Publications by authors named "Vicent Hernandez"

41 Publications

Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry.

J Crohns Colitis 2021 Apr 16. Epub 2021 Apr 16.

Hospital General San Jorge, Huesca, Spain.

Background: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice.

Aims: To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life.

Methods: Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS. Short-term response was assessed at week 16.

Results: A total of 95 patients were included. At week 16, 53% of patients had response (including 35% of patients in remission). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at weeks 24 and 52, respectively. Thirty-six percent of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72; primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection.

Conclusions: Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.
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http://dx.doi.org/10.1093/ecco-jcc/jjab070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8083263PMC
April 2021

The use of 5-aminosalicylate for patients with Crohn's disease in a prospective European inception cohort with 5 years follow-up - an Epi-IBD study.

United European Gastroenterol J 2020 10 26;8(8):949-960. Epub 2020 Jul 26.

Hull University Teaching Hospitals NHS Trust, Hull, UK.

Background: The lack of scientific evidence regarding the effectiveness of 5-aminosalicylate in patients with Crohn's disease is in sharp contrast to its widespread use in clinical practice.

Aims: The aim of the study was to investigate the use of 5-aminosalicylate in patients with Crohn's disease as well as the disease course of a subgroup of patients who were treated with 5-aminosalicylate as maintenance monotherapy during the first year of disease.

Methods: In a European community-based inception cohort, 488 patients with Crohn's disease were followed from the time of their diagnosis. Information on clinical data, demographics, disease activity, medical therapy and rates of surgery, cancers and deaths was collected prospectively. Patient management was left to the discretion of the treating gastroenterologists.

Results: Overall, 292 (60%) patients with Crohn's disease received 5-aminosalicylate period during follow-up for a median duration of 28 months (interquartile range 6-60). Of these, 78 (16%) patients received 5-aminosalicylate monotherapy during the first year following diagnosis. Patients who received monotherapy with 5-aminosalicylate experienced a mild disease course with only nine (12%) who required hospitalization, surgery, or developed stricturing or penetrating disease, and most never needed more intensive therapy. The remaining 214 patients were treated with 5-aminosalicylate as the first maintenance drug although most eventually needed to step up to other treatments including immunomodulators (75 (35%)), biological therapy (49 (23%)) or surgery (38 (18%)).

Conclusion: In this European community-based inception cohort of unselected Crohn's disease patients, 5-aminosalicylate was commonly used. A substantial group of these patients experienced a quiescent disease course without need of additional treatment during follow-up. Therefore, despite the controversy regarding the efficacy of 5-aminosalicylate in Crohn's disease, its use seems to result in a satisfying disease course for both patients and physicians.
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http://dx.doi.org/10.1177/2050640620945949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707880PMC
October 2020

Switching to a Second Thiopurine in Adult and Elderly Patients With Inflammatory Bowel Disease: A Nationwide Study From the ENEIDA Registry.

J Crohns Colitis 2020 Sep;14(9):1290-1298

Hospital Universitari Germans Trias i Pujol, Badalona, Spain.

Background And Aims: Although commonly used in inflammatory bowel disease [IBD], thiopurines frequently cause intolerance, and switching to a second thiopurine has only been reported in some small series. Ours aims in this study were to evaluate the safety of switching to a second thiopurine in a large cohort, and to assess the impact of age on tolerance.

Methods: Adult IBD patients from the ENEIDA registry, who were switched to a second thiopurine due to adverse events [excluding malignancies and infections], were identified. At the beginning of thiopurine treatment, patients were divided by age into two groups: 18-50 and over 60 years of age. The rate and concordance of adverse events between the first and second thiopurines, treatment intolerance, and persistence with the second thiopurine were evaluated.

Results: A total of 1278 patients [13% over 60 years of age] were switched to a second thiopurine. At 12 months, the cumulative probability of switch intolerance was 43%, and persistence with treatment was 49%. Independent risk factors of switch intolerance were age over 60 years (odds ratio [OR] 1.49; 95% confidence interval [CI] 1.07-2.07; p = 0.017) , previous gastrointestinal toxicity [OR 1.4; 95% CI 1.11-1.78; p = 0.005], previous acute pancreatitis [OR 6.78; 95% CI 2.55-18.05; p <0.001], and exposure to the first thiopurine <6 months [OR 1.59; 95% CI 1.14-2.23; p = 0.007].

Conclusions: In a large series in clinical practice, switching to a second thiopurine proved to be a valid strategy. Tight monitoring of elderly IBD patients switching to a second thiopurine because of adverse events is recommended.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa055DOI Listing
September 2020

Health-care costs of inflammatory bowel disease in a pan-European, community-based, inception cohort during 5 years of follow-up: a population-based study.

Lancet Gastroenterol Hepatol 2020 05 13;5(5):454-464. Epub 2020 Feb 13.

Hull University Teaching Hospitals NHS Trust, Hull, UK; Hull York Medical School, Hull, UK.

Background: Inflammatory bowel disease (IBD) places a significant burden on health-care systems because of its chronicity and need for expensive therapies and surgery. With increasing use of biological therapies, contemporary data on IBD health-care costs are important for those responsible for allocating resources in Europe. To our knowledge, no prospective long-term analysis of the health-care costs of patients with IBD in the era of biologicals has been done in Europe. We aimed to investigate cost profiles of a pan-European, community-based inception cohort during 5 years of follow-up.

Methods: The Epi-IBD cohort is a community-based, prospective inception cohort of unselected patients with IBD diagnosed in 2010 at centres in 20 European countries plus Israel. Incident patients who were diagnosed with IBD according to the Copenhagen Diagnostic Criteria between Jan 1, and Dec 31, 2010, and were aged 15 years or older the time of diagnosis were prospectively included. Data on clinical characteristics and direct costs (investigations and outpatient visits, blood tests, treatments, hospitalisations, and surgeries) were collected prospectively using electronic case-report forms. Patient-level costs incorporated procedures leading to the initial diagnosis of IBD and costs of IBD management during the 5-year follow-up period. Costs incurred by comorbidities and unrelated to IBD were excluded. We grouped direct costs into the following five categories: investigations (including outpatient visits and blood tests), conventional medical treatment, biological therapy, hospitalisation, and surgery.

Findings: The study population consisted of 1289 patients with IBD, with 1073 (83%) patients from western Europe and 216 (17%) from eastern Europe. 488 (38%) patients had Crohn's disease, 717 (56%) had ulcerative colitis, and 84 (6%) had IBD unclassified. The mean cost per patient-year during follow-up for patients with IBD was €2609 (SD 7389; median €446 [IQR 164-1849]). The mean cost per patient-year during follow-up was €3542 (8058; median €717 [214-3512]) for patients with Crohn's disease, €2088 (7058; median €408 [133-1161]) for patients with ulcerative colitis, and €1609 (5010; median €415 [92-1228]) for patients with IBD unclassified (p<0·0001). Costs were highest in the first year and then decreased significantly during follow-up. Hospitalisations and diagnostic procedures accounted for more than 50% of costs during the first year. However, in subsequent years there was a steady increase in expenditure on biologicals, which accounted for 73% of costs in Crohn's disease and 48% in ulcerative colitis, in year 5. The mean annual cost per patient-year for biologicals was €866 (SD 3056). The mean yearly costs of biological therapy were higher in patients with Crohn's disease (€1782 [SD 4370]) than in patients with ulcerative colitis (€286 [1427]) or IBD unclassified (€521 [2807]; p<0·0001).

Interpretation: Overall direct expenditure on health care decreased over a 5-year follow-up period. This period was characterised by increasing expenditure on biologicals and decreasing expenditure on conventional medical treatments, hospitalisations, and surgeries. In light of the expenditures associated with biological therapy, cost-effective treatment strategies are needed to reduce the economic burden of inflammatory bowel disease.

Funding: Kirsten og Freddy Johansens Fond and Nordsjællands Hospital Forskningsråd.
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http://dx.doi.org/10.1016/S2468-1253(20)30012-1DOI Listing
May 2020

Validation of miR-1228-3p as Housekeeping for MicroRNA Analysis in Liquid Biopsies from Colorectal Cancer Patients.

Biomolecules 2019 12 20;10(1). Epub 2019 Dec 20.

Gastrointestinal & Pancreatic Oncology Group, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD) /Hospital Clínic of Barcelona/Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, 08036 Barcelona, Catalonia, Spain.

Background: Circulating microRNA (miRNA) analysis is a growing research field. However, it usually requires an endogenous control or housekeeping (HK) in order to normalize expression of specific miRNAs throughout different samples. Unfortunately, no adequate HK for circulating miRNA analysis is still known in the colorectal cancer (CRC) context whereas several have been suggested. Hence, our aims were to validate the previously suggested miR-1228-3p as HK for CRC studies, to compare its suitability with the widely used miR-16-5p, and to evaluate the influence of hemolysis on both miRNAs.

Methods: We analyzed by quantitative reverse-transcription polymerase chain reaction (qRT-PCR) the expression of miR-1228-3p, miR-16-5p and the spike-in cel-miR-39 in a set of 297 plasmas (92 CRC, 101 advanced adenomas -AA-, and 100 controls) and 213 serum samples (59 CRC, 74 AA and 80 controls). We also analyzed both miRNAs depending on the hemolysis degree in 7 plasmas and 31 serums.

Results: Levels of miR-1228-3p and miR-16-5p did not show significant differences between groups although miR-16-5p exhibited more variability in plasma and serum samples. Importantly, the combination of cel-miR-39 and miR-1228-3p was the most stable one. Moreover, we observed that miR-16-5p was significantly influenced by hemolysis in contrast with miR-1228-3p that exhibited no correlation with this confounding factor in both biofluids.

Conclusion: MiR-1228-3p has been validated as an adequate endogenous control for circulating miRNA analysis in CRC and AA liquid biopsies.
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http://dx.doi.org/10.3390/biom10010016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7022916PMC
December 2019

Clinical Characteristics, Associated Malignancies and Management of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients: A Multicentre Retrospective Cohort Study.

J Crohns Colitis 2019 Dec;13(12):1492-1500

Consorci Sanitari Terrassa, Terrassa, Spain.

Background And Aims: Primary sclerosing cholangitis [PSC] is usually associated with inflammatory bowel disease [IBD]. An increased risk of malignancies, mainly colorectal cancer [CRC] and cholangiocarcinoma [CCA], has been reported in PSC-IBD patients. Our aim was to determine the clinical characteristics and management of PSC in IBD patients, and the factors associated with malignancies.

Methods: PSC-IBD patients were identified from the Spanish ENEIDA registry of GETECCU. Additional data were collected using the AEG-REDCap electronic data capture tool.

Results: In total, 277 PSC-IBD patients were included, with an incidence rate of 61 PSC cases per 100 000 IBD patient-years, 69.7% men, 67.5% ulcerative colitis and mean age at PSC diagnosis of 40 ± 16 years. Most patients [85.2%] were treated with ursodeoxycholic acid. Liver transplantation was required in 35 patients [12.6%] after 79 months (interquartile range [IQR] 50-139). It was more common in intra- and extrahepatic PSC compared with small-duct PSC (16.3% vs 3.3%; odds ratio [OR] 5.7: 95% confidence interval [CI] = 1.7-19.3). The incidence rate of CRC since PSC diagnosis was 3.3 cases per 1000 patient-years [95% CI = 1.9-5.6]. Having symptoms of PSC at PSC diagnosis was the only factor related to an increased risk of CRC after IBD diagnosis [hazard ratio= 3.3: 95% CI = 1.1-9.9]. CCA was detected in seven patients [2.5%] with intra- and extrahepatic PSC, with median age of 42 years [IQR 39-53], and presented a lower life expectancy compared with patients without CCA and patients with or without CRC.

Conclusions: PSC-IBD patients with symptoms of PSC at PSC diagnosis have an increased risk of CRC. CCA was only diagnosed in patients with intra- and extrahepatic PSC and was associated with poor survival.
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http://dx.doi.org/10.1093/ecco-jcc/jjz094DOI Listing
December 2019

Plasma MicroRNA Signature Validation for Early Detection of Colorectal Cancer.

Clin Transl Gastroenterol 2019 01;10(1):e00003

Advanced Marker Discovery (Amadix), Valladolid, Spain.

Objectives: Specific microRNA (miRNA) signatures in biological fluids can facilitate earlier detection of the tumors being then minimally invasive diagnostic biomarkers. Circulating miRNAs have also emerged as promising diagnostic biomarkers for colorectal cancer (CRC) screening. In this study, we investigated the performance of a specific signature of miRNA in plasma samples to design a robust predictive model that can distinguish healthy individuals from those with CRC or advanced adenomas (AA) diseases.

Methods: Case control study of 297 patients from 8 Spanish centers including 100 healthy individuals, 101 diagnosed with AA, and 96 CRC cases. Quantitative real-time reverse transcription was used to quantify a signature of miRNA (miRNA19a, miRNA19b, miRNA15b, miRNA29a, miRNA335, and miRNA18a) in plasma samples. Binary classifiers (Support Vector Machine [SVM] linear, SVM radial, and SVM polynomial) were built for the best predictive model.

Results: Area under receiving operating characteristic curve of 0.92 (95% confidence interval 0.871-0.962) was obtained retrieving a model with a sensitivity of 0.85 and specificity of 0.90, positive predictive value of 0.94, and negative predictive value of 0.76 when advanced neoplasms (CRC and AA) were compared with healthy individuals.

Conclusions: We identified and validated a signature of 6 miRNAs (miRNA19a, miRNA19b, miRNA15b, miRNA29a, miRNA335, and miRNA18a) as predictors that can differentiate significantly patients with CRC and AA from those who are healthy. However, large-scale validation studies in asymptomatic screening participants should be conducted.
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http://dx.doi.org/10.14309/ctg.0000000000000003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6369870PMC
January 2019

Detection of serrated lesions in proximal colon by simulated sigmoidoscopy vs faecal immunochemical testing in a multicentre, pragmatic, randomised controlled trial.

United European Gastroenterol J 2018 Dec 26;6(10):1527-1537. Epub 2018 Sep 26.

Gastroenterology Department, Hospital del Mar, Barcelona, Spain.

Background: The diagnostic yield of the faecal immunochemical test and sigmoidoscopy in detecting proximal serrated polyps in a colorectal cancer screening programme has not been fully assessed.

Aim: We determined the detection rate of proximal serrated polyps by simulated sigmoidoscopy and faecal immunochemical test compared with total colonoscopy in a population-based, multicentre, nationwide, randomised controlled trial (ColonPrev study).

Methods: Sigmoidoscopy yield was simulated based on the UK-Flexible Sigmoidoscopy Trial for total colonoscopy referral. Definitions were: proximal serrated polyp (proximal serrated polyp): sessile serrated polyp or hyperplastic polyp of any size and proximal at-risk serrated polyp (at-risk proximal serrated polyp): sessile serrated polyp of any size or hyperplastic polyp ≥ 10 mm, both located proximally to the splenic flexure.

Results: A total of 10,611 individuals underwent faecal immunochemical test and 5059 underwent total colonoscopy and were evaluated by simulated sigmoidoscopy. Sigmoidoscopy and faecal immunochemical test were less accurate in detecting proximal serrated polyps (odds ratio: 0.13; 95% confidence interval: 0.10-0.18 and 0.13; 0.09-0.18,  < 0.0001, respectively). Both tests were inferior to colonoscopy in detecting at-risk proximal serrated polyps, and sigmoidoscopy was inferior to faecal immunochemical test in detecting these lesions (odds ratio: 0.17; 95% confidence interval: 0.10-0.30 and 0.25; 0.17-0.37,  < 0.0001, respectively).

Conclusion: Sigmoidoscopy and faecal immunochemical test are less accurate in detecting proximal serrated polyps than colonoscopy, particularly in women.
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http://dx.doi.org/10.1177/2050640618804722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6297927PMC
December 2018

Natural Disease Course of Ulcerative Colitis During the First Five Years of Follow-up in a European Population-based Inception Cohort-An Epi-IBD Study.

J Crohns Colitis 2019 Feb;13(2):198-208

IBD Clinical and Research Centre, ISCARE, Prague, Czech Republic.

Background And Aims: Few population-based cohort studies have assessed the disease course of ulcerative colitis [UC] in the era of biological therapy and widespread use of immunomodulators. The aim of this study was to assess the 5-year outcome and disease course of patients with UC in the Epi-IBD cohort.

Methods: In a prospective, population-based inception cohort of unselected patients with UC, patients were followed up from the time of their diagnosis, which included the collection of their clinical data, demographics, disease activity, medical therapy, and rates of surgery, cancers, and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis.

Results: A total of 717 patients were included in the study. During follow-up, 43 [6%] patients underwent a colectomy and 163 [23%] patients were hospitalised. Of patients with limited colitis [distal to the left flexure], 90 [21%] progressed to extensive colitis. In addition, 92 [27%] patients with extensive colitis experienced a regression in disease extent, which was associated with a reduced risk of hospitalisation (hazard ratio [HR]: 0.5 95% CI: 0.3-0.8]. Overall, patients were treated similarly in both geographical regions; 80 [11%] patients needed biological therapy and 210 [29%] patients received immunomodulators. Treatment with immunomodulators was found to reduce the risk of hospitalisation [HR: 0.5 95% CI: 0.3-0.8].

Conclusions: Although patients in this population-based cohort were treated more aggressively with immunomodulators and biological therapy than in cohorts from the previous two decades, their disease outcomes, including colectomy rates, were no different. However, treatment with immunomodulators was found to reduce the risk of hospitalisation.
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http://dx.doi.org/10.1093/ecco-jcc/jjy154DOI Listing
February 2019

Importance of endoscopist quality metrics for findings at surveillance colonoscopy: The detection-surveillance paradox.

United European Gastroenterol J 2018 May 24;6(4):622-629. Epub 2017 Nov 24.

1Department of Gastroenterology, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL-Fundación FISABIO), Alicante, Spain.

Background: Guidelines recommend surveillance colonoscopies based exclusively on findings at baseline colonoscopy. This recommendation leads to the paradox that the higher the baseline colonoscopy quality, the more surveillance colonoscopies will be indicated according to current guidelines.

Objective: The aim of this study was to evaluate the effect on follow-up findings of different quality metrics of the endoscopist performing the baseline colonoscopy.

Methods: This retrospective cohort study included individuals with advanced adenomas at baseline colonoscopy. Adenoma detection rate (ADR) and adenomas per colonoscopy rate (APCR) were determined for 44 endoscopists. Surveillance colonoscopies were checked after systematic tracking.

Results: A total of 574 individuals were diagnosed with advanced adenomas, of whom 270 received a surveillance colonoscopy. Patients whose baseline colonoscopy endoscopist had an ADR lower than the median of 33.8% had significantly higher rates of advanced neoplasia at follow-up (13.1% vs 4.0%;  = 0.001). On univariate analysis, high-risk advanced adenomas at baseline (HR 0.43; 95% CI 0.19-0.97) and ADR (HR 0.94; 95% CI 0.89-0.99) showed a significant relationship with advanced neoplasia at surveillance. In a multivariate Cox model, the ADR of the endoscopist who performed the baseline colonoscopy was the only independent predictor of risk for developing advanced neoplasia at follow-up (HR 0.94; 95% CI 0.89-0.99).

Conclusions: Our results suggest that the risk of identifying advanced adenomas at follow-up is closely related to the quality metrics of the endoscopist who performs the baseline colonoscopy.
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http://dx.doi.org/10.1177/2050640617745458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987282PMC
May 2018

Effect of aspirin on the diagnostic accuracy of the faecal immunochemical test for colorectal advanced neoplasia.

United European Gastroenterol J 2018 Feb 21;6(1):123-130. Epub 2017 Apr 21.

Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.

Background: Aspirin (ASA) is a drug that can cause gastrointestinal lesions and symptoms. Colorectal cancer (CRC) is the most prevalent type of cancer in Western countries. We assessed the effect of aspirin on the diagnostic accuracy of the faecal immunochemical test (FIT) for CRC and/or advanced neoplasia (AN) in patients undergoing colonoscopy for gastrointestinal symptoms.

Methods: We conducted a prospective multicentre observational study of diagnostic tests that included patients with gastrointestinal symptoms undergoing colonoscopy between March 2012 and 2014 (the COLONPREDICT study). Symptoms were assessed and a FIT and blood tests assessing haemoglobin and carcinoembryonic antigen (CEA) levels were performed.

Results: The study included 3052 patients: A total of 2567 did not take aspirin (non-user group) and 485 (16%) took aspirin (user group). Continuous treatment with ASA did not change the AUC (0.88, 0.82;  = 0.06), sensitivity (92%, 88%;  = 0.5) or specificity (71%, 67%;  = 0.2) of the FIT for CRC detection. Similarly, we found no differences in the AUC (0.81, 0.79;  = 0.6), sensitivity (74%, 75.5%;  = 0.3) or specificity (76%, 73.6%;  = 0.3) for AN detection. Patients with an aspirin use of ≥ 300 mg/day had a lower prevalence of AN and the sensitivity, specificity and AUC for AN for these patients were 54%, 68% and 0.66, significantly lower than for the non-user group ( = 0.03).

Conclusions: Aspirin does not modify the diagnostic accuracy of FIT for CRC and/or AN in patients with gastrointestinal symptoms. Aspirin use of ≥ 300 mg/day decreases the accuracy of the test.
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http://dx.doi.org/10.1177/2050640617707094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5802670PMC
February 2018

Natural disease course of Crohn's disease during the first 5 years after diagnosis in a European population-based inception cohort: an Epi-IBD study.

Gut 2019 03 23;68(3):423-433. Epub 2018 Jan 23.

IBD Clinical and Research Centre, ISCARE, Prague, Czech Republic.

Objective: The Epi-IBD cohort is a prospective population-based inception cohort of unselected patients with inflammatory bowel disease from 29 European centres covering a background population of almost 10 million people. The aim of this study was to assess the 5-year outcome and disease course of patients with Crohn's disease (CD).

Design: Patients were followed up prospectively from the time of diagnosis, including collection of their clinical data, demographics, disease activity, medical therapy, surgery, cancers and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis.

Results: In total, 488 patients were included in the study. During follow-up, 107 (22%) patients received surgery, while 176 (36%) patients were hospitalised because of CD. A total of 49 (14%) patients diagnosed with non-stricturing, non-penetrating disease progressed to either stricturing and/or penetrating disease. These rates did not differ between patients from Western and Eastern Europe. However, significant geographic differences were noted regarding treatment: more patients in Western Europe received biological therapy (33%) and immunomodulators (66%) than did those in Eastern Europe (14% and 54%, respectively, P<0.01), while more Eastern European patients received 5-aminosalicylates (90% vs 56%, P<0.05). Treatment with immunomodulators reduced the risk of surgery (HR: 0.4, 95% CI 0.2 to 0.6) and hospitalisation (HR: 0.3, 95% CI 0.2 to 0.5).

Conclusion: Despite patients being treated early and frequently with immunomodulators and biological therapy in Western Europe, 5-year outcomes including surgery and phenotype progression in this cohort were comparable across Western and Eastern Europe. Differences in treatment strategies between Western and Eastern European centres did not affect the disease course. Treatment with immunomodulators reduced the risk of surgery and hospitalisation.
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http://dx.doi.org/10.1136/gutjnl-2017-315568DOI Listing
March 2019

No controversial role of alcohol consumption in the development of inflammatory bowel diseases.

Eur J Clin Nutr 2018 02 19;72(2):305-306. Epub 2017 Dec 19.

Norwich Medical School, Department of Medicine, University of East Anglia, Norwich, UK.

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http://dx.doi.org/10.1038/s41430-017-0045-2DOI Listing
February 2018

Diet, Gut Microbiome and Epigenetics: Emerging Links with Inflammatory Bowel Diseases and Prospects for Management and Prevention.

Nutrients 2017 Aug 30;9(9). Epub 2017 Aug 30.

Department of Gastroenterology, Instituto Investigación Sanitaria Galicia Sur, Estrutura Organizativa de Xestión Integrada de Vigo, 36312 Vigo, Spain.

Inflammatory bowel diseases (IBD) represent a growing public health concern due to increasing incidence worldwide. The current notion on the pathogenesis of IBD is that genetically susceptible individuals develop intolerance to dysregulated gut microflora (dysbiosis) and chronic inflammation develops as a result of environmental triggers. Among the environmental factors associated with IBD, diet plays an important role in modulating the gut microbiome, influencing epigenetic changes, and, therefore, could be applied as a therapeutic tool to improve the disease course. Nevertheless, the current dietary recommendations for disease prevention and management are scarce and have weak evidence. This review summarises the current knowledge on the complex interactions between diet, microbiome and epigenetics in IBD. Whereas an overabundance of calories and some macronutrients increase gut inflammation, several micronutrients have the potential to modulate it. Immunonutrition has emerged as a new concept putting forward the importance of vitamins such as vitamins A, C, E, and D, folic acid, beta carotene and trace elements such as zinc, selenium, manganese and iron. However, when assessed in clinical trials, specific micronutrients exerted a limited benefit. Beyond nutrients, an anti-inflammatory dietary pattern as a complex intervention approach has become popular in recent years. Hence, exclusive enteral nutrition in paediatric Crohn's disease is the only nutritional intervention currently recommended as a first-line therapy. Other nutritional interventions or specific diets including the Specific Carbohydrate Diet (SCD), the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyol (FODMAP) diet and, most recently, the Mediterranean diet have shown strong anti-inflammatory properties and show promise for improving disease symptoms. More work is required to evaluate the role of individual food compounds and complex nutritional interventions with the potential to decrease inflammation as a means of prevention and management of IBD.
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http://dx.doi.org/10.3390/nu9090962DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5622722PMC
August 2017

Assessing medication adherence in inflammatory bowel diseases. A comparison between a self-administered scale and a pharmacy refill index.

Rev Esp Enferm Dig 2017 Aug;109(8):542-551

Aparato Digestivo, Hospital Álvaro Cunqueiro.Fundación Biomédica Galicia Sur.Complexo Hospitalario Universitario de Vig, España.

Background: Medication non-adherence in inflammatory bowel disease (IBD) has a negative impact on disease outcome. Different tools have been proposed to assess non-adherence. We aimed to compare a self-administered scale and a pharmacy refill index as a reliable measure of medication adherence and to determine what factors are related to adherence.

Methods: Consecutive non-active IBD outpatients were asked to fill in the self-reported Morisky Medication Adherence Scale (MMAS-8) and the Beliefs about Medication Questionnaire (BMQ). Pharmacy refill data were reviewed from the previous three or six months and the medication possession ratio (MPR) was calculated. Non-adherence was defined as MMAS-8 scores < 6 or MPR < 0.8.

Results: Two-hundred and three patients were enrolled (60% ulcerative colitis, 40% Crohn's disease); 51% were men, and the mean age was 46.3 (14) years. Seventy-four per cent of patients were on monotherapy and 26% on combination therapy; altogether, 65% received mesalazine, 46% thiopurines and 16% anti-tumor necrosis factor alfa. Non-adherence rate assessed by MPR was 37% and 22.4% by MMAS-8. Receiver operator curve analysis using a MMAS-8 cut-off of six gave an area under the curve of 0.6 (95% CI 0.5-0.7), p = 0.001. This score had an 85% sensitivity and 34% specificity to predict medication non-adherence, with negative and positive predictive values of 57% and 70% respectively. High scores in the BMQ potential for harm of medication were significantly associated with MPR non-adherence (p = 0.01).

Conclusion: The accuracy of MMAS-8 to identify medication non-adherence in inactive IBD outpatients in our setting is poor due to a low specificity and a negative predictive value. Psychosocial factors such as beliefs about medication seem to be related to IBD non-adherence.
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http://dx.doi.org/10.17235/reed.2017.5137/2017DOI Listing
August 2017

Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients.

BMC Med 2016 08 31;14(1):128. Epub 2016 Aug 31.

Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32005, Ourense, Spain.

Background: Risk prediction models for colorectal cancer (CRC) detection in symptomatic patients based on available biomarkers may improve CRC diagnosis. Our aim was to develop, compare with the NICE referral criteria and externally validate a CRC prediction model, COLONPREDICT, based on clinical and laboratory variables.

Methods: This prospective cross-sectional study included consecutive patients with gastrointestinal symptoms referred for colonoscopy between March 2012 and September 2013 in a derivation cohort and between March 2014 and March 2015 in a validation cohort. In the derivation cohort, we assessed symptoms and the NICE referral criteria, and determined levels of faecal haemoglobin and calprotectin, blood haemoglobin, and serum carcinoembryonic antigen before performing an anorectal examination and a colonoscopy. A multivariate logistic regression analysis was used to develop the model with diagnostic accuracy with CRC detection as the main outcome.

Results: We included 1572 patients in the derivation cohort and 1481 in the validation cohorts, with a 13.6 % and 9.1 % CRC prevalence respectively. The final prediction model included 11 variables: age (years) (odds ratio [OR] 1.04, 95 % confidence interval [CI] 1.02-1.06), male gender (OR 2.2, 95 % CI 1.5-3.4), faecal haemoglobin ≥20 μg/g (OR 17.0, 95 % CI 10.0-28.6), blood haemoglobin <10 g/dL (OR 4.8, 95 % CI 2.2-10.3), blood haemoglobin 10-12 g/dL (OR 1.8, 95 % CI 1.1-3.0), carcinoembryonic antigen ≥3 ng/mL (OR 4.5, 95 % CI 3.0-6.8), acetylsalicylic acid treatment (OR 0.4, 95 % CI 0.2-0.7), previous colonoscopy (OR 0.1, 95 % CI 0.06-0.2), rectal mass (OR 14.8, 95 % CI 5.3-41.0), benign anorectal lesion (OR 0.3, 95 % CI 0.2-0.4), rectal bleeding (OR 2.2, 95 % CI 1.4-3.4) and change in bowel habit (OR 1.7, 95 % CI 1.1-2.5). The area under the curve (AUC) was 0.92 (95 % CI 0.91-0.94), higher than the NICE referral criteria (AUC 0.59, 95 % CI 0.55-0.63; p < 0.001). On the basis of the thresholds with 90 % (5.6) and 99 % (3.5) sensitivity, we divided the derivation cohort into three risk groups for CRC detection: high (30.9 % of the cohort, positive predictive value [PPV] 40.7 %, 95 % CI 36.7-45.9 %), intermediate (29.5 %, PPV 4.4 %, 95 % CI 2.8-6.8 %) and low (39.5 %, PPV 0.2 %, 95 % CI 0.0-1.1 %). The discriminatory ability was equivalent in the validation cohort (AUC 0.92, 95 % CI 0.90-0.94; p = 0.7).

Conclusions: COLONPREDICT is a highly accurate prediction model for CRC detection.
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http://dx.doi.org/10.1186/s12916-016-0668-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5007726PMC
August 2016

Incidence of advanced neoplasia during surveillance in high- and intermediate-risk groups of the European colorectal cancer screening guidelines.

Endoscopy 2016 Nov 2;48(11):995-1002. Epub 2016 Aug 2.

Servicio de Gastroenterología, Hospital Clínic, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain.

The European guidelines for quality assurance in colorectal cancer (CRC) screening have established high-risk (≥ 5 adenomas or an adenoma ≥ 20 mm) and intermediate-risk (3 - 4 adenomas or at least one adenoma 10 - 19 mm in size, or villous histology, or high grade dysplasia) groups with different endoscopic surveillance intervals. The aim of this study was to evaluate the difference in the incidence of advanced neoplasia (advanced adenoma or CRC) between the two risk groups. This retrospective group study included patients meeting high- or intermediate-risk criteria for adenomas detected in CRC screening programs and the COLONPREV study before European guidelines were adopted in Spain (June 2011) with a 3-year surveillance recommendation according to Spanish guidelines. The primary outcome measure was the incidence of advanced neoplasia in patients undergoing surveillance. The secondary outcome measure was the CRC incidence. We used an adjusted proportional hazards regression model to control confounding variables. The study included 5401 patients (3379 intermediate risk, 2022 high risk). Endoscopic surveillance was performed in 65.5 % of the patients (2.8 ± 1 years). The incidence of advanced neoplasia in the high- and intermediate-risk groups was 16.0 % (59.0 cases/1000 patient-years) and 12.3 % (41.2 cases/1000 patient-years), respectively. The CRC incidence was 0.5 % (1.4 cases/1000 patient-years) and 0.4 % (1 case/1000 patient-years), respectively. The advanced neoplasia and CRC attributable risk to the high risk group was of 3.7 % and 0.1 %, respectively. In the proportional hazards analysis, the risk of advanced neoplasia was greater in the high-risk group (hazard ratio [HR] 1.5, 95 % confidence interval [CI] 1.2 - 1.8), with no significant differences in the CRC incidence (HR 1.6, 95 %CI 0.6 - 3.8). Patients meeting high-risk criteria have a higher incidence of advanced neoplasia during endoscopic surveillance. No differences were found in the CRC incidence at a 3-year surveillance recommendation.
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http://dx.doi.org/10.1055/s-0042-112571DOI Listing
November 2016

Evaluation of serum nucleoside diphosphate kinase A for the detection of colorectal cancer.

Sci Rep 2016 05 25;6:26703. Epub 2016 May 25.

Department of Biochemistry, Genetics and Immunology, Universidade de Vigo, Vigo, Spain.

We previously described the over-expression of nucleoside diphosphate kinase A (NDKA) in tumours and serum from colorectal cancer (CRC) patients, suggesting its use as biomarker. In this study we evaluated the diagnostic accuracy of serum NDKA to detect advanced neoplasia (CRC or advanced adenomas). Furthermore, the performance of NDKA was compared with the faecal immunochemical test (FIT). The study population included a case-control cohort and a screening cohort (511 asymptomatic first-degree relatives of CRC patients that underwent a colonoscopy and a FIT). Serum NDKA was elevated in CRC patients in the case-control cohort (p = 0.002). In the screening cohort, NDKA levels were higher for advanced adenomas (p = 0.010) and advanced neoplasia (p = 0.006) compared to no neoplasia. Moreover, elevated NDKA was associated with severe characteristics of adenomas (≥3 lesions, size ≥ 1 cm or villous component). Setting specificity to 85%, NDKA showed a sensitivity of 30.19% and 29.82% for advanced adenomas and advanced neoplasia, respectively. NDKA combined with FIT (100 ng/mL cut-off) detected advanced adenomas and advanced neoplasia with 45.28% and 49.12% sensitivity, with specificity close to 90%. The combination of serum NDKA and FIT can improve the detection of advanced neoplasia, mainly for lesions located on the proximal colon, in asymptomatic individuals with CRC family-risk.
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http://dx.doi.org/10.1038/srep26703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879623PMC
May 2016

Impact of age- and gender-specific cut-off values for the fecal immunochemical test for hemoglobin in colorectal cancer screening.

Dig Liver Dis 2016 May 9;48(5):542-551. Epub 2016 Feb 9.

Department of Gastroenterology, Hospital del Mar, Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Autonomous University of Barcelona and Pompeu Fabra University, Barcelona, Catalonia, Spain. Electronic address:

Background: There is no information on the impact of age and gender on the diagnostic yield of different positivity thresholds for the fecal immunochemical test for hemoglobin (FIT).

Objectives: To evaluate the performance of this test at distinct positivity cut-offs in a population-based colorectal cancer (CRC) screening program.

Methods: CRC detection rate (DR), and analysis of resources were evaluated retrospectively, at different cut-offs of FIT (20, 25, 30, 35 and 40μg Hb/g) respect to a reference value (15μg Hb/g), according to age and gender, in a screening population of 10,611 participants of the ColonPrev study (Quintero. NEJM 2013).

Results: At the reference cut-off value, 36 CRC and 252 advanced adenomas (AA) were diagnosed. Increasing the cut-off in women ≤60 years decreases colonoscopies performed by 44.5% without modifying the CRC (DR). Same CRC DR was observed in men ≤60 years and women >60 years increasing cut-off at 25-30μg Hb/g. In men >60 years, all increases in the cut-off affected the CRC DR, especially when the cut-off was increased from 35 to 40μg Hb/g (CRC miss rate 25%).

Conclusions: To improve the performance of FIT in CRC screening programs, FIT cut-offs could be individualized by age and gender.
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http://dx.doi.org/10.1016/j.dld.2016.02.001DOI Listing
May 2016

European experience with methotrexate treatment in Crohn's disease: a multicenter retrospective analysis.

Eur J Gastroenterol Hepatol 2016 Jul;28(7):802-6

aDepartment of Gastroenterology, Sheba Medical Center, Ramat Gan bSackler Medical School, Tel-Aviv University, Tel-Aviv cDepartment of Gastroenterology and Hepatology, Ben-Gurion University of the Negev, Beer Sheva, Israel dDivision of Gastroenterology, University of Ioannina, Ioannina eDepartment of Gastroenterology, Venizeleio General Hospital, Heraklion fFirst Department of Gastroenterology, Evangelismos Hospital, Athens gDepartment of Gastroenterology, University Hospital Heraklion, Crete, Greece hDepartment of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, The Netherlands iDepartment of Gastroenterology, Instituto de Investigacion Biomedica Ourense-Pontevedra-Vigo, Xerencia Xestion Integrada de Vigo, Spain jDepartment of Gastroenterology and Hepatology, Zvezdara University Clinical Centre, Zvezdara kMedical Faculty, University of Belgrade, Belgrade, Serbia lCentral IBD Clinic, Nicosia, Cyprus mIBD Center, Department of Gastroenterology, Humanitas Research Hospital, Milan, Italy.

Introduction: Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD.The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort.

Patients And Methods: This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome.

Results: Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival.

Conclusion: MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.
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http://dx.doi.org/10.1097/MEG.0000000000000609DOI Listing
July 2016

Endoscopist characteristics that influence the quality of colonoscopy.

Endoscopy 2016 Mar 4;48(3):241-7. Epub 2016 Feb 4.

Department of Gastroenterology, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, Santa Cruz de Tenerife, Spain.

Background And Study Aim: Several factors have been shown to be related to colonoscopy quality; however, little is known about the effects of endoscopist factors. This study analyzed the influence of endoscopist-related characteristics on quality indicators for colonoscopy.

Patients And Methods: The study included 48 endoscopists who each performed at least 20 colonoscopies in the colonoscopy arm of a randomized controlled trial comparing fecal immunochemical test vs. colonoscopy in colorectal cancer screening. These endoscopists performed a total of 3838 procedures in the trial. The following were calculated for each endoscopist: adenoma detection rate (ADR), advanced ADR, proximal ADR, distal ADR, and adenoma per colonoscopy rate (APCR). The characteristics of endoscopists were assessed with regard to colonoscopy quality using multivariate regression analysis. Endoscopist characteristics included age, sex, exclusive endoscopy practice, years as a physician, years as a specialist, specialty, total (life-long) number of colonoscopies performed, annual colonoscopy volume, number of hours/week dedicated to endoscopy and number of educational activities in the previous year.

Results: Factors associated with ADR were age of the endoscopist (odds ratio [OR] 1.11, 95 % confidence interval [CI] 1.01 - 1.21; P = 0.01) and life-long number of colonoscopies (OR 1.06, 95 %CI 1.01 - 1.11; P = 0.01). Only exclusive dedication to endoscopy practice was found to be independently related to proximal ADR (OR 1.71, 95 %CI 1.15 - 2.74; P = 0.001). Life-long number of colonoscopies was independently related to detection of distal adenomas (OR 1.07, 95 %CI 1.01 - 1.13; P = 0.01). None of the analyzed endoscopist characteristics was associated with advanced ADR or APCR.

Conclusions: This study found that the experience of the endoscopist and exclusive dedication to endoscopy practice, but not annual colonoscopy volume, were associated with better colonoscopy quality.
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http://dx.doi.org/10.1055/s-0042-100185DOI Listing
March 2016

Serum matrix metalloproteinase-9 in colorectal cancer family-risk population screening.

Sci Rep 2015 Aug 12;5:13030. Epub 2015 Aug 12.

Department of Biochemistry, Genetics and Immunology, Universidade de Vigo. Vigo, Spain.

Matrix metalloproteinase-9 (MMP-9) is related to tumour development and progression in colorectal cancer (CRC) and its utility as biomarker has been suggested. The aim of our study was to measure serum MMP-9 in asymptomatic first-degree relatives of CRC patients, and to analyse its diagnostic accuracy for the detection of advanced neoplasia (AN: advanced adenomas and CRC). Additionally, we compared its diagnostic capability with the most used non-invasive faecal immunochemical test (FIT). Serum MMP-9 was quantified by ELISA in 516 asymptomatic individuals that underwent a colonoscopy and a FIT. MMP-9 levels were significantly related to age and gender and therefore the concentration was corrected by these confounders. Corrected MMP-9 (cMMP-9) levels were higher in individuals with advanced adenomas (AA; p-value = 0.029) and AN (p-value = 0.056) compared to individuals with no neoplasia. Moreover, elevated cMMP-9 concentration was associated with more severe characteristics of adenomas (number of lesions, size and histology). Nevertheless, the diagnostic accuracy of cMMP-9 was considerably lower than that of FIT for identifying AA (22.64% vs. 47.17% sensitivity, 90% specificity) or AN (19.30% vs. 52.63% sensitivity, 90% specificity). According to our results, serum MMP-9 cannot be considered of utility for the diagnosis of AN in CRC family-risk population screening.
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http://dx.doi.org/10.1038/srep13030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4532998PMC
August 2015

Incidence and phenotype at diagnosis of inflammatory bowel disease. Results in Spain of the EpiCom study.

Gastroenterol Hepatol 2015 Nov 15;38(9):534-40. Epub 2015 Apr 15.

Servicio de Aparato Digestivo, Complexo Hospitalario Universitario de Vigo, Spain; 'IBIV' Institute of Biomedical Research of Vigo, Vigo, Spain.

Introduction: Incidence of inflammatory bowel disease (IBD) is increasing progressively. Few recent epidemiological prospective studies are available in Spain. The Epicom study, a population-based inception cohort of unselected IBD patients developed within the European Crohn's and Colitis Organization, was started in 2010. Vigo is the only Spanish area participating.

Objective: To describe the incidence of IBD in the Vigo area and the phenotypical characteristics at diagnosis and to compare them with previous data available in Spain.

Material And Methods: Epidemiological, descriptive, prospective, and population-based study. All incident cases of IBD during 2010 and living in the Vigo area at diagnosis were included. The Copenhagen Diagnostic criteria were used to define cases. Background population at the start of the study was 579,632 inhabitants. Data were prospectively entered in the EpiCom database.

Results: A total of 106 patients were included (57.5% men, median age 39.5 years). Of them 53 were diagnosed of as Crohn's disease (CD), 47 ulcerative colitis (UC) and six IBD unclassified (IBDU). The incidence rate per 100,000 per year for patients aged 15 years or older was 21.4 (10.8 for CD, 9.4 for UC, 1.2 IBDU). Including pediatric population incidence rates were 18.3 (10.3 CD, 8.7 UC, 1.2 IBDU). Median time since onset of symptoms until diagnosis was 2 months.

Conclusions: The incidence rate of IBD in Vigo is the highest compared to former Spanish cohorts, especially in CD patients. Median time since onset of symptoms until diagnosis is relatively short.
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http://dx.doi.org/10.1016/j.gastrohep.2015.03.001DOI Listing
November 2015

Clinical, biological, and endoscopic responses to adalimumab in antitumor necrosis factor-naive Crohn's disease: predictors of efficacy in clinical practice.

Eur J Gastroenterol Hepatol 2015 Apr;27(4):430-5

aGastroenterology Department, Complejo Hospitalario Universitario de Ferrol, Ferrol bGastroenterology Department, Hospital Universitario de Santiago, Santiago de Compostela, A Coruña cGastroenterology Department, Hospital Povisa dGastroenterology Department, Complejo Hospitalario Universitario de Vigo eGastroenterology Department, Complejo Hospitalario Universitario de Pontevedra, Vigo, Pontevedra fEIGA Group: Galician Inflammatory Bowel Disease Study Group, Galicia, Spain.

Background And Aims: Endoscopic healing and clinical remission are important parameters to evaluate therapeutic efficacy in Crohn's disease. The aim of this study was to investigate the clinical effectiveness of adalimumab in terms of clinical and endoscopic response and to identify predictors of efficacy in clinical practice.

Materials And Methods: A prospective analysis was carried out of 68 antitumor necrosis factor-naive Crohn's disease patients treated with adalimumab for 2 years. Clinical and endoscopic response was assessed using the Harvey-Bradshaw index and the Simple Endoscopic Score for Crohn's disease, respectively.

Results: Adalimumab treatment was associated with clinical remission in 76.6, 90.6, and 87.5% of patients at 6, 12, and 24 months. Loss of efficacy occurred in 17.6% of cases after 24 months of therapy. Clinical remission with normal C-reactive protein at 2 months or with endoscopic response at 6 months was predictive of better outcomes. Mucosal healing rates were 17.2, 44.7, and 39.5% and endoscopic responses were 55.1, 76.6, and 76.3% at the respective time points. Mucosal healing was higher in the early treatment group than in the group with disease of at least 5 years' duration (64.7 vs. 19.1%, P=0.004). Inflammatory phenotype showed a higher percentage of mucosal healing (70%) than stricturing (29.4%) or penetrating (27.3%) disease.

Conclusion: Adalimumab was effective in providing sustained clinical remission. In patients in clinical remission, the C-reactive protein level at 2 months, endoscopic response at 6 months, or inflammatory phenotype and short disease duration could be considered as good predictors of efficacy.
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http://dx.doi.org/10.1097/MEG.0000000000000296DOI Listing
April 2015

Diagnostic accuracy of fecal immunochemical test in average- and familial-risk colorectal cancer screening.

United European Gastroenterol J 2014 Dec;2(6):522-9

Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.

Background: There is little information about the fecal immunochemical test (FIT) in familial-risk colorectal cancer (CRC) screening.

Objectives: The objective of this article is to investigate whether FIT diagnostic accuracy for advanced neoplasia (AN) differs between average and familial-risk (first-degree relative) patients.

Methods: A total of 1317 consecutive participants (595 familial) who collected one stool sample before performing a colonoscopy as a CRC screening test were included. FIT diagnostic accuracy for AN was evaluated with Chi-square test at a 20 µg hemoglobin/g of feces cut-off value. Finally, we determined which variables were independently related to AN.

Results: An AN was found in 151 (11.5%) patients. The overall accuracy was not statistically different between both cohorts for AN (88.4%, 91.7%; p = 0.051). At the cut-off stablished, differences in FIT sensitivity (31.1%, 40.6%; p = 0.2) or specificity (96.5%, 97.3%; p = 0.1) were not statistically significant. Finally, independent variables such as sex (male) (odds ratio (OR) 2.1, 95% confidence interval (CI) 1.4-3.1), age (50-65, >65 years) (OR 2.1, 95% CI 1.1-4.3; OR 2.7, 95% CI 1.2-6.1), previous colonoscopy (OR 0.4, 95% CI 0.2-0.9) and FIT ≥20 µg/g feces (OR 17.7, 95% CI 10.8-29.1) were associated with AN diagnosis.

Conclusions: FIT accuracy for AN detection is equivalent in average and familial-risk CRC screening cohorts.
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http://dx.doi.org/10.1177/2050640614553285DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4245302PMC
December 2014

Diagnostic performance of fecal immunochemical test and sigmoidoscopy for advanced right-sided colorectal neoplasms.

Dig Dis Sci 2015 May 19;60(5):1424-32. Epub 2014 Nov 19.

Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32003, Ourense, Spain.

Background: Colorectal cancer screening effect on right-sided colorectal neoplasia is limited. We compared fecal immunochemical test and simulated sigmoidoscopy diagnostic accuracy for advanced right-sided neoplasia detection.

Methods: We analyzed 1,292 individuals with complete screening colonoscopy with a fecal immunochemical test determination before colonoscopy. Sigmoidoscopy and "hybrid strategy" (sigmoidoscopy or fecal hemoglobin concentration ≥ 20 µg hemoglobin/g) diagnostic yield were simulated according to UK Flexible Sigmoidoscopy, Screening for COlon REctum (SCORE), and Norwegian Colorectal Cancer Prevention (NORCCAP) trials criteria to complete colonic examination. We compared sensitivity and specificity of both strategies and of "hybrid strategy" for advanced right-sided neoplasia with McNemar test.

Results: An advanced right-sided neoplasia was detected in 47 (3.6 %) subjects. A fecal hemoglobin concentration ≥ 20 µg hemoglobin/g was determined in 6.6 % of the subjects and 10.1, 12.7, and 23.5 % met UK, SCORE, and NORCCAP criteria, respectively. Fecal immunochemical test was statistically more specific than sigmoidoscopy strategies (93.8 %, UK 90.3 %, SCORE 87.7 %, NORCCAP 77.8 %; p < 0.001). In contrast, fecal immunochemical test sensitivity for advanced right-sided neoplasia (17 %) was not statistically different than UK (21.3 %; p = 0.7) or SCORE (23.4 %; p = 0.5), although it was inferior than NORCCAP strategy (42.5 %; p < 0.001). Adding fecal immunochemical test to sigmoidoscopy increased number of positives (8.5-25.7 %), sensitivity (10-30 %), and significantly reduced advanced right-sided neoplasia specificity (p < 0.001).

Conclusions: Fecal immunochemical test and sigmoidoscopy diagnostic yield for advanced right-sided neoplasia are low. Fecal immunochemical test is more specific than sigmoidoscopy but less sensitive than sigmoidoscopy according to NORCCAP criteria.
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http://dx.doi.org/10.1007/s10620-014-3434-6DOI Listing
May 2015

Characteristics of adenomas detected by fecal immunochemical test in colorectal cancer screening.

Cancer Epidemiol Biomarkers Prev 2014 Sep 24;23(9):1884-92. Epub 2014 Jun 24.

Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain.

Background: Fecal immunochemical test (FIT) diagnostic accuracy for colorectal adenoma detection in colorectal cancer screening is limited.

Methods: We analyzed 474 asymptomatic subjects with adenomas detected on colonoscopy in two blinded diagnostic tests studies designed to assess FIT diagnostic accuracy. We determined the characteristics of adenomas (number, size, histology, morphology, and location) and the risk of metachronous lesions (according to European guidelines). Finally, we performed a logistic regression to identify those variables independently associated with a positive result.

Results: Advanced adenomas were found in 145 patients (75.6% distal and 24.3% only proximal to splenic flexure). Patients were classified as low (59.5%), intermediate (30.2%), and high risk (10.3%) according to European guidelines. At a 100-ng/mL threshold, FIT was positive in 61 patients (12.8%). Patients with advanced adenomas [odds ratio (OR), 8.8; 95% confidence interval (CI), 4.76-16.25], distal advanced adenomas (OR, 6.7; 95% CI, 1.9-8.8), high risk (OR, 20.1; 95% CI, 8.8-45.8), or intermediate risk lesions (OR, 6; 95% CI, 2.9-12.4) had more probabilities to have a positive test. The characteristics of adenomas independently associated were number of adenomas (OR, 1.22; 95% CI, 1.04-1.42), distal flat adenomas (OR, 0.44; 95% CI, 0.21-0.96), pedunculated adenomas (OR, 2.28; 95% CI, 1.48-3.5), and maximum size of distal adenomas (mm; OR, 1.24; 95% CI, 1.16-1.32).

Conclusions: European guidelines classification and adenoma location correlates with the likelihood of a positive FIT result.

Impact: This information allows us to understand the FIT impact in colorectal cancer prevention. Likewise, it should be taken into account in the development of new colorectal adenomas biomarkers.
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http://dx.doi.org/10.1158/1055-9965.EPI-13-1346DOI Listing
September 2014

Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests.

Clin Gastroenterol Hepatol 2014 Oct 27;12(10):1708-16.e4. Epub 2014 Mar 27.

Department of Gastroenterology, Hospital Clínic, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), IDIBAPS, University of Barcelona, Barcelona, Catalonia.

Background & Aims: We compared the ability of biennial fecal immunochemical testing (FIT) and one-time sigmoidoscopy to detect colon side-specific advanced neoplasms in a population-based, multicenter, nationwide, randomized controlled trial.

Methods: We identified asymptomatic men and women, 50-69 years old, through community health registries and randomly assigned them to groups that received a single colonoscopy examination or biennial FIT. Sigmoidoscopy yield was simulated from results obtained from the colonoscopy group, according to the criteria proposed in the UK Flexible Sigmoidoscopy Trial for colonoscopy referral. Patients who underwent FIT and were found to have ≥75 ng hemoglobin/mL were referred for colonoscopy. Data were analyzed from 5059 subjects in the colonoscopy group and 10,507 in the FIT group. The main outcome was rate of detection of any advanced neoplasm proximal to the splenic flexure.

Results: Advanced neoplasms were detected in 317 subjects (6.3%) in the sigmoidoscopy simulation group compared with 288 (2.7%) in the FIT group (odds ratio for sigmoidoscopy, 2.29; 95% confidence interval, 1.93-2.70; P = .0001). Sigmoidoscopy also detected advanced distal neoplasia in a higher percentage of patients than FIT (odds ratio, 2.61; 95% confidence interval, 2.20-3.10; P = .0001). The methods did not differ significantly in identifying patients with advanced proximal neoplasms (odds ratio, 1.17; 95% confidence interval, 0.78-1.76; P = .44). This was probably due to the lower performance of both strategies in detecting patients with proximal lesions (sigmoidoscopy detected these in 19.1% of patients and FIT in 14.9% of patients) vs distal ones (sigmoidoscopy detected these in 86.8% of patients and FIT in 33.5% of patients). Sigmoidoscopy, but not FIT, detected proximal lesions in lower percentages of women (especially those 50-59 years old) than men.

Conclusions: Sigmoidoscopy and FIT have similar limitations in detecting advanced proximal neoplasms, which depend on patients' characteristics; sigmoidoscopy underperforms for women 50-59 years old. Screening strategies should be designed on the basis of target population to increase effectiveness and cost-effectiveness. ClinicalTrials.gov number: NCT00906997.
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http://dx.doi.org/10.1016/j.cgh.2014.03.022DOI Listing
October 2014

Fecal immunochemical test accuracy in average-risk colorectal cancer screening.

World J Gastroenterol 2014 Jan;20(4):1038-47

Vicent Hernandez, Felipe Iglesias, Lucía Cid, Luisa de Castro, Jose Antonio Hermo, Alfonso Martínez-Turnes, David Martínez-Ares, Pamela Estevez, M Carmen Vidal, Jose Ignacio Rodriguez-Prada; the COLONPREV study investigators, Department of Gastroenterology, Complexo Hospitalario Universitario de Vigo, 36200 Vigo, Spain.

Aim: To assess the fecal immunochemical test (FIT) accuracy for colorectal cancer (CRC) and advanced neoplasia (AN) detection in CRC screening.

Methods: We performed a multicentric, prospective, double blind study of diagnostic tests on asymptomatic average-risk individuals submitted to screening colonoscopy. Two stool samples were collected and the fecal hemoglobin concentration was determined in the first sample (FIT1) and the highest level of both samples (FITmax) using the OC-sensor™. Areas under the curve (AUC) for CRC and AN were calculated. The best FIT1 and FITmax cut-off values for CRC were determined. At this threshold, number needed to scope (NNS) to detect a CRC and an AN and the cost per lesion detected were calculated.

Results: About 779 individuals were included. An AN was found in 97 (12.5%) individuals: a CRC in 5 (0.6%) and an advanced adenoma (≥ 10 mm, villous histology or high grade dysplasia) in 92 (11.9%) subjects. For CRC diagnosis, FIT1 AUC was 0.96 (95%CI: 0.95-0.98) and FITmax AUC was 0.95 (95%CI: 0.93-0.97). For AN, FIT1 and FITmax AUC were similar (0.72, 95%CI: 0.66-0.78 vs 0.73, 95%CI: 0.68-0.79, respectively, P = 0.34). Depending on the number of determinations and the positivity threshold cut-off used sensitivity for AN detection ranged between 28% and 42% and specificity between 91% and 97%. At the best cut-off point for CRC detection (115 ng/mL), the NNS to detect a CRC were 10.2 and 15.8; and the cost per CRC was 1814€ and 2985€ on FIT1 and FITmax strategies respectively. At this threshold the sensitivity, NNS and cost per AN detected were 30%, 1.76, and 306€, in FIT1 strategy, and 36%, 2.26€ and 426€, in FITmax strategy, respectively.

Conclusion: Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.
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http://dx.doi.org/10.3748/wjg.v20.i4.1038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921527PMC
January 2014