Marte Lie Høivik

Work disability in inflammatory bowel disease patients 10 years after disease onset: results from the IBSEN Study

Objective To compare the work disability (WD) rate in inflammatory bowel disease (IBD) patients 10 years after disease onset, with the WD rate in the background population,and to assess whether clinical or demographic factors in the early disease course could predict WD after 10 years disease. Design A large, population-based inception cohort (the Inflammatory Bowel in South Eastern Norway cohort) was prospectively followed up at 1, 5 and 10 years after diagnosis. At the 10-year follow-up data on WD were collected. Data on disability pension (DP) in the background population were retrieved from public databases. We calculated overall and age-standardised relative risks (RR) for DP. Logistic regression analysis was used to examine predictive factors. Results A total of 518 patients completed the 10-year follow-up (response rate 83.5%). The overall disability rate in the IBD population was 18.8%, and the RR was 1.8 (95% CI 1.4 to 2.3) for ulcerative colitis (UC) and 2.0 (95% CI 1.4 to 2.7) for Crohns disease (CD). The RR for DP was highest in patients aged below 40 years while patients aged over 60 years had no increased RR. Steroid treatment at the 1-year follow-up predicted WD after 10 years disease in both CD and UC. In UC, increased C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) at diagnosis, early colectomy, and more than two relapses during the first year of the disease also predicted WD. Conclusion Ten years after disease onset IBD patients had an increased RR for DP as compared with the background population. The youngest patients had the highest RR. Markers of severe disease course predicted WD.

The gut microbial profile in patients with primary sclerosing cholangitis is distinct from patients with ulcerative colitis without biliary disease and healthy controls.

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.

Health-related quality of life in patients with ulcerative colitis after a 10-year disease course: results from the IBSEN study.

Background: Ulcerative colitis (UC) negatively affects health‐related quality of life (HRQoL), but population‐based and long‐term data on this topic are scarce. Our aim was to determine the HRQoL in UC patients after a 10‐year disease duration. Methods: UC patients from a population‐based inception cohort met at a prescheduled 10‐year follow‐up visit. In addition to a clinical examination, interview, and blood samples, the patients completed the Short Form 36 (SF‐36) and the Norwegian Inflammatory Bowel Disease Questionnaire (N‐IBDQ). The SF‐36 scores were compared to scores from a general population sample using one‐sample t‐tests. Standardized scores were calculated and interpreted according to Cohens effect size index. The associations between relevant clinical and demographic factors and HRQoL were examined through linear regression analyses. Results: A total of 196 patients completed the HRQoL questionnaires (response rate: 80%), of whom 54% were women; the mean age of all patients was 48 years (range: 22–86). The SF‐36 scores were comparable to those of the general population except for lower scores in the General Health dimension. The SF‐36 scores were significantly lower in the presence of current symptoms, in patients who had used corticosteroids, and in patients who reported not working. Overall N‐IBDQ scores were equivalent to scores of patients in remission. Female gender, work status (not working), current symptoms, and smoking were associated with significantly lower N‐IBDQ scores. Conclusions: SF‐36 scores were not reduced compared to the general population sample. The presence of current symptoms, the use of corticosteroids, work status (not working), female gender, and smoking had a negative impact on HRQoL. (Inflamm Bowel Dis 2012)

Switching from Remicade® to Remsima® is well Tolerated and Feasible: A Prospective, Open-label Study

Background and Aims A biosimilar version of infliximab [CT-P13/Remsima®] recently entered the European market. The clinical data on its use in inflammatory bowel disease [IBD] are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population. Methods All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima. The follow-up lasted for 6 months. In addition, a retrospective registration was performed with a start time of 6 months before switching drugs. The primary endpoints were [i] the proportion of patients remaining on medication 6 months after switching and [ii] adverse events during the 6 months after switching. The secondary endpoints included [i] disease activity scores [Harvey-Bradshaw Index and Partial Mayo Score], C-reactive protein, haemoglobin, faecal calprotectin, infliximab dose and interval, and p-infliximab and [ii] the development of antidrug antibodies. Results In total, 143 IBD patients were switched, 99 with Crohns disease and 44 with ulcerative colitis. The large majority [97%] remained on the medication throughout follow-up. A low number of adverse events were observed. No change in disease activity, C-reactive protein, haemoglobin, faecal calprotectin, infliximab dose and interval or p-infliximab was detected. Three patients developed new detectable antidrug antibodies. Conclusions Switching from Remicade to Remsima was feasible and with few adverse events, including very limited antidrug antibody formation and loss of response.

Patients with Crohn's disease experience reduced general health and vitality in the chronic stage: ten-year results from the IBSEN study.

BACKGROUND AND AIMS Data on the long-term effects of Crohns disease (CD) on health-related quality of life (HRQoL) is scarce. We aimed to determine the HRQoL in CD patients 10 years after disease onset, to compare the results to the general population and to identify variables that could affect HRQoL. METHODS CD patients from a population-based inception cohort (the IBSEN Study) met at a prescheduled ten-year follow-up. In addition to a structured interview, review of hospital records, clinical examination, laboratory tests and ileocolonoscopy, they completed a patient-reported questionnaire including the Short Form 36 (SF-36) and the Norwegian Inflammatory Bowel Disease Questionnaire (N-IBDQ). The SF-36 scores were compared to scores from the general population using one-sample t-tests. Standardized scores were calculated and interpreted according to Cohens effect size index. The associations between relevant clinical and demographic factors and HRQoL were examined through linear regression analyses. RESULTS Ninety-nine patients completed the HRQoL questionnaires (response rate 86%). Median age 39 years, 42% women. Compared to the general population the patients reported significantly lower SF-36 scores on the general health and vitality dimensions. IBDQ total scores were in line with scores of patients in remission. Except for current symptom severity no clinical parameters affected HRQoL scores. Work status and sick leave affected HRQoL negatively. CONCLUSIONS In this chronic stage of CD, reduced general health and vitality scores need attention while reductions in disease specific HRQoL seem to be less predominant.

Anaemia in inflammatory bowel disease: a population‐based 10‐year follow‐up

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.

Complementary and alternative medicine in patients with inflammatory bowel disease: The results of a population-based inception cohort study (IBSEN)

BACKGROUND AND AIMS The use of complementary and alternative medicine (CAM) has been increasing in recent decades. Our aim was to determine the proportion of CAM use among patients with inflammatory bowel disease (IBD) in a longitudinal, population-based cohort and to identify predictive factors for CAM use. METHODS The Inflammatory Bowel South-Eastern Norway (IBSEN) study is a population-based IBD cohort that has been followed prospectively for 10 years. The ten-year follow-up was conducted from 2000 to 2004 and included a questionnaire regarding CAM, a structured interview, a review of hospital records, a clinical examination, laboratory tests, and an ileocolonoscopy. RESULTS Of the 620 patients evaluated at the ten-year follow-up, 517 (84%) completed the CAM questionnaire, 353 had ulcerative colitis (UC), 164 had Crohns disease (CD), and 50% were male. Thirty percent reported the use of CAM at some point since their IBD diagnosis, and 7.5% reported current CAM use. More CD patients than UC patients reported CAM use (38% vs. 27%, respectively; p=0.01). Younger age, female gender, and higher education level predicted CAM use in UC, whereas younger age was the only predictor of CAM use in CD. Thirty-six percent of the CAM users were mostly satisfied or very satisfied with the treatment. CONCLUSION One third of the patients in this population-based cohort had used CAM at some point during a ten-year disease course, but only 7.5% reported current CAM use. CAM use was more common in the CD than in the UC patients. Only socio-demographic factors, such as age, gender and education, predicted CAM use.

Health-related quality of life in inflammatory bowel disease in a European-wide population-based cohort 10 years after diagnosis.

Background:Chronic inflammatory bowel disease (IBD) negatively affects the patients health-related quality of life (HRQoL). Only a few population-based studies have compared the HRQoL of patients with the background population. The aim of this study was to evaluate the HRQoL in a European cohort of patients with ulcerative colitis and Crohns disease 10 years after diagnosis (European Collaborative study group of Inflammatory Bowel Disease) compared with the national background population in each country and to assess possible country-specific differences. Methods:Patients with IBD from 7 European countries were invited to a follow-up visit 10 years after their diagnosis of IBD. We assessed their clinical and demographic data, including the generic HRQoL questionnaire short form health survey-36. Countrywise comparison with the background population was performed with z-scores using the Cohens effect size index. Results:Seven hundred sixty-nine patients were eligible for the study. We registered statistically significant and clinically relevant decreases in the short form health survey-36 dimensional scores in patients with symptoms at the time of follow-up and for patients reporting sick leave during the previous year or having received disablement pension. In the Netherlands and Norway, there was a moderate difference between the patients with IBD and the background population for the general health dimension. Conclusions:Overall, the HRQoL was not reduced in the IBD cohort compared with the background populations. However, in addition to older age and female gender, current symptoms at follow-up, disablement pension, and sick leave during the previous year were significantly associated with a reduced HRQoL in patients with IBD.

Risk matrix model for prediction of colectomy in a population-based study of ulcerative colitis patients (the IBSEN study)

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

Need for standardization in population-based quality of life studies: A review of the current literature

&NA; In this systematic review we focus on the current use of and knowledge on health related quality of life in unselected, population‐based IBD cohorts. We made a systematic literature search and included for comprehensive review papers that described a population‐based cohort and that used validated HRQoL instruments. We show that even studies defined by the authors as population‐based do not always meet the criteria set for being population‐based. The heterogeneity of the study populations we have reviewed emphasizes that “population‐based” must be defined very meticulously and that study populations need to be scrutinized with regard to all characteristics of the cohort before one can compare their results. Different definitions of study populations as population‐based affect outcomes. We also show that use of the same HRQoL questionnaires does not guarantee comparable results as there are several different versions of the questionnaires, the different translations are not always comparable and at last there are several methods of computing and presenting the data. Detailed accumulation of knowledge and thorough meta analyses is therefore difficult hence we find it necessary to raise a discussion on the need of standardization in this field of research and we make some simple recommendations on factors we find important. (Inflamm Bowel Dis 2010)