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Immune responses following SARS-CoV-2 vaccination in patients with inflammatory bowel disease (IBD) are not well characterized. The aims of this study were to explore the serological response associated with IBD, and immunosuppressive medications including serum concentrations of biologics and thiopurine metabolites. This prospective, observational study included adult patients with ulcerative colitis (UC) and Crohn’s disease (CD), and healthy controls. Antibodies to the receptor-binding domain of SARS-CoV-2 spike proteins, and serum concentrations of ongoing biologic and immunomodulatory medications were assessed prior to, and 2-5 weeks after the second vaccine dose. Serologic response was defined as anti-Spike antibodies ≥70 AU/ml. In 958 IBD patients (380 UC, 578 CD) and 323 healthy controls, the median (Q1; Q3) anti-Spike antibody level (AU/ml) was lower in patients (618 (192; 4370)) compared to controls (3355 (896; 7849)) (p < 0.001). The antibody levels were lower in CD (439 (174; 3304)) compared to UC (1088 (251; 5975)) (p < 0.001). No associations were demonstrated between antibody levels and serum drug concentrations for TNF inhibitor (TNFi), vedolizumab and ustekinumab. Patients receiving TNFi + thiopurines with a subtherapeutic 6-thioguanine nucleotide (6-TGN) level had higher response rate (93%) compared to patients with 6-TGN within the therapeutic range (53%) (p = 0.003). A diagnosis of UC, mRNA-1273 vaccine, and other treatments than TNFi + thiopurines were associated with humoral response. Patients with CD had an attenuated humoral response to SARS-COV-2 vaccination as compared to patients with UC. The lack of association between serum levels of biologics and serologic response indicates vaccination regardless of proximity to drug administration.

Purpose This unselected, population-based cohort study aimed to determine the level of health-related quality of life (HRQoL) in patients with Crohn’s disease (CD) and ulcerative colitis (UC) at the time of diagnosis compared with a reference population and identify the demographic factors, psychosocial measures, and disease activity markers associated with HRQoL. Methods Adult patients newly diagnosed with CD or UC were prospectively enrolled. HRQoL was measured using the Short Form 36 (SF-36) and Norwegian Inflammatory Bowel Disease Questionnaires. Clinical significance was assessed using Cohen’s d effect size and further compared with a Norwegian reference population. Associations between HRQoL and symptom scores, demographic factors, psychosocial measures, and disease activity markers were analyzed. Results Compared with the Norwegian reference population, patients with CD and UC reported significantly lower scores in all SF-36 dimensions, except for physical functioning. Cohen’s d effect sizes for men and women in all SF-36 dimensions were at least moderate, except for bodily pain and emotional role for men with UC and physical functioning for both sexes and diagnoses. In the multivariate regression analysis, depression subscale scores ≥ 8 on the Hospital Anxiety and Depression Scale, substantial fatigue, and high symptom scores were associated with reduced HRQoL. Conclusion Patients newly diagnosed with CD and UC reported statistically and clinically significantly lower scores in seven of the eight SF-36 dimensions than the reference population. Symptoms of depression, fatigue, and elevated symptom scores were associated with poorer HRQoL.

Made available in DSpace on 2022-04-29T08:30:08Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-01-01 Background and aims: The role of thiopurines in therapeutic algorithms of Crohn's disease (CD) and Ulcerative colitis (UC) is being questioned. This work aimed to investigate current practice and future perspectives of Inflammatory Bowel Disease (IBD) physicians regarding the efficacy, safety, and role of precision medicine with thiopurines in IBD. Methods: A 29-questions web-based survey was developed and distributed to IBD physicians worldwide. Results: We collected the complete answers of 408 physicians from 50 countries. Most participants were experienced physicians in IBD; 26.0% met our definition of “IBD expert”. Four physicians reported to not use thiopurines in clinical practice. Most respondents used thiopurines in monotherapy and in combination therapy, both in CD and UC. Respondents tended to consider thiopurines as drugs with a good safety profile, with the agreement of 61.5% of the overall cohort. A minority of physicians (~6%) considered that thiopurines will not be used in the future in IBD patients, while 57.8% believed that these drugs will still be used, in mono and combination therapy. Conclusion: Despite the many emerging treatments in IBD, according to the beliefs of most physicians surveyed, thiopurines will still be an important part of the treatment algorithm of both CD and UC. Department of Gastroenterology Viseu Unit Tondela-Viseu Hospital Centre IBD Center Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica Department of Medicine I Agaplesion Markus Hospital Goethe-University Department of Gastroenterology Oslo University Hospital IBD Unit Department of Gastroenterology Hospital Clínico Universitario de Santiago de Compostela Division of Gastroenterology and Hepatology University Hospital Department of Internal Medicine São Paulo State University (Unesp) Medical School Colorectal Surgery Unit IBD outpatient clinics Catholic University of Paraná (PUCPR) Department of Gastroenterology and Inserm NGERE U1256 University Hospital of Nancy University of Lorraine Department of Biomedicine Unit of Pharmacology and Therapeutics University of Porto Department of Gastroenterology São João University Hospital MedInUP Centre for Drug Discovery and Innovative Medicines Department of Internal Medicine São Paulo State University (Unesp) Medical School

Diagnostic assays currently used to monitor the efficacy of COVID-19 vaccines measure levels of antibodies to the receptor-binding domain of ancestral SARS-CoV-2 (RBDwt). However, the predictive value for protection against new variants of concern (VOCs) has not been firmly established. Here, we used bead-based arrays and flow cytometry to measure binding of antibodies to spike proteins and receptor-binding domains (RBDs) from VOCs in 12,000 serum samples. Effects of sera on RBD-ACE2 interactions were measured as a proxy for neutralizing antibodies. The samples were obtained from healthy individuals or patients on immunosuppressive therapy who had received two to four doses of COVID-19 vaccines and from COVID-19 convalescents. The results show that anti-RBDwt titers correlate with the levels of binding- and neutralizing antibodies against the Alpha, Beta, Gamma, Delta, Epsilon and Omicron variants. The benefit of multiplexed analysis lies in the ability to measure a wide range of anti-RBD titers using a single dilution of serum for each assay. The reactivity patterns also yield an internal reference for neutralizing activity and binding antibody units per milliliter (BAU/ml). Results obtained with sera from vaccinated healthy individuals and patients confirmed and extended results from previous studies on time-dependent waning of antibody levels and effects of immunosuppressive agents. We conclude that anti-RBDwt titers correlate with levels of neutralizing antibodies against VOCs and propose that our method may be implemented to enhance the precision and throughput of immunomonitoring.

Objectives The use of biologic therapy in inflammatory bowel disease (IBD) is likely to increase with lower costs and more biologics and biosimilars becoming available. Our aim was to estimate the trends in use of first-line biologics during the first year after diagnosis in a Norwegian IBD population from 2010 to 2016. Methods Data were collected from the Norwegian National Patient Registry and Norwegian Prescription Database. Patients defined as incident IBD cases between 2010 and 2016 were included and followed for 12 months. Patients were stratified by year of diagnosis to examine change over time. Chi-square test was used for calculations on proportions. Time from diagnosis to first biologic was calculated by Kaplan-Meier failure estimates. Results 14,645 patients were included, 5283 (36%) with Crohn’s disease (CD) and 9362 (64%) with ulcerative colitis (UC). In the 2010 and 2016 cohort, the proportion initiating biologics increased from 17% to 33% (p

Sandre Svatun Lirhus,1 Marte Lie Høivik,2,3 Bjørn Moum,2,3 Karoline Anisdahl,2,3 Hans Olav Melberg1 1Department of Health Management and Health Economics, University of Oslo, Oslo, Norway; 2Department of Gastroenterology, Oslo University Hospital, Oslo, Norway; 3Institute of Clinical Medicine, University of Oslo, Oslo, NorwayCorrespondence: Sandre Svatun LirhusDepartment of Health Management and Health Economics, University of Oslo, Forskningsveien 3A, Harald Schjelderups Hus, Oslo, 0373, NorwayTel +47 97 58 29 25Email s.s.lirhus@medisin.uio.noBackground: Countries have different diagnostic procedures and treatment regimens for inflammatory bowel disease (IBD) patients. In addition to differences in population characteristics, completeness of data and health registries, different follow-up time and case definitions can have a large impact on estimates of the incidence and prevalence of IBD.Aim: The aim of this study was to use hospital and prescription data to estimate incidence and prevalence of Crohn’s disease (CD) and ulcerative colitis (UC), using different case definitions.Methods: This study used nationwide data from the Norwegian Patient Registry (2008 to 2017) and the Norwegian Prescription Database (2004 to April 2018). Incidence and prevalence were estimated using different case definitions of an IBD patient, varying the number of IBD-related hospital visits and IBD prescriptions required. The base case definition included patients with at least one IBD hospital visit and two IBD prescriptions or two IBD hospital visits.Results: From 2010 to 2017, 16,758 incident IBD patients fulfilled our base case definition, with 6045 diagnosed with CD (36.1%) and 10,713 (63.9%) with UC. For CD, 47.2% of the patients were male while 53.8% of UC patients were male. The base case incidence varied between 14.1 and 16.0 per 100,000 person-years for CD and 24.7 and 28.4/100,000 person-years for UC patients in the years 2010– 2017. When we required at least two IBD hospital visits, not utilizing the prescription data, the CD incidence was 22.3 per 100,000 person-years in 2010 and 13.9 per 100,000 person-years in 2017. For UC, the incidence was 47.4 and 20.6 per 100,000 person-years in 2010 and 2017. In 2017, the prevalence of CD was 0.27% (95% CI: 0.26– 0.27) and 0.50% (95% CI: 0.490– 0.502) for UC.Conclusion: According to our base case definition, the incidence of IBD in Norway was stable from 2010 to 2017. Both the incidence and prevalence of IBD in Norway is among the highest in the world. Moreover, the study also highlights the consequences of different case definitions.Keywords: inflammatory bowel disease, incidence, prevalence, real-world data

Despite the increasing use of biologics in patients with inflammatory bowel disease (IBD), real-world data about outcomes in the era of biologics remain inconclusive.To investigate trends in surgeries, hospitalisations and medication use in patients with IBD in a multinational, population-based cohort METHODS: We included 42,894 patients with ulcerative colitis (UC) and 24,864 with Crohn's disease (CD) who were diagnosed between 2010 and 2017 in Denmark, Norway and Sweden. We extracted data about surgeries, hospitalisations and medications from national registries and compared across countries and diagnosis years.Between 2010 and 2017, 2-year surgery rates were 4-7% in UC and 10-15% in CD and were stable over time. Two-year hospitalisation rates increased in Denmark (UC: 20% to 35%; CD: 27% to 32%) but were stable in Norway and Sweden (fluctuating between 33% and 37% in UC, and 46% and 52% in CD). Two-year rates of biologic use increased in both UC (7% to 16% in Denmark, 8% to 18% in Norway) and CD (22% to 26% in Denmark; 21% to 35% in Norway). Two-year rates of immunomodulator use increased in Norway (from 14% to 23% in UC; 37% to 45% in CD) and Sweden (from 41% to 52% in CD), but were stable in Denmark (between 17% and 21% in UC; 39% to 46% in CD).Between 2010 and 2017, surgery rates among Scandinavian patients with IBD remained stable, with no clear changes in hospitalisation rates despite the increasing use of immunomodulators and biologics.

The efficacy of vedolizumab (VDZ) has been demonstrated in clinical trials. The aim of this report is to evaluate the long-term effectiveness and safety of VDZ in a real-world cohort and to explore possible associations between concentration measurements of VDZ and treatment effectiveness.This is a prospective clinical follow-up including all adult patients with ulcerative colitis (UC) and Crohn's disease (CD) treated with VDZ from October 2014 until September 2017 at a single center in Norway. The patients were followed for at least 14 weeks or until termination of treatment. Clinical and biochemical activity were obtained at every infusion throughout follow-up. Plasma measurements of VDZ (p-VDZ) were performed before every infusion during maintenance therapy.In total, 71 patients received VDZ. Improvement of CRP and hemoglobin was observed in CD but not in UC, whereas Partial Mayo Score improved in UC while no change in Harvey Bradshaw Index was revealed in CD. Furthermore, CRP at baseline was negatively correlated with p-VDZ at week 14 in CD but not in UC patients.Improvement of biochemical markers of inflammation was observed in CD while clinical activity scores improved in UC patients. For CD, baseline CRP was correlated with lower concentrations of p-VDZ at week 14.

Background & Aims To influence host and disease phenotype, compositional microbiome changes, which have been demonstrated in patients with primary sclerosing cholangitis (PSC), must be accompanied by functional changes. We therefore aimed to characterize the genetic potential of the gut microbiome in patients with PSC compared with healthy controls (HCs) and patients with inflammatory bowel disease (IBD). Methods Fecal DNA from 2 cohorts (1 Norwegian and 1 German), in total comprising 136 patients with PSC (58% with IBD), 158 HCs, and 93 patients with IBD without PSC, were subjected to metagenomic shotgun sequencing, generating 17 billion paired-end sequences, which were processed using HUMAnN2 and MetaPhlAn2, and analyzed using generalized linear models and random effects meta-analyses. Results Patients with PSC had fewer microbial genes compared with HCs (P < .0001). Compared with HCs, patients with PSC showed enrichment and increased prevalence of Clostridium species and a depletion of, for example, Eubacterium spp and Ruminococcus obeum. Patients with PSC showed marked differences in the abundance of genes related to vitamin B6 synthesis and branched-chain amino acid synthesis (Qfdr < .05). Targeted metabolomics of plasma from an independent set of patients with PSC and controls found reduced concentrations of vitamin B6 and branched-chain amino acids in PSC (P < .0001), which strongly associated with reduced liver transplantation–free survival (log-rank P < .001). No taxonomic or functional differences were detected between patients with PSC with and without IBD. Conclusions The gut microbiome in patients with PSC exhibits large functional differences compared with that in HCs, including microbial metabolism of essential nutrients. Alterations in related circulating metabolites associated with disease course, suggesting that microbial functions may be relevant for the disease process in PSC. publishedVersion

Background and aim: Modern treatment strategies for inflammatory bowel disease (IBD) are postulated to change the natural disease course. Inception cohort studies are the gold standard for investigating such changes. We have initiated a new population-based inception cohort study; Inflammatory bowel disease in South Eastern Norway III (IBSEN III). In this article, we describe the study protocol and baseline characteristics of the cohort. Methods: IBSEN III is an ongoing, population-based observational inception cohort study with prospective follow-up. Adult and pediatric patients with suspected IBD in the South-Eastern Health Region of Norway (catchment area of 2.95 million inhabitants in 2017), during the 3-year period from 2017 to 2019, were eligible for inclusion. Comprehensive clinical, biochemical, endoscopic, demographic, and patient-reported data were collected at the time of diagnosis and throughout standardized follow-up. For a portion of the patients, extensive biological material was biobanked. Results: The study included 2168 patients, of whom 1779 were diagnosed with IBD (Crohn's disease: 626, ulcerative colitis: 1082, IBD unclassified: 71). In 124 patients, there were subtle findings indicative of, but not diagnostic for, IBD. The remaining 265 patients were classified as symptomatic non-IBD controls. Conclusion: We have included patients in a comprehensive population-based IBD cohort from a catchment population of 2.95 million, and a unique biobank with materials from newly diagnosed and treatment-naïve IBD patients and symptomatic non-IBD controls. We believe this cohort will add important knowledge about IBD in the years to come.

Introduction: Serological antibodies have been associated with complicated disease course in Crohn’s disease (CD), including the need for surgery. Aim: The aim of this study was to investigate if a panel of relevant antibodies could predict surgery in a prospective population-based cohort of patients with CD. Methods: The population-based IBSEN cohort has been followed prospectively for 20years. At the 10and 20-year follow-up, the following panel of serological antibodies was analysed: pANCA, ASCA IgA, ASCA IgG, anti-OmpC, anti-I2, and anti-CBir1. At the 20-year follow-up or until lost to follow-up, all CDrelated surgeries were registered. Results: Serum was available from 159 patients at 10-year follow-up and 135 patients at 20-year follow-up. In 113 patients, serum was available at both time points. No significant change of antibody status (positive vs. negative) was found from 10-year to 20-year follow-up. Negative pANCA, positive ASCA IgA and positive ASCA IgG at 10-year follow-up were all individually associated with increased risk for CD-related surgery. There was no association between anti-OmpC, anti-I2 or anti-CBir1 and CDrelated surgery. In a multiple regression model including disease location and behaviour, only stricturing or penetrating disease behaviour and negative pANCA remained significantly associated with higher odds for surgery. Conclusion: Positive ASCA IgA and IgG, and negative pANCA were associated with higher odds for CD-related surgery in univariate analysis. Since disease phenotype changes during the disease course, while serological antibodies are stable, our results support the use of pANCA, ASCA IgA and ASCA IgG as prognostic markers in CD. VAK has received a postdoctoral grant from the South Eastern Health Region of Norway.

Our aim in this study was to analyze the importance of childbearing for risk of inflammatory bowel disease. Using data from the Norwegian Population Register and the Norwegian Patient Register, we fitted discrete-time hazard models for diagnosis of Crohn disease (CD) or ulcerative colitis (UC) among men and women aged 18–81 years in 2011–2016. Year and various sociodemographic factors were controlled for. The data included 4,304 CD cases and 8,866 UC cases. Women whose youngest child was ≤4 years of age had lower CD risk the following year than childless women (odds ratio (OR) = 0.73, 95% confidence interval (CI): 0.62, 0.86). There was no such reduction in CD risk among fathers. Men whose youngest child was aged ≥20 years had higher risks of CD (OR = 1.22, 95% CI: 1.01, 1.49) and UC (OR = 1.15, 95% CI: 1.02, 1.30) than childless men. UC risk was also increased among men whose youngest child was aged ≤4 years (OR = 1.14, 95% CI: 1.02, 1.27). The short-term reduction in women’s CD risk after a birth may reflect biological effects of pregnancy. Alternatively, it may reflect residual confounding or lifestyle effects of parenthood that are of special relevance for CD in women. In particular, differences in use of oral contraceptives (which it was not possible to control for) may have contributed to the observed pattern.

AIM To investigate if vitamin D deficiency is associated with fatigue in patients with inflammatory bowel disease (IBD). METHODS IBD patients were recruited from nine hospitals in the southeastern and western regions of Norway to participate in a multicenter cross-sectional study lasting from March 2013 to April 2014. Data were collected by interviews, from medical records and laboratory tests. The Fatigue Questionnaire (FQ) was used to measure fatigue. Linear and logistic regression models were applied to explore the possible association between vitamin D deficiency and total fatigue scores and chronic fatigue, respectively. The analyses were adjusted for age, gender, disease activity, depressive symptoms and sleep disturbance. RESULTS In total, 405 patients were included in the analyses, of which 227 (56%) had Crohn’s disease (CD) and 178 (44%) had ulcerative colitis (UC). Vitamin D deficiency (< 50 nmol/L) was present in half (203/405) of the patients. Chronic fatigue was reported by 116 (29%) of all included patients with substantial fatigue reported by 194 (48%). Vitamin D levels were neither associated with total fatigue nor with chronic fatigue. Higher total fatigue scores and chronic fatigue were both associated with increased disease activity scores in patients with UC and CD, but not with increased CRP or fecal calprotectin. In UC patients, female gender was associated with fatigue in the univariate analysis, but no such difference was found when adjusted for elevated disease activity scores. Sleep disturbance and more depressive symptoms were associated with total fatigue scores in both UC and CD patients, but with chronic fatigue only in CD patients. CONCLUSION In this study, no significant association between fatigue and vitamin D deficiency in IBD patients was revealed. Key Words: Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis, Fatigue, Chronic fatigue, Vitamin D deficiency Core tip: Fatigue is common in inflammatory bowel diseases (IBD) and is especially prevalent in active disease. We wanted to investigate if vitamin D deficiency was associated to fatigue in IBD as this is a common belief among both patients and physicians. To the best of our knowledge, no previous studies have investigated this possible association in IBD patients. We also wanted to take into account the multidimensional approach in understanding fatigue making it difficult to single out any one contributing factor. In this study, no significant association between fatigue and vitamin D deficiency in IBD patients was revealed.

Background and aims: During the last decades, substantial progress has been made in both medical and surgical treatment of inflammatory bowel disease (IBD). The aim of this study was to determine the use of anti-TNFs and surgery during the first 3 years after diagnosis in IBD patients across the four health regions in Norway using nationwide patient registry data. Methods: This study used nationwide data from the Norwegian Patient Registry. Cumulative incidence of anti-TNF exposure and major surgery was calculated for patients diagnosed in 2010–2012. The analyses were stratified by diagnosis and health region. All patients were followed for an equal period of 3 years from diagnosis. Results: The study population included 8,257 IBD patients first registered between 2010 and 2012, of whom 2,829 were diagnosed with Crohn’s disease (CD) and 5,428 with ulcerative colitis (UC). Across Norway’s health regions, the cumulative incidence of major surgery after 3 years varied from 11.4% to 17.1% for CD and from 4.6% to 6.9% for UC. The cumulative incidence of anti-TNF exposure varied from 20.9% to 31.4% for CD and from 8.0% to 13.5% for UC. The region with the lowest anti-TNF use had the highest surgery rates for both UC and CD. Conclusions: Cumulative incidence of anti-TNF exposure and surgery varied significantly across Norway’s health regions during the three first years after IBD diagnosis.

Long-term data regarding switching from originator infliximab to biosimilar CT-P13 are sparse. Concerns about increased immunogenicity after switching have been raised. We aimed to study the effectiveness, safety and immunogenicity after switching from originator infliximab to CT-P13 in a real-world IBD population with 18 months prospective follow-up.All adult IBD patients treated with originator infliximab at the Department of Gastroenterology, Oslo University Hospital, were switched to CT-P13 and followed prospectively for 18 months. The primary endpoints were (i) the proportion of patients remaining on CT-P13 18 months after switching and (ii) immunogenicity during 18 months after switching. The secondary endpoints included (i) adverse events, (ii) changes in disease activity, C-reactive protein, anaemia, faecal calprotectin, infliximab dose and interval and p-infliximab.In total, 143 IBD patients were switched, 99 with Crohn's disease and 44 with ulcerative colitis. Altogether, 130 (91%) remained on CT-P13 throughout 18 months. Two patients developed ADAs at moderate level and discontinued CT-P13. Another 10 patients discontinued CT-P13 (two due to loss of response without ADAs, four due to adverse events, and four in remission and a personal wish to stop). There was no overall change in disease activity scores or in the other studied variables except for p-infliximab, which increased significantly.The present study provides valuable evidence for the safety and effectiveness of switching from originator to biosimilar infliximab over a prolonged period of 18 months and demonstrates that switching was well tolerated and did not affect the long term clinical outcome.

Background The efficacy and safety of anti-TNF treatment for ulcerative colitis (UC) have been well documented in clinical trials. More data are required to increase knowledge on treatment success in a real world setting. This study reports real world data on treatment success, drug persistence and safety of anti-TNF treatment in patients with UC. Methods Patients with UC starting anti-TNF treatment with infliximab (IFX) or adalimumab (ADA) between January 2014 and December 2019 at Oslo University Hospital in Norway were included in a retrospective review of medical records. Eligible patients were biologically naïve adults (≥18 years) with no history of UC-related surgery. Follow-up was 12 months. Drug persistence was defined as the proportion of patients still receiving first-line anti-TNF treatment without addition of a second biologic agent. Remission was defined as i) clinical remission (six-point Mayo Score Results In total, 116 patients were included (mean age 35.5 ±13.9 years (SD), 58% male), of which 95 received IFX treatment and 21 ADA. Drug persistence was 74%. Treatment success by different definitions of remission and remission rates for drug persistent patients according to these definitions are reported in the table. SAEs were recorded on 18 occasions (four immediate infusion reactions, two colectomies, five infections and seven other events). Conclusion Treatment success by the strictest definition of remission was 40%. Of drug persistent patients, 44% were not in remission when applying the same definition. Whether these results reflect inadequacies in definitions of remission, a tendency for clinicians to let other variables guide treatment or a delay in drug switching warrants further investigation.

Background With the development of new drugs for inflammatory bowel disease (IBD), the role of thiopurines in the therapeutic algorithm of Crohn’s disease (CD) and Ulcerative Colitis (UC) is questioned. We aimed to investigate the current practice and future perspective of IBD physicians regarding the efficacy, safety, and role of precision medicine of thiopurines in IBD. Methods A 29-question web-based survey was developed and distributed to IBD physicians internationally, via national IBD associations and word of mouth. The final survey form was reviewed and approved by the clinical committee of ECCO. In the absence of a universal definition of an “IBD expert”, we defined them as senior physicians observing more than 20 patients per week. Results Complete answers from 408 physicians from 50 countries were obtained, the majority from European countries. Participants were mainly experienced physicians in IBD, with 26.0% meeting our definition of “IBD expert”. Only four physicians reported not using thiopurines in clinical practice. Azathioprine was the most used drug (97.1% of participants), while 61.3% of physicians reported using mercaptopurine; only 6.6% of participants used thioguanine. Most respondents used thiopurines in both monotherapy and in combination therapy, for both CD and UC, and consider them as effective treatments (Figures 1 and 2). Respondents tended to consider thiopurines as drugs with a good safety profile, with the agreement of 61.5% of the overall cohort; this was true especially in patients aged between 30 and 50 years old, with the agreement of 80.2% of the overall cohort (Figure 3). Access to TPMT activity assessment and metabolites measurement varied regionally. Physicians considered access to metabolites measurement as an important tool to improve thiopurines’ efficacy and safety, and to increase confidence when prescribing these drugs (Figure 4). Only a minority of the physicians (~6%) considered that thiopurines will not be used in the future in IBD, while 57.8% believed they will still be used both in mono and combination therapy in CD and UC. Conclusion Despite the many emerging treatments in IBD, thiopurines will still be part of the treatment algorithm of both CD and UC in the future. Access to tools for precision medicine varies around the globe, and wider implementation of these instruments, especially metabolite measurement, may improve confidence in thiopurines prescription, improving safety and efficacy.

Background and aims An increased prevalence of irritable bowel syndrome [IBS]-like symptoms has been reported in patients with ulcerative colitis [UC]. Whether ongoing inflammation increases the prevalence of such symptoms is unknown. The aims of this study were to determine the prevalence of IBS-like symptoms in a population-based cohort of UC patients 20 years after diagnosis, and to assess the possible association between such symptoms and ongoing inflammation. Methods Patients diagnosed with UC between 1990 and 1994, in a geographically well-defined area, were included in a prospective follow-up study, and IBS symptoms according to Rome III criteria were recorded 20 years after diagnosis. The patients underwent colonoscopy with biopsies and/or the level of faecal calprotectin was analysed. Results A total of 260 patients answered the Rome III questionnaire. The overall prevalence of IBS-like symptoms was 27%. In patients who had no signs of inflammation in colonic biopsies [n = 96] [deep remission], the prevalence was 29%. No difference in prevalence of IBS-like symptoms was found between patients with ongoing inflammation and patients in deep remission. Conclusions IBS-like symptoms in UC patients are frequent after 20 years of disease. Deep remission did not change the frequency of IBS-like symptoms.

Background With 25% prevalence of Crohn's disease, Familial GUCY2C diarrhea syndrome (FGDS) is a monogenic disorder potentially suited to study initiating factors in inflammatory bowel disease (IBD). We aimed to characterize the impact of an activating GUCY2C mutation on the gut microbiota in patients with FGDS controlling for Crohn's disease status and to determine whether changes share features with those observed in unrelated patients with IBD. Methods Bacterial DNA from fecal samples collected from patients with FGDS (N = 20), healthy relatives (N = 11), unrelated healthy individuals (N = 263), and IBD controls (N = 46) was subjected to sequencing of the V3-V4 region of the 16S rRNA gene to determine gut microbiota composition. Food frequency questionnaires were obtained from patients with FGDS and their relatives. Results Compared with healthy controls, FGDS displayed prominent changes in many microbial lineages including increase in Enterobacteriaceae, loss of Bifidobacterium and Faecalibacterium prausnitzii but an unchanged intraindividual (alpha) diversity. The depletion of F. prausnitzii is in line with what is typically observed in Crohn's disease. There was no significant difference in the dietary profile between the patients and related controls. The gut microbiota in related and unrelated healthy controls was also similar, suggesting that diet and familial factors do not explain the gut microbiota alterations in FGDS. Conclusions The findings support that the activating mutation in GUCY2C creates an intestinal environment with a major influence on the microbiota, which could contribute to the increased susceptibility to IBD in patients with FGDS.

Background Magnetic resonance enterography (MRE) has become an important tool in the diagnosis and follow-up of Crohn’s disease (CD). MRE findings are used in the calculation of the Lémann index (LI), a score that quantifies accumulated bowel damage. However, calculating the score is demanding; thus, serum biomarkers reflecting tissue damage and fibrosis are warranted for monitoring purposes. Increased extracellular matrix (ECM) remodelling and collagen tissue deposition is the result of accumulated bowel damage, eventually leading to intestinal fibrosis; particularly, the basement membrane and interstitial matrix are affected. We aimed to investigate ECM serum biomarkers of type III collagen formation (PRO-C3), type IV collagen degradation (C4M), degradation of citrullinated vimentin (VICM) and their association with LI and the degree of bowel wall fibrosis assessed by contrast-enhanced MRE in CD patients. Methods Serum from CD patients was analysed (n = 85, part of IBSEN population). Competitive ELISA was applied for the quantification of PRO-C3, C4M and VICM in the serum samples. The LI score was calculated based on the surgical history, MRE findings and the endoscopy findings. The suggested cut-off for substantial bowel damage is LI >/= 2. Increased contrast enhancement of the bowel wall at 5 min and the presence of stenosis on MRE was considered severe fibrosis. Student’s t-test, Spearman’s r correlation and one-way-ANOVA with FDR correction was applied for statistical analysis. Results Serum levels of C4M were elevated in patients with confirmed fibrosis by contrast MRE compared with patients without fibrosis (p = 0.031, AUC: 0.61) (Figure 1A). VICM correlated to the LI score in CD patients (r = 0.26, p = 0.015) and serum VICM levels were elevated in patients with an LI score >2 (p = 0.005, AUC: 0.67) (Figure 1B). VICM was significantly associated with intestinal damage for LI > 20 (LI 0 vs. >20: p = 0.005, AUC: 0.72). PRO-C3 was not associated with intestinal damage or intestinal fibrosis. Conclusion Our results indicate that the accumulated intestinal damage and the bowel wall fibrosis in CD are associated with elevated serum levels of VICM and C4M, respectively. Thus, serological biomarkers of basement membrane degradation and inflammation may be a useful tool to monitor intestinal tissue damage and fibrosis development.

Background Biological therapy has been suggested to decrease surgery and hospitalisation risk in patients diagnosed with inflammatory bowel disease (IBD). During 2010 to 2016, the use of biologics in Denmark (DEN), Sweden (SWE) and Norway (NOR) increased dramatically and the time to first biologic treatment declined.1 However, the impact of increasing use of biologics on disease outcomes remains to be shown in real-life practice. In this nationwide study in three Nordic countries, we aimed to investigate trends in surgery and hospitalisation rates in IBD patients in the biological era.1 Høivik ML et al. Time to first treatment with biologic agents for Ulcerative Colitis and Crohn’s Disease across four Nordic countries: Results from the TRINordic study, Submitted to ECCO 2020. Methods A total number of 67 758 IBD patients (42 894 patients with ulcerative colitis (UC) and 24 864 Crohn’s disease (CD) diagnosed during the period from 2010 to 2017 in DEN, NOR and SWE were included using the National Patient Registries. Patients were required to have 1-year follow-up; results are limited to patients diagnosed between 2010 and 2016, inclusive. Using the unique personal identification number, individual-level information on surgery, hospitalisation and drug treatment were extracted from the National Patient Registries and the National Prescription Registries. Disease outcomes within two years after diagnosis were compared across annual cohorts. Results During 2010 to 2016, 2-year surgery rates in CD patients showed a non-significant decline from 11.9% in 2011 to 9.5% in 2016 in SWE while remaining stable in NOR and DEN (Figure 1). No temporal pattern in surgery risk was observed for UC. The proportion of CD patients being hospitalised within two years from diagnosis declined in SWE and NOR from 52.3% and 51.0% in 2011 to 47.3% and 38.5% in 2015 (p < 0.001), respectively, while hospitalisation in UC remained stable. In contrast, 2-year hospitalisation rates in DEN increased in CD from 27.0% in 2011 to 31.5% in 2016 (p = 0.045) and similarly in UC from 20.4 to 35.0% (p < 0.001), respectively (Figure 2). Conclusion No clear pattern was seen in two-year surgery and hospitalisation rates in IBD patients during 2010 to 2017 despite a concurrent increase in biological use in all countries. However, differences in treatment practices across countries might influence these findings. The impact of increased biological use on long-term outcomes in IBD remains to be shown.

Background Real-world data on time from diagnosis to first biologic treatment is limited for ulcerative colitis (UC) and Crohn’s disease (CD) patient populations. Methods This retrospective observational study collected data from the National Patient Registries and National Prescription Registries in Sweden (data on biologic use was only available for Stockholm [STK], Norway [NOR], Denmark [DEN]) and one university hospital database (Turku, Finland [FIN]) during 2010–2017 to investigate time from diagnosis to first biologic treatment for UC and CD. Patients with ≥2 ICD-10 diagnosis codes for UC (K51) or CD (K50) from 2010 or later were included; patients were classified according to their last code. The look-back period for SWE was until 2000, for NOR until 2008, for DEN until 1995, and for FIN until 2004. Time to first biologic was defined as the period from the first UC or CD code to first biologic record. In FIN, it was only possible to investigate infliximab (IFX). Results A total of 47,568 patients were included (STK n = 5594, NOR n = 20,761, FIN n = 2118, DEN n = 19,095). Of them, 30 397 patients had UC and 17 171 CD diagnosed during 2010–2017. Time to first biologic following diagnosis of UC or CD was decreased over time. For patients diagnosed with CD in 2015, in STK, NOR, FIN, and DEN, 30%, 35%, 25%, and 26%, respectively, received a biologic within 2 years; in 2010, the proportions were less than 10%, 20%, 5%, and 22%, respectively. FIN results may be attributed to only IFX use captured in the data sources. NOR had in most cohorts the shortest time between diagnosis and first treatment with a biologic agent, e.g. 33%, 35%, 36%, 34% and 33% of patients diagnosed with CD in 2011, 2012, 2013, 2014 and 2015, respectively, received a biologic already one month after diagnosis compared with 2%, 1%, 3%, 4% and 6%, respectively, in STK, 7%, 5%, 9%, 4% and 5%, respectively, in FIN and 3%, 10%, 28%, 12% and 23%, respectively, in DEN. Fewer UC than CD patients received biologics, but the time to first biologic was shortened to the same extent (Figure 1 and 2, respectively). In NOR, FIN and DEN, the most common biologic used was IFX for UC and CD, e.g. 18%, 14% and 15%, respectively, of UC and 35%, 17% and 35%, respectively, of CD patients diagnosed in 2015 had received IFX; in STK it was IFX for UC (8% of patients diagnosed in 2015) and adalimumab for CD (20% of patients diagnosed in 2015). Conclusion This retrospective observational study of >45 000 patients with inflammatory bowel disease in four Nordic countries showed reduced time between diagnosis and first biologic from 2010 to 2017, with the shortest time between diagnosis and first biologic in Norway. IFX was most commonly used.

Background: Pain and vitamin D deficiency are common in inflammatory bowel disease (IBD). Disease activity, fatigue, frequent relapses, prior surgery and psychological factors all seem to influence the experience of pain in IBD. Vitamin D deficiency has been associated with muscle and skeletal pain. This study aimed to determine whether there is an association between vitamin D deficiency and severity of pain in patients with IBD, and to investigate the influence of other socio-demographic and psychological variables on the experience of pain. Methods: Patients with IBD were recruited from nine hospitals in Norway in a multicenter cross-sectional study. The Brief Pain Inventory (BPI) questionnaire was used to measure pain. Disease activity was assessed using clinical disease activity indices, C-reactive protein (CRP) and fecal calprotectin. Regression models were fitted to explore a possible association between 25-hydroxyvitamin D and pain severity. Results: Of 407 patients included in the analyses, 229 (56%) had Crohn&rsquo, s disease (CD) and 178 (44%) had ulcerative colitis (UC). Vitamin D deficiency was present in half (203/407) of patients. Presence of pain was reported by 76% (309/407). More severe pain was associated with female gender and increased disease activity scores, but not with increased CRP or fecal calprotectin. In CD, patients without prior intra-abdominal surgery reported more severe pain. In multivariate analyses, there was no association between 25-hydroxyvitamin D and pain severity. Conclusions: In this study, no significant association between pain severity and vitamin D deficiency was revealed in patients with IBD.

Background: Patients with inflammatory bowel disease (IBD) often suffer from musculoskeletal manifestations. Health-related quality of life (HRQoL) and fatigue are known to be associated with IBD activity and musculoskeletal complaints. The aim of this study was to determine the association between spondyloarthritis, arthralgia, or back pain and the patient-reported outcomes of HRQoL and fatigue in IBD patients 20 years after their diagnosis. Methods: The IBSEN cohort was followed prospectively for 20 years. At the 20-year follow-up, the patients answered detailed questionnaires regarding rheumatological manifestations, intestinal symptoms, HRQoL, and fatigue. Multiple regression analyses were used to evaluate associations between spondyloarthritis or joint symptoms and HRQoL or fatigue. Sex, IBD diagnosis, and age were included in all the multiple regression models, in addition to other clinically relevant confounders. Results: In total, 441 patients (94%) completed the questionnaires at the 20-year follow-up. The criteria for spondyloarthritis (axial or peripheral) were fulfilled in 158 patients (36%), current back pain during the previous 3 months was reported by 79 patients (18%), and current arthralgia was reported by 178 patients (40%). Current back pain and arthralgia were independently associated with lower HRQoL, higher levels of fatigue, and chronic fatigue. A diagnosis of spondyloarthritis was not associated with reduced HRQoL or fatigue when adjusted for possible confounders. Conclusions: Current joint symptoms in IBD patients 20 years after diagnosis were associated with poorer HRQoL, higher levels of fatigue, and chronic fatigue, whereas spondyloarthritis did not impact HRQoL or fatigue negatively in this cohort.

Fatigue is a major concern for patients with ulcerative colitis (UC) and Crohn's disease (CD), but evidence from population-based studies regarding fatigue in long-standing inflammatory bowel disease (IBD) patients is scarce. Our aims were to assess fatigue scores and the prevalence of chronic fatigue in IBD patients 20 years after diagnosis and to identify variables associated with fatigue in this cohort.Twenty years after diagnosis, patients from a cohort with incident IBD were invited to a follow-up visit that included a structured interview, a clinical examination, laboratory tests and the Fatigue Questionnaire (FQ). Fatigue scores were obtained, and factors associated with fatigue were assessed via linear and logistic regression analyses.Of the 599 invited patients, 440 (73.5%) completed the FQ. Among those with active disease, we found significantly higher fatigue scores than among those with quiescent disease (fatigue scores: UC 17.1 versus 12.4, p .001, and CD 17.5 versus 13.3, p .001). The fatigue scores of those with quiescent disease were comparable with those of the reference population. Chronic fatigue was more frequent among IBD patients than in the reference population. Factors associated with fatigue included self-perceived disease activity, poor sleep quality, anxiety and depression.At 20 years after IBD diagnosis, fatigue scores were higher and chronic fatigue was more frequent among IBD patients with active disease than in the reference population and among those with quiescent IBD. Subjectively perceived disease activity, sleep quality, anxiety and depression were associated with fatigue in IBD patients.

Objective Gut microbiota could influence gut, as well as hepatic and biliary immune responses. We therefore thoroughly characterised the gut microbiota in primary sclerosing cholangitis (PSC) compared with healthy controls (HC) and patients with ulcerative colitis without liver disease. Design We prospectively collected 543 stool samples. After a stringent exclusion process, bacterial DNA was submitted for 16S rRNA gene sequencing. PSC and HC were randomised to an exploration panel or a validation panel, and only significant results (p

ObjectiveThe association between ulcerative colitis (UC) and colorectal cancer (CRC) is widely accepted, although attenuated risk has been reported in recent years. Colonoscopic surveillance is recommended with intervals based on established clinical risk factors. Nevertheless, a significant number of patients develop interval cancers, indicating the need of improved individualised assessment. In the present study, we evaluated clinical risk factors associated with CRC during a prescheduled follow-up 20 years after diagnosis, the IBSEN study.DesignA population-based inception cohort of patients diagnosed with inflammatory bowel disease from 1 January 1990 until 31 December 1993, prospectively followed at 1, 5, 10 and 20 years after diagnosis. A total of 517 patients with UC were included; 264 (51 %) men; median age at inclusion 37.4 years (4–88).ResultsThe overall incidence of CRC was 1.6% (8/517) at a 20-year follow-up. The total lifetime risk of CRC prior to or after UC diagnosis was 2.3%. (12/517). Patients older than 70 years at diagnosis had a 15-fold higher risk of CRC compared with those diagnosed when younger than 40 years, with HR 15.68 (95% CI: 1.31 to 187.92). Neither sex, first-degree relative with CRC, extent of colitis nor primary sclerosing cholangitis affected the risk of CRC.ConclusionThe risk of CRC in UC was low and comparable with the risk of CRC in the background population of Norway.

Background The use of biologic therapy has increased significantly during the last decade. In 2015, one in three Crohn’s disease (CD) patients and one in five ulcerative colitis (UC) patients had received biologics within 2 years of diagnosis 1 in Denmark (DEN), Sweden (SWE) and Norway (NOR). Whether this change in treatment strategy has resulted in changes in the use of conventional drugs (5-aminosalicylates [5-ASA], immunomodulators [IM] or corticosteroids) remains unknown. An aim of this study was to investigate the use of these drugs in the biological era.1 Høivik ML et al. Time to first treatment with biologic agents for ulcerative colitis and Crohn’s disease across four Nordic countries: Results from the TRINordic study, Submitted to ECCO 2020. Methods A total of 67,758 incident IBD patients (42,894 UC, 24,864 CD) diagnosed between 2010 to 2017 were included in a nationwide cohort in DEN, NOR and SWE. Information on drug treatment was extracted from the National Patient Registries and the National Prescription Registries. Patients were required to have at least 1-year of follow-up post-diagnosis; results are limited to patients diagnosed between 2010 to 2016, inclusive. Results During 2010 to 2016, cumulative exposure to 5-ASA in CD patients at 2 years after diagnosis declined from 19.0%, 39.0% and 50.5% in 2011 to 16.3%, 31.1% and 39.6% in 2016 in DEN, NOR and SWE, respectively (p < 0.001). The opposite trend was observed in UC where 87.3–91.1% received 5-ASA within 2 years in 2015 compared with 75.8–87.3% in 2011 (p < 0.001) (Figure 1). In all countries, corticosteroid use remained stable in CD with more than half of patients receiving corticosteroids within 2 years of diagnosis. In UC, corticosteroid use within 2 years of diagnosis increased in NOR from 42.2% in 2011 to 51.6% in 2015 (p < 0.001) but remained stable in DEN and SWE (Figure 2). The use of IM within 2 years increased in CD patients in NOR and SWE from 36.5% and 40.8% in 2010 to 51.3% and 52.1% in 2015 (p < 0.001). IM were less frequently used in UC but increased similarly from 14.0% and 21.1% in 2010 to 22.5% and 26.4% in 2015 (p < 0.001). In DEN, IM use remained stable over time (Figure 3). Conclusion The use of 5-ASA declined over time in patients diagnosed with CD but increased over time in patients diagnosed with UC. Corticosteroid use remained stable in CD but increased over time in UC patients in NOR. The increasing and earlier use of biologics was accompanied by increasing use of IM in all countries. While this could suggest a more aggressive treatment approach, differences in treatment practices across countries might contribute to these findings. The impact of changes in treatment strategies on disease outcomes remains to be shown.

Objectives: Peripheral arthritis and related musculoskeletal manifestations, often classified as peripheral spondyloarthritis, are frequently seen in patients with inflammatory bowel disease (IBD). Few long-term studies have reported on the prevalence of these conditions. The aim of this study was to determine the prevalence of IBD-related peripheral arthritis and peripheral spondyloarthritis in IBD patients during 20 years of disease course, and to assess whether these conditions were associated with the intestinal IBD severity and activity. Materials and methods: In an inception cohort (the IBSEN study), IBD patients were followed prospectively for 20 years. At the 5 year follow-up the patients underwent a rheumatological examination and at the 20 year follow-up they completed a questionnaire with identical questions. When peripheral arthritis was characteristic and not explained by other specific diagnoses, it was defined as IBD-related peripheral arthritis. The Assessment of Spondyloarthritis International Society criteria were used to define peripheral spondyloarthritis, including patients with peripheral arthritis, enthesitis and/or dactylitis. Results: After 20 years of follow-up, 441 patients were included (296 ulcerative colitis and 145 Crohn’s disease). The prevalence of IBD-related peripheral arthritis was 17.2% and peripheral spondyloarthritis 27.9% during the disease course. IBD severity and activity were not different between those with a history of IBD-related peripheral arthritis or peripheral spondyloarthritis and those without. A higher proportion of women had IBD-related peripheral arthritis and peripheral spondyloarthritis. Conclusion: During 20 years of disease course, more than every sixth patient had suffered from IBD-related peripheral arthritis and every fourth from peripheral spondyloarthritis.

Identifying ulcerative colitis (UC) patients with increased risk of colectomy is essential for appropriate treatment. We aimed to develop a prediction model assessing the risk of having colectomy within the first 10 years after diagnosis.A population-based inception cohort of UC patients diagnosed in south-eastern Norway between 1990 and 1994 has been followed for 10 years. Altogether 519 patients were recruited including 49 patients who were colectomized. Based on the best-fitted multivariate model, the probabilities of colectomy were computed for selected levels of baseline covariates, and the results arranged in a prediction matrix. The following risk factors at diagnosis were analyzed: age, smoking, sex, disease extent, weight loss and fever and need for systemic steroids. Biochemical markers included C-reactive protein (CRP,30 or ≥30 mg/l); erythrocyte sedimentation rate (ESR,30 or ≥30 mm/h) and hemoglobin (Hgb,10.5 or ≥ 10.5 g/dL).Extent of disease, age (40 years, ≥40 years), need for systemic steroids and CRP or ESR (30 or ≥30) at diagnosis were independently associated with colectomy and were combined in a prediction matrix. The probabilities of colectomy during the follow-up period ranged from 2.6% to 40.1% depending on the combination of predictors at diagnosis.Our prediction model revealed significant differences in the probability of undergoing colectomy during a 10-years course of disease, which supports an early individualized treatment approach in UC.

Background Anti-tumor necrosis factor α (anti-TNF-α) is important in the treatment of inflammatory bowel disease, but some patients experience only a partial response. In these patients, a combination of anti-TNF-α and vedolizumab (VDZ) may act as a bridge until the full VDZ effect occurs. At present, clinical data on combination treatment with anti-TNF-α and VDZ are not available. The aim of this case series was to evaluate the safety and clinical response of combination therapy with anti-TNF-α and VDZ in clinical practice. Methods All patients started on combination treatment with anti-TNF-α and VDZ from November 2015 to July 2016 were prospectively followed for at least 12 months. Results Six patients with ulcerative colitis and four patients with Crohn's disease received combination treatment. These patients were followed for a median of 1712-20 months. No more adverse events than expected with anti-TNF-α alone were observed during combination treatment. At the end of follow-up, all patients were in clinical remission, and 8 patients could discontinue anti-TNF-α treatment and receive VDZ monotherapy. Two of the patients with Crohn's disease required combination treatment throughout follow-up to obtain sustained remission. Conclusion Our findings suggest that combination treatment with anti TNF-α and VDZ is safe and might represent a long-term treatment option in selected patients.

Background Patients with inflammatory bowel disease [IBD] often suffer from rheumatic manifestations, including inflammatory back disorders. The prevalence of these disorders late in the course of IBD is poorly investigated. The aim of this study was to estimate the prevalence of inflammatory back disorders in patients with IBD 20 years after diagnosis, and to investigate possible associations with IBD severity, HLA-B27, and the NOD2 genotype. Methods A population-based cohort [the IBSEN study] was followed prospectively for 20 years. Information covering IBD activity and rheumatic diseases was collected at the regular follow-ups. HLA-B27 and NOD2 were analysed as present or absent. Results At 20 years, 599 members of the original cohort were alive, of whom 470 [78.5%] were investigated [314 ulcerative colitis and 156 Crohn's disease patients]. Ankylosing spondylitis was diagnosed in 21 patients [4.5%], axial spondyloarthritis was diagnosed in 36 patients [7.7%], and inflammatory back pain was diagnosed in 54 patients [11.5%]. Chronic back pain [back pain > 3 months] was present in 220 patients [46.8%]. HLA-B27 was associated with ankylosing spondylitis, axial spondyloarthritis, and inflammatory back pain, whereas no significant association was found for NOD2. A more chronic IBD course was associated with axial spondyloarthritis. Conclusions Our data revealed a high prevalence of ankylosing spondylitis, axial spondyloarthritis, and inflammatory back pain 20 years after the IBD diagnosis. HLA-B27 but not NOD-2 was a predisposing factor for the inflammatory back disorders in IBD patients. Axial spondyloarthritis was associated with a more chronic active IBD disease course.

Background & Aims Magnetic resonance enterography (MRE) is used to evaluate the extent and complications of Crohn's disease (CD). MRE results are used in calculation of the Lemann index (LI) score, which quantifies bowel damage. The long-term outcomes of CD are uncertain; we aimed to assess bowel disease and damage in patients with CD for 20 years using MRE and the LI. Methods We performed a follow-up analysis of a population-based cohort of 237 patients in southeastern Norway diagnosed with CD from 1990 to 1993. Twenty years after diagnosis, 156 attended the evaluation in which they were offered routine clinical blood tests and colonoscopies. Ninety-six patients were examined by MRE and LI scores were calculated. The independent association of the LI score with clinical variables was examined by univariate analysis. Results Sixty-five patients (67.7%) had CD manifestations based on findings from MRE (36.9%), colonoscopy (29.2%), or both (33.9%). MRE findings changed disease classification for 8 patients (8.3%). The median LI score was 4.6 (interquartile range, 17.5) and associated with younger age ( P = . 02), complicated ileocolonic phenotype ( P 001), and use of biologic ( P 001), or immunosuppressant therapies ( P = . 045). Factors independently associated with LI score during the follow-up period were age, complicated disease, use of medication, and markers of inflammation. Conclusions In a population-based study of 237 patients with CD in Norway, we found that almost 68% had imaging features of CD, half of which were only detectable by MRE. LI score associated with ongoing active disease. Young age, complicated disease, and persistent inflammation were associated with bowel damage.

Background: Biological agents, mainly tumor necrosis factor-α inhibitors, play an important role in the treatment of inflammatory bowel disease (IBD). These drugs are expensive and constitute a major cost in the IBD care. In 2013, the first biosimilar monoclonal antibody, infliximab (IFX), was approved in the EU. Key Messages: There has been considerable skepticism regarding the use of biosimilars. Both clinicians and patients have questioned the safety and efficacy of these new drugs. In particular, the extrapolation of treatment effects between patients with different diagnoses has been debated. Due to national negotiations, the price reductions vary considerably between countries. In Norway, the biosimilars Remsima® and Inflectra® come at a very favourable price, and have supplanted the originator Remicade® almost completely. The total sale of IFX has also increased, indicating that extended indications and increased doses are being implemented in clinical use. Conclusions: The introduction of biosimilars has raised questions not only about the efficacy and safety but also about health politics. There is reason to believe that the introduction of cheaper biosimilars will change the clinical use of biologics.

Summary Background The point prevalence estimates of anaemia in patients with inflammatory bowel disease (IBD) range between 6% and 74%. The variation is probably due to differences in the definition of anaemia and the study populations. Aim To retrospectively determine the prevalence of anaemia at diagnosis and at the 1-, 5- and 10-year follow-ups in patients with IBD from a prospectively followed, population-based inception cohort (the IBSEN Study). To compare the prevalence of anaemia after a 10-year disease course with the prevalence of anaemia in the background population, and to assess clinical factors associated with anaemia at diagnosis and during follow-up. Methods Newly diagnosed IBD patients were included in a population-based, prospective cohort. Follow-up was performed at 1, 5 and 10 years. All visits included clinical examinations and blood samples. Anaemia was defined according to the WHO. Results A total of 756 patients (UC, n = 519 and CD, n = 237) were included; 48.8% of CD and 20.2% of UC patients were anaemic at diagnosis (P

Vitamin D deficiency is common in inflammatory bowel disease (IBD). The aims of the present study were to determine the prevalence of vitamin D deficiency and to identify clinical and epidemiological variables associated with vitamin D deficiency in an outpatient population with IBD.Participants were recruited from nine hospitals in the southeastern and western regions of Norway as part of an observational, multicentre study from March 2013 to April 2014. Clinical and epidemiological data were collected by interview and from medical records. All analyses of serum 25-hydroxyvitamin D (25-OH-D) were performed in the same laboratory.In total, 49% (200/408) of the patients had a 25-OH-D concentration50 nmol/L, including 53% (122/230) of the Crohn's disease (CD) patients and 44% (78/178) of the ulcerative colitis (UC) patients. In CD patients, disease activity, measured as the HBI, was inversely associated with vitamin D deficiency. No such association was observed with the Simple Clinical Colitis Activity Index (SCCAI) scores in UC, but in UC patients, vitamin D deficiency was associated with elevated faecal calprotectin100 mg/kg. In patients with CD, there were significantly more relapses during the previous year in patients with vitamin D deficiency.Vitamin D deficiency was common, especially in CD, and was associated with increased disease activity, a relapsing disease course and higher inflammatory activity.