Bjørn Allan Moum

• Berset, Ingrid Prytz; Lerang, Frode; Moum, Bjørn Allan; Jahnsen, Jørgen; Grimstad, Tore Bjørn & Kristensen, Vendel Ailin [Show all 26 contributors for this article] (2026). Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial. Journal of Crohn's and Colitis. ISSN 1873-9946. 20(8). doi: 10.1093/ecco-jcc/jjag110. Full text in Research Archive Show summary

  Background and Aims: Anti-tumour necrosis factor (anti-TNF) treatment is effective in ulcerative colitis (UC). Optimal treatment duration is uncertain. This trial studies outcome after anti-TNF withdrawal compared to maintenance treatment in UC. Methods: In this prospective, multicentre, randomized, controlled, open-label non-inferiority study, patients in deep clinical, biochemical and endoscopic remission were randomized 1:1 to anti-TNF withdrawal or maintenance treatment. Primary endpoint was endoscopically confirmed remission (Mayo Endoscopic Score 0 or 1) after two years, including UC flares treated with anti-TNF, or non-biologic agents. Secondary endpoints were clinical remission, UC flare rate and treatment response. We needed 170 participants to show non-inferiority with a 15% margin. Results: Between June 2017 and December 2021, 172 UC patients from 19 Norwegian hospitals were randomized; 86 in each group. The per-protocol population was 163 patients. Nine patients were excluded due to consent withdrawal or protocol violation. Eighty percent (66/82) of anti-TNF withdrawal and 96% (78/81) of maintenance patients were in endoscopic remission after 2 years. UC flares occurred in 52% (45/86) of withdrawal and 12% (10/86) of maintenance patients. Anti-TNF retreatment was successful in 74% (20/27). Conclusion: Two years after anti-TNF withdrawal in UC patients in deep remission, endoscopically confirmed remission rate was significantly lower compared to maintenance treatment. Non-inferiority could not be proven. UC flare rate after anti-TNF withdrawal was high, but most were successfully treated. The majority did not receive AZA. Importantly, 48% of anti-TNF withdrawal patients remained in steroid-free remission. No significant predictors for UC activity after anti-TNF withdrawal were identified.

• Mahdy, Aya K. H.; ElAbd, Hesham; Kokubun, Érika Endo; Kriukova, Valeriia; Pesesky, Mitchell & May, Damon H. [Show all 24 contributors for this article] (2026). Multi-centered T cell repertoire profiling identifies alterations in the immune repertoire of individuals with inflammatory bowel disease across different disease stages. Genome Medicine. 18. doi: 10.1186/s13073-025-01575-w. Full text in Research Archive Show summary

  Abstract Background Inflammatory bowel disease (IBD) is an incurable immune-mediated inflammatory disease, affecting the gut with a high rate of primary- and secondary- loss-of-response to therapy. By investigating the T cell receptor repertoire of individuals with IBD, novel therapeutic and preventive strategies can be identified, and a better understanding of IBD can be obtained. Methods To identify and validate T cell clonotypes implicated in the pathogenesis of IBD, we profiled the T cell receptor alpha (TRA) repertoire of three cohorts containing treatment-naive, treated individuals, and individuals living with the disease for >20 years, resulting in an exhaustive dataset containing the TRA repertoire of 1,732 individuals. Results Using the generated datasets, we were able to replicate previous findings describing the expansion of Crohn’s-associated invariant T (CAIT) cells in individuals with Crohn’s disease (CD) in the three cohorts. Using a hypothesis-free statistical testing framework, we identified clonotypes that were associated with the disease at its different stages, e.g., at the time of diagnosis and decades post-diagnosis. By conducting a meta-analysis across the three cohorts, we were able to identify a set of clonotypes that were associated with the disease regardless of its stage. We validated our findings in a previously published independent test dataset from a German cohort, showing the robustness of the identified clonotypes. Conclusions The identified clonotypes are novel therapeutic targets to treat IBD, for example, through targeted depletion. By identifying antigens recognized by these T cells, a better understanding of the etiopathology of IBD, particularly CD, can be obtained.

• Jahnsen, Marte Eide; Detlie, Trond Espen; Eide, Geir Egil; Moum, Bjørn Allan; Reime, Marit Hegg & Jahnsen, Jørgen (2026). High-dose intravenous iron improves quality of life in patients with inflammatory Bowel disease and iron deficiency. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 61(2), p. 192–200. doi: 10.1080/00365521.2025.2608181. Full text in Research Archive Show summary

  Background Iron deficiency is common in patients with inflammatory bowel disease (IBD) and may lead to a variety of distressing symptoms negatively impacting quality of life. Aims This prospective observational cohort study aimed to assess quality of life, measured using the Short Form-36 (SF-36) questionnaire before and after treatment with high-dose intravenous iron in patients with IBD and iron deficiency. Materials and methods Over a 15-month period, 130 patients with a well-established diagnosis of IBD (either ulcerative colitis (UC) or Crohns disease (CD)) and confirmed iron deficiency were consecutively assessed for study eligibility at two university hospitals in South-Eastern Norway. Of these, 112 patients were included in the per protocol set. Demographic characteristics were recorded at study inclusion. Clinical, and biochemical variables, as well as SF-36 questionnaires were collected just before and 5–7 weeks after treatment with intravenous iron. Results An improvement was observed in six of the eight SF-36 domains six weeks after treatment with intravenous iron. Females had lower scores compared to males at both visits, but there were no differences between UC and CD patients. Both sexes and the two diagnoses had a significant increase in vitality scores. Haemoglobin level was a significant predictor for improvement of quality of life. Conclusions Treatment with high dose intravenous iron improves quality of life in IBD patients and iron deficiency and particularly in those with anaemia. The most significant improvements were observed in vitality and energy levels, suggesting a clinically meaningful change.

• Louis, Edouard; Sebastian, Shaji; Siegmund, Britta; Bossuyt, Peter; Danese, Silvio & Boer, Nanne de [Show all 15 contributors for this article] (2025). Long-Term Safety of Vedolizumab in Patients With Ulcerative Colitis/Crohn’s Disease: A Prospective Observational Study. Clinical Gastroenterology and Hepatology. ISSN 1542-3565. doi: 10.1016/j.cgh.2025.10.006. Full text in Research Archive Show summary

  Background & Aims This postauthorization safety study compared long-term safety of vedolizumab or other biologics in patients with ulcerative colitis (UC) or Crohn’s disease (CD). Methods This was a prospective, observational, multicenter cohort study in patients with UC or CD starting treatment with vedolizumab or other biologics (NCT02674308, EUPAS6469). The primary safety outcome was serious infections compared between cohorts using a Cox proportional hazards model adjusted by propensity score. Clinical effectiveness was a secondary outcome. Results The full analysis set comprised 5008 patients (vedolizumab: n = 2502; other biologic: n = 2506) and mean follow-up duration was 37.4 ± 14.1 months. Patients in the vedolizumab group had greater age, duration of disease, and concomitant medication use at baseline, indicating more advanced disease. In patients with UC, the incidence rate per 100 person-years of serious infections was 5.5 (95% confidence interval [CI], 4.7–6.5) (vedolizumab) and 7.0 (95% CI, 5.8–8.5) (other biologic), with an adjusted hazard ratio of 0.89 (95% CI, 0.69–1.15) (P = .38). In patients with CD, corresponding findings were 7.9 (95% CI, 6.8–9.1) (vedolizumab) and 6.5 (95% CI, 5.7–7.3) (other biologic) with adjusted hazard ratio of 1.15 (95% CI, 0.95–1.40) (P = .16). There were no safety issues relating to pregnancy, and no cases of progressive multifocal leukoencephalopathy were observed. There were 18 deaths in the vedolizumab group and 13 in the other biologics group. Clinical effectiveness was comparable between cohorts and was similar to the levels seen in other prospective observations of vedolizumab. Conclusions There was no new safety signal identified in relation to vedolizumab. Results regarding safety and effectiveness were consistent with the known profile of vedolizumab.

• Strande, Vibeke; Hagen, Milada; Lund, Charlotte; Asak, Øivind Wessel; Bengtson, May-Bente & Cetinkaya, Raziye Boyar [Show all 26 contributors for this article] (2025). Predicting severe inflammatory bowel disease: a risk matrix model based on the IBSEN III inception cohort. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 60(7), p. 716–727. doi: 10.1080/00365521.2025.2512591. Full text in Research Archive Show summary

  Background and aims: Identifying patients at risk of developing severe inflammatory bowel disease (IBD) can aid treatment decisions. However, predicting disease course remains challenging. We aimed to identify predictive factors associated with severe disease course in the first year after IBD diagnosis. Methods: Newly diagnosed adult (≥18 years) patients with IBD were recruited from a population-based inception cohort (IBSEN III study). Preselected baseline factors were tested for associations with severe disease course, defined as IBD-related hospitalisation, surgery, treatment with ≥2 steroid courses, >2 biologics and/or new event of complication (stricture, fistula, abscess only applicable Crohn's disease (CD)). From a best fitted multivariable logistic regression model stratified by diagnosis and age (18-40/>40 years), probability of severe disease for given combinations of predictive factors was summarised in prediction matrices. Results: At one-year follow-up, 90/559 (16%) patients with ulcerative colitis (UC) and 74/312 (24%) with CD had severe disease. Treatment with systemic steroids, vitamin D deficiency, Simple Clinical Colitis Activity Index >2, and hypoalbuminemia at diagnosis were all significantly associated with severe disease in UC patients. CD patients with stricturing or penetrating disease behaviour, systemic steroids and hypoalbuminemia at diagnosis were associated with severe disease course. The least favourable combination of these factors increased the probability of severe disease from 3% (95%CI[0-5%]) to 72% (95%CI[66-79%]) for UC and from 8% (95%CI[3-13%]) to 88% (95%CI[84-93%]) for CD. Conclusions: Our study identified predictive factors associated with severe disease the first year after diagnosis. The probability of severe disease summarised in matrices enables easy risk stratification.

• Helm, Thea Elisabeth; Høivik, Marte Lie; Anisdahl, Karoline; Buer, Lydia Celine Tansem; Warren, David & Bolstad, Nils [Show all 9 contributors for this article] (2024). Subcutaneous Vedolizumab Treatment in a Real-World Inflammatory Bowel Disease Cohort Switched From Intravenous Vedolizumab: Eighteen-Month Prospective Follow-up Study. Crohn's & Colitis 360. 6(1). doi: 10.1093/crocol/otae013. Full text in Research Archive Show summary

  Background: Vedolizumab has since 2021 been available as a subcutaneous formulation. We aimed to assess 18-month drug persistence and possible predictive factors associated with discontinuation, safety, serum drug profile, drug dosing, and disease activity in a real-world cohort of patients with inflammatory bowel disease switched from intravenous to subcutaneous vedolizumab maintenance treatment. Methods: Eligible patients were switched to subcutaneous vedolizumab and followed for 18 months or until discontinuation of subcutaneous treatment. Data on preferred route of administration, adverse events, drug dosing, serum-vedolizumab, disease activity, fecal calprotectin, and C-reactive protein were collected. Persistence was described using Kaplan–Meier analysis. The impact of clinical and biochemical variables on persistence was analyzed with Cox proportional hazard models. Results: We included 108 patients, and the estimated 18-month drug persistence was 73.6% (95% CI [64.2–80.1]). Patients in clinical remission at switch were less likely to discontinue SC treatment (HR = 0.34, 95% CI [0.16–0.73], P = .006), and patients favoring intravenous treatment at switch were almost 3 times more likely to discontinue (HR = 2.78, 95% CI [1.31–5.90], P = .008). Four patients discontinued subcutaneous vedolizumab due to injection site reactions. At 18 months, 88% of patients administered subcutaneous vedolizumab with an interval of ≥ 14 days, and serum-vedolizumab was 39.1 mg/L. Disease activity was stable during follow-up. Conclusions: Three of the four patients remained on subcutaneous vedolizumab after 18 months, a large proportion received treatment at standard dosing intervals, and disease activity remained stable. This indicates that switching from intravenous to subcutaneous vedolizumab treatment is convenient and safe.

• Anisdahl, Karoline; Lirhus, Sandre Svatun; Medhus, Asle Wilhelm; Moum, Bjørn Allan; Melberg, Hans Olav & Høivik, Marte Lie (2024). Frailty risk and treatment strategy in elderly-onset inflammatory bowel disease. A Norwegian nationwide population-based registry study. Digestive and Liver Disease. ISSN 1590-8658. doi: 10.1016/j.dld.2024.02.002. Full text in Research Archive Show summary

  Background/Aims: To determine real-world medical and surgical treatment patterns in elderly-onset inflammatory bowel disease in a nationwide cohort, and to investigate associations between frailty and treatment choices.<p> <p>Methods: Norwegian health registries were used to identify adult-onset (born 1950–1989) and elderlyonset (born 1910–1949) patients with Crohn’s disease (CD) and ulcerative colitis (UC) diagnosed 2010– 2017 (n = 13,006). Patients were classified as no, low and intermediate/high frailty risk after the Hospital Frailty Risk Score. Outcomes included use of medical and surgical treatment. <p>Results: Within five years, elderly-onset patients received less biologics (13% [CD], 7% [UC]) and immunomodulators (24% [CD], 11% [UC]), and major surgery was more frequent (22% [CD], 9% [UC]) than in adult-onset. Respective log rank tests were significant (p < 0.01). Compared to no frailty risk groups, elderly-onset UC with intermediate/high frailty risk had lower probability of starting biologics (4% versus 9%), immunomodulators (7% versus 13%) and 5-aminosalisylic acids (66% versus 84%), and elderly-onset CD with intermediate/high frailty risk had higher probability of starting prednisolone (67% versus 49%). Respective log rank tests were significant (p < 0.05). <p>Conclusions: Elderly-onset patients received less biologics and immunomodulators and a larger proportion underwent major surgery. Frailty risk in elderly-onset patients was associated with increased use of prednisolone, and less use of 5-aminosalisylic acids, immunomodulators and biologics.

• Follin-Arbelet, Benoit; Småstuen, Milada Cvancarova; Hovde, Øistein; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn Allan (2023). Incidence of cancer in patients with ulcerative colitis 30 years after diagnosis (the IBSEN study). Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 58(11). doi: 10.1080/00365521.2023.2223709. Full text in Research Archive Show summary

  Objectives: Patients with ulcerative colitis (UC) have shown an increased risk for colorectal cancer, hepatobiliary, hematologic, and skin cancers, but updated long-term data is needed. This study aimed to estimate the risk of cancer in patients with UC compared to the general Norwegian population, in a population-based cohort (the IBSEN study), 30 years after diagnosis; and to identify possible risk factors associated with cancer. Methods: The IBSEN cohort prospectively included all incident patients between 1990 and 1993. Cancer incidence data were obtained from the Cancer Registry of Norway. The overall and cancer-specific hazard ratios (HR) were modelled using Cox regression. Standardized incidence ratios were estimated compared to the general population. Results: In total, the cohort included 519 patients, and 83 cases were diagnosed with cancer. There was no statistically significant difference in the overall cancer risk (HR = 1.01, 95% CI: [0.79-1.29]) and colorectal cancer risk (HR = 1.37, 95% CI: [0.75-2.47]) between patients and controls. The incidence of biliary tract cancer was higher than expected (SIR = 9.84, 95%CI: [3.19-20.15]), especially when UC patients suffered from primary sclerosing cholangitis. Male UC patients were also more at risk of being diagnosed with hematologic malignancies (HR = 3.48, 95% CI: [1.55-7.82]). Being prescribed thiopurines was associated with a higher risk of cancer (HR = 2.03, 95% CI: [1.02-4.01]). Conclusions: At 30 years after diagnosis, the risk of all cancer in patients with UC was not significantly increased compared with the general population. However, the risks of biliary tract cancer and hematologic cancers were increased, particularly in male patients.

• Horrigan, Jamie M; Louis, Edouard; Spinelli, Antonino; Travis, Simon; Moum, Bjørn Allan & Salwen-Deremer, Jessica [Show all 11 contributors for this article] (2023). The Real-World Global Use of Patient-Reported Outcomes for the Care of Patients with Inflammatory Bowel Disease. Crohn's & Colitis 360. 5(2). doi: 10.1093/crocol/otad006. Full text in Research Archive Show summary

  Abstract Background Many patient-reported outcomes (PROs) have been developed for inflammatory bowel disease (IBD) without recommendations for clinical use. PROs differ from physician-reported disease activity indices; they assess patients’ perceptions of their symptoms, functional status, mental health, and quality of life, among other areas. We sought to investigate the current global use and barriers to using PROs in clinical practice for IBD. Methods A cross-sectional survey was performed. An electronic questionnaire was sent to an international group of providers who care for patients with IBD. Results There were 194 respondents, including adult/pediatric gastroenterologists, advanced practice providers, and colorectal surgeons from 5 continents. The majority (80%) use PROs in clinical practice, 65% frequently found value in routine use, and 50% frequently found PROs influenced management. Thirty-one different PROs for IBD were reportedly used. Barriers included not being familiar with PROs, not knowing how to incorporate PRO results into clinical practice, lack of electronic medical record integration, and time constraints. Most (91%) agreed it would be beneficial to have an accepted set of consistently used PROs. The majority (60%) thought that there should be some cultural differences in PROs used globally but that PROs for IBD should be consistent around the world. Conclusions PROs are used frequently in clinical practice with wide variation in which are used and how they influence management. Education about PROs and how to use and interpret an accepted set of PROs would decrease barriers for use and allow for global harmonization.

• Helm, Thea Elisabeth; Høivik, Marte Lie; Buer, Lydia Celine Tansem; Warren, David; Bolstad, Nils & Moum, Bjørn Allan [Show all 9 contributors for this article] (2023). Switching from intravenous to subcutaneous vedolizumab maintenance treatment in patients with inflammatory bowel disease followed by therapeutic drug monitoring. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 58(8), p. 863–873. doi: 10.1080/00365521.2023.2176252. Full text in Research Archive Show summary

  Objective: Vedolizumab (VDZ) for subcutaneous (SC) administration has recently become available. We aimed to assess feasibility, safety and clinical outcome when switching from intravenous (IV) to SC VDZ maintenance treatment in a real world cohort of patients with inflammatory bowel disease (IBD) followed by therapeutic drug monitoring (TDM). Methods: Eligible IBD patients were switched from IV to SC treatment and assessed six months prior to switch, at baseline and six, twelve and twenty-six weeks after switch. Primary outcome was propor- tion of patients on SC treatment after 26 weeks. Secondary outcomes included adverse events (AEs), clinical disease activity, biochemical markers, treatment interval, serum-VDZ (s-VDZ), preferred route of administration and health-related quality of life. Results: In total, 108 patients were switched. After 26 weeks, 100 patients (92.6%) were still on SC treatment and median s-VDZ was 47.6 mg/L (IQR 41.3 54.6). The most frequent AE was injection site reaction (ISR), reported by 20 patients (18.5%). There were no clinically significant changes in disease activity, biochemical markers and quality of life. The proportion of patients preferring SC administra- tion increased from 28.0% before switch to 59.4% after 26 weeks (p < 0.001). Conclusions: Nine out of ten patients still received SC treatment after 26 weeks. No change in disease activity occurred, and levels of serum VDZ increased. Although almost one fifth of patients experi- enced ISRs, a higher proportion favored SC administration at 26 weeks. This study demonstrates that SC maintenance treatment is a safe and feasible alternative to IV treatment.

• Jørgensen, Kristin Kaasen; Høivik, Marte Lie; Chopra, Adity; Benth, Jurate Saltyte; Ricanek, Petr & Moum, Bjørn Allan [Show all 18 contributors for this article] (2023). Humoral immune response to SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive medication: association to serum drug levels and disease type. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 58(8), p. 874–882. doi: 10.1080/00365521.2023.2177884. Full text in Research Archive Show summary

  Objectives 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. Materials and methods 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. Results 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. Conclusions 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.

• Follin-Arbelet, Benoit; Småstuen, Milada Cvancarova; Hovde, Øistein; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn Allan (2023). Risk of Cancer in Patients With Crohn's Disease 30 Years After Diagnosis (the IBSEN Study). Crohn's & Colitis 360. 5(4), p. 1–6. doi: 10.1093/crocol/otad057. Full text in Research Archive Show summary

  Background: Patients with Crohn's disease (CD) are most often diagnosed as young adults; therefore, long-term studies are needed to assess the risk of cancer over their lifetime. Thus, the aims of the present study were to determine the risk of cancer in a Norwegian population-based cohort (the Inflammatory Bowel South Eastern Norway [IBSEN] study), 30 years after diagnosis, and to assess whether patients with CD were at an increased risk of specific cancer types. Methods: The IBSEN cohort prospectively included all incident patients diagnosed between 1990 and 1993. Data on cancer incidence were obtained from the Cancer Registry of Norway. Overall and cancer-specific hazard ratios (HRs) for CD patients compared with age- and sex-matched controls were modeled using Cox regression. Standardized incidence ratios (SIRs) were estimated compared to the general population. Results: In total, the cohort included 237 patients with CD, and 36 of them were diagnosed with cancer. Compared to the general Norwegian population, patients with CD had an increased overall risk of cancer (HR = 1.56, 95% CI: 1.06-2.28), particularly male patients (HR = 1.85, 95% CI: 1.08-3.16). The incidence of lung cancer and nonmelanoma skin cancer was increased; however, the difference was not statistically significant (SIR = 2.29, 95% CI: 0.92-4.27 and SIR = 2.45, 95% CI: 0.67-5.37, respectively). Conclusions: After 30 years of follow-up, the risk of all cancers in patients with CD was increased compared to the general population. Keywords: Cancer; Crohn’s disease. © The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.

• Burisch, Johan; Zhao, Mirabella; Odes, Selwyn; Cruz, Peter De; Vermeire, Severine & Bernstein, Charles N [Show all 33 contributors for this article] (2023). The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission. The Lancet Gastroenterology and Hepatology. ISSN 2468-1253. 8(5), p. 458–492. doi: 10.1016/S2468-1253(23)00003-1. Full text in Research Archive Show summary

  The cost of caring for patients with inflammatory bowel disease (IBD) continues to increase worldwide. The cause is not only a steady increase in the prevalence of Crohn's disease and ulcerative colitis in both developed and newly industrialised countries, but also the chronic nature of the diseases, the need for long-term, often expensive treatments, the use of more intensive disease monitoring strategies, and the effect of the diseases on economic productivity. This Commission draws together a wide range of expertise to discuss the current costs of IBD care, the drivers of increasing costs, and how to deliver affordable care for IBD in the future. The key conclusions are that (1) increases in health-care costs must be evaluated against improved disease management and reductions in indirect costs, and (2) that overarching systems for data interoperability, registries, and big data approaches must be established for continuous assessment of effectiveness, costs, and the cost-effectiveness of care. International collaborations should be sought out to evaluate novel models of care (eg, value-based health care, including integrated health care, and participatory health-care models), as well as to improve the education and training of clinicians, patients, and policy makers.

• Zhao, Mirabella; Lirhus, Sandre Svatun; Lördal, Mikael; Langholz, Ebbe; Knudsen, Torben & Voutilainen, Markku [Show all 15 contributors for this article] (2022). Therapeutic management and outcomes in inflammatory bowel diseases, 2010 to 2017 in cohorts from Denmark, Sweden and Norway. Alimentary Pharmacology and Therapeutics. ISSN 0269-2813. 56(6), p. 989–1006. doi: 10.1111/apt.17145. Full text in Research Archive
• Follin-Arbelet, Benoit; Småstuen, Milada Cvancarova; Hovde, Øistein; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn Allan (2022). Mortality in Patients with Inflammatory Bowel Disease: Results from 30 Years of Follow-up in a Norwegian Inception Cohort (the IBSEN study). Journal of Crohn's and Colitis. ISSN 1873-9946. 17(4), p. 497–503. doi: 10.1093/ecco-jcc/jjac156. Full text in Research Archive Show summary

  Background and Aims: Patients with longstanding inflammatory bowel disease [IBD] may be at an increased risk of death compared to the general population, especially elderly patients. The Inflammatory Bowel South-Eastern Norway [IBSEN] study has previously detected a small but not statistically significant increase in mortality 20 years after diagnosis. The aim of this study was to evaluate the overall and cause-specific mortality at 30 years of follow-up. Methods: The IBSEN cohort included 519 incident patients with ulcerative colitis [UC] and 237 patients with Crohn’s disease [CD] between 1990 and 1993, each matched with five controls. Death certificate data were obtained from the Norwegian Cause of Death Registry. The underlying causes of death were categorized into five groups: all cancers, gastrointestinal cancers, cardiovascular diseases, infections and all other causes. Hazard ratios [HRs] were modelled using Cox regression. Results: There was no statistically significant difference in the overall mortality rates. However, in patients with CD, male sex (HR = 1.65 [95% CI: 1.04–2.62]), onset after 40 years of age (HR = 1.72 [1.19–2.48]), colonic disease (HR = 1.57 [1.05–2.35]) and penetrating behaviour (HR = 3.3 [1.41–7.76]) were clinical factors associated with an increased mortality. IBD patients were at a higher risk of death due to cardiovascular disease: HR = 1.51 [1.10–2.08] for UC and 2.04 [1.11–3.77] for CD. When taking into account both the underlying and the immediate cause of death, infection was more frequent in patients with IBD. Conclusions: Overall, all-cause mortality rates were similar between patients with IBD and controls. However, clinicians should remain alert to cardiovascular diseases and infections, particularly in specific subgroups of CD patients. Key Words: Inflammatory bowel disease; mortality; population-based study © The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

• Opheim, Randi; Moum, Kristian Marling; Småstuen, Milada Cvancarova & Moum, Bjørn Allan (2022). The impact of restrictions on psychological outcomes in patients with inflammatory bowel disease on biological treatment during the coronavirus pandemic in Norway. Quality of Life Research. ISSN 0962-9343. 20. doi: 10.1007/s11136-022-03254-4. Full text in Research Archive Show summary

  Abstract Purpose The coronavirus (COVID-19) pandemic restrictions have led to changes in the follow-up routine of patients in outpatient clinics at hospitals in Norway. The purpose of this study was to assess possible associations between psychological health and concerns regarding COVID-19 societal and hospital restrictions in patients with inflammatory bowel disease on biological therapy. Methods Patients with IBD (≥ 18 years) undergoing biological treatment (TNF-alpha inhibitor, ustekinumab, vedolizumab) for IBD were recruited from an IBD outpatient clinic in Norway. Data were collected through self-report, including questions covering concerns regarding their disease, medical therapy, and follow-up during the pandemic, Patient Health Questionnaire–9 (PHQ-9) and Generalized Anxiety Disorder–7 questionnaire (GAD-7). Multiple logistic regression with backward conditional selection was fitted to examine associations between patients’ depression and anxiety levels and their concerns about COVID-19 restrictions, controlled for sociodemographic and disease-related factors. Results Five-hundred and six patients were included in this study. General condition, self-isolation, employment status, fear of visiting the hospital, and changes to patients’ appointments made by the hospital were independently associated with higher levels of depression. Female gender, experiencing symptoms of COVID-19, self-isolation, experiencing an increased risk of COVID-19 because of IBD, being afraid to visit the hospital because of COVID-19 restrictions, and having their appointment cancelled due to COVID-19 were independently associated with higher anxiety levels. Conclusion Concerns about physical health and societal and hospital restrictions were associated with anxiety and depression in patients with IBD undergoing biological treatment. The findings will help facilitate healthcare services for patients with IBD in outpatient clinics and develop guidelines for follow-up.

• Jelsness-Jørgensen, Lars-Petter; Moum, Bjørn Allan; Grimstad, Tore Bjørn; Jahnsen, Jørgen; Hovde, Øistein & Frigstad, Svein Oskar [Show all 7 contributors for this article] (2022). The multidimensional fatigue inventory (MFI-20): psychometrical testing in a Norwegian sample of inflammatory bowel disease (IBD) patients. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. p. 1–7. doi: 10.1080/00365521.2022.2029939. Full text in Research Archive Show summary

  OBJECTIVES To evaluate the psychometric properties of the Norwegian version of the multidimensional fatigue inventory (MFI-20) in patients with inflammatory bowel disease. METHODS Participants were recruited from nine hospitals in the southeastern and western parts of Norway. Clinical and sociodemographic data were collected, and participants completed the MFI-20, as well as the Fatigue Questionnaire (FQ). In addition to a confirmatory factor analysis, validity, reliability, test-retest and responsiveness were evaluated. RESULTS In total, 410 patients were included. The Norwegian MFI-20 had an acceptable model fit when compared to the original five-dimensional structure. A positive correlation was observed between the dimensions of MFI-20 and the FQ. MFI-20 scores increased according to subjective disease activity, but no differences were observed when using a calprotectin cut-off < or > =250 µg/g mg/kg. All MFI-20 dimensions except ‘reduced motivation’ in both ulcerative colitis (UC) and Crohn’s disease (CD) patients had alpha Cronbach alpha values ≥70, and test-retest reliability revealed good to excellent values. Merely one dimension (Reduced activity) in UC patients reporting improvement did not reach the threshold for acceptable responsiveness according to Guyatt statistics. CONCLUSIONS The Norwegian version of MFI-20 is valid, reliable and responsive. The instrument can safely be used in studies using fatigue as an endpoint.

• Anisdahl, Karoline; Lirhus, Sandre Svatun; Medhus, Asle Wilhelm; Moum, Bjørn; Melberg, Hans Olav & Høivik, Marte Lie (2021). First-line biologic treatment of inflammatory bowel disease during the first 12 months after diagnosis from 2010 to 2016: a Norwegian nationwide registry study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. p. 1–7. doi: 10.1080/00365521.2021.1955147. Full text in Research Archive Show summary

  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 < .001) for CD and 7% to 13% (p < .001) for UC. The most frequently used first-line biologics were infliximab (CD: 64% and UC: 82%) and adalimumab (CD: 36% and UC: 15%). The highest registered use of adalimumab was in the 2012 cohort (CD: 56% and UC: 39%). In the 2014–2016 cohorts, infliximab was the most used first-line biologic for both CD and UC. Conclusions The proportion of IBD patients initiating biologics within 12 months after diagnosis increased between 2010 and 2016. The use of infliximab as first-line biologic increased after the approval of biosimilar infliximab in 2013.

• Moum, Kristian Marling; Moum, Bjørn & Opheim, Randi (2021). Patients with inflammatory bowel disease on immunosuppressive drugs: perspectives’ on COVID-19 and health care service during the pandemic. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 56(5), p. 1–8. doi: 10.1080/00365521.2021.1901308. Full text in Research Archive Show summary

  Background and aims Patients with inflammatory bowel diseases (IBD) have experienced changes to the routine management because of the SARS-CoV-2 pandemic. The aim of this study was to examine patients with IBD’s adherence to the restrictions imposed by society and the hospital, worries and concerns regarding medical treatment and clinical follow-up under the pandemic. Methods IBD patients (≥18 years) at the outpatient clinic at Oslo University Hospital were included and answered a self-report questionnaire including concerns regarding their disease, medical therapy and follow-up during SARS-CoV-2 pandemic. Results In total, 522 IBD patients were included, 317 Crohn’s disease, 205 ulcerative colitis, 386 patients <50 years. Eighteen percent were in obligatory quarantine, and more often patients <50 years compared to patients ≥50 years. Five patients tested positive to SARS- CoV-2. A higher proportion <50 years reported worries for their medical treatment and risk of COVID −19 disease compared to those ≥50 years. Forty percent avoided family, two-thirds avoided friends, and 4% cancelled their scheduled consultation at the hospital. The hospital changed physical consultation to telephone consultation for 15% of the patients. The preferred follow-up was physical consultation. A higher proportion of the patients <50 years preferred telephone consultation compared to those ≥50 years. Four out of five IBD patients were satisfied with the information about their IBD and COVID-19. Conclusions SARS-CoV-2 pandemic affects the daily lives for patients with IBD. It is important to develop evidence-base guidelines in follow-up and treatment, as well as patient information about COVID-19and IBD.

• Vesterhus, Mette; Nielsen, Mette Juul; Hov, Johannes Roksund; Saffioti, Francesca; Manon-Jensen, Tina & Leeming, Diana Julie [Show all 12 contributors for this article] (2021). Comprehensive assessment of ECM turnover using serum biomarkers establishes PBC as a high-turnover autoimmune liver disease. JHEP Reports. 3(1), p. 1–11. doi: 10.1016/j.jhepr.2020.100178. Full text in Research Archive Show summary

  Background & Aims: Primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) are phenotypically distinct autoimmune liver diseases that progress to cirrhosis and liver failure; however, their histological fibrosis distribution differs. We investigated the extracellular matrix (ECM) profiles of patients with PSC, PBC, and AIH to establish whether the diseases display differential patterns of ECM turnover. Methods: Serum samples were retrospectively collected from the UK (test cohort; PSC n = 78; PBC n = 74; AIH n = 58) and Norway (validation cohort; PSC n = 138; PBC n = 28; AIH n = 27). Patients with ulcerative colitis without liver disease (n = 194) served as controls. We assessed specific serological biomarkers of ECM turnover: type III and V collagen formation (PRO-C3, PRO-C5), degradation of type III and IV collagen (C3M, C4M), biglycan (BGM) and citrullinated vimentin (VICM). Results: Most of the ECM markers showed elevated serum levels in PBC compared with PSC or AIH (p <0.01). PRO-C3 correlated well with liver stiffness and showed the most striking differences between advanced and non-advanced liver disease; several of the other ECM markers were also associated with stage. PRO-C3 and other ECM markers were inversely associated with ursodeoxycholic acid treatment response in PBC and remission in AIH. All ECM remodelling markers were significantly elevated (p <0.05) in patients with PSC, PBC, or AIH compared with ulcerative colitis. Conclusions: In this first study comparing ECM turnover in autoimmune liver diseases, we found increased ECM turnover in PBC compared with either PSC or AIH. The study indicates that ECM remodelling is different in PSC, PBC, and AIH, suggesting differing opportunities for therapeutic intervention.

• Detlie, Trond Espen; Jahnsen, Marte Eide; Jahnsen, Jørgen; Lindstrøm, Jonas Christoffer; Moum, Bjørn & Finnes, Elisabeth [Show all 7 contributors for this article] (2021). Hypophosphatemia after high-dose intravenous iron treatment in patients with inflammatory bowel disease: Mechanisms and possible clinical impact. World Journal of Gastroenterology (WJG). ISSN 1007-9327. 27(17), p. 2039–2053. doi: 10.3748/wjg.v27.i17.2039. Full text in Research Archive
• Monstad, Iril Lovise; Solberg, Inger Camilla; Småstuen, Milada Cvancarova; Hovde, Oistein; Henriksen, Magne & Huppertz-Hauss, Gert [Show all 12 contributors for this article] (2021). Outcome of Ulcerative Colitis 20 Years after Diagnosis in a Prospective Population-based Inception Cohort from South-Eastern Norway, the IBSEN Study. Journal of Crohn's and Colitis. ISSN 1873-9946. 15(6), p. 969–979. doi: 10.1093/ecco-jcc/jjaa232. Full text in Research Archive Show summary

  Background and aims: The long-term course of ulcerative colitis [UC] is difficult to predict. Mortality, colectomy, cancer, and hospitalisation represent hard outcomes of disease. Moreover, knowledge on the risk of relapses and need for potent medication add important information about living with UC. We aimed to evaluate the course and prognosis of UC during the first 20 years after diagnosis, and to identify early prognostic risk factors. Methods: From 1990 to 1994, a population-based inception cohort of patients with inflammatory bowel disease was enrolled in South-Eastern Norway. A systematic follow-up [FU] was conducted at 1,5, 10, and 20 years after diagnosis. Clinical outcomes were recorded continuously, and possible relationships between early disease characteristics and outcomes were analysed using multiple regression analysis. Results: Among 519 UC patients, 119 died, 60 were lost to FU, and 340 were included in the FU cohort. The 20-year cumulative risk of colectomy was 13.0% (95% confidence interval [CI] [11.4-14.6]). Extensive colitis at diagnosis was independently associated with an increased risk of colectomy compared with proctitis (hazard ratio [HR] = 2].8, 95% CI [1.3-6.1]). In contrast, mucosal healing at 1-year FU was independently associated with reduced risk of colectomy [HR = 0.4, 95% CI [0.2-0.8]), and inversely associated with subsequent risk of relapse [adjusted HR = 0.5, 95% CI [0.3-0.7]). Conclusions: The overall risk of colectomy in our cohort was lower than expected from previous studies, although considerable for patients with extensive colitis at diagnosis. Early mucosal healing was associated with better disease outcomes 20 years after diagnosis.

• Lirhus, Sandre Svatun; Høivik, Marte Lie; Moum, Bjørn; Anisdahl, Karoline & Melberg, Hans Olav (2021). Incidence and prevalence of inflammatory bowel disease in norway and the impact of different case definitions: A nationwide registry study. Clinical Epidemiology. 13, p. 287–294. doi: 10.2147/CLEP.S303797. Full text in Research Archive Show summary

  Background: 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.

• Kristensen, Vendel Ailin; Småstuen, Milada Cvancarova; Høivik, Marte Lie; Moum, Bjørn & Vatn, Morten H (2020). Serological antibodies and surgery in a population-based inception cohort of Crohn's disease patients - the IBSEN study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. doi: 10.1080/00365521.2020.1745879. Full text in Research Archive Show summary

  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.

• Opheim, Randi; Moum, Bjørn; Grimstad, Tore; Jahnsen, Jørgen; Berset, Ingrid Prytz & Hovde, Øistein [Show all 9 contributors for this article] (2020). Self-esteem in patients with inflammatory bowel disease. Quality of Life Research. ISSN 0962-9343. 29(7), p. 1839–1846. doi: 10.1007/s11136-020-02467-9. Full text in Research Archive Show summary

  Purpose The purpose of this study was to explore self-esteem and associations between self-esteem and sociodemographic, clinical, and psychological factors in patients with infammatory bowel disease (IBD), a disease of chronic relapsing infammation of the gastrointestinal tract. IBD symptoms, including pain, fatigue, and diarrhea, as well as potential life-long medical treatment and surgery, may be demanding, cause signifcant challenges, and infuence self-esteem. Methods In this cross-sectional multicenter study, participants were recruited from nine hospitals in the southeastern and western regions of Norway from March 2013 to April 2014. Data were collected using self-report questionnaires. Selfesteem was assessed by the Rosenberg Self-Esteem Scale, fatigue was assessed by the Fatigue Questionnaire, self-efcacy was assessed by the General Self-Efcacy Scale, and disease activity was assessed by the Simple Clinical Colitis Activity Index for ulcerative colitis (UC) and Harvey Bradshaw Index for Crohn’s disease (CD). Multiple linear regression analysis was applied to examine associations between self-esteem and sociodemographic, clinical, and psychological factors. Results In total, 411 of 452 (91%) patients had evaluable data and were included in this study. The mean scores on selfesteem, self-efcacy, total fatigue, anxiety, and depression were similar between UC patients and CD patients. Male gender, being employed, and higher self-efcacy were independently associated with higher self-esteem, whereas anxiety and depression were independently associated with lower self-esteem. Neither disease activity nor fatigue were associated with self-esteem in the fnal multiple regression analyses. Conclusion Patient-centered interventions that improve self-esteem and reduce anxiety and depression seem to be important to optimize IBD management. Keywords Self-esteem · Self-efcacy · Coping · Infammatory bowel disease · Ulcerative colitis · Crohn’s disease · Health psychology · Chronic disease · Health-related quality of life

• Klepp, Pasquale Catherine; Brackmann, Stephan; Småstuen, Milada Cvancarova; Høivik, Marte Lie; Hovde, Øistein & Henriksen, Magne [Show all 15 contributors for this article] (2020). Risk of colorectal cancer in a population-based study 20 years after diagnosis of ulcerative colitis: results from the IBSEN study. BMJ open gastroenterology. 7. doi: 10.1136/bmjgast-2019-000361. Full text in Research Archive Show summary

  Objective The 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. Design A 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). Results The 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. Conclusion The risk of CRC in UC was low and comparable with the risk of CRC in the background population of Norway.

• Hedin, Charlotte Rose Hawkey; Sado, Gina; Ndegwa, Nelson; Lytvyak, Ellina; Mason, Andrew & Montano-Loza, Aldo [Show all 36 contributors for this article] (2020). Effects of Tumor Necrosis Factor Antagonists in Patients With Primary Sclerosing Cholangitis. Clinical Gastroenterology and Hepatology. ISSN 1542-3565. 18(10), p. 2295–2304.e2. doi: 10.1016/j.cgh.2020.02.014. Full text in Research Archive
• Kravdal, Øystein; Magnus, Per; Moum, Bjørn & Høivik, Marte Lie (2020). Childbearing is Associated with a Short-term Reduced Risk of Crohn’s Disease in Mothers. American Journal of Epidemiology. ISSN 0002-9262. 189(4), p. 294–304. doi: 10.1093/aje/kwz285. Full text in Research Archive Show summary

  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.

• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Småstuen, Milada C; Grimstad, Tore & Berset, Ingrid Prytz [Show all 11 contributors for this article] (2020). Pain Severity and Vitamin D Deficiency in IBD Patients. Nutrients. 12(1), p. 1–12. doi: 10.3390/nu12010026. Full text in Research Archive Show summary

  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'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. Keywords: pain severity; patient reported outcomes; vitamin D deficiency.

• Kravdal, Øystein; Magnus, Per; Moum, Bjørn & Høivik, Marte Lie (2020). Association of Childbearing with a Short-Term Reduced Risk of Crohn Disease in Mothers. American Journal of Epidemiology. ISSN 0002-9262. 189(4), p. 294–304. doi: 10.1093/aje/kwz285. Full text in Research Archive
• Jørgensen, Kristin Kaasen; Goll, Guro Løvik; Sexton, Joseph; Bolstad, Nils; Olsen, Inge Christoffer & Asak, Øivind Wessel [Show all 29 contributors for this article] (2020). Efficacy and safety of CT-P13 in inflammatory bowel disease after switching from originator infliximab: Exploratory analyses from the NOR-SWITCH main and extension trials. BioDrugs. ISSN 1173-8804. 34(5), p. 681–694. doi: 10.1007/s40259-020-00438-7. Full text in Research Archive Show summary

  Background: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested. Objective: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. Patients and methods: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period. Results: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events. Conclusion: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.

• Ossum, Alvilde Maria; Palm, Øyvind; Småstuen, Milada C; Bernklev, Tomm; Jahnsen, Jørgen & Moum, Bjørn [Show all 7 contributors for this article] (2020). The Impact of Spondyloarthritis and Joint Symptoms on Health-Related Quality of Life and Fatigue in IBD Patients. Results from a Population-Based Inception Cohort (20-Year Follow-up in the Ibsen Study). Inflammatory Bowel Diseases. ISSN 1078-0998. doi: 10.1093/ibd/izz105. Full text in Research Archive Show summary

  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.

• Goll, Guro Løvik; Jørgensen, Kristin Kaasen; Sexton, Joseph; Olsen, Inge Christoffer; Bolstad, Nils & Haavardsholm, Espen A. [Show all 48 contributors for this article] (2019). Long‐term efficacy and safety of biosimilar infliximab (CT‐P13) after switching from originator infliximab: Open‐label extension of the NOR‐SWITCH trial. Journal of Internal Medicine. ISSN 0954-6820. 285(6), p. 653–669. doi: 10.1111/joim.12880. Full text in Research Archive Show summary

  Background and objectives The 52‐week, randomized, double‐blind, noninferiority, government‐funded NOR‐SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT‐P13 was not inferior to continued treatment with infliximab originator. The NOR‐SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT‐P13 throughout the 78‐week study period (maintenance group) versus patients switched to CT‐P13 at week 52 (switch group). The primary outcome was disease worsening during follow‐up based on disease‐specific composite measures. Methods Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis. Results Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per‐protocol set). Adjusted risk difference was 5.9% (95% CI −1.1 to 12.9). Frequency of adverse events, anti‐drug antibodies, changes in generic disease variables and disease‐specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases. Conclusion The NOR‐SWITCH extension showed no difference in safety and efficacy between patients who maintained CT‐P13 and patients who switched from originator infliximab to CT‐P13, supporting that switching from originator infliximab to CT‐P13 is safe and efficacious.

• Kisiel, John; Klepp, Pasquale Catherine; Allawi, Hatim T.; William, Taylor; Giakoumopoulos, Maria & Sander, Tamara [Show all 13 contributors for this article] (2019). Analysis of DNA Methylation at Specific Loci in Stool Samples Detects Colorectal Cancer and High-Grade Dysplasia in Patients With Inflammatory Bowel Disease. Clinical Gastroenterology and Hepatology. ISSN 1542-3565. 17(5), p. 914–921. doi: 10.1016/j.cgh.2018.05.004. Full text in Research Archive
• Dhillon, Amandeep Kaur; Kummen, Martin; Trøseid, Marius; Åkra, Sissel; Liaskou, Evaggelia & Moum, Bjørn [Show all 10 contributors for this article] (2019). Circulating markers of gut barrier function associated with disease severity in primary sclerosing cholangitis. Liver international (Print). ISSN 1478-3223. 39(2), p. 371–381. doi: 10.1111/liv.13979. Full text in Research Archive Show summary

  Background & Aims: One important hypothesis in primary sclerosing cholangitis pathophysiology suggests that bacterial products from an inflamed leaky gut lead to biliary inflammation. We aimed to investigate whether circulating markers of bacterial translocation were associated with survival in a Norwegian primary sclerosing cholangitis cohort. Methods: Serum levels of zonulin, intestinal fatty acid binding protein, soluble CD14, lipopolysaccharide and lipopolysaccharide‐binding protein were measured in 166 primary sclerosing cholangitis patients and 100 healthy controls. Results: Lipopolysaccharide‐binding protein and soluble CD14 were elevated in primary sclerosing cholangitis compared with healthy controls (median 13 662 vs 12 339 ng/mL, P = 0.010 and 1657 vs 1196 ng/mL, P < 0.001, respectively). High soluble CD14 and lipopolysaccharide‐binding protein (values >optimal cut‐off using receiver operating characteristics) were associated with reduced liver transplantation–free survival (P < 0.001 and P = 0.005, respectively). The concentration of soluble CD14 was higher in patients with hepatobiliary cancer compared to other primary sclerosing cholangitis patients and healthy controls. Zonulin was lower in primary sclerosing cholangitis than controls, but when excluding primary sclerosing cholangitis patients with increased prothrombin time zonulin concentrations were similar in primary sclerosing cholangitis and healthy controls. Concomitant inflammatory bowel disease did not influence the results, while inflammatory bowel disease patients without primary sclerosing cholangitis (n = 40) had lower concentration of soluble CD14. In multivariable Cox regression, high soluble CD14 and high lipopolysaccharide‐binding protein were associated with transplantation‐free survival, independent from Mayo risk score (HR: 2.26 [95% CI: 1.15‐4.43], P = 0.018 and HR: 2.00 [95% CI: 1.17‐3.43], P = 0.011, respectively). Conclusions: Primary sclerosing cholangitis patients show increased levels of circulating markers of bacterial translocation. High levels are associated with poor prognosis measured by transplantation‐free survival, indicating that ongoing gut leakage could have clinical impact in primary sclerosing cholangitis.

• Detlie, Trond Espen; Lindstrøm, Jonas Christoffer; Jahnsen, Marte Eide; Finnes, Elisabeth; Zoller, Heinz & Moum, Bjørn [Show all 7 contributors for this article] (2019). Incidence of hypophosphatemia in patients with inflammatory bowel disease treated with ferric carboxymaltose or iron isomaltoside. Alimentary Pharmacology and Therapeutics. ISSN 0269-2813. 50(4), p. 397–406. doi: 10.1111/apt.15386. Full text in Research Archive Show summary

  Background: Iron deficiency and iron deficiency anaemia are common complications in inflammatory bowel disease (IBD). In patients with moderate‐to‐severe anaemia, oral iron intolerance or ineffectiveness of oral iron, ferric carboxymaltose and iron isomaltoside are widely used. Hypophosphatemia is a side effect of both preparations. Aims: To investigate the occurrence of hypophosphatemia in IBD patients with iron deficiency/iron deficiency anaemia treated with high‐dose intravenous iron. Methods: A prospective observational study of adult IBD patients with iron deficiency/iron deficiency anaemia was conducted at two study sites where patients received 1000 mg of ferric carboxymaltose or iron isomaltoside. At baseline, weeks 2 and 6, blood and faecal samples were collected. The primary endpoint was to determine the incidence of moderate‐to‐severe hypophosphatemia. Secondary endpoints included the total incidence of hypophosphatemia, possible risk factors for hypophosphatemia, and response to single‐dose intravenous iron. Results: One hundred and thirty patients were included. In the per‐protocol set, 52 patients received ferric carboxymaltose and 54 patients received iron isomaltoside. Ferric carboxymaltose treatment had a significantly higher incidence of moderate‐to‐severe hypophosphatemia compared with iron isomaltoside at week 2 (56.9% vs 5.7%, P < 0.001) and a higher incidence at week 6 (13.7% vs 1.9%, P = 0.054).The overall incidence of hypophosphatemia was significantly higher with ferric carboxymaltose compared with iron isomaltoside treatment at weeks 2 (72.5% vs 11.3%, P < 0.001) and 6 (21.6% vs 3.7%, P = 0.013). Conclusions: In IBD patients with iron deficiency/iron deficiency anaemia, ferric carboxymaltose was associated with higher incidence, severity and persistence of hypophosphatemia compared with iron isomaltoside. The presence of moderate‐to‐severe hypophosphatemia beyond 6 weeks is a clinical concern that requires further investigation.

• Buer, Lydia Celine Tansem; Moum, Bjørn; Småstuen, Milada Cvancarova; Warren, David; Bolstad, Nils & Medhus, Asle Wilhelm [Show all 7 contributors for this article] (2018). Real world data on effectiveness, safety and therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease. A single center cohort. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. p. 1–9. doi: 10.1080/00365521.2018.1548646. Full text in Research Archive
• Ossum, Alvilde Maria; Palm, Øyvind; Småstuen, Milada Cvancarova; Solberg, Inger Camilla; Vatn, Morten H & Moum, Bjørn [Show all 7 contributors for this article] (2018). Peripheral arthritis in patients with long-term inflammatory bowel disease. Results from 20 years of follow-up in the IBSEN study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. p. 1–8. doi: 10.1080/00365521.2018.1518482. Full text in Research Archive Show summary

  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 IBDrelated 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 IBDrelated peripheral arthritis and every fourth from peripheral spondyloarthritis.

• Lirhus, Sandre Svatun; Høivik, Marte Lie; Moum, Bjørn & Melberg, Hans Olav (2018). Regional differences in anti-TNF-a therapy and surgery in the treatment of inflammatory bowel disease patients: a Norwegian nationwide cohort study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 53(8), p. 952–957. doi: 10.1080/00365521.2018.1495258. Full text in Research Archive Show summary

  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.

• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Småstuen, Milada Cvancarova; Grimstad, Tore & Berset, Ingrid Prytz [Show all 11 contributors for this article] (2018). Fatigue is not associated with vitamin D deficiency in inflammatory bowel disease patients. World Journal of Gastroenterology (WJG). ISSN 1007-9327. 24(29), p. 3293–3301. doi: 10.3748/wjg.v24.i29.3293. Full text in Research Archive Show summary

  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.

• Engebretsen, Kristin V Thunheim; Høgestøl, Ingvild Kristine; Hewitt, Stephen I; Risstad, Hilde; Moum, Bjørn & Kristinsson, Jon Adalsteinn [Show all 7 contributors for this article] (2018). Anemia following Roux-en-Y gastric bypass for morbid obesity; a 5-year follow-up study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 53(8), p. 917–922. doi: 10.1080/00365521.2018.1489892. Full text in Research Archive
• Ossum, Alvilde Maria; Palm, Øyvind; Kapica, Aida; Småstuen, Milada C; BANITALEBI, HASAN & Negård, Anne [Show all 10 contributors for this article] (2018). Ankylosing Spondylitis and Axial Spondyloarthritis in Patients With Long-term Inflammatory Bowel Disease: Results From 20 Years of Follow-up in the IBSEN Study. Journal of Crohn's and Colitis. ISSN 1873-9946. 12(1), p. 96–104. doi: 10.1093/ecco-jcc/jjx126. Full text in Research Archive Show summary

  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.

• Siegel, Corey A.; Whitman, Cynthia B.; Spiegel, Brennan M.R.; Feagan, Brian; Sands, Bruce & Loftus, Edward V. [Show all 36 contributors for this article] (2018). Development of an index to define overall disease severity in IBD. Gut. ISSN 0017-5749. 67(2), p. 244–254. doi: 10.1136/gutjnl-2016-312648. Full text in Research Archive
• Shah, Shailja C.; Khalili, Hamed; Gower-Rousseau, Corinne; Olén, Ola; Benchimol, Eric I. & Lynge, Elsebeth [Show all 28 contributors for this article] (2018). Sex-based differences in incidence of inflammatory bowel diseases-Pooled analysis of population-based studies from Western countries. Gastroenterology. ISSN 0016-5085. 155(4), p. 1079–1089.e3. doi: 10.1053/j.gastro.2018.06.043. Full text in Research Archive
• Høivik, Marte Lie; Buer, Lydia Celine Tansem; Småstuen, Milada Cvancarova; Warren, David; Bolstad, Nils & Moum, Bjørn [Show all 7 contributors for this article] (2018). Switching from originator to biosimilar infliximab?real world data of a prospective 18 months follow-up of a single-centre IBD population. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 53(6), p. 692–699. doi: 10.1080/00365521.2018.1463391. Full text in Research Archive
• Klepp, Pasquale Catherine; Kisiel, John; Allawi, Hatim T; Taylor, William R; Giakoumopoulos, Maria & sander, Tamara [Show all 13 contributors for this article] (2018). Analysis of DNA Methylation at Specific Loci in Stool Samples Detects Colorectal Cancer and High-grade Dysplasia in Patients with Inflammatory Bowel Disease. Clinical Gastroenterology and Hepatology. ISSN 1542-3565. doi: 10.1016/j.cgh.2018.05.004. Full text in Research Archive
• Nielsen, MJ; Thorburn, Douglas; Leeming, DJ; Hov, Johannes Espolin Roksund; Nygård, Ståle & Moum, Bjørn [Show all 15 contributors for this article] (2018). Serological markers of extracellular matrix remodeling predict transplant-free survival in primary sclerosing cholangitis. Alimentary Pharmacology and Therapeutics. ISSN 0269-2813. 48, p. 179–189. doi: 10.1111/apt.14806. Full text in Research Archive
• Klepp, Pasquale Catherine; Kisiel, John; Småstuen, Milada Cvancarova; Røseth, Arne; Andersen, Solveig Norheim & Vatn, Morten H [Show all 9 contributors for this article] (2018). Multi-target stool DNA test in the surveillance of inflammatory bowel disease: a cross-sectional cohort study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 53(3), p. 273–278. doi: 10.1080/00365521.2018.1424935. Full text in Research Archive
• Buer, Lydia Celine Tansem; Høivik, Marte Lie; Warren, David; Medhus, Asle Wilhelm & Moum, Bjørn (2018). Combining Anti-TNF-? and Vedolizumab in the Treatment of Inflammatory Bowel Disease: A Case Series. Inflammatory Bowel Diseases. ISSN 1078-0998. 24(5), p. 997–1004. doi: 10.1093/ibd/izx110. Full text in Research Archive Show summary

  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.

• Klepp, Pasquale Catherine; Tollisen, Anita; Røseth, Arne; Småstuen, Milada Cvancarova; Andersen, Solveig Norheim & Vatn, Morten H [Show all 8 contributors for this article] (2018). Real-life chromoendoscopy for dysplasia surveillance in ulcerative colitis. World Journal of Gastroenterology (WJG). ISSN 1007-9327. 24(35), p. 4069–4076. doi: 10.3748/wjg.v24.i35.4069. Full text in Research Archive Show summary

  AIM: To evaluate the use of chromoendoscopy for surveillance of ulcerative colitis in a real-life community hospital setting. METHODS: Patients with extensive ulcerative colitis, having disease duration of more than 8 years and who presented between the years of 1999 to 2013, were offered enrolment in this single cohort prospective study. All participants underwent standard bowel preparation with sodium phosphate and chromoendoscopy. Two expert endoscopists, novice to chromoendoscopy, evaluated each segment of the colon with standard-definition colonoscopes after spray application of 0.4% indigo carmine. All observed lesions were recorded and evaluated before being removed and/or biopsied. In addition, nontargeted biopsies were taken from each segment of the colon. The dysplasia detection rate and dysplasia detection yield were ascertained. RESULTS: A total of 21 neoplastic lesions (2 carcinomas, 4 of high-grade dysplasia and 15 of low-grade dysplasia) and 27 nondysplastic lesions were detected in 16 of the total 67 patients (70% male; median disease duration: 17 years; median age at diagnosis: 25 years; 92% aminosalicylate-treated). The dysplasia detection rate was 10.5% (7/67 patients). The dysplasia detection yield was 20.8% (10/48) for targeted biopsies and 3.5% (11/318) for nontargeted biopsies. The sensitivity and specificity for the macroscopic evaluation of neoplasia using chromoendoscopy were 48% [95% confidence interval (CI): 26%-70%] and 96% (95%CI: 93%-98%), respectively. The positive predictive and negative predictive values were 42% (95%CI: 27%-59%) and 97% (95%CI: 95%-98%), respectively. A total of 19/21 dysplastic lesions were detected in mucosa with histologic inflammation. CONCLUSION: Chromoendoscopy seems to be of value for dysplasia surveillance of ulcerative colitis in a community hospital setting. The yield of non-targeted biopsies is negligible.

• Henriksen, Magne; Høivik, Marte Lie; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn (2018). Irritable bowel-like symptoms in ulcerative colitis are as common in patients in deep remission as with inflammation; results from a population-based study (the IBSEN study). Journal of Crohn's and Colitis. ISSN 1873-9946. 12(4), p. 389–393. doi: 10.1093/ECCO-JCC/JJX152. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte; Jahnsen, Jørgen; Dahl, Sandra Rinne; Småstuen, Milada C & Grimstad, Tore [Show all 13 contributors for this article] (2017). Vitamin D deficiency in inflammatory bowel disease: Prevalence and predictors in a Norwegian outpatient population. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 52(1), p. 100–106. doi: 10.1080/00365521.2016.1233577. Full text in Research Archive Show summary

  Background and aim: 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. Methods: 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. Results: In total, 49% (200/408) of the patients had a 25-OH-D concentration <50 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 calprotectin >100 mg/kg. In patients with CD, there were significantly more relapses during the previous year in patients with vitamin D deficiency. Conclusions: Vitamin D deficiency was common, especially in CD, and was associated with increased disease activity, a relapsing disease course and higher inflammatory activity.

• Jelsness-Jørgensen, Lars-Petter; Frigstad, Svein Oskar; Moum, Bjørn; Grimstad, Tore; Opheim, Randi & Jahnsen, Jørgen [Show all 7 contributors for this article] (2017). Pain may be an important factor to consider in inflammatory bowel disease patients troubled by fatigue. United European Gastroenterology Journal (UEG Journal). ISSN 2050-6406. 5(5), p. 687–693. doi: 10.1177/2050640616674654. Full text in Research Archive
• Kristensen, Vendel Ailin; Røseth, Arne; Ahmad, Tahir Riaz; Skar, Viggo Øystein & Moum, Bjørn (2017). Fecal Calprotectin: A Reliable Predictor of Mucosal Healing after Treatment for Active Ulcerative Colitis. Gastroenterology Research and Practice. ISSN 1687-6121. 2017. doi: 10.1155/2017/2098293. Full text in Research Archive Show summary

  Objectives. Mucosal healing has become the new goal of treatment in ulcerative colitis. Fecal calprotectin has been demonstrated to differentiate between mucosal inflammation and mucosal healing. With this project, we investigated whether a reduction in f-calprotectin to <250 μg/g after medical treatment for active ulcerative colitis could predict mucosal healing. Material and Methods. After a baseline colonoscopy, 20 patients with active ulcerative colitis were followed with consecutive fecal calprotectin monthly until two measurements of fecal calprotectin < 250 μg/g or a maximum follow-up of 12 months. A flexible sigmoidoscopy was then performed and Mayo endoscopic subscore was used to evaluate degree of inflammation. Simple Clinical Colitis Activity Index was used for evaluation of clinical disease activity. Results. A total of 16 patients achieved fecal calprotectin < 250 μg/g during follow-up, and all 16 patients had endoscopic mucosal healing (Mayo endoscopic subscore of ≤1) on the second endoscopy. The remaining four patients had persistently high f-calprotectin levels before the second endoscopy with Mayo endoscopic subscore corresponding to endoscopic mucosal healing in three out of four patients. Conclusions. Fecal calprotectin <250 μg/g after medical treatment for active ulcerative colitis is a reliable marker of endoscopic mucosal healing.

• Burisch, Johan; Vegh, Zsuzsanna; Katsanos, Konstantinos H.; Christodoulou, Dimitrios K.; Lazar, Daniela & Goldis, Adrian [Show all 52 contributors for this article] (2017). Occurrence of anaemia in the first year of inflammatory bowel disease in a European population-based inception cohort-An ECCO-EpiCom study. Journal of Crohn's and Colitis. ISSN 1873-9946. 11(10), p. 1213–1222. doi: 10.1093/ecco-jcc/jjx077. Full text in Research Archive
• Tronstad, Rune Rose; Kummen, Martin; Holm, Kristian; Volkmann, Hilde Løland Von; Anmarkrud, Jarl Andreas & Høivik, Marte Lie [Show all 13 contributors for this article] (2017). Guanylate cyclase C activation shapes the intestinal microbiota in patients with familial diarrhea and increased susceptibility for Crohn's disease. Inflammatory Bowel Diseases. ISSN 1078-0998. 23(10), p. 1752–1761. doi: 10.1097/MIB.0000000000001264. Full text in Research Archive
• Lerdal, Anners; Opheim, Randi; Gay, Caryl; Moum, Bjørn; Fagermoen, May Solveig & Kottorp, Anders (2017). Psychometric limitations of the 13-item Sense of Coherence Scale assessed by Rasch analysis. BMC Psychology. 5(18). doi: 10.1186/s40359-017-0187-y. Full text in Research Archive Show summary

  Background A person’s sense of coherence (SOC) reflects their perception that the world is meaningful and predictable, and impacts their ability to deal with stressors in a health-promoting manner. A valid, reliable, and sensitive measure of SOC is needed to advance health promotion research based on this concept. The 13-item Sense of Coherence Scale (SOC-13) is widely used, but we reported in a previous evaluation its psychometric limitations when used with adults with morbid obesity. To determine whether the identified limitations were specific to that population or also generalize to other populations, we have replicated our prior study design and analysis in a new sample of adults with inflammatory bowel disease (IBD). Methods A sample of 428 adults with IBD completed the SOC-13 at a routine clinic visit in Norway between October 1, 2009 and May 31, 2011. Using a Rasch analysis approach, the SOC-13 and its three subscales were evaluated in terms of rating scale functioning, internal scale validity, person-response validity, person-separation reliability and differential item functioning. Results Collapsing categories at the low end of the 7-category rating scale improved its overall functioning. Two items demonstrated poor fit to the Rasch model, and once they were deleted from the scale, the remaining 11-item scale (SOC-11) demonstrated acceptable item fit. However, neither the SOC-13 nor the SOC-11 met the criteria for unidimensionality or person-response validity. While both the SOC-13 and SOC-11 were able to distinguish three groups of SOC, none of the subscales could distinguish any such groups. Minimal differential item functioning related to demographic characteristics was also observed. Conclusions An 11-item version of the sense of coherence scale has better psychometric properties than the original 13-item scale among adults with IBD. These findings are similar to those of our previous evaluation among adults with morbid obesity and suggest that the identified limitations may exist across populations. Further refinement of the SOC scale is therefore warranted.

• Buer, Lydia Celine Tansem; Høivik, Marte Lie; Medhus, Asle Wilhelm & Moum, Bjørn (2017). Does the Introduction of Biosimilars Change Our Understanding about Treatment Modalities for Inflammatory Bowel Disease? Digestive Diseases. ISSN 0257-2753. 35(1-2), p. 74–82. doi: 10.1159/000449087. Full text in Research Archive
• Huppertz-Hauss, Gert; Høivik, Marte; Jelsness-Jørgensen, Lars-Petter; Opheim, Randi; Henriksen, Magne & Høie, Ole Ingebreth [Show all 13 contributors for this article] (2017). Fatigue in a population-based cohort of patients with inflammatory bowel disease 20 years after diagnosis: The IBSEN study. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 52(3), p. 351–358. doi: 10.1080/00365521.2016.1256425. Full text in Research Archive
• Vesterhus, Mette; Holm, Anders; Hov, Johannes Espolin Roksund; Nygård, Ståle; Schrumpf, Erik & Melum, Espen [Show all 23 contributors for this article] (2017). Novel serum and bile protein markers predict primary sclerosing cholangitis disease severity and prognosis. Journal of Hepatology. ISSN 0168-8278. 66(6), p. 1214–1222. doi: 10.1016/j.jhep.2017.01.019. Full text in Research Archive Show summary

  Background & Aims Prognostic biomarkers are lacking in primary sclerosing cholangitis, hampering patient care and the development of therapy. We aimed to identify novel protein biomarkers of disease severity and prognosis in primary sclerosing cholangitis (PSC). Methods Using a bead-based array targeting 63 proteins, we profiled a derivation panel of Norwegian endoscopic retrograde cholangiography bile samples (55 PSC, 20 disease controls) and a Finnish validation panel (34 PSC, 10 disease controls). Selected identified proteins were measured in serum from two Norwegian PSC cohorts (n = 167 [1992–2006] and n = 138 [2008–2012]), inflammatory bowel disease (n = 96) and healthy controls (n = 100). Results In the bile derivation panel, the levels of 14 proteins were different between PSC patients and controls (p <0.05); all were confirmed in the validation panel. Twenty-four proteins in the bile derivation panel were significantly (p <0.05) different between PSC patients with mild compared to severe cholangiographic changes (modified Amsterdam criteria); this was replicated for 18 proteins in the validation panel. Interleukin (IL)-8, matrix metallopeptidase (MMP)9/lipocalin (LCN)2-complex, S100A8/9, S100A12 and tryptophan hydroxylase (TPH)2 in the bile were associated with both a PSC diagnosis and grade of cholangiographic changes. Stratifying PSC patients according to tertiles of serum IL-8, but not MMP9/LCN2 and S100A12, provided excellent discrimination for transplant-free survival both in the serum derivation and validation cohort. Furthermore, IL-8 was associated with transplant-free survival in multivariable analyses in both serum panels independently of age and disease duration, indicating an independent influence on PSC progression. However, the Enhanced Liver Fibrosis (ELF®) test and Mayo risk score proved to be stronger predictors of transplant-free survival. Conclusions Based on assaying of biliary proteins, we have identified novel biliary and serum biomarkers as indicators of severity and prognosis in PSC. Lay summary Prognostic biomarkers are lacking in primary sclerosing cholangitis, hampering patient care and the development of therapy. We have identified inflammatory proteins including calprotectin and IL-8 as important indicators of disease severity and prognosis in bile and serum from patients with primary sclerosing cholangitis.

• Jørgensen, Silje Fjellgård; Trøseid, Marius; Kummen, Martin; Anmarkrud, Jarl Andreas; Michelsen, Annika & Osnes, Liv T. N. [Show all 21 contributors for this article] (2016). Altered gut microbiota profile in common variable immunodeficiency associates with levels of lipopolysaccharide and markers of systemic immune activation. Mucosal Immunology. ISSN 1933-0219. doi: 10.1038/mi.2016.18. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Moum, Bjørn; Grimstad, Tore; Jahnsen, Jørgen; Opheim, Randi & Berset, Ingrid Prytz [Show all 11 contributors for this article] (2016). Validity, reliability, and responsiveness of the brief pain inventory in inflammatory bowel disease. Canadian Journal of Gastroenterology and Hepatology. ISSN 2291-2789. 2016:5624261. doi: 10.1155/2016/5624261. Full text in Research Archive
• Jelsness-Jørgensen, Lars-Petter; Bernklev, Tomm; Hovde, Øistein; Berset, Ingrid Prytz; Huppertz-Hauss, Gert & Moum, Bjørn [Show all 7 contributors for this article] (2016). Patients’ perceptions of quality of care and follow-up in inflammatory bowel disease. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 51(4), p. 434–441. doi: 10.3109/00365521.2015.1102319. Full text in Research Archive
• Kummen, Martin; Vesterhus, Mette; Trøseid, Marius; Moum, Bjørn; Svardal, Asbjørn M. & Boberg, Kirsten Muri [Show all 10 contributors for this article] (2016). Elevated trimethylamine-N-oxide (TMAO) is associated with poor prognosis in primary sclerosing cholangitis patients with normal liver function. United European Gastroenterology Journal (UEG Journal). ISSN 2050-6406. 5(4), p. 532–541. doi: 10.1177/2050640616663453. Full text in Research Archive Show summary

  Background Trimethylamine-N-oxide (TMAO) is produced in the liver from trimethylamine, which is exclusively generated by gut bacteria. Objective The objective of this article is to investigate the relationship between TMAO and primary sclerosing cholangitis (PSC) and its clinical characteristics. Methods Serum TMAO was measured in 305 PSC patients, 90 ulcerative colitis patients and 99 healthy controls. Results In PSC patients with normal liver function (n = 197), TMAO was higher in patients reaching liver transplantation or death during follow-up than those who did not, with an optimal TMAO cut-off of 4.1 µM (AUC = 0.64, p < 0.001). PSC patients with high TMAO (>4.1 µM, n = 77) exhibited shorter transplantation-free survival than patients with low TMAO (n = 120, log-rank test: p < 0.0001). High TMAO (>4.1 µM) was associated with reduced transplantation-free survival (HR 1.87, p = 0.011), independently of the Mayo risk score (HR 1.74, p < 0.001). Overall, PSC patients demonstrated reduced TMAO values compared with ulcerative colitis and healthy controls, mainly caused by PSC patients with reduced liver function (INR > 1.2), suggesting impaired oxidation of trimethylamine to TMAO. PSC patients with and without inflammatory bowel disease had similar TMAO levels. Conclusion In PSC patients with normal liver function, elevated TMAO was associated with shorter transplantation-free survival, potentially reflecting clinically relevant metabolic changes resulting from dietary interactions with the gut microbiota.

• Kristensen, Vendel Ailin; Lauritzen, Trine; Jelsness-Jørgensen, Lars-Petter; Frigstad, Svein Oskar; Corwin, Christian & Moum, Bjørn (2016). Patient-performed extraction of faecal calprotectin. Clinical Chemistry and Laboratory Medicine. ISSN 1434-6621. 54(8), p. 1357–1363. doi: 10.1515/cclm-2015-1037. Full text in Research Archive
• Kapica, Aida; Hov, Johannes Espolin Roksund; Borthne, Arne Sigmund; Gleditsch, Jostein; Johannesen, Glenn & Tveit, Knut [Show all 19 contributors for this article] (2016). Prevalence of Sclerosing Cholangitis Detected by Magnetic Resonance Cholangiography in Patients With Long-term Inflammatory Bowel Disease. Gastroenterology. ISSN 0016-5085. 151(4), p. 660–669. doi: 10.1053/j.gastro.2016.06.021. Full text in Research Archive
• Opheim, Randi; Høivik, Marte; Bernklev, Tomm; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn (2016). The use of complementary and alternative medicine (CAM) among patients with inflammatory bowel disease (IBD) is associated with reduced health-related quality of life (HRQoL). Gastroenterology Research and Practice. ISSN 1687-6121. 2016. doi: 10.1155/2016/6453657. Full text in Research Archive
• Wanderås, Magnus; Moum, Bjørn; Høivik, Marte Lie & Hovde, Øistein (2016). Predictive factors for a severe clinical course in ulcerative colitis: Results from population-based studies. World Journal of Gastrointestinal Pharmacology and Therapeutics (WJGPT). 7(2), p. 235–241. doi: 10.4292/WJGPT.v7.i2.235. Full text in Research Archive
• Arbelet, Benoit Follin - & Moum, Bjørn (2016). Fluoride: a risk factor for inflammatory bowel disease? Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 51(9), p. 1019–1024. doi: 10.1080/00365521.2016.1177855. Full text in Research Archive
• Huppertz-Hauss, Gert; Høivik, Marte; Jelsness-Jørgensen, Lars-Petter; Henriksen, Magne; Høie, Ole Ingebreth & Jahnsen, Jørgen [Show all 9 contributors for this article] (2016). Health-related quality of life in patients with inflammatory bowel disease 20 years after diagnosis: results from the IBSEN study. Inflammatory Bowel Diseases. ISSN 1078-0998. 22(7), p. 1679–1687. doi: 10.1097/MIB.0000000000000806. Full text in Research Archive
• Hovde, Øistein; Høivik, Marte Lie; Henriksen, Magne; Solberg, Inger Camilla; Småstuen, Milada Cvancarova & Moum, Bjørn A (2016). Malignancies in Patients with Inflammatory Bowel Disease: Results from 20 Years of Follow-up in the IBSEN Study. Journal of Crohn's and Colitis. ISSN 1873-9946. doi: 10.1093/ecco-jcc/jjw193. Full text in Research Archive Show summary

  Background and Aims: Whether patients with inflammatory bowel diseases [IBDs] have increased risk of developing cancer has been debated. The aims of the study were to determine the prevalence of intestinal/extraintestinal cancers in an IBD cohort 20 years after diagnosis and to assess whether these patients had an increased cancer-specific risk compared with a matched control population. Methods: Patients with ulcerative colitis [UC] and Crohn′s disease [CD] diagnosed 1990–1993 have been prospectively followed up for 20 years. Follow-up visits were carried out 1, 5, 10, and 20 years after inclusion. Data on all cancer cases, deaths, and causes of death were collected from the Cancer Registry of Norway and from the Norwegian Cause of Death Registry. Results: In all, 756 patients [519 UC and 237 CD] were diagnosed with IBD. Increased risk of cancer was seen in UC patients (hazard ratio [HR] = 1.40, 95% confidence interval [CI] 1.08–1.81, p < 0.01), but not in CD patients [HR = 1.23, 95% CI 0.80–2.03, p = 0.30]. Stratified by gender, our data revealed a statistically increased risk for all cancers only in male UC patients compared with the controls [HR = 1.51, 95% CI 1.08–2.11, p = 0.017]. In both groups breast cancer was seen more often than expected. Conclusions: Male UC patients display an increased risk of development of colorectal cancer and, also all cancers combined, compared with the controls. In both UC and CD, standardized incidence ratio for breast cancer was increased.

• Hovde, Øistein; Småstuen, Milada C; Høivik, Marte; Bernklev, Tomm; Huppertz-Hauss, Gert & Høie, Ole Ingebreth [Show all 11 contributors for this article] (2016). Mortality and Causes of Death in Ulcerative Colitis: Results from 20 Years of Follow-up in the IBSEN Study. Inflammatory Bowel Diseases. ISSN 1078-0998. 22(1), p. 141–145. doi: 10.1097/MIB.0000000000000582. Full text in Research Archive
• Kummen, Martin; Holm, Kristian; Anmarkrud, Jarl Andreas; Nygård, Ståle; Vesterhus, Mette & Høivik, Marte [Show all 14 contributors for this article] (2016). The gut microbial profile in patients with primary sclerosing cholangitis is distinct from patients with ulcerative colitis without biliary disease and healthy controls. Gut. ISSN 0017-5749. 66(4), p. 611–619. doi: 10.1136/gutjnl-2015-310500. Full text in Research Archive Show summary

  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<0.05, QFDR<0.20) in both panels were reported, followed by a combined comparison of all samples against UC. Results: Patients with PSC (N=85) had markedly reduced bacterial diversity compared with HC (N=263, p<0.0001), and a different global microbial composition compared with both HC (p<0.001) and UC (N=36, p<0.01). The microbiota of patients with PSC with and without IBD was similar. Twelve genera separated PSC and HC, out of which 11 were reduced in PSC. However, the Veillonella genus showed a marked increase in PSC compared with both HC (p<0.0001) and UC (p<0.02). Using receiver operating characteristic analysis, Veillonella abundance yielded an area under the curve (AUC) of 0.64 to discriminate PSC from HC, while a combination of PSC- associated genera yielded an AUC of 0.78. Conclusions: Patients with PSC exhibited a gut microbial signature distinct from both HC and UC without liver disease, but similar in PSC with and without IBD. The Veillonella genus, which is also associated with other chronic inflammatory and fibrotic conditions, was enriched in PSC.

• Kristensen, Vendel Ailin; Malmstrøm, Gunn Helen; Skar, Viggo Øystein; Røseth, Arne & Moum, Bjørn (2016). Clinical importance of faecal calprotectin variability in inflammatory bowel disease: Intra-individual variability and standardisation of sampling procedure. Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 51(5), p. 548–555. doi: 10.3109/00365521.2015.1117650. Full text in Research Archive
• Buer, Lydia Celine Tansem; Moum, Bjørn; Småstuen, Milada Cvancarova; Warren, David; Medhus, Asle Wilhelm & Høivik, Marte Lie (2016). Switching from Remicade® to Remsima® is well tolerated and feasible: a prospective, open-label study. Journal - Crohn's and Colitis Foundation of Canada. ISSN 1197-4982. doi: 10.1093/ecco-jcc/jjw166. Full text in Research Archive
• Huppertz-Hauss, Gert; Aas, Eline; Høivik, Marte; Langholz, Ebbe; Odes, Selwyn & Småstuen, Milada C [Show all 10 contributors for this article] (2016). Comparison of the Multiattribute Utility Instruments EQ-5D and SF-6D in a Europe-Wide Population-Based Cohort of Patients with Inflammatory Bowel Disease 10 Years after Diagnosis. Gastroenterology Research and Practice. ISSN 1687-6121. 2016:5023973, p. 1–9. doi: 10.1155/2016/5023973. Full text in Research Archive
• Huppertz-Hauss, Gert; Høivik, Marte; Langholz, E; Odes, Selwyn; Småstuen, Milada Cvancarova & Stockbrügger, Reinhold [Show all 9 contributors for this article] (2015). Health-related Quality of Life in Inflammatory Bowel Disease in a European-wide Population-based Cohort 10 Years After Diagnosis. Inflammatory Bowel Diseases. ISSN 1078-0998. 21(2), p. 337–344. doi: 10.1097/MIB.0000000000000272. Full text in Research Archive
• Larsson, Geir; Bjune, Gunnar Aksel; Moum, Bjørn; Shenoy, K.T. & Småstuen, Milada Cvancarova (2015). A Risk Matrix Model for the Prediction of Intestinal Tuberculosis and Differentiation from Crohn’s Disease. Austin Journal of Gastroenterology. ISSN 2381-9219. 2(5). Full text in Research Archive
• Larsson, Geir; Shenoy, Kotacherry Thrivikrama; Ramasubramanian, Ramalingom; Thayumanavan, Lakshmikanthan; Balakumaran, Leena Kondarappassery & Bjune, Gunnar Aksel [Show all 7 contributors for this article] (2015). High faecal calprotectin levels in intestinal tuberculosis are associated with granulomas in intestinal biopsies. Infectious Diseases. ISSN 2374-4235. 47(3), p. 137–143. doi: 10.3109/00365548.2014.974206. Full text in Research Archive
• Kristensen, Vendel Ailin; Lauritzen, Trine; Jelsness-Jørgensen, Lars-Petter & Moum, Bjørn (2015). Validation of a new extraction device for measuring faecal calprotectin in inflammatory bowel disease, and comparison to established extraction methods. Scandinavian Journal of Clinical and Laboratory Investigation. ISSN 0036-5513. 75(5), p. 355–361. doi: 10.3109/00365513.2015.1030765. Full text in Research Archive Show summary

  Objective: Faecal (f-) calprotectin is a widely used surrogate marker of intestinal inflammation. F-calprotectin analysis is labour demanding partly due to a time consuming extraction step. The aim of this project was to validate a new extraction method for f-calprotectin. Material and methods: A prospective multicentre study included 135 patients with an established diagnosis of inflammatory bowel disease. The patients submitted a faeces sample, which was extracted with both the conventional method at the participating laboratory and the new extraction device. The extracts were analyzed by an automated ELISA instrument. Results: Method comparison of the traditional method and the new device showed a slope of 1.01 (0.93–1.07) with intercept of − 2.2 (− 4.9–0.6). The Spearman rank correlation coefficient was 0.96. Conclusions: The new extraction device is a reliable and time saving alternative to the conventional extraction method.

• Solberg, Inger Camilla; Høivik, Marte; Småstuen, Milada C & Moum, Bjørn (2015). Risk matrix model for prediction of colectomy in a population-based study of ulcerative colitis patients (the IBSEN study). Scandinavian Journal of Gastroenterology. ISSN 0036-5521. 50(12), p. 1456–1462. doi: 10.3109/00365521.2015.1064991. Full text in Research Archive
• Vesterhus, Mette; Hov, Johannes Espolin Roksund; Holm, Anders; Schrumpf, Erik; Nygård, Ståle & Godang, Kristin [Show all 25 contributors for this article] (2015). Enhanced liver fibrosis score predicts transplant-free survival in primary sclerosing cholangitis. Hepatology. ISSN 0270-9139. 62(1), p. 188–197. doi: 10.1002/hep.27825. Full text in Research Archive
• Dahlerup, Jens F.; Moum, Bjørn & Lindgren, Stefan (2015). Järnbrist och järnbristanemi är globala hälsoproblem. Läkartidningen. ISSN 0023-7205. 112. Full text in Research Archive
• Kristensen, Vendel Ailin; Klepp, Pasquale Catherine; Småstuen, Milada Cvancarova; Røseth, Arne; Skar, Viggo Øystein & Moum, Bjørn (2015). Prediction of endoscopic disease activity in ulcerative colitis by two different assays for faecal calprotectin. Journal of Crohn's and Colitis. ISSN 1873-9946. 9(2), p. 164–169. doi: 10.1093/ecco-jcc/jju015. Full text in Research Archive

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• Mortensen, Joachim Høg; Lunder, Aida Kapic; Manon-Jensen, Tina; Karsdal, MA; Nielsen, Mette & Leeming, DJ [Show all 13 contributors for this article] (2020). P117 Biomarkers of extracellular matrix remodelling are associated with intestinal fibrosis assessed by magnetic resonance enterography and accumulated intestinal damage (Lémann index): the IBSEN study. Full text in Research Archive
• Opheim, Randi; Jahnsen, Jørgen; Bernklev, Tomm; Høie, Ole Ingebreth; Huppertz-Hauss, Gert & Moum, Bjørn (2019). Complementary and alternative medicine in patients with inflammatory bowel disease 20 years after diagnosis: Results from the IBSEN study. American Journal of Gastroenterology. ISSN 0002-9270. 114, p. S12–S13. doi: 10.14309/01.ajg.0000578256.56976.23. Full text in Research Archive
• Kristensen, Vendel Ailin; Småstuen, Milada Cvancarova; Høivik, Marte Lie; Moum, Bjørn & Vatn, Morten (2018). Long term stability of serological antibodies in a population-based inception cohort of inflammatory bowel disease - The IBSEN study. Full text in Research Archive
• Frigstad, Svein Oskar; Bernklev, Tomm; Dahl, Sandra Rinne; Hovde, Øistein; Jahnsen, Jørgen & Grimstad, Tore [Show all 10 contributors for this article] (2017). Vitamin D deficiency is not associated with chronic fatigue in inflammatory bowel disease. Full text in Research Archive
• Henriksen, Magne; Jelsness-Jørgensen, Lars-Petter; Høivik, Marte Lie & Moum, Bjørn (2017). Symptomer på irritabel tarmsyndrom (IBS)forekommer hyppig ved ulcerøs kolitt (UC) uavhengig av hvordan remisjon defineres. Resultater fra 20 års oppfølging i IBSEN studien. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Småstuen, Milada C; Jahnsen, Jørgen; Dahl, Sandra Rinne & Berset, Ingrid Prytz [Show all 13 contributors for this article] (2017). Fatigue er ikke assosiert med vitamin D mangel hos IBD pasienter. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Moum, Bjørn; Dahl, Sandra Rinne; Jahnsen, Jørgen & Småstuen, Milada Cvancarova [Show all 12 contributors for this article] (2017). Vitamin D deficiency is not associated with depression in IBD patients. Full text in Research Archive
• Hovde, Øistein; Høivik, Marte Lie; Henriksen, Magne; Solberg, Inger Camilla; Småstuen, Milada Cvancarova & Moum, Bjørn Allan (2017). Corrigendum: Malignancies in Patients with Inflammatory Bowel Disease (IBD): Results from 20 Years of Follow-up in the IBSEN (Inflammatory Bowel South-Eastern Norway) Study. Journal of Crohn's and Colitis. ISSN 1873-9946. 11(12), p. 1511–1511. doi: 10.1093/ecco-jcc/jjw218. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Dahl, Sandra Rinne; Cvancarova, Milada & Grimstad, Tore [Show all 13 contributors for this article] (2017). Vitamin D deficiency is not associated with depression in IBD patients. Journal of Crohn's and Colitis. ISSN 1873-9946. 11, p. 444–445. doi: 10.1093/ecco-jcc/jjx002.834. Full text in Research Archive
• Frigstad, Svein Oskar; Høivik, Marte Lie; Jahnsen, Jørgen; Småstuen, Milada C; Grimstad, Tore & Berset, Ingrid Prytz [Show all 12 contributors for this article] (2017). Fatigue is not Associated with Vitamin D Deficiency in IBD Patients. Gastroenterology. ISSN 0016-5085. 152(5), p. S945–S945. doi: 10.1016/S0016-5085(17)33218-3. Full text in Research Archive
• Bernklev, Tomm; Huppertz-Hauss, Gert; Opheim, Randi; Høivik, Marte; Moum, Bjørn & Jelsness-Jørgensen, Lars-Petter [Show all 7 contributors for this article] (2016). Co-existing Irritable Bowel Syndrome (IBS) in Inflammatory Bowel Disease (IBD) is associated with increased risk of chronic fatigue (CF), especially in females. Full text in Research Archive
• Kristensen, Vendel Ailin; Røseth, Arne; Ahmad, Tahir; Skar, Viggo Øystein & Moum, Bjørn (2016). Faecal calprotectin is a useful marker of mucosal healing after treatment for active ulcerative colitis. Full text in Research Archive
• Kristensen, Vendel Ailin; Malmstrøm, Gunn; Skar, Viggo Øystein & Moum, Bjørn (2015). Clinical relevance of faecal calprotectin variability in inflammatory bowel disease. Full text in Research Archive
• Kristensen, Vendel Ailin; Malmstrøm, Gunn; Skar, Viggo Øystein & Moum, Bjørn (2015). Clinical relevance of faecal calprotectin variability in inflammatory bowel disease. Full text in Research Archive
• Kummen, Martin; Vesterhus, Mette; Trøseid, Marius; Moum, Bjørn; Svardal, Asbjørn M. & Boberg, Kirsten Muri [Show all 10 contributors for this article] (2015). P1174: Microbiota-dependent marker trimethylamine-N-oxide (TMAO) is associated with the severity of primary sclerosing cholangitis. Full text in Research Archive Show summary

  Background and Aims: Trimethylamine-N-oxide (TMAO) is produced in the liver from trimethylamine, which is exclusively generated by gut bacteria from dietary choline and carnitine found in e.g. red meat and dairy products. TMAO influences bile acid levels, metabolism and potentially also inflammation. Given the production in the liver, link to the gut microbiota and bile acid homeostasis, we aimed to investigate the regulation of TMAO in primary sclerosing cholangitis (PSC). Methods: We measured serum TMAO in 305 PSC patients, 90 ulcerative colitis (UC) patients and 99 healthy controls (HC), with a median age (male %) of 41 (76), 38 (51) and 40 (60), respectively. Reduced liver function was defined by increased prothrombin time (International Normalized Ratio >1.2 or Normotest <70). Results: TMAO level was lower in PSC patients than in UC and HC (medians 3.1, 4.0 and 3.5, respectively, p < 0.05 versus HC and UC). We hypothesized that this could be explained by reduced liver function affecting TMAO production. In line with this, TMAO in PSC with reduced liver function, but not TMAO in those with normal liver function, was lower than in HC (p < 0.05). The TMAO level in UC was higher than in PSC irrespective of liver function (p < 0.05), while TMAO was similar in PSC patients with and without inflammatory bowel disease. Focusing on PSC patients with normal liver function, the TMAO level was higher in patients reaching an end-point during follow-up (liver transplantation, n = 70, or all-cause death, n = 21) than those without (median 4.6 versus 2.7, p = 0.001). AUROC-analysis yielded an AUC of 0.64 (p < 0.001) with a suggested optimal TMAO cut-off of 4.1mM. When stratified by this value, PSC patients with high TMAO exhibited shorter transplantation-free survival than patients with low TMAO (median 3.0 versus 16.2 years, p < 0.001, Figure 1). In Cox regressions, TMAO>4.1mM and Mayo risk score were independently associated with transplantation-free survival, with HR 2.0 (95% CI 1.2–3.1, p = 0.005) and 1.5 (95% CI 1.2–1.8, p < 0.001), respectively. Conclusions: PSC patients with impaired liver function had decreased TMAO level, suggesting that TMAO may be influenced by reduced liver function. On the other hand, in PSC patients with normal liver function, elevated TMAO was associated with a shorter liver transplantation-free survival, suggesting that dietary factors and gut microbiota profile may be relevant for the disease prognosis in PSC.

• Jelsness-Jørgensen, Lars-Petter; Høivik, Marte Lie; Moum, Bjørn; Opheim, Randi; Huppertz-Hauss, Gert & Grimstad, Tore [Show all 10 contributors for this article] (2015). Fatigue is associated with increased pain intensity and interference in IBD. Inflammatory Bowel Diseases. ISSN 1078-0998. doi: 10.1080/00365521. Full text in Research Archive

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