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- Development and validation of risk matrices for Crohn's Disease outcomes in patients who underwent early therapeutic interventionsPublication . Dias, Cláudia Camila; Rodrigues, Pedro Pereira; Coelho, Rosa; Santos, Paula Moura; Fernandes, Samuel; Lago, Paula; Caetano, Cidalina; Rodrigues, Angela; Portela, Francisco; Oliveira, Ana; Ministro, Paula; Cancela, Eugenia; Vieira, Ana Isabel; Barosa, Rita; Cotter, Jose; Carvalho, Pedro; Cremers, Isabelle; Trabulo, Daniel; Caldeira, Paulo; Antunes, Artur; Rosa, Isadora; Moleiro, Joana; Peixe, Paula; Herculano, Rita; Gonçalves, Raquel; Gonçalves, Bruno; Sousa, Helena Tavares; Contente, Luis; Morna, Henrique; Lopes, Susana; Magro, FernandoIntroduction: The establishment of prognostic models for Crohn's disease [CD] is highly desirable, as they have the potential to guide physicians in the decision-making process concerning therapeutic choices, thus improving patients' health and quality of life. Our aim was to derive models for disabling CD and reoperation based solely on clinical/demographic data. Methods: A multicentric and retrospectively enrolled cohort of CD patients, subject to early surgery or immunosuppression, was analysed in order to build Bayesian network models and risk matrices. The final results were validated internally and with a multicentric and prospectively enrolled cohort. Results: The derivation cohort included a total of 489 CD patients [64% with disabling disease and 18% who needed reoperation], while the validation cohort included 129 CD patients with similar outcome proportions. The Bayesian models achieved an area under the curve of 78% for disabling disease and 86% for reoperation. Age at diagnosis, perianal disease, disease aggressiveness and early therapeutic decisions were found to be significant factors, and were used to construct user-friendly matrices depicting the probability of each outcome in patients with various combinations of these factors. The matrices exhibit good performance for the most important criteria: disabling disease positive post-test odds = 8.00 [2.72-23.44] and reoperation negative post-test odds = 0.02 [0.00-0.11]. Conclusions: Clinical and demographical risk factors for disabling CD and reoperation were determined and their impact was quantified by means of risk matrices, which are applicable as bedside clinical tools that can help physicians during therapeutic decisions in early disease management.
- Sexual quality of life in inflammatory bowel disease: A multicenter, national-level studyPublication . Roseira, Joana; Magro, Fernando; Fernandes, Samuel; Simoes, Carolina; Portela, Francisco; Vieira, Ana Isabel; Patita, Marta; Leal, Carina; Lago, Paula; Caldeira, Paulo; Gago, Tania; Currais, Pedro; Dias, Claudia Camila; Santiago, Mafalda; Dias, Sandra; Sousa, Helena TavaresBackground: The impact of inflammatory bowel disease (IBD) on sexual health is a leading concern among patients. Most studies focus on sexual dysfunction rather than patient-perceived sexual quality of life (SQoL). We aimed to assess SQoL in IBD patients compared with healthy controls. Methods: This is a multicenter, cross-sectional study of IBD patients (n = 575 with Crohn's disease and n = 294 with ulcerative colitis), compared with healthy controls (n = 398), that used an anonymous self-administered questionnaire. This multimodal questionnaire included sociodemographic data and 4 validated instruments: Short IBD Questionnaire, Social Desirability Scale, Sexual QoL Questionnaire-Male/Female, Nine-item Patient Health Questionnaire. Results: Inflammatory bowel disease patients reported lower SQoL (men: 77.29 vs 83.83; P < 0.001; women: 70.40 vs 81.63; P < 0.001) compared with controls. Among IBD patients, SQoL was positively correlated with health-related quality of life (HRQoL) and negatively correlated with depression symptoms. Perianal disease was associated with lower HRQoL and higher incidence of depression, but only impacted SQoL in men. In linear regression analysis for men, SQoL was associated with age, marital status, and depression (beta, -2.101; 95% confidence interval [CI], -2.505 to -1.696; P < 0.001). In women, SQoL was associated with depression (beta, -1.973; 95% CI, -2.313 to -1.632; P < 0.001) only. Conclusions: Patients with IBD had impaired SQoL compared with healthy controls. Age, widow status, and depression were independent predictors of SQoL in men with IBD, whereas in women depression was the only independent predictor. Emotional and self-esteem issues were the main concerns reported by IBD patients regarding sexual health.
- How many biomarker measurements are needed to predict prognosis in Crohn's disease patients under infliximab?—A prospective studyPublication . Magro, Fernando; Estevinho, Maria Manuela; Catalano, Gaia; Patita, Marta; Arroja, Bruno; Lago, Paula; Rosa, Isadora; Sousa, Helena Tavares; Ministro, Paula; Mocanu, Irina; Vieira, Ana; Castela, Joana; Moleiro, Joana; Roseira, Joana; Cancela, Eugénia; Sousa, Paula; Portela, Francisco; Correia, Luís; Moreira, Paula; Santiago, Mafalda; Dias, Sandra; Afonso, Joana; Danese, Silvio; Peyrin‐Biroulet, Laurent; Dias, Cláudia CamilaBackgroundTimely 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. ObjectiveWe aimed to evaluate the performance of readily available biomarkers and develop risk matrices to predict CD progression. MethodsData 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. ResultsThe 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 mu g/g) in at least one visit were also significant predictors, while milder elevations (3.1-10.0 mg/L and 250.1-500.0 mu g/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. ConclusionThe 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.
- Today, in the endoscopist handsPublication . Roseira, Joana; Sousa, Helena Tavares; Queirós, P.; Antunes, A. G.; Vaz, A. M.; Gago, T.; Contente, L.; Guerreiro, H.Endoscopic submucosal dissection (ESD) was first described as a non-surgical promise for early gastric epithelial lesions.
- Delayed intramural duodenal hematoma after a simple diagnostic endoscopic ultrasonography fine-needle aspiration procedurePublication . Roseira, Joana; Cunha, Miguel; Sousa, Helena Tavares; Rachadell, J.; Brito, JorgeA 65-year-old man was evaluated for a difficult-to-characterize pancreatic head mass in the setting of idiopathic chronic pancreatitis. He had no other relevant medical history and was not taking any anticoagulant or antiplatelet treatment. Endoscopic ultrasonography fine-needle aspiration (EUS-FNA) failed to reveal neoplasm cells. A linear array echoendoscope (Olympus GF-UCT140, Center Valley, PA) was advanced up to the duodenal bulb, from which the head of the pancreas was visualized. After ensuring a vessel-free access to the pancreatic parenchyma, the FNA was performed using a 22G needle (Slimline 22G Handle Needle; Boston Scientific, Marlborough, MA) with a total of 3 passes (Figure 1). Three weeks after this procedure, the patient was admitted for hematemesis preceded by vomiting. On admission, his general physical examination was unremarkable except for jaundice. His blood tests showed no anemia; his platelet count, prothrombin time, amylase, and liver enzymes were within normal range, but his total bilirubin level was elevated (7.4 mg/dL). Upper gastrointestinal endoscopy showed Mallory-Weiss tears, an evident extrinsic compression of the knee, and the second portion of the duodenum, which could not be passed by the endoscope. The investigation by computed tomography and magnetic resonance cholangiopancreatography led to the diagnosis of an 11-cm intramural duodenal hematoma (IDH), leading to both gastric outlet and main biliary duct obstruction (Figure 2). The case was successfully managed with nasogastric decompression and exclusive parenteral feeding. Symptoms improved within 15 days, and cholestasis progressively disappeared.
- Proactive therapeutic drug monitoring of infliximab: a comparative study of a new point-of-care quantitative test with two established ELISA assaysPublication . Afonso, J.; Lopes, S.; Gonçalves, R.; Caldeira, Paulo; Lago, P.; Sousa, Helena Tavares; Ramos, J.; Gonçalves, A. R.; Ministro, P.; Rosa, I.; Vieira, A. I.; Dias, C. C.; Magro, F.BackgroundTherapeutic drug monitoring is a powerful strategy known to improve the clinical outcomes and to optimise the healthcare resources in the treatment of autoimmune diseases. Currently, most of the methods commercially available for the quantification of infliximab (IFX) are ELISA-based, with a turnaround time of approximately 8h, and delaying the target dosage adjustment to the following infusion.AimTo validate the first point-of-care IFX quantification device available in the market - the Quantum Blue Infliximab assay (Buhlmann, Schonenbuch, Switzerland) - by comparing it with two well-established methods.MethodsThe three methods were used to assay the IFX concentration of spiked samples and of the serum of 299 inflammatory bowel diseases (IBD) patients undergoing IFX therapy.ResultsThe point-of-care assay had an average IFX recovery of 92%, being the most precise among the tested methods. The Intraclass Correlation Coefficients of the point-of-care IFX assay vs. the two ELISA-based established methods were 0.889 and 0.939. Moreover, the accuracy of the point-of-care IFX compared with each of the two reference methods was 77% and 83%, and the kappa statistics revealed a substantial agreement (0.648 and 0.738).ConclusionsThe Quantum Blue IFX assay can successfully replace the commonly used ELISA-based IFX quantification kits. This point-of-care IFX assay is able to deliver the results within 15min makes it ideal for an immediate target concentration adjusted dosing. Moreover, it is a user-friendly desktop device that does not require specific laboratory facilities or highly specialised personnel.
- Methylation patterns in dysplasia in inflammatory bowel disease patientsPublication . Rosa, Isadora; Silva, Patricia; da Mata, Sara; Magro, Fernando; Carneiro, Fatima; Peixoto, Armando; Silva, Marco; Sousa, Helena Tavares; Roseira, Joana; Parra, Jose; Barosa, Rita; Vieira, Ana; Brito, Maria Jos; Lago, Paula; Coelho, Andre; Moleiro, Joana; da Silva, Joao Pereira; Fonseca, Ricardo; Albuquerque, Cristina; Dias Pereira, A.Background and aims:Inflammatory Bowel Disease (IBD) with colonic involvement increases colorectal cancer risk. However, the distinction between IBD related and sporadic dysplasia in IBD patients is difficult. Some data favors the importance of abnormal DNA methylation in IBD-related carcinogenesis. We aimed to define methylation patterns in patients with colonic cancer or dysplasia diagnosis following an IBD diagnosis. Methods:Multicentric cross-sectional study-91 samples from colonic mucosa with/without dysplasia from 9 patients with IBD-related dysplasia/cancer and 26 patients with IBD and sporadic dysplasia/cancer were included. Methylation patterns of CpG islands in the promoter regions of 67 genes were studied by Methylation-specific Multiplex Ligation-dependent Probe Amplification. Results:Mean age at IBD diagnosis: 42 +/- 16 years;at dysplasia diagnosis: 56 +/- 14 years. Twenty-ninepatients had ulcerative colitis. Twenty-five patients had at least 1 lesion endoscopically described as adenoma-like, 4 at least 1 non-adenoma like, 3 had cancer and 3 had dysplasia in flat mucosa. No patient had both adenoma-like and non-adenoma-like lesions. Patients with an IBD-related lesion were significantly younger at IBD diagnosis (p = .003) and at dysplasia/cancer diagnosis (p = .039). Promoter methylation ofIGF2, RARB, ESR1, CHFR, CDH13, WT1, GATA5, WIF1genes was significantly associated to dysplasia/cancer; methylation ofMSH6, TIMP3was significantly associated to IBD-related dysplasia/cancer. Promoter methylation ofMSH6, MSH3, RUNX3, CRABP1, TP73, RARB, CDH13, PAX5, WT1, THBS1, TP53, SFRP1, WIF1, APAF1,BCL2genes was significantly associated to active IBD. Conclusions:Methylation analysis, namely ofMSH6, may contribute to the classification of dysplastic lesions in IBD- to be further tested in prospective studies.
- Short Inflammatory Bowel Disease Questionnaire: translation and validation to the Portuguese languagePublication . Roseira, Joana; Sousa, Helena Tavares; Marreiros, Ana; Contente, Luís F.; Magro, FernandoBackground The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a widely used instrument to assess Health-related Quality of Life (HRQoL) among inflammatory bowel disease (IBD) patients. Our aim was to translate and adapt the SIBDQ so that it could be adequately used in Portugal. Methods This is a prospective design cohort study undertaken at a tertiary hospital. This study took place simultaneously with the first part of the SexIDI study, a study aiming to assess the impact of IBD on patients’ sexual QoL. The original SIBDQ was translated by two independent translators and adapted by an IBD expert panel following the opinions of a convenient sample of 5 IBD patients. Afterwards, IBD patients from the outpatient clinic were consecutively invited to fill the Portuguese version of the questionnaire (SIBDQ-PT) at three different timepoints (0, 2, 4 weeks). Ninety-two patients completed the SIBDQ-PT at baseline, whereas 33 did so after 2 and 4 weeks (approximately). Statistical analysis was performed using SPSS version 25, and the following aspects were analysed: reliability (through internal consistency, test–retest and intraclass correlation), validity (through exploratory factor analysis [EFA], and Pearson correlation coefficient for linear correlations), score distribution, and responsiveness analysis (through t-student tests). Results Overall, SIBDQ-PT was shown to have a high internal consistency (Cronbach's α = 0.80) and a high test–retest reliability (0.80 [CI 0.74–0.86] and 0.69 [CI 0.50–0.82]). EFA detected four dimensions—bowel, social, emotional and systemic. As expected, an overall SIBDQ-PT score was positively correlated with sexual satisfaction (r = 0.27; p < 0.05) and negatively correlated with depression (r = − 0.63; p < 0.01). Moreover, SIBDQ-PT was found to have an adequate score distribution, and to be responsive, as there was a significant subscore change for patients who reported an “overall worsening in general well-being” (0.93 ± 0.13 decrease; p < 0.01). Conclusions The Portuguese version of the SIBDQ hereby presented is a reliable, valid and responsive instrument that can be used to measure HRQoL among Portuguese IBD patients.
- Clinical performance of an infliximab rapid quantification assayPublication . Magro, Fernando; Afonso, Joana; Lopes, Susana; Coelho, Rosa; Gonçalves, Raquel; Caldeira, Paulo; Lago, Paula; Sousa, Helena Tavares; Ramos, Jaime; Gonçalves, Ana Rita; Ministro, Paula; Rosa, Isadora; Meira, Tania; Andrade, Patrícia; Soares, João-Bruno; Carvalho, Diana; Sousa, Paula; Vieira, Ana Isabel; Lopes, Joanne; Dias, Cláudia Camila; Geboes, Karel; Carneiro, FátimaBackground: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. Methods: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit. Results: Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman's rank correlation coefficient = 0.843, p < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791-0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 mu g/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 mu g/ml was 88% both for a Mayo endoscopic score <= 1 and for an FC concentration <250 mu g/g. Conclusions: Based on this study, we concluded that using the rapid IFX assessment system with a 3 mu g/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.
- Transmural histological scoring systems in Crohn's Disease: A systematic review With assessment of methodological quality and operating propertiesPublication . Sousa, Helena Tavares; Estevinho, Maria Manuela; Peyrin-Biroulet, Laurent; Danese, Silvio; Dias, Claudia Camila; Carneiro, Fatima; Magro, FernandoBackground: The relative proportion of inflammation and fibrosis in a stricture is highly relevant in defining the clinical approach for Crohn's disease [CD] patients. Whereas transmural inflammation in CD can be accurately estimated by cross-sectional imaging, evaluating the extent and severity of fibrosis still requires surgical pathology of intestinal resection specimens.This study systematically reviewed all existing transmural histopathological scoring systems developed for the assessment of inflammation and/or fibrosis in CD. Methods: A systematic review of histopathological scoring systems for the assessment of transmural inflammation and/or fibrosis in CD, focusing on originally developed scoring systems. Risk of bias, methodological quality, and operating or psychometric properties [validity, reliability, responsiveness, and feasibility] of each histological scoring system were analysed. Results: A total of 29 original scoring systems were included in this review. Three scoring systems were highlighted as the most widely reproduced, one aimed at assessing inflammation only and two aimed at assessing inflammation and fibrosis. These scores were more widely reproduced probably due to their ease of application in clinical studies. Two highly comprehensive scores were identified, showing good operating properties and high methodological quality, as well as the lowest risk of bias; these should, therefore, be further validated in clinical research studies. Conclusions: This study reviewed all existing transmural histopathological scoring systems for the assessment of inflammation and/or fibrosis in CD and identified the most reliable and accurate scores for clinical research and clinical practice settings.