05). Conclusion: The results of bowel preparation using Aquanet EC-2000® were similar to using Mannitol solution.

RESUMO Racional: Cinquenta e cinco por cento dos norte-americanos entre 50-65 anos fazem colonoscopia. Acima de 65 anos o número foi de 64%. No Brasil, estima-se crescente aumento da população submetida à colonoscopia, apesar da preparação inadequada ainda ser um grande problema. Objetivo: Analisar e comparar a qualidade do novo método de preparo intestinal por meio do Aquanet EC-2000® frente ao uso de solução oral de Manitol. Método: Por randomização 200 pacientes foram divididos em dois grupos de 100. Um recebeu Aquanet EC-2000® e o outro Manitol. O presente estudo seguiu modelo prospectivo longitudinal por meio da seleção de 200 pacientes com indicação à colonoscopia, formando dois grupos de 100. Para analisar os resultados foi utilizada a escala de Boston. Resultados: Ambos os preparos foram estatisticamente significativos com p<0,05. A escala 3 de Boston foi a mais frequente para ambos os métodos.Além disso, na estatística aplicada às diferentes regiões do cólon para ambos os procedimentos as proporções observadas concordaram com o esperado (3-excelente). Conclusão: Os resultados do preparo intestinal utilizando Aquanet EC-2000® foram semelhantes aos do Manitol.

Low toxicity and favorable clinical and quality of life impact after non-myeloablative autologous hematopoietic stem cell transplant in Crohn's disease.

OBJECTIVE: The incidence of adverse events in myeloablative transplant protocols is high in refractory Crohn's disease; this study used low doses of cyclophosphamide. Fourteen patients were submitted to non-myeloablative autologous hematopoietic stem cell transplantation. RESULTS: The average number of days of anemia (hemoglobin < 10 g/dL) was 5.4 ± 4.2 and 14 ± 2.4 in the mobilization and conditioning phases, respectively. The mean number of days of neutropenia (neutrophils < 0.5 × 109/L) in the mobilization phase was 1.7 ± 1.5 while it was 7.6 ± 1.4 in the conditioning phase. When comparing the conditioning and mobilization phases, there was an increased number days of leukopenia (white blood cells < 1.0 × 109/L), lymphocytopenia (lymphocytes < 0.5 × 109/L) and thrombocytopenia (platelets < 25 × 109/L). Crohn's Disease Activity Index values before the transplant ranged from 155 to 450.5 (mean 281.2 ± 79.0) and at 30 days after the procedures they ranged from 45.4 to 177 (mean 95.8 ± 35.4). Moreover, the procedure improved in overall quality of life of patients. Non-myeloablative autologous hematopoietic stem cell transplantation with lower doses of cyclophosphamide leads to lower rates of hematological toxicity and adverse events compared to protocols described in the literature. Trial registration NCT 03000296: Date 9 December 2016.