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Background and Aims: Effective management of inflammatory bowel disease (IBD) relies on a comprehensive understanding of infliximab (IFX) pharmacokinetics (PK). This study's primary goal was to develop a robust PK model, identifying key covariates influencing IFX clearance (CL), while concurrently evaluating the risk of disease progression during the maintenance phase of IBD treatment., Methods: The multicenter, prospective, real-world DIRECT study was conducted in several care centers, which included 369 IBD patients in the maintenance phase of IFX therapy. A two-compartment population PK model was used to determine IFX CL and covariates. Logistic and Cox regressions were applied to elucidate the associations between disease progression and covariates embedded in the PK model., Results: The PK model included the contributions of weight, albumin, antidrug antibody (ADA), and fecal calprotectin (FC). On average, higher ADA, FC concentration and weight, and lower albumin concentration resulted in higher IFX CL. In the multivariate regression analyses, FC levels influenced the odds of disease progression in the majority of its definitions, when adjusted for several confounding factors. Additionally, alongside FC, both IFX and CL demonstrated a significant impact on the temporal aspect of disease progression., Conclusion: In this 2-year real-world study, readily available clinical covariates, notably FC, significantly impacted IFX availability in IBD patients. We demonstrated that subclinical active inflammation, as mirrored by FC or CRP, substantially influenced IFX clearance. Importantly, FC emerged as a pivotal determinant, not only of IFX pharmacokinetics but also of disease progression. These findings underscore the need to integrate FC into forthcoming IFX pharmacokinetic models, amplifying its clinical significance., (© The Author(s) 2024. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: The emergence of new treatments the inflammatory bowel diseases (IBD) raised questions regarding the role of older agents, namely thiopurines., Aims: To clarify the benefits of combination treatment with thiopurines on Crohn's disease (CD) patients in the maintenance phase of infliximab., Methods: In this analysis of the 2-year prospective multicentric DIRECT study, patients were assessed in terms of clinical activity, faecal calprotectin (FC), C-reactive protein (CRP), and infliximab pharmacokinetics. A composite outcome based on clinical- and drug-related items was used to define treatment failure., Results: The study included 172 patients; of these, 35.5 % were treated with combination treatment. Overall, 18 % of patients achieved the composite outcome, without statistically significant differences between patients on monotherapy and on combination treatment (21.6% vs 11.5 %, p = 0.098). Median CRP, FC, and infliximab pharmacokinetic parameters were similar in both groups. However, in the sub-analysis by infliximab treatment duration, in patients treated for less than 12 months, the composite outcome was reached in fewer patients in the combination group than in the monotherapy group (7.1% vs 47.1 %, p = 0.021)., Conclusion: In CD patients in maintenance treatment with infliximab, combination treatment does not seem to have benefits over infliximab monotherapy beyond 12 months of treatment duration., Competing Interests: Conflict of interest PS served as speaker for Janssen and received Congress support from Janssen, Abbvie, Dr. Falk, Norgine and Pfizer. IR reports personal fees and/or non-financial support from Faes Pharma, Ferring, Pharmakern, Janssen and Takeda, outside the submitted work. She also reports research grants from Abbvie and Ferring, outside the submitted work. HTS served as speaker for Janssen and received Congress support from Abbvie, Ferring, Janssen, Pfizer, Takeda, Tillots, Dr. Falk and Biogen. FM served as a speaker and received honoraria from Abbvie, Biogen, Falk, Ferring, Hospira, Janssen, Laboratórios Vitória, Lilly, Pfizer, Merck Sharp & Dohme, Sandoz, Takeda, UCB and Vifor. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Empyema necessitans is a rare entity that consists on the development of an abscess that begins in the pleural space and then extends to the adjacent tissues. This case shows a rare and very late complication of a total pneumonectomy, emphasizing the importance of the multidisciplinary approach and the potential of endoscopic therapy with over-the-scope clips.

A 45-year-old male, with a recent surgery for odontoid fracture, presented to the emergency department with a 15-days history of abdominal pain associated with fever and weight loss. He reported a recent history of antibiotic therapy due to respiratory infection and a frequent use of anti-inflammatory drugs (NSAIDs) in the last three months.

Background: Timely stratification of Crohn's disease (CD) is essential for patients' management. The use of noninvasive accurate biomarkers is key to monitor treatment and to pursue mucosal healing, the ultimate treatment endpoint in CD., Objective: We aimed to evaluate the performance of readily available biomarkers and develop risk matrices to predict CD progression., Methods: Data from 289 CD patients receiving infliximab (IFX) maintenance therapy for 2 years was collected; those patients were included in DIRECT, a prospective multicenter observational study. Disease progression was evaluated using two composite outcomes incorporating clinical and drug-related factors, the first including IFX dose and/or frequency adjustments. Univariate and multivariable logistic regressions were used to calculate the odds ratios (OR) and to develop risk matrices., Results: The isolated presence of anemia at least once during follow-up was a significant predictor of disease progression (OR 2.436 and 3.396 [p ≤ 0.001] for composite outcomes 1 and 2, respectively) regardless of confounding factors. Isolated highly elevated C-reactive protein (CRP; >10.0 mg/L) and fecal calprotectin (FC; >500.0 μg/g) in at least one visit were also significant predictors, while milder elevations (3.1-10.0 mg/L and 250.1-500.0 μg/g) were only relevant when detected in at least two visits (consecutive or not). The combination of biomarkers in risk matrices had good ability to predict progression; patients simultaneously presenting anemia, highly elevated CRP and FC at least once had 42%-63% probability of achieving the composite outcomes., Conclusion: The combined evaluation of hemoglobin, CRP, and FC in at least one time point and their incorporation into risk matrices seems to be the optimal strategy for CD management, as data from additional visits did not meaningfully influence the predictions and may delay decision-making., (© 2023 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Background and Aims: Subclinical intestinal inflammation is common in Crohn's disease (CD). We aimed to explore its impact in the disease progression of infliximab-treated patients and the usefulness of fecal calprotectin (FC) and C-reactive protein (CRP) as surrogate minimally invasive biomarkers., Methods: The registry-based, prospective, observational, multicenter DIRECT (study to investigate the correlation of fecal calprotectin with serum Drug levels and development of an antI-dRug antibodiEs among adult patients with inflammatory bowel disease reCeiving anti-TNF-alfa treatment or vedoluzimab treatment) study followed infliximab-treated CD patients for 2 years in a tertiary care setting. Persistent inflammation definition was based on FC (>150 μg/g, >250 μg/g, or >350 μg/g) or serum CRP (>3 μg/mL) concentrations over 2 consecutive or at least 3 visits. Patients were categorized according to a composite outcome reflecting disease progression that incorporated surgery; hospitalizations; new fistulae, abscess, or stricture; and treatment escalation., Results: Of 322 DIRECT study patients, 180 asymptomatic, infliximab treated on maintenance regimen were included in the analysis. Patients developing the composite endpoint (n = 96) presented higher median levels of FC (205 [interquartile range, 98-515] μg/g; P = .045) but not of CRP (2.50 [interquartile range, 0.80-6.00] μg/mL; P = .895). Biomarker-defined persistent subclinical inflammation prevalence ranged from 24% to 81%. Considering FC >250 μg/g in 2 consecutive visits, prevalence was 50%, odds of achieving the endpoint were increased 3-fold (odds ratio, 2.996 [95% confidence interval, 1.557-5.776]), and time-to-outcome occurrence was significantly lower among subjects with persistent inflammation (median time: 11 months). Both clinical-related and treatment-related components were significantly associated with persistent inflammation. Definitions based on CRP >3 μg/mL, FC >150 μg/g, FC >350 μg/g, double biomarkers (FC >250 μg/g and/or CRP >3 μg/mL), or more visits did not improve predictive ability., Conclusions: Persistent inflammation, defined simply and readily by FC >250 μg/g over 2 consecutive visits, was associated with a significantly higher risk and shorter time to occurrence of a composite outcome reflecting disease progression in asymptomatic infliximab-treated CD patients., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Introduction: The COVID-19 pandemic drastically changed the daily routine of all healthcare systems worldwide, and endoscopy units were no exception. Endoscopic exams were considered to have a high risk of transmission, and therefore, the safety of endoscopy units and the consequent need for pre-endoscopy SARS-CoV-2 screening were questioned early on. The aim of our study was to assess the safety of endoscopy units during the COVID-19 pandemic, as well as the effectiveness/necessity for SARS-CoV-2 screening prior to endoscopies., Material and Methods: This is a retrospective and single-center study carried out in a Portuguese tertiary hospital. All patients who underwent endoscopic procedures between September 1, 2020 and February 28, 2021 were included. The pre-endoscopy screening consisted of a specific questionnaire or a RT-PCR test for SARS-CoV-2 (nasal and oropharyngeal swab). Data were obtained through patient's clinical records and the Trace COVID platform., Results: A total of 2,166 patients were included. Patients had a mean age of 61.8 years and were predominantly male (56.2%, n = 1,218). Eighty-one (3.7%) patients had previous SARS-CoV-2 infection, with a median difference of 74 days (IQ 40.5:160.5) between infection and endoscopy. Most patients (70.2%, n = 1,521) underwent PCR screening for SARS-CoV-2 up to 72 h before the procedure, with the remaining patients (29.8%, n = 645) answering a questionnaire of symptoms and risk contacts up to 3 days before endoscopy. Of the patients who underwent RT-PCR screening for SARS-CoV-2, 21 (1.4%) tested positive, and all were asymptomatic at the time of the screening. The evaluation for SARS-CoV-2 infection up to 14 days after the endoscopic exams identified 9 positive patients (0.42%) for SARS-CoV-2. The median difference in days between endoscopy and the diagnosis of infection was 10 days., Discussion/conclusion: Pre-endoscopy screening with RT-PCR test for SARS-CoV-2 identified a very small number of patients with COVID-19 infection as well as patients with COVID-19 infection in the following 14 days. Therefore, the risk of infection in endoscopy units is negligible if screening of symptoms and risk contacts is applied and individual protective equipment is used., Competing Interests: The authors have no conflicts of interest to declare., (Copyright © 2022 by The Author(s). Published by S. Karger AG, Basel.)

Objective: The aim of this study was to validate the IBD-Disk in a Portuguese cohort according to the COnsensus-based Standards for the selection of the health Measurement INstruments (COSMIN) recommendations., Methods: After translation of the original IBD-Disk to Portuguese, a group of IBD patients was invited to complete the IBD-Disk at baseline (T0), after 1-4 weeks (T1) and after more than 3 months (T2), from July 2020 to February 2021. At T0 and T2, the patients also completed the IBD Disability Index. We evaluated reliability (internal consistency, test-retest, interrater reliability and measurement error), construct validity, responsiveness, interpretability of IBD-Disk, sociodemographic and clinical factors associated with IBD-Disk., Results: At T0, 154 patients (107 - Crohn's disease; 46 - ulcerative colitis) completed the IBD-Disk; 1 - IBD-unclassified). At T1 and T2, 64 and 114 patients repeated the questionnaire, respectively. Factor analysis confirmed the unidimensionality of the scale and reduced the final version to 10 items. Internal consistency was excellent with a Cronbach's α of 0.916. The intraclass correlation coefficient was 0.95 for test-retest (T0 and T1). To evaluate construct validity, the IBD-Disk was compared with the IBD Disability Index and Manitoba IBD Index with a significative positive correlation (r = 0.850 and r = 0.459, respectively; P < 0.001 for both). IBD-Disk scores ranged from 0 to 93 with a mean of 38.18 ± 25.39. Female sex, professional inactivity, longer IBD duration and clinical activity were associated with significantly higher IBD-Disk scores., Conclusion: The Portuguese version of IBD-Disk is a reliable and valid tool to assess disability in Portuguese IBD patients., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background & Aims: In addition to findings from endoscopy, histologic features of colon biopsies have been associated with outcomes of patients with ulcerative colitis (UC). We investigated associations between Geboes scores (a system to quantify structural changes and inflammatory activity in colon biopsies) and UC progression, and the time period over which this association is valid., Methods: We analyzed data from 399 asymptomatic patients with UC enrolled in the ACERTIVE study, followed at 13 inflammatory bowel disease (IBD) centers in Portugal through 31 December 2019. Blood and stool samples were collected and analyzed, and all patients underwent sigmoidoscopy within 24 h of sample collection. We assessed baseline endoscopic status (Mayo endoscopic subscore), histologic features of 2 sigmoid and 2 rectal biopsies (Geboes score), and concentration of fecal calprotectin (FC). The primary outcome was UC progression (surgical, pharmacologic, and clinical events). We generated survival curves for 36 months or less and more than 36 months after biopsy according to Geboes score using the Kaplan-Meier method and compared findings with those from a log rank test. Cox regression was adjusted for Mayo endoscopic subscore, Geboes score, and level of FC; results were expressed as adjusted hazard ratios (HR) with 95% CIs., Results: Patients with Geboes scores >2B.0, Geboes scores >3.0, or Geboes scores >4.0 had a higher frequency of, and a shorter time to UC progression, than patients with Geboes scores ≤2B.0, Geboes scores ≤3.0, or Geboes score ≤4.0 (P < .001). Disease progression occurred earlier in patients with Geboes scores >2B.0, Geboes scores >3.0, or Geboes scores >4.0 compared with patients with Geboes scores ≤2B.0 (HR, 2.021; 95% CI, 1.158-3.526), Geboes scores ≤3.0 (HR, 2.007; 95% CI, 1.139-3.534), or Geboes scores ≤4.0 (HR, 2.349; 95% CI, 1.269-4.349), respectively, in the first 36 months after biopsy. Similar results were found for patients with concentrations of FC below 150 μg/g., Conclusions: We found histologic features of colon biopsies (Geboes score) to be an independent risk factor for progression of UC in the first 36 months after biopsy., (Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Infection due to severe acute respiratory syndrome coronavirus 2 is typically associated with a respiratory syndrome, but gastrointestinal symptoms have been described in early reports from China. However, data from European centres are scarce., Objectives: We aimed to characterise the gastrointestinal manifestations of patients with coronavirus disease 2019 (COVID-19) and their disease course., Methods: Patients admitted at our centre between March and April 2020 with diagnosis of COVID-19 were included. Asymptomatic patients or those without symptom information were excluded. Clinical features, laboratory data and disease severity (mechanical ventilation, intensive care admission or death) were analysed., Results: Two-hundred one patients were included (median age 71 years; 56.2% male). Digestive symptoms were reported by 60 (29.9%) patients during the disease course, being part of the disease presentation in 34 (16.9%). The most frequent were diarrhoea in 36 patients (17.9%). Patients with gastrointestinal symptoms were younger (P = 0.032), had higher haemoglobin levels (P = 0.002) and lower C-reactive protein (P = 0.045) and potassium levels (P = 0.004). Patients with digestive symptoms had less severe disease (28.3 vs. 44.0%; P = 0.038). Regarding liver damage, aspartate aminotransferase (AST) was elevated in 65.2% of patients and alanine aminotransferase (ALT) in 62.7%, but these patients did not present a more severe disease (elevated AST P = 0.062; elevated ALT P = 0.276)., Conclusion: A significant portion of COVID-19 patients have digestive symptoms, mostly at presentation. This should be taken into account in order to keep a high level of suspicion to reach an early diagnosis and setup infection control measures to control the transmission rate. This subgroup of patients appears to have a less severe disease course., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Video capsule endoscopy (VCE) revolutionized the diagnosis and management of obscure gastrointestinal bleeding, though the rate of detection of small bowel lesions by the physician is still disappointing. Our group developed a novel algorithm (CMEMS-Uminho) to automatically detect angioectasias which display greater accuracy in VCE static frames than other methods previously published. We aimed to evaluate the algorithm overall performance and assess its diagnostic yield and usability in clinical practice., Methods: Algorithm overall performance was determined using 54 full-length VCE recordings. To assess its diagnostic yield and usability in clinical practice, 38 VCE examinations with the clinical diagnosis of angioectasias consecutively performed (2017-2018) were evaluated by three physicians with different experiences. The CMEMS-Uminho algorithm was also applied. The performance of the CMEMS-Uminho algorithm was defined by a positive concordance between a frame automatically selected by the software and a study independent capsule endoscopist., Results: Overall performance in complete VCE recordings was 77.7%, and diagnostic yield was 94.7%. There were significant differences between physicians in regard to global detection rate ( p < 0.001), detection rate per capsule ( p < 0.001), diagnostic yield ( p = 0.007), true positive rate ( p < 0.001), time ( p < 0.001), and speed viewing ( p < 0.001). The application of CMEMS-Uminho algorithm significantly enhanced all readers' global detection rate ( p < 0.001) and the differences between them were no longer observed., Conclusion: The CMEMS-Uminho algorithm detained a good overall performance and was able to enhance physicians' performance, suggesting a potential usability of this tool in clinical practice., Competing Interests: The authors have no conflicts (financial, professional, or personal) to declare., (Copyright © 2020 by S. Karger AG, Basel.)

Background: There is growing evidence about the relationship between sleep quality (SQ) and disease activity in inflammatory bowel disease (IBD). This study aimed to identify the prevalence of sleep disturbance in IBD and its predictive factors and to assess its association with worse outcome., Methods: IBD patients were prospectively enrolled. Clinical activity, inflammatory activity (high C-reactive protein or fecal calprotectin), and SQ (assessed using the Pittsburgh Sleep Quality Index) were evaluated, and logistic regression was used to identify predictors of poor SQ at baseline. The development of disability or disease progression at 6 months (surgery, hospitalization, development of stenosis, penetrating or perianal disease, steroid dependency, or start/change immunosuppression) was compared between patients with and without poor SQ., Results: Two hundred and five patients were enrolled, with 44.9% (n = 92) reporting poor SQ. On multivariate analysis, current smoking (OR 2.80), extraintestinal manifestations (OR 2.68), clinical activity (OR 3.31), and inflammatory activity (OR 4.62) were predictive factors of poor SQ. Cox proportional hazards model showed that poor SQ was predictive of worse prognosis at 6 months (HR 2.470)., Conclusion: There is a high prevalence of poor SQ in IBD patients, highlighting the importance of its inclusion in patient-reported outcomes. Sleep disturbance seems to have prognostic value in IBD., (© 2021 S. Karger AG, Basel.)

Background and Aims: Therapeutic drug monitoring (TDM) of infliximab (IFX) and anti-infliximab antibodies (ATIs) is essential for treatment optimisation in inflammatory bowel disease (IBD) patients. The aim of this study was to estimate and compare the agreement and accuracy between a new rapid test and three established enzyme-linked immunosorbent assays (ELISAs) to quantify ATIs levels, and to evaluate the impact of exogenous IFX on the performance of these assays., Methods: We analysed 200 serum samples from 57 IBD outpatients in IFX induction or maintenance therapy at six IBD centres in Portugal. ATI levels were quantified using the rapid test Quantum Blue® (QB) Anti-Infliximab (Bühlmann) and three established ELISAs: In-House, Theradiag (Lisa Tracker Anti-Infliximab), and Immundiagnostik (IDKmonitor Infliximab). ATIs were quantified in patients' serum samples and spiked samples with exogenous IFX, based on analytical and clinical cutoffs. Qualitative agreement and accuracy were estimated by Cohen's kappa ( k ) with 95% confidence intervals., Results: ATIs quantification with clinical cutoffs showed a slight agreement between QB rapid test and In-House [ k  = 0.163 (0.051-0.276)] and Immundiagnostik [ k  = 0.085 (0.000-0.177)]. Regarding IFX/ATIs status, the QB rapid test showed a substantial agreement with Theradiag [ k  = 0.808 (0.729-0.888)] and a fair agreement with In-House [ k  = 0.343 (0.254-0.431)] and Immundiagnostik [ k  = 0.217 (0.138-0.297)]. The QB rapid test could not detect ATI-positive levels in samples with exogenous IFX at 5-300 µg/ml. Interference on ATIs detection was observed at exogenous IFX ⩾30 µg/ml for In-house and Immundiagnostik assays., Conclusion: QB rapid test is only suitable to detect ATI-positive levels in the absence of IFX., Competing Interests: Conflict of interest statement: Fernando Magro served as a speaker and received honoraria from Abbvie, Biogen, Falk, Ferring, Hospira, Laboratorios Vitoria, Merck Sharp & Dohme, and Vifor Pharma. All other authors declare no conflicts of interest., (© The Author(s), 2020.)

Purpose: Nonsurgical treatment of hemorrhoidal disease (HD) includes medical and instrumental techniques. We aimed to compare the efficacy of the most frequently used nonsurgical strategies, either alone or in combination, applied in an ambulatory setting., Methods: Patients who received nonsurgical treatment for HD by proctology appointment at the Gastroenterology Department of Braga Hospital were evaluated. Isolated rubber band ligation (RBL) and a combination of RBL with a micronized purified flavonoid fraction (MPFF) were the 2 most frequently used strategies. Symptoms of HD (bleeding, pruritus, pain at rest, pain at defecation and prolapse) were assessed at days 0, 7, and 28 by using a severity grading scale (0 to 4/5). A Global Symptom score was constructed to assess the overall severity and compare the overall improvements of the HD symptoms between the 2 most frequently used strategies., Results: Nineteen patients underwent the combined treatment (RBL + MPFF group) and 25 the RBL treatment (RBL group). A comparison of the 2 treatment groups showed significant improvements in the combined treatment group in terms of bleeding at days 7 (P = 0.001) and 28 (P = 0.002) and in the pruritus intensity during the first week (P < 0.001). A trend toward clinical benefit was also verified in the combined treatment group for all other HD symptoms (pain at rest, pain at defecation and prolapse)., Conclusion: A combined treatment approach with MPFF and RBL significantly reduced the intensity of bleeding during the first month and the pruritus during the first week.

Competing Interests: Conflict of Interest: None

Background and Aim: inflammatory bowel disease (IBD) is a potentially disabling chronic disease that negatively affects many aspects of the patients' life. This study aimed to assess the IBD-associated disability in the outpatient setting and analyze how optimism and disability are related., Methods: a cross-sectional study was performed via the application of the Portuguese version of the IBD-Disability Index (PT-IBD-DI) and the Revised Life Orientation Test (PT-LOT-R) for the assessment of disability and optimism, respectively., Results: a total of 143 patients were analyzed, the mean age was 38 ± 13 years, 50% were females and 51% had UC. The mean PT-IBD-DI score was 22 ± 17, which was classified as follows: 0-20: no disability; 20-35: mild disability; 35-50: moderate disability; and 50-100: severe disability. There were no significant differences between Crohn's disease (CD) and ulcerative colitis (UC) (p = 0.944). Female gender (p = 0.001), low level of education (p = 0.018), the number of days out of work (p = 0.020), rheumatologic manifestations (p = 0.005), the number of comorbidities (p = 0.002), the use psychotropic drugs (p = 0.043) and low PT-LOT-R scores (p < 0.001) were associated with higher IBD-DI scores according to the univariate analysis. According to the linear regression analysis, only female sex (p = 0.001), the number of comorbidities (p = 0.034) and low PT-LOT-R scores (p < 0.001) were associated with higher PT-IBD-DI scores. Optimism correlated inversely with PT-IBD-DI scores (ρ = -0.345, p < 0.001)., Conclusion: IBD outpatients reported low levels of IBD-disability (mild disability: PT-IBD-DI score 20-35). Comorbidities and psychological factors (optimism) emerged as the main predictive factors of increased disability, reinforcing the importance of a multidisciplinary approach for these patients.

Background: The loss of response to adalimumab (ADL) has been related to low serum concentrations at trough. Currently, most methods commercially available for the quantification of ADL are enzyme-linked immunosorbent assay (ELISA) based, with a turnaround time of approximately 8 h, delaying the target dosage adjustment to the subsequent infusion. In this study, we aimed to evaluate the performance of the newly available rapid-test ADL quantification assay by comparing it with three established ELISA methods, using spiked samples and a set of clinical samples., Methods: Spiked samples from control donors and 120 serum samples from inflammatory bowel disease (IBD) patients undergoing ADL therapy were quantified using lateral flow Quantum Blue ® Adalimumab and, the ELISA formats from Immundiagnostik, R-Biopharm and an in-house assay., Results: The rapid-test assay had intraclass correlation coefficients of 0.590, 0.864 and 0.761 when comparing with the Immundiagnostik, R-Biopharm and in-house assays, respectively. For the five therapeutic windows, the accuracy was high: ADL rapid test compared with the Immundiagnostik (58-88%); R-Biopharm, 68-89%; and in house, 60-88%; and kappa statistics revealed 0.492-0.602, 0.531-0.659 and 0.545-0.682, respectively., Conclusions: The Quantum Blue ® Adalimumab assay can replace the commonly used ELISA-based ADL quantification kits and it is a reliable alternative to these methods. This rapid-test assay enables the quantitative determination of ADL serum trough level in only 15 min. The developed assay allows measurement of ADL over a wide range. Hence, it represents a valuable tool for the clinician to assess the ADL trough level., Competing Interests: Conflict of interest statement: FM served as speaker and received honoraria from Merck Sharp & Dohme, Abbvie, Vifor, Falk, Laboratorios Vitoria, Ferring, Hospira and Biogen.

Background: Chronic anal fissure is a frequent and disabling disease, often affecting young adults. Botulinum toxin and lateral internal sphincterotomy are the main therapeutic options for refractory cases. Botulinum toxin is minimally invasive and safer compared with surgery, which carries a difficult post-operative recovery and fecal incontinence risk. The long-term efficacy of Botulinum toxin is not well known., Objective: The aim of this study was to evaluate the long-term efficacy and safety of Botulinum toxin in the treatment of chronic anal fissure., Methods: This was a retrospective study at a single center, including patients treated with Botulinum toxin from 2005 to 2010, followed over at least a period of 5 years. All patients were treated with injection of 25U of Botulinum toxin in the intersphincteric groove. The response was registered as complete, partial, refractory and relapse., Results: Botulinum toxin was administered to 126 patients, 69.8% ( n  = 88) were followed over a period of 5 years. After 3 months, 46.6% ( n  = 41) had complete response, 23.9% ( n  = 21) had partial response and 29.5% ( n  = 26) were refractory. Relapse was observed in 1.2% ( n  = 1) at 6 months, 11.4% ( n  = 10) at 1 year, 2.3% ( n  = 2) at 3 years; no relapse at 5 years. The overall success rate was 64.8% at 5 years of follow-up. Botulinum toxin was well tolerated by all patients and there were no complications., Conclusion: The use of Botulinum toxin to treat patients with chronic anal fissure was safe and effective in long-term follow-up.

Background and Aim: Recently, the Inflammatory Bowel Disease-Disability Index (IBD-DI) was developed to assess disability in inflammatory bowel disease (IBD). Our aim was to validate the Portuguese version of IBD-DI according to the COnsensus-based Standards for the selection of the health Measurement INstruments (COSMIN) recommendations., Materials and Methods: After translation into Portuguese, the IBD-DI was administered by two interviewers to IBD patients at baseline and after 4 weeks and 4 months. We evaluated reliability (internal consistency, test-retest, and inter-rater reliability and measurement error), construct validity, responsiveness, and interpretability., Results: At baseline, 129 patients (73=Crohn's disease; 56=ulcerative colitis) completed the IBD-DI. After 4 weeks and 4 months, 118 and 89 patients repeated the questionnaire, respectively. Factor analysis confirmed the unidimensionality of the scale and reduced the final version to 14 items. The Cronbach's α was 0.88. The intraclass correlation coefficients were 0.87 and 0.99 for test-retest (baseline and 4 weeks) and inter-rater reliability, respectively. The smallest detectable change was 18.64 at the individual level and 1.87 at the group level. IBD-DI scores correlated negatively with the total, physical, and mental scores of Short Form-36 items. The change score of IBD-DI between baseline and 4 months correlated negatively with the clinical evolution of patients. The minimal important change was 16.96. IBD-DI scores ranged from 0 to 78.6, with a mean of 21.8±18.1. Female sex, professional inactivity, and clinical disease activity were associated with higher IBD-DI scores., Conclusion: The Portuguese version of IBD-DI obtained is a reliable, valid, responsive, and interpretable (at the group level) tool to assess disability in Portuguese IBD patients.

Background: Nonvariceal upper gastrointestinal bleeding (NVUGIB) is associated with important mortality. More information is needed in order to improve NVUGIB management. The aims of this study were: (a) characterizing Portuguese patients and clinical approaches used in NVUGIB, (b) comparing management used in Portugal with management globally used in European countries, (c) identify factors associated with management options, and (d) identify factors associated with adverse outcome., Methods: ENERGiB was an observational, retrospective cohort study, on NVUGIB with endoscopic evaluation, carried across Europe. This study focuses on Portuguese patients of the ENERGiB study. Patients were managed according to routine care. Later, data were collected from files. Multivariate/univariate analyses were conducted on predictive factors of poor outcome and clinical decisions., Results: Patients (n=404) were mostly men (66.8%), mean age 68, with co-morbidities (72%), frequently on NSAIDs/aspirin. Most were assisted by general medical (57.8%) or surgical team (20.6%), only 19.4% by gastroenterology/GI-bleeding team. PPI was largely used. Gastric/duodenal ulcers, erosive gastritis and esophagitis were the main bleeding causes. 10% had bleeding persistence/recurrence. Death occurred in 24 patients, 20 from a non-bleeding related cause. Poor outcomes were related with age >65, co-morbidities, fresh blood haematemesis, shock/syncope, bleeding through previous nasogastric tube, massive fluid replacement or transfusions besides erythrocytes., Conclusions: This study contributed to characterization of Portuguese patients and NVUGIB episodes in real clinical setting and identified factors associated with a poor outcome. It also identified differences, especially in the organization of GI bleeding teams, which might help us to improve the management of these patients., (Copyright © 2011 Elsevier España, S.L. and AEEH y AEG. All rights reserved.)

Introduction: Acute lower gastrointestinal bleeding (ALGIB) is a common event, which consumes considerable human and economic resources. Its incidence is expected to rise in the coming years due to an increasing aging population., Patients and Methods: Multicentric prospective analysis of patients was carried out with ALGIB in 13 Portuguese hospitals from April 2008 to May 2009, using a protocol designed by the French Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux. Statistical analysis was carried out with SPSS 16.0., Results: In a total of 371 hemorrhagic events in 364 patients (51.4% men, mean age: 72 years), 28.4% patients showed hemodynamic instability and 54.2% were under single/combined medication with antiaggregants/NSAIDs/heparin/anticoagulants; blood transfusion was administered in 34.8% of patients. Sigmoidoscopy was the first endoscopic procedure performed in 61.3% of patients and rectal enema was the first method of bowel preparation in 67.3% of them. Endoscopic hemostasis was performed in 22.2% of all cases with efficacy ranging from 84.6 to 96.2%. Most frequent diagnoses were ischemic colitis (23.7%), diverticulosis (20.8%), and colorectal malignancies (12.4%). Surgery was needed in 8% of patients, and global mortality rate was 2.2%. Risk factors for poor outcome on multivariate analysis were heparin use before bleeding (hazards ratio: 10.6; 95% confidence interval: 0.94-119.48) and in-hospital bleeding (hazards ratio: 5.6; 95% confidence interval: 1.01-19.70)., Conclusion: ALGIB seems to occur frequently in Portugal with a low mortality rate. Previous heparin use and in-hospital bleeding are associated with worse prognosis. Our management relies on early endoscopic examinations, which are highly available, safe, and accurate. A successful endoscopic therapeutic approach was possible in one fifth of the patients.