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Background: In this study we compared the accuracy of seven diagnostic tests in diagnosing Helicobacter pylori infection. Methods: Over 1 year 351 consecutive dyspeptic patients were tested for H. pylori infection by means of antral biopsy specimens for the rapid urease test (RUT), culture, microscopy (acridine stain), and the laboratory urease test (LUT) and, in addition, with C urea breath test (UBT), IgG serology, and IgA serology (Orion Diagnostica Pyloriset New EIA-G and New EIA-A). The criterion for H. pylori infection was a minimum of three positive tests. Before being tested, 38% of the patients had used an H-receptor antagonist (HRA). Results: Two-hundred and twenty-four patients (64%) were H. pylori-positive. The sensitivity and specificity of the tests were as follows (percentages): RUT, 85, 99; culture, 93, 100; microscopy, 81, 98; LUT, 80, 100; UBT, 95, 95; IgG serology, 99, 91; and IgA serology, 88, 91. The accuracy of the RUT and LUT was reduced in patients receiving HRA therapy (P = 0.04 and 0.01, respectively). Conclusions: Culture, UBT, and IgG serology were all superior to the other four tests in diagnosing H. pylori infection. Invasive urease-based tests were less accurate in patients receiving HRAs. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the cure rate of Helicobacter pylori infection, including the impact of in vitro metronidazole resistance (M-R), and the side effects of a simplified 10-day bismuth triple therapy in routine clinical practice. Methods: From September 1995 to March 1996,248 consecutive H. pylori-positive patients received 10 days of bismuth subnitrate 150 mg, oxytetracycline 500 mg, and metronidazole 400 mg, all t.i.d. Before treatment, upper endoscopy, including biopsy specimens for microbiological analysis and IgG serology were performed. M-R was found in 45% of females and 36% of males. At least 2 months after treatment, H. pylori status was assessed by the 14C urea breath test (n = 131), endoscopy (n = 37), urea breath test and endoscopy (n = 63), or solely by IgG serology (n = 7). Ten patients withdrew. IgG serology was performed again after 1 yr. Results: H. pylori infection was cured in 205 patients: 86% by all-patients-treated analysis and 83% by intention-to-treat analysis. When patients were classified according to pretreatment metronidazole susceptibility, cure of infection was achieved in 76% of females harboring M-R strains versus 96% of those with sensitive strains (p = 0.002) and in 81% versus 88% (p = 0.34) of males with M-R versus sensitive strains, respectively. Twelve patients (5%) had to stop treatment prematurely because of severe side effects, but eight of them were treated successfully. One case of H. pylori infection (0.6%) was detected at 1-yr follow-up. Conclusions: Ten-day bismuth triple therapy t.i.d. was effective in curing H. pylori infection in the context of routine clinical practice. The efficacy was reduced in females harboring M-R strains. [ABSTRACT FROM AUTHOR]

Objectives: To compare the efficacy and side effects of standard bismuth triple therapy with those of omeprazole-based triple therapy in patients with Helicobacter pylori infection and duodenal ulcer disease. Methods: One hundred patients were prospectively recruited and randomized to receive either bismuth subnitrate 75 mg q.i.d., oxytetracycline 500 mg q.i.d., and metronidazole 400 mg b.i.d. (regimen BTM), or omeprazole 20 mg b.i.d., amoxicillin 750 mg b.i.d., and metronidazole 400 mg b.i.d. (regimen OAM), both for 14 days. Upper endoscopy (with antral biopsy specimens for microbiology and antral and corpus biopsy specimens for histology) was performed before treatment, after 2 months, and again 1 yr after treatment. Serum samples for serology (IgG) were taken. Patients with in vitro metronidazole-resistant (M-R) H. pylori strains were excluded. In a nonrandomized study, 41 patients with M-R strains were given either BTM or OAM. Results: According to intention-to-treat analysis, H. pylori cure rates were 91% and 96% with BTM and OAM, respectively (p = 0.45). In the BTM group, the mean total side effect score was higher (p < 0.001), and more severe side effects were reported (32% vs. 4%, p < 0.001). In the nonrandomized group of patients with M-R strains, H. pylori cure rates were 88% and 67% with BTM and OAM, respectively. All of the successfully treated patients were still H. pylori-negative after 1 yr. Conclusions: Both treatment regimens were highly effective in curing H. pylori infection in patients with metronidazole-sensitive strains. Omeprazole-based triple therapy was tolerated better than standard bismuth-based triple therapy. [ABSTRACT FROM AUTHOR]

Background: In this study we assessed the accuracy of IgG serology and other tests in confirming Helicobacter pylori eradication. Methods: The outcome of anti-H. pylori therapy was established by at least two of the following tests: rapid urease test (RUT), culture, [sup 14]C urea breath test (non-capsule or capsule UBT), and IgG serology (Orion Diagnostica Pyloriset New EIA-G). Results: Successful H. pylori eradication was confirmed in 698 of 794 patients (88%). The percentage decrease in IgG antibody titre was related to the patients' pre-treatment IgG titre and time interval after treatment. A decrease in IgG titres of 40% or more confirmed H. pylori eradication with 100% specificity, whereas the sensitivity was 82%, 90%, 98%, and 98% 3, 4, 5, and 6 months after therapy, respectively. The 40% cut-off confirmed eradication 3 to 6 months after therapy in 328 of 339 patients (97%) with pre-treatment IgG titres of >700, in 36 of 45 patients (80%) with pre-treatment titres of 300-700, and in 5 of 12 patients (42%) with pre-treatment titres of <300. The sensitivity and specificity of the other tests 2 months after treatment were as follows: RUT, 84% and 100%; culture, 88% and 100%; non-capsule UBT, 100% and 89%; and capsule UBT, 100% and 97%. Conclusion: A decrease in IgG antibody titre of 40% or more 3 to 6 months after therapy and the capsule [sup 14]C UBT at the 2-month follow-up were both highly accurate in confirming H. pylori eradication. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented regarding the article on the recommendation of the European Medicines Agency (EMA) for allergic reactions to intravenous iron-containing medicines.

Background The point prevalence estimates of anaemia in patients with inflammatory bowel disease (IBD) range between 6% and 74%. The variation is probably due to differences in the definition of anaemia and the study populations. Aim To retrospectively determine the prevalence of anaemia at diagnosis and at the 1-, 5- and 10-year follow-ups in patients with IBD from a prospectively followed, population-based inception cohort (the IBSEN Study). To compare the prevalence of anaemia after a 10-year disease course with the prevalence of anaemia in the background population, and to assess clinical factors associated with anaemia at diagnosis and during follow-up. Methods Newly diagnosed IBD patients were included in a population-based, prospective cohort. Follow-up was performed at 1, 5 and 10 years. All visits included clinical examinations and blood samples. Anaemia was defined according to the WHO. Results A total of 756 patients ( UC, n = 519 and CD, n = 237) were included; 48.8% of CD and 20.2% of UC patients were anaemic at diagnosis ( P < 0.001). The proportion of patients with anaemia decreased during the disease course in all patients, except in women with CD. After 10 years of disease, the relative risk for anaemia was increased in all groups, except for women with UC. The variables associated with anaemia were generally unchanged during the disease course, and elevated CRP was the strongest predictor of risk. Conclusions Anaemia was more common in CD than in UC. The prevalence of anaemia decreased during the disease course. Women with CD were at high risk for anaemia. Elevated CRP was independently associated with anaemia. [ABSTRACT FROM AUTHOR]

Background Iron deficiency is a common and undertreated problem in inflammatory bowel disease (IBD). Aim To develop an online tool to support treatment choice at the patient-specific level. Methods Using the RAND/UCLA Appropriateness Method (RUAM), a European expert panel assessed the appropriateness of treatment regimens for a variety of clinical scenarios in patients with non-anaemic iron deficiency (NAID) and iron deficiency anaemia (IDA). Treatment options included adjustment of IBD medication only, oral iron supplementation, high-/low-dose intravenous (IV) regimens, IV iron plus erythropoietin-stimulating agent (ESA), and blood transfusion. The panel process consisted of two individual rating rounds (1148 treatment indications; 9-point scale) and three plenary discussion meetings. Results The panel reached agreement on 71% of treatment indications. 'No treatment' was never considered appropriate, and repeat treatment after previous failure was generally discouraged. For 98% of scenarios, at least one treatment was appropriate. Adjustment of IBD medication was deemed appropriate in all patients with active disease. Use of oral iron was mainly considered an option in NAID and mildly anaemic patients without disease activity. IV regimens were often judged appropriate, with high-dose IV iron being the preferred option in 77% of IDA scenarios. Blood transfusion and IV+ESA were indicated in exceptional cases only. Conclusions The RUAM revealed high agreement amongst experts on the management of iron deficiency in patients with IBD. High-dose IV iron was more often considered appropriate than other options. To facilitate dissemination of the recommendations, panel outcomes were embedded in an online tool, accessible via http://ferroscope.com/ [ABSTRACT FROM AUTHOR]

Background: In Crohn's disease (CD), studies associating phenotype at diagnosis and subsequent disease activity are important for patient counselling and health care planning. Aims: To calculate disease recurrence rates and to correlate these with phenotypic traits at diagnosis. Methods: A prospectively assembled uniformly diagnosed European population based inception cohort of CD patients was classified according to the Vienna classification for disease phenotype at diagnosis. Surgical and non-surgical recurrence rates throughout a 10 year follow up period were calculated. Multivariate analysis was performed to classify risk factors present at diagnosis for recurrent disease. Results: A total of 358 were classified for phenotype at diagnosis, of whom 262 (73.2%) had a first recurrence and 113 patients (31.6%) a first surgical recurrence during the first 10 years after diagnosis. Patients with upper gastrointestinal disease at diagnosis had an excess risk of recurrence (hazard ratio 1.54 (95% confidence interval (CI) 1.13-2.10)) whereas age ⩾40 years at diagnosis was protective (hazard ratio 0.82 (95% Cl 0.70-0.97)). Colonic disease was a protective characteristic for resective surgery (hazard ratio 0.38 (95% Cl 0.21-0.69)). More frequent resective surgical recurrences were reported from Copenhagen (hazard ratio 3.23 (95% Cl 1.32-7.89)). Conclusions: A mild course of disease in terms of disease recurrence was observed in this European cohort. Phenotype at diagnosis had predictive value for disease recurrence with upper gastrointestinal disease being the most important positive predictor. A phenotypic North-South gradient in CD may be present, illustrated by higher surgery risks in some of the Northern European centres. [ABSTRACT FROM AUTHOR]

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., Methods: Norwegian health registries were used to identify adult-onset (born 1950-1989) and elderly-onset (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., 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)., 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., Competing Interests: Conflict of interest K.A. reports consultant fees from Takeda outside the submitted work. S.S.L. reports grants and consultant fees from Takeda. A.W.M. reports grants from Takeda. B.M. reports consultant fees from Takeda, Janssen, AbbVie, Galapagos, Pfizer, Sandoz, Pharmacosmos as, Ferring as, Tillotts Pharma; speaker fees from Takeda, Janssen, Pfizer, AbbVie, Sandoz, Orion Pharma, Ferring as, Tillotts Pharma. H.O.M. reports grants and consultant fees from Takeda. M.L.H. reports speaker fees from Galapagos, Ferring, BMS, Janssen, AbbVie, Meda, Tillotts and Takeda; advisory boards for Takeda, Galapagos, BMS and AbbVie; investigator-initiated research grants from: Takeda, Pfizer, Tillotts and Ferring., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., Competing Interests: Ø.H. has received personal fees from AbbVie, Janssen-Cilag AS, Takeda and Ferring. L.-P.J.-J. has received personal fees for lectures and advisory boards for Takeda, Ferring and Tillots Pharmaceuticals. B.M. has received personal fees from Gilead, Galapagos, AbbVie, Janssen-Cilag, Takeda, Ferring, Tillots, Bristol Myers Squibb, Pfizer, Norgine, Vifor France, Norsk elektronisk legehåndbok. None were related to the submitted work.None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

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.

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., Competing Interests: Declaration of interests JB reports personal fees from AbbVie, Celgene, Pfizer, Samsung Bioepis, Pharmacosmos, Ferring, and Galapagos; grants and personal fees from Janssen, MSD, Takeda, Tillots Pharma, and Bristol Myers Squibb; and grants from Novo Nordisk. MZ has received support for attending a meeting from Takeda. PDC has received grants or contracts from Janssen, Takeda, Ferring, Shire, AbbVie, Celltrion, and Baxter. PDC has been a speaker, consultant, and advisory board member for AbbVie, Janssen, Takeda, Celltrion, Ferring, Shire, and Baxter; received support for travel or attending meetings or both from Ferring, Shire, Janssen, AbbVie, Takeda, Celltrion, and Baxter; and has been a member of the Australia and New Zealand IBD Research Consortium. SV has received research grants from Pfizer, Galapagos, AbbVie, Johnson & Johnson, and Takeda; consulting fees from AbbVie, AbolerIS Pharma, Agomab, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech–Roche, Gilead, GSK, Hospira, Imidomics, Janssen, Johnson & Johnson, Eli Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance, Tillots Pharma, Zealand Pharma; speaker fees from Alimentiv, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Ferring, Galapagos, Genentech–Roche, Gilead, GSK, Janssen, Johnson & Johnson, Eli Lilly, Materia Prima, Pfizer, Takeda, and Tillots Pharma. CNB has served on advisory Boards for AbbVie Canada, Amgen Canada, Bristol Myers Squibb Canada, JAMP Pharma, Roche Canada, Janssen Canada, Sandoz Canada, Takeda Canada, and Pfizer Canada; is a consultant for Mylan Pharmaceuticals and Takeda; and educational grants from AbbVie Canada, Pfizer Canada, Takeda Canada, and Janssen Canada. CNB is on the speaker's panel for AbbVie Canada, Janssen Canada, Medtronic Canada, and Takeda Canada; and has received research funding from AbbVie Canada and Pfizer Canada. GGK has received honoraria for speaking or consultancy from AbbVie, Janssen, Pfizer, Amgen, Sandoz, Pendopharm, and Takeda. He has received research support from Ferring. He shares ownership of a patent: treatment of inflammatory disorders, autoimmune disease, and pbc (WO2019046959A1. PCT/CA2018/051098) since Sept 7, 2018. DD has received lecture or consultancy fees from Takeda, Janssen, and Pfizer, and support for travel or attending meetings or both from Janssen and Takeda. MW has received grants or contracts from Mitsubishi Tanabe Pharma, Takeda, Zeria Pharmaceutical, Nippon Kayaku, Mochida Pharmaceutical, Kyorin Pharmaceutical, AbbVie, EA Pharma, Kissei Pharmaceutical, and Alfresa Pharma; consulting fees from AbbVie, EA Pharma, Eli Lilly Japan, Gilead Sciences, Nippon Boehringer Ingelheim, and Takeda Pharmaceutical; and honoraria from EA Pharma, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Zeria Pharmaceutical, Pfizer Japan, Kissei Pharmaceutical, Nippon Boehringer Ingelheim, Gilead Sciences, Janssen Pharmaceutical, Celltrion Healthcare, JIMRO, Eli Lilly Japan, and Mochida Pharmaceutical. LT has received grants or contracts from Janssen, AbbVie, Pfizer, Takeda, Roche, Gilead, Sandoz, and Amgen; consulting fees from Janssen, AbbVie, Pfizer, Takeda, Roche, Gilead, Sandoz, Amgen, Fresnius Kabi, and Viatris; and honoraria for lectures from Janssen, AbbVie, Pfizer, Takeda, Roche, Gilead, Sandoz, Amgen, and Organon. KP is an employee of Genentech–Roche and a shareholder of the Roche Group. KHK has served as speaker, consultant, and advisory member for or has received research funding from AbbVie, Amgen, Enorasis, Epsilon Health, Dr Falk Pharma, Faran Ferring, Genesis, Grifols, Janssen, Koper, MSD, Mylan, Shire, Takeda, and Vianex. MLH has received investigator-initiated research grants from Tillotts, Ferring, Takeda, and Pfizer; advisory board honoraria from Takeda and AbbVie; and speaking fees from Takeda, AbbVie, Tillotts, Ferring, Galapagos, Janssen, and MSD. ZK has served as speaker for AbbVie, Takeda, Janssen, Freseinus, and Oktal Pharma/Celltrion. MC has served as a speaker, as a consultant, or has received research or education funding from MSD, AbbVie, Hospira, Pfizer, Takeda, Janssen, Ferring, Shire Pharmaceuticals, Dr Falk Pharma, Tillotts Pharma, Biogen, Gilead, and Eli Lilly. EVL has received grants or contracts from AbbVie, Bristol Myers Squibb, Celgene/Receptos, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, Takeda, Theravance, and UCB; consulting fees from AbbVie, Amgen, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Calibr, Celgene, Fresenius Kabi, Genentech, Gilead, Gossamer Bio, Janssen, Iterative Scopes, Ono Pharma, Pfizer, Protagonist, Scipher Medicine, Surrozen, Takeda, and UCB; reports the following patents: USA 11 249 084 (issued), USA 10 041 948 (issued), and USA 17 668 915 (pending); has participated on a data safety monitoring board or advisory board for Eli Lilly and Morphic; owns stock in Exact Sciences; and is a board member of Crohn's & Colitis Foundation, Minnesota-Dakotas Chapter. PLL has been a speaker or advisory board member, or both, for AbbVie, Amgen, BioJamp, Bristol Myers Squibb, Fresenius Kabi, Genentech, Gilead, Janssen, Merck, Mylan, Organon, Pendopharm, Pfizer, Roche, Takeda, Tillots, and Viatris, and has received unrestricted research grants from AbbVie, Gilead, Takeda, and Pfizer. JPG has served as a speaker, consultant, and advisory member for or has received research funding from MSD, AbbVie, Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers Squibb, Gilead/Galapagos, Eli Lilly, Ferring, Faes Farma, Shire Pharmaceuticals, Dr Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, Norgine, and Vifor Pharma. WB has received research grants from Vifor Pharma and B Braun Medical; consulting fees from Takeda and B Braun Medical; speaker fees from Medtronic, Takeda, B Braun Medical, and Johnson & Johnson; and is a stock owner of Semiflex Company. RBG has received grants or contracts from AbbVie and Janssen; consulting fees from AbbVie; and honoraria for lectures from AbbVie and Cornerstone Health. MDK has received grants or contracts from Pfizer, Takeda, Janssen, AbbVie, Eli Lilly, Genentech, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, and Arenapharm; consulting fees from Takeda and Pfizer; speaker fees from AbbVie; has participated on data safety monitoring board or advisory board for Eli Lilly; and owns stock in Johnson & Johnson. MJP has received grants or contracts from Takeda, Janssen, Galapagos, Tramedico, MSD, Takeda, Janssen, and Bristol Myers Squibb; honoraria for lectures from Bristol Myers Squibb, Janssen, AbbVie, and Galapagos; consulting fees from Janssen and Gilead; and has a leadership or fiduciary role in the MyCoach foundation. JMA has served as speaker, consultant, and advisory member for AbbVie, Allergan, Anatara, Atmo Capsule, Bayer, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Ferring Fresenius Kabi, Gilead, Hospira, Immuninc, ImmunsanT, Janssen, MSD, Nestle, Novartis, Pfizer, Sandoz, Shire, Takeda, and Vifor; has participated on a data safety monitoring board or advisory board for Janssen; has received research grants from the Royal Adelaide Hospital research fund, The Hospital Research Fund 2020–22, and The Helmsley Trust 2020–23. SCN has received grants or contracts from AbbVie, Ferring, and Olympus and Janssen; consulting fees from AbbVie, Pfizer, Ferring, and Janssen; honoraria for lectures from AbbVie, Ferring, Janssen, Menarini, Takeda, Tillotts and Pfizer; has participated on a data safety monitoring board or advisory board for AbbVie, Pfizer, Ferring, and Janssen; is a shareholder of GeniBiome; and is a director of the Microbiota I-Center, Hong Kong. HOM has received research grants from Takeda and Biogen, consulting fees from Takeda, and speaking fees from Pfizer and Biogen. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

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., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.)

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., (© 2022. The Author(s).)

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., Competing Interests: J.M.H.: None declared. E.L. has served as a consultant to AbbVie; as a speaker for AbbVie, Janssen, Fresenius-Kabi, and Takeda; as a speaker for AbbVie, Falk, Ferring, Janssen, Pfizer, Galapagos, and Takeda; received research grants from Janssen, Pfizer, Ferring, Falk, AbbVie, and Takeda; received educational grants from AbbVie, Janssen, Fresenius-Kabi, and Takeda; has served on the advisory committee for AbbVie, Celgene, Ferring, Janssen, BMS, Pfizer, and Takeda, Galapagos, Gilead, Arena, Elli Lilly. A.S. has served as a consultant to Johnson & Johnson and Takeda. S.T. has served as a consultant for Abacus, AbbVie, Actial, ai4gi, Alcimed, Allergan, Amgen, Apexian, Aptel, Arena, Asahi, Aspen, Astellas, Atlantic, AstraZeneca, Barco, Biocare, Biogen, BLPharma, Boehringer Ingelheim, BMS, Buhlmann, Calcico, Celgene, Cellerix, Cerimon, ChemoCentryx, Chiesi, CisBio, ComCast, Coronado, Cosmo, Ducentis, Dynavax, Elan, Enterome, EQrX, Equillium, Falk, Ferring, FPRT Bio, Galapagos, Genentech/Roche, Genzyme, Gilead, Glenmark, Grunenthal, GSK, GW Pharmaceuticals, Immunocore, Immunometabolism, Indigo, Janssen, Lexicon, Lilly, Medarex, Medtrix, Merck, Merrimack, Mestag, Millenium, Neovacs, Novartis, Novo Nordisk, NPS-Nycomed, Ocera, Optima, Origin, Otsuka, Palau, Pentax, Pfizer, Pharmaventure, Phesi, Phillips, P&G, Pronota, Protagonist, Proximagen, Resolute, Robarts, Sandoz, Santarus, Satisfai, Sensyne Health, Shire, SigmoidPharma, Sorriso, Souffinez, Syndermix, Synthon, Takeda, Theravance, Tigenix, Tillotts, Topivert, Trino Therapeutics with Wellcome Trust, TxCell, UCB Pharma, Vertex, VHsquared, Vifor, Warner Chilcott, and Zeria; as a speaker for AbbVie, Amgen, Biogen, Falk; Ferring, Janssen, Pfizer, Shire, Takeda, and UCB; and received grant support from AbbVie, Buhlmann, Celgene, ECCO, Helmsley Trust, IOIBD, Janssen, Lilly, Pfizer, Takeda, UCB, UKIERI, Vifor, and Norman Collisson Foundation. B.M. has served as consultant to Galapagos; as a speaker for Ferring, Janssen Cilag, and Takeda; has served on the advisory committee for Janssen Cilag, Pfizer, and Takeda. J.S.-D. holds the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. J.H. has served as a consultant to AbbVie, Galapagos, Janssen, Pfizer, Takeda, and Thermo Fisher Scientific; has received research support from Janssen, MSD, Takeda, and Thermo Fisher Scientific; has as served on the advisory committee for AbbVie, Galapagos, Gilead, Janssen, Pfizer, Takeda, and Thermo Fisher Scientific. R.P. has served as a consultant to Abbott, AbbVie, Alimentiv, Amgen, Arena, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Therapeutics, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Schering-Plough, Shire, Sublimity Therapeutics, Takeda, Theravance, and UCB; as a speaker for AbbVie, Arena, Celgene, Eli Lilly, Ferring, Gilead Sciences, Janssen, Merck, Pfizer, Roche, Sandoz, Shire, and Takeda; has served on the advisory committee for AbbVie, Amgen, Arena, Bristol Myers Squibb, Celgene, Celltrion, Eli Lilly, Ferring, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Mylan, Oppilan Pharma, Pandion Pharma, Pfizer, Sandoz, Shire, Sublimity Therapeutics, Takeda, and Theravance; has received grant support from AbbVie, Ferring, Janssen, Pfizer, and Takeda. M.C.D. has served as a consultant to AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Genetech, Gilead Sciences, Janssen Pharmaceuticals, Pfizer Inc, Prometheus Laboratories, Takeda, and UCB, and is a shareholder in Trellus Health. P.M. has received consulting or lecture fees from AbbVie, Calpro, Falk Pharma, Ferring Pharmaceuticals, Janssen-Cilag, Merck Sharp and Dohme, Takeda, and Tillotts Pharma, and research funds from AbbVie, Calpro, Coloplast, Ferring Pharmaceuticals, Janssen-Cilag, Merck Sharp and Dohme, Pharmaforce, Takeda, and Tillotts Pharma. C.A.S. has served as a consultant to AbbVie, BMS, Lilly, Janssen, Pfizer, Prometheus, Takeda, and Trellus Health, as a speaker for AbbVie, Janssen, Pfizer, and Takeda, and received grant support from AbbVie, Janssen, Pfizer, and Takeda., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Iron deficiency, defined as ferritin <100 µg/L or ferritin 100-299 µg/L if the transferrin saturation is <20 %, with or without anaemia is a common comorbidity in patients with acute and chronic heart failure. International and Swedish guidelines recommend treatment of iron deficiency with intravenous iron in patients with symptomatic heart failure and ejection fraction <50 %. Controlled studies document positive effects from treatment with iron carboxymaltose on symptoms, quality of life, functional parameters and risk of hospitalisation. We present a simple algoritm based on published data to help the responsible physician to manage these patients in clinical practice.

Background: Despite the increasing use of biologics in patients with inflammatory bowel disease (IBD), real-world data about outcomes in the era of biologics remain inconclusive., Aims: To investigate trends in surgeries, hospitalisations and medication use in patients with IBD in a multinational, population-based cohort METHODS: We included 42,894 patients with ulcerative colitis (UC) and 24,864 with Crohn's disease (CD) who were diagnosed between 2010 and 2017 in Denmark, Norway and Sweden. We extracted data about surgeries, hospitalisations and medications from national registries and compared across countries and diagnosis years., Results: Between 2010 and 2017, 2-year surgery rates were 4-7% in UC and 10-15% in CD and were stable over time. Two-year hospitalisation rates increased in Denmark (UC: 20% to 35%; CD: 27% to 32%) but were stable in Norway and Sweden (fluctuating between 33% and 37% in UC, and 46% and 52% in CD). Two-year rates of biologic use increased in both UC (7% to 16% in Denmark, 8% to 18% in Norway) and CD (22% to 26% in Denmark; 21% to 35% in Norway). Two-year rates of immunomodulator use increased in Norway (from 14% to 23% in UC; 37% to 45% in CD) and Sweden (from 41% to 52% in CD), but were stable in Denmark (between 17% and 21% in UC; 39% to 46% in CD)., Conclusion: Between 2010 and 2017, surgery rates among Scandinavian patients with IBD remained stable, with no clear changes in hospitalisation rates despite the increasing use of immunomodulators and biologics., (© 2022 John Wiley & Sons Ltd.)