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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.)

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.)

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.