Search

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 =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. publishedVersion

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

Background: TNF-alpha inhibitors have improved treatment of chronic immune-mediated inflammatory disorders. The NOR-SWITCH main and extension trial addressed switching from infliximab originator (IFX) to CT-P13 across six diseases. Here we present the exploratory post-hoc analyses in Crohn's disease (CD) and ulcerative colitis (UC). Methods: The 52-week, randomized, non-inferiority, double blind, multicenter, 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 were assessed throughout the 78-week study period. The primary endpoint was disease worsening. Findings: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. The baseline characteristics were comparable between treatment arms in both diseases. Disease worsening in the main trial occurred in 14 (21%) of CD patients in the IFX group and 23 (37%) in the CT-P13 group (risk difference -14⋅3%, CI -29⋅3 to 0⋅7). In the extension study, disease worsening occurred in 13 (21%) patients in the CT-P13 maintenance group and 8 (13%) in the IFX/CT-P13 switch group (risk difference 7⋅9%, CI -5⋅2 to 21). The corresponding results in UC were 3 (9%) and 5 (12%) patients (risk difference -2⋅6%, CI -15⋅2 to 10⋅0) in the main trial, and 6 (15%) and 1 (3%) patients (risk difference 12⋅4%, CI -0⋅1 to 25⋅0) in the extension trial. In both diseases, the treatment groups were similar across disease activity measures, drug levels and immunogenicity. Interpretation: The subgroup analyses of IBD in the NOR-SWITCH main and extension trials support switching from originator infliximab to CT-P13 for non-medical reasons. Trial Registration: ClinicalTrials.gov NCT-02148640, EudraCT Number: 2014-002056-40. Funding Statement: This work was supported by the Norwegian Ministry of Health and Care Services. Declaration of Interests: KKJ reports personal fees from Intercept, Norgine and Celltrion. GLG reports personal fees from AbbVie, Biogen, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Orion Pharma, Celltrion and Boehringer Ingelheim. NB reports personal fees received from Orion Pharma, Roche, Napp Pharmaceuticals, Pfizer, and Takeda. ICO reports grants from Norwegian Ministry of Health and Care Services during the conduct of the study, and personal fees from Pfizer. EAH reports grants from AbbVie, Pfizer, UCB, Roche, and MSD. IPB reports personal fees from AbbVie, MSD, Takeda, Hospira, and Ferring. KEAL reports grants from MSD, personal fees from Takeda, Orion, Abbvie, Pfizer, and MSD. JJ reports personal fees from MSD, AbbVie, Celltrion, Orion Pharma, Takeda, Napp Pharm, AstroPharma, Hikma and Pfizer. TKK reports reports grants from Norwegian Ministry of Health and Care Services during the conduct of the study and personal fees from AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, and UCB Pharma. SOF reports personal fees from Takeda, Pharmacosmos, Tillotts, Janssen, Intercept and Pfizer. Ethics Approval Statement: The study was conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The study protocol and consent documents were approved by an independent ethics committee (Regional Committees for Medical and Health Research Ethics South East; reference number 2014/848), by appropriate institutional review boards and by the Norwegian Medicines Agency (reference number 14/07192-11).

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

Objective. Case reports and short-term clinical trials have suggested that treatment for chronic hepatitis B (CHB) may lead to improvement of cirrhosis. The aim of the present study was to measure liver stiffness in patients diagnosed with advanced fibrosis or cirrhosis prior to prolonged treatment with nucleoside or nucleotide analogs (NUCs) for CHB. Materials and methods. Patients with CHB and advanced fibrosis or cirrhosis prior to treatment with NUCs for at least 1 year were offered inclusion in the study. We measured liver stiffness using transient elastography (TE) at follow-up. TE cut-off levels to Metavir classification for fibrosis stage F2, F3 and F4 were ≥7.2 kPa, ≥8.1, and ≥11.0 kPa, respectively. Results. Among 66 patients with a successful TE examination at follow-up, 53 patients (80%) had cirrhosis and 13 had (20%) advanced fibrosis (F3) prior to treatment. Median treatment duration was 50.5 months. Among patients with cirrhosis prior to treatment, 26 (49%) had liver stiffness below 11.0 kPa at follow-up, suggesting regression of cirrhosis. Among patients with advanced fibrosis (F3) prior to treatment, 10 (77%) had liver stiffness below 8.1 kPa after treatment, suggesting improvement of fibrosis. Conclusion. Transient elastography examinations demonstrate that prolonged treatment with NUCs in patients with CHB results in low liver stiffness, suggesting regression of fibrosis in a majority of patients with advanced fibrosis or cirrhosis.