Publications by authors named "Pia Munkholm"

119 Publications

Surgery, cancer and mortality among patients with ulcerative colitis diagnosed 1962-1987 and followed until 2017 in a Danish population-based inception cohort.

Aliment Pharmacol Ther 2021 Oct 29. Epub 2021 Oct 29.

Department of Gastroenterology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.

Background: Long-term data on the natural disease course of unselected patients with ulcerative colitis (UC) are limited.

Aims: To determine the long-term course and prognosis of UC, including patients' risks of surgery, cancer and mortality, in a population-based cohort followed for over 50 years METHODS: All incident patients with UC diagnosed between 1962 and 1987 in Copenhagen County, Denmark were included in a population-based cohort. We extracted information about IBD-related surgeries, cancers and mortality from patient files from 1962 to 1987, and from the Danish National Patient Registry, Cancer Registry, and Register of Causes of Death during 1988-2017. Patients were matched with up to 50 individuals from the general population.

Results: We followed 1161 patients for a median of 34 years (range: 0.1-56.0). Median age at diagnosis was 33 years (range: 2-88). The cumulative probability of colectomy 10, 20, 30, 40 and 50 years after diagnosis was 22% (95% CI: 20%-25%), 27% (95% CI: 25%-30%), 31% (95% CI: 28%-34%), 34% (95% CI: 31%-37%), and 40% (95% CI: 36%-44%), respectively. The risk of small intestinal, colon, rectal and anal cancer was higher than among controls, as was cancer of the skin, pancreas and thyroid. All-cause mortality was lower than controls (adjusted RR: 0.90, 95% CI: 0.82-0.99).

Conclusion: In this population-based cohort of UC patients diagnosed between 1962 and 1987, 40% underwent colectomy within 50 years of diagnosis. Physicians need to be aware that UC patients are at increased risk of intestinal and extra-intestinal cancers. However, UC patients' risk of mortality is comparable to that of the background population.
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http://dx.doi.org/10.1111/apt.16677DOI Listing
October 2021

The clinical course of Crohn's disease in a Danish population-based inception cohort with more than 50 years of follow-up, 1962-2017.

Aliment Pharmacol Ther 2021 Sep 20. Epub 2021 Sep 20.

Department of Gastroenterology, North Zealand Hospital, University of Copenhagen, Copenhagen, Denmark.

Background: Few population-based studies have investigated the long-term prognosis of Crohn's disease (CD).

Aim: To determine the long-term natural disease course of CD with regard to surgery, cancer and mortality in a population-based cohort followed for more than 50 years.

Methods: All patients diagnosed with CD from 1962 to 1987 in Copenhagen County, Denmark were included in a population-based cohort. Information about surgeries, cancers and mortality was collected from patient files from 1962 to 1987 and from the Danish National Patient Registry, Cancer Registry, and from the Register of Causes of Death, 1987-2017. Patients were matched with individuals from the general population.

Results: A total of 373 patients were followed for a median of 33 years (range: 0-56 years). The cumulative probability of surgery 10, 20, 30, 40 and 50 years after diagnosis was 62% (CI 95%: 57%-67%), 71% (CI 95%: 66%-75%), 72% (CI 95%: 67%-76%), 74% (CI 95%: 69%-79%) and 74% (CI 95%: 69%-79%), respectively. A total of 142 patients (54%) were operated upon at least twice: 69 (26%) needing two surgeries and 73 (28%) needing three or more. Patients with CD were found to be at increased risk of intestinal (small bowel, rectum and anus) and extra-intestinal (respiratory organs and skin) cancer. All-cause mortality among CD patients was higher than among controls (RR: 1.22, CI 95%: 1.04-1.43), whereas mortality due to gastrointestinal cancer was not.

Conclusion: After 50 years of follow-up, 75% CD patients had undergone surgery, with most needing repeat surgery. The risk of intestinal and extra-intestinal cancers, as well as mortality, was higher among CD patients than the background population.
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http://dx.doi.org/10.1111/apt.16615DOI Listing
September 2021

The cost burden of Crohn's disease and ulcerative colitis depending on biologic treatment status - a Danish register-based study.

BMC Health Serv Res 2021 Aug 18;21(1):836. Epub 2021 Aug 18.

Janssen-Cilag, High Wycombe, UK.

Background: Patients diagnosed with inflammatory bowel disease may be treated with biologics, depending on several medical and non-medical factors. This study investigated healthcare costs and production values of patients treated with biologics.

Methods: This national register study included patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) between 2003 and 2015, identified in the Danish National Patient Register (DNPR). Average annual healthcare costs and production values were compared for patients receiving biologic treatment or not, and for patients initiating biologic treatment within a year after diagnosis or at a later stage. Cost estimates and production values were based on charges, fees and average gross wages.

Results: Twenty-six point one percent CD patients and ten point seven percent of UC patients were treated with biologics at some point in the study period. Of these, 46.4 and 45.5 % of patients initiated biologic treatment within the first year after diagnosis. CD and UC patients treated with biologics had higher average annual healthcare costs after diagnosis compared to patients not treated with biologics. CD patients receiving biologics early had lower production values both ten years before and eight years after treatment initiation, compared to patients receiving treatment later. UC patients receiving biologics early had lower average annual production values the first year after treatment initiation compared to UC patients receiving treatment later.

Conclusions: CD and UC patients receiving biologic treatment had higher average annual healthcare costs and lower average annual production values, compared to patients not receiving biologic treatment. The main healthcare costs drivers were outpatient visit costs and admission costs.
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http://dx.doi.org/10.1186/s12913-021-06816-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8371832PMC
August 2021

E-Health and remote management of patients with inflammatory bowel disease: lessons from Denmark in a time of need.

Intern Med J 2021 08 3;51(8):1207-1211. Epub 2021 Aug 3.

Department of Gastroenterology, Alfred Health and Monash University, Melbourne, Victoria, Australia.

In Denmark, remote monitoring and management of inflammatory bowel disease (IBD) started two decades ago with the web application Constant Care. The disease monitoring in Constant Care consists of simple disease activity questionnaires and home measurement of faecal calprotectin, a stool biomarker for inflammation. It has now been implemented in clinical practice at North Zealand University Hospital in Denmark. Digital health care solutions facilitate remote contact between patients and healthcare providers and have been shown to reduce time to remission, outpatient visits and hospital admissions, and increase adherence to medical therapy, quality of life and disease and treatment knowledge. In Australia, E-Health is an area of increasing interest, particularly given the significant distances travelled by rural patients to access specialist care. There are several foreseeable benefits to incorporating E-Health/remote monitoring into Australian IBD management, including reduced burdens of time and cost on rural patients, and more efficient management of well outpatients, thereby increasing clinic availability for acutely unwell patients. The significant portion of IBD patients managed in private practice in Australia, and the infrastructure within private practice that is well suited to implementation of E-Health makes Australia a viable setting for an E-Health IBD management model like Denmark's Constant Care model. One pilot study is currently underway investigating the feasibility of rapid and remote IBD monitoring and E-Health in an Australian IBD population. The current COVID-19 pandemic has further illustrated the importance of telehealth as a means of maintaining health services to patients in geographic, or social, isolation.
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http://dx.doi.org/10.1111/imj.15132DOI Listing
August 2021

Microscopic colitis in Denmark: regional variations in risk factors and frequency of endoscopic procedures.

J Crohns Colitis 2021 Jul 7. Epub 2021 Jul 7.

Department of Gastroenterology, North Zealand University Hospital, Capital Region, Denmark.

Objective: Microscopic colitis (MC), encompassing collagenous colitis (CC) and lymphocytic colitis (LC), is an increasingly prevalent gastrointestinal disease with an unknown aetiology. Previous research has reported significant differences in the incidence of MC within Denmark, with the lowest incidence found in the most populated region (Capital Region of Denmark). Our aim was to elucidate the causes of these regional differences.

Design: All incident MC patients (n=14,302) with a recorded diagnosis of CC (n=8,437) or LC (n=5,865) entered in The Danish Pathology Register between 2001 and 2016 were matched to 10 reference individuals (n=142,481). Information regarding drug exposure, including proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), statins and nonsteroidal anti-inflammatory drugs (NSAIDs), were retrieved from The Danish National Prescription Registry. Information regarding endoscopy rate, smoking related diseases and immune-mediated inflammatory diseases were acquired from The Danish National Patient Registry.

Results: Smoking, immune-mediated inflammatory diseases, exposure to PPIs, SSRIs statins and NSAIDs were significantly associated with MC in all Danish regions. The association between drug exposure and MC was weakest in the Capital Region of Denmark with an Odds Ratio of 1.8 (95% confidence interval (CI): 1.61-2.01). The relative risk of undergoing a colonoscopy with biopsy was significantly increased in sex and age-matched controls in all regions compared to controls from the Capital Region of Denmark, with the greatest risk found in the Region of Southern Denmark, 1.37 (95%CI: 1.26-1.50).

Conclusions: The cause of the regional differences in MC incidence in Denmark seems to be multifactorial, including variations in disease awareness and distribution of risk factors.
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http://dx.doi.org/10.1093/ecco-jcc/jjab119DOI Listing
July 2021

Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy: a real-world, nationwide cohort of patients with inflammatory bowel diseases.

Scand J Gastroenterol 2021 09 5;56(9):1040-1048. Epub 2021 Jul 5.

Gastrounit, Medical Division, Copenhagen University Hospital, Hvidovre, Denmark.

Background: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging.

Objective: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD.

Methods: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52.

Results: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 11.1%,  .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 44.4%,  = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event.

Conclusion: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.
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http://dx.doi.org/10.1080/00365521.2021.1946588DOI Listing
September 2021

Increased use of biologics in the era of TNF-α inhibitors did not reduce surgical rate but prolonged the time from diagnosis to first time intestinal resection among patients with Crohn's disease and ulcerative colitis - a Danish register-based study from 2003-2016.

Scand J Gastroenterol 2021 May 18;56(5):537-544. Epub 2021 Mar 18.

Incentive, Holte, Denmark.

Background: During the last decade, a significant increase in the use of biologic medicine has occurred, accounting for the greatest healthcare expenditure, among inflammatory bowel disease (IBD) patients. The objective of this study was to analyse the prevalence of and time to first intestinal resection surgery in a Danish nationwide cohort of Crohn's disease (CD) and ulcerative colitis (UC) patients, stratified on biologic treatment status.

Methods: This retrospective population-based study included IBD patients diagnosed between 2003 and 2015 identified in the Danish National Patient Registry (NPR). The frequency of first-time surgery with intestinal resection and time to surgery was analysed among CD and UC patients between 2003 and 2016.

Results: A total of 2328 CD and 2128 UC patients underwent surgery between 2003 and 2016 (23% and 10% of all incident CD and UC patients, respectively). Up until 2008, the frequency of surgery gradually declined for both patient groups and an increase in the frequency of patients receiving biological treatment was observed. Subsequently, the frequency of surgery for both CD and UC patients remained stable despite a steady increase in biologic treatment use.

Conclusions: The registered increase in the fraction of patients on biologic treatment (mostly TNF-α inhibitors) did not result in changes in the rates of major surgeries with intestinal resection in CD and UC patients.
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http://dx.doi.org/10.1080/00365521.2021.1897670DOI Listing
May 2021

Costs of electronic health vs. standard care management of inflammatory bowel disease across three years of follow-up-a Danish register-based study.

Scand J Gastroenterol 2021 May 28;56(5):520-529. Epub 2021 Feb 28.

Department of Gastroenterology, North Zealand University Hospital, Frederikssund, Denmark.

Background: Costs of using eHealth in inflammatory bowel disease (IBD) management has only been assessed for short follow-up periods. The primary aim was to compare the direct costs of eHealth (cases) relative to standard care (matched controls) for IBD during three years of follow-up.

Methods: The study design was a retrospective, registry-based follow-up study of patients diagnosed with IBD two years prior, and three years subsequent, to their enrolment in eHealth. Cases were matched 1:4 with controls receiving standard care based on diagnosis, gender, biologics (yes/no) and age (+/- 5 years).

Results: We identified 116 cases (76 (66%) with ulcerative colitis (UC) and 40 (34%) with Crohn's disease (CD)) and matched them with 433 controls. IBD-related outpatient costs were only significantly higher for cases in the year of their inclusion in eHealth (€2,949 vs. €1,621 per patient,  =.01). Mean IBD-related admission costs tended to fall after enrolment in eHealth, with mean admission costs per patient at year 3 of follow-up of €74 for cases and €383 for controls ( = .02). Linear extrapolation of the reduction in costs beyond year 3 after enrolment in eHealth revealed that eHealth would be cost neutral or saving, relative to standard care, from year 4.

Conclusion: IBD-related outpatient costs in both groups were similar and only significantly higher for cases in the year of their enrolment in eHealth, with admission costs typically falling after a patient's inclusion in eHealth. Estimation revealed eHealth to be cost neutral or saving from year 4.
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http://dx.doi.org/10.1080/00365521.2021.1892176DOI Listing
May 2021

Occurrence of Colorectal Cancer and the Influence of Medical Treatment in Patients With Inflammatory Bowel Disease: A Danish Nationwide Cohort Study, 1997 to 2015.

Inflamm Bowel Dis 2021 10;27(11):1795-1803

Department of Gastroenterology, North Zealand University Hospital, Frederikssund, Denmark.

Background: The risk of colorectal cancer (CRC) for patients with inflammatory bowel disease (IBD) has previously been investigated with conflicting results. We aimed to investigate the incidence and risk of CRC in IBD, focusing on its modification by treatment.

Methods: All patients with incident IBD (n = 35,908) recorded in the Danish National Patient Register between 1997 and 2015 (ulcerative colitis: n = 24,102; Crohn's disease: n = 9739; IBD unclassified: n = 2067) were matched to approximately 50 reference individuals (n = 1,688,877). CRC occurring after the index date was captured from the Danish Cancer Registry. Exposure to medical treatment was divided into categories including none, systemic 5-aminosalicylates, immunomodulators, and biologic treatment. The association between IBD and subsequent CRC was investigated by Cox regression and Kaplan-Meier estimates.

Results: Of the IBD patients, 330 were diagnosed with CRC, resulting in a hazard ratio (HR) of 1.15 (95% confidence interval [CI], 1.03-1.28) as compared with the reference individuals. However, when excluding patients diagnosed with CRC within 6 months of their IBD diagnosis, the HR decreased to 0.80 (95% CI, 0.71-0.92). Patients with ulcerative colitis receiving any medical treatment were at significantly higher risk of developing CRC than patients with ulcerative colitis who were not given medical treatment (HR, 1.35; 95% CI, 1.01-1.81), whereas a similar effect of medical treatment was not observed in patients with Crohn's disease or IBD unclassified.

Conclusions: Medical treatment does not appear to affect the risk of CRC in patients with IBD. The overall risk of developing CRC is significantly increased in patients with IBD as compared with the general population. However, when excluding patients diagnosed with CRC within 6 months of their IBD diagnosis, the elevated risk disappears.
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http://dx.doi.org/10.1093/ibd/izaa340DOI Listing
October 2021

Authors' Response: Interpretations of Trends in Incidence of Microscopic Colitis.

J Crohns Colitis 2021 02;15(2):344

Department of Gastroenterology, North Zealand University Hospital, Capital Region, Denmark.

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http://dx.doi.org/10.1093/ecco-jcc/jjaa262DOI Listing
February 2021

Disease Activity Patterns, Mortality, and Colorectal Cancer Risk in Microscopic Colitis: A Danish Nationwide Cohort Study, 2001 to 2016.

J Crohns Colitis 2021 Apr;15(4):594-602

Department of Gastroenterology, North Zealand University Hospital, Capital Region, Denmark.

Background And Aims: The disease course of microscopic colitis [MC], encompassing collagenous colitis [CC] and lymphocytic colitis [LC], is not well known. In a Danish nationwide cohort, we evaluated the disease activity patterns as well as the risk of colorectal cancer [CRC] and mortality based on disease severity.

Methods: All incident MC patients [n = 14 302] with a recorded diagnosis of CC [n = 8437] or LC [n = 5865] in the Danish Pathology Register, entered between 2001 and 2016, were matched to 10 reference individuals [n = 142 481]. Incident cases of CRC after the index date were captured from the Danish Cancer Registry. Mortality data were ascertained from the Danish Registry of Causes of Death, and information about treatment was obtained from the Danish National Prescription Registry. The risk of CRC and mortality analyses were investigated by Cox regression and Kaplan-Meier estimates.

Results: We identified a self-limiting or transient disease course in 70.6% of LC patients and in 59.9% of CC patients, p <0.001. Less than 5% of MC patients experienced a budesonide-refractory disease course and were treated with immunomodulators or biologic treatment. A total of 2926 [20.5%] MC patients and 24 632 [17.3%] reference individuals died during the study period. MC patients with a severe disease had a relative risk [RR] of mortality of 1.41 (95% confidence interval [CI]: 1.32-1.50) compared with reference individuals. Only 90 MC patients were diagnosed with CRC during follow-up, corresponding to an RR of 0.48 [95% CI: 0.39-0.60].

Conclusions: A majority of MC patients experience an indolent disease course with a lower risk of developing CRC compared with the background population.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa207DOI Listing
April 2021

eHealth: Disease activity measures are related to the faecal gut microbiota in adult patients with ulcerative colitis.

Scand J Gastroenterol 2020 Nov 12;55(11):1291-1300. Epub 2020 Oct 12.

Department of Gastroenterology, North Zealand University Hospital, Capital Region, Frederikssund, Denmark.

Background/aim: Microbial dysbiosis in inflammatory bowel disease (IBD) is poorly understood. Faecal samples collected for the purposes of microbiota analysis are not yet a part of everyday clinical practice. To explore associations between faecal microbiota and disease activity measures in adult IBD patients, for the purpose of possibly integrating microbiota measures in an existing IBD eHealth application for disease-monitoring.

Methods: We collected faecal samples from adult IBD patients for one year while they were home-monitoring for disease activity, using faecal calprotectin (FC) and the Simple Clinical Colitis Activity Index (SCCAI). Faecal samples were analysed in two different ways: commercially available test consisting of 54 pre-determined bacterial markers (DNA test) and 16S rRNA gene sequencing (16S-seq). Univariable linear mixed effect models were fitted to predict disease scores using normalised relative abundances as fixed effects.

Results: Seventy-eight IBD patients provided a total of 288 faecal samples for microbiota analysis. Two hundred and thirty-four of the samples were from patients with ulcerative colitis (UC). was found to correlate significantly with increasing FC, while an additional 24 genera were found to be associated with FC and/or SCCAI (16S-seq). Bacterial markers (DNA test) for Proteobacteria spp. and spp., were significantly correlated with increasing FC measures, while another 14 markers were found to be associated with FC and/or SCCAI.

Conclusions: In patients with UC, results of both methods are associated with disease activity, correlating significantly with (16S-seq) and with Proteobacteria, spp. and spp. (DNA test).
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http://dx.doi.org/10.1080/00365521.2020.1829031DOI Listing
November 2020

The use of 5-aminosalicylate for patients with Crohn's disease in a prospective European inception cohort with 5 years follow-up - an Epi-IBD study.

United European Gastroenterol J 2020 10 26;8(8):949-960. Epub 2020 Jul 26.

Hull University Teaching Hospitals NHS Trust, Hull, UK.

Background: The lack of scientific evidence regarding the effectiveness of 5-aminosalicylate in patients with Crohn's disease is in sharp contrast to its widespread use in clinical practice.

Aims: The aim of the study was to investigate the use of 5-aminosalicylate in patients with Crohn's disease as well as the disease course of a subgroup of patients who were treated with 5-aminosalicylate as maintenance monotherapy during the first year of disease.

Methods: In a European community-based inception cohort, 488 patients with Crohn's disease were followed from the time of their diagnosis. Information on clinical data, demographics, disease activity, medical therapy and rates of surgery, cancers and deaths was collected prospectively. Patient management was left to the discretion of the treating gastroenterologists.

Results: Overall, 292 (60%) patients with Crohn's disease received 5-aminosalicylate period during follow-up for a median duration of 28 months (interquartile range 6-60). Of these, 78 (16%) patients received 5-aminosalicylate monotherapy during the first year following diagnosis. Patients who received monotherapy with 5-aminosalicylate experienced a mild disease course with only nine (12%) who required hospitalization, surgery, or developed stricturing or penetrating disease, and most never needed more intensive therapy. The remaining 214 patients were treated with 5-aminosalicylate as the first maintenance drug although most eventually needed to step up to other treatments including immunomodulators (75 (35%)), biological therapy (49 (23%)) or surgery (38 (18%)).

Conclusion: In this European community-based inception cohort of unselected Crohn's disease patients, 5-aminosalicylate was commonly used. A substantial group of these patients experienced a quiescent disease course without need of additional treatment during follow-up. Therefore, despite the controversy regarding the efficacy of 5-aminosalicylate in Crohn's disease, its use seems to result in a satisfying disease course for both patients and physicians.
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http://dx.doi.org/10.1177/2050640620945949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707880PMC
October 2020

Incidence and prevalence of microscopic colitis between 2001 and 2016: A Danish nationwide cohort study.

J Crohns Colitis 2020 Jun 5. Epub 2020 Jun 5.

Department of Gastroenterology, North Zealand University Hospital, Capital Region, Denmark.

Background: Epidemiological studies suggest an increasing global incidence of microscopic colitis, including collagenous colitis and lymphocytic colitis.

Aims: To investigate the incidence and prevalence of microscopic colitis in Denmark.

Methods: In a nationwide cohort study, we included all incident patients with a recorded diagnosis of collagenous colitis or lymphocytic colitis in the Danish Pathology Register between 2001 and 2016.

Results: A total of 14,302 microscopic colitis patients - 8,437 (59%) with collagenous and 5,865 (41%) with lymphocytic colitis - were identified during the study period. The prevalence in December 2016 was estimated to be 197.9 cases per 100,000 inhabitants. Microscopic colitis was more prevalent among females (n=10,127 (71%)), with a mean annual incidence of 28.8, compared to 12.3 per 100,000 person-years among males. The overall mean incidence during the study period was 20.7 per 100,000 person-years. Mean age at time of diagnosis was 65 (SD:14) for microscopic colitis, 67 (SD:13) for collagenous colitis and 63 (SD:15) for lymphocytic colitis. The overall incidence increased significantly from 2.3 cases in 2001 to 24.3 cases per 100,000 person-years in 2016. However, the highest observed incidence of microscopic colitis was 32.3 cases per 100,000 person-years in 2011. Large regional differences were found, with the highest incidence observed in the least populated region.

Conclusions: The incidence of microscopic colitis in Denmark has increased 10-fold during the last 15 years and has now surpassed that of Crohn's disease and ulcerative colitis. However, incidence has stabilised since 2012, suggesting that a plateau has been reached.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa108DOI Listing
June 2020

[Telemedicine applications for monitoring inflammatory bowel disease and irritable bowel syndrome].

Ugeskr Laeger 2020 02;182(8)

Inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) are chronic relapsing diseases with major impact on the patients' everyday life, and increasing incidences affect the burden on the healthcare system. This review summarises the evidence of telemedicine applications (TA) to patients suffering from IBD and IBS in Denmark and abroad. TA have been shown to: reduce time-to-remission, increase quality of life and medical adherence, and reduce hospital admissions and outpatient visits in adult patients with IBD. In paediatric patients with IBD, TA have been shown to reduce: the need of outpatient visits, the number of school absences, and the symptom scores.
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February 2020

Treatment patterns for biologics in ulcerative colitis and Crohn's disease: a Danish Nationwide Register Study from 2003 to 2015.

Scand J Gastroenterol 2020 Mar 2;55(3):265-271. Epub 2020 Mar 2.

Gastroenterology Department, North Zealand University Hospital, Frederikssund, Denmark.

The choice of treatment for Crohn's disease (CD) and ulcerative colitis (UC) depends among other factors, disease severity. Patients with moderate-to-severe disease should be prescribed biologic response modifiers (biologics), according to guidelines. This study aims to explore the treatment patterns of patients diagnosed with CD and UC between 2003 and 2015 that were treated with biologics in Denmark between the years 2003 and 2016. This national register study included patients diagnosed between 2003 and 2015, identified in the Danish National Patient Registry. Biologic therapies available during the study period were infliximab, adalimumab, vedolizumab and golimumab. The share of patients initiating and receiving biologic treatment in each year was estimated. Additionally, the time from IBD diagnosis to first biologic treatment and time between treatments was calculated. Among 10,302 CD patients and 22,144 UC patients, 28.5% of CD patients and 11.3% of UC patients received treatment with biologics during the study period, with an increasing trend in the number of patients initiating treatment with biologics each year. About 46% of CD patients and 45% of UC patients received their first biologic treatment within the first year after IBD diagnosis. About 57-68% of CD and UC patients received treatment with their second line biologic within 2 months of the last treatment of their first line. The number of patients initiating biologic treatments after diagnosis increased throughout the study period. Most patients diagnosed with CD and UC are receiving biologic treatments relatively soon after their diagnosis.
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http://dx.doi.org/10.1080/00365521.2020.1726445DOI Listing
March 2020

Health-care costs of inflammatory bowel disease in a pan-European, community-based, inception cohort during 5 years of follow-up: a population-based study.

Lancet Gastroenterol Hepatol 2020 05 13;5(5):454-464. Epub 2020 Feb 13.

Hull University Teaching Hospitals NHS Trust, Hull, UK; Hull York Medical School, Hull, UK.

Background: Inflammatory bowel disease (IBD) places a significant burden on health-care systems because of its chronicity and need for expensive therapies and surgery. With increasing use of biological therapies, contemporary data on IBD health-care costs are important for those responsible for allocating resources in Europe. To our knowledge, no prospective long-term analysis of the health-care costs of patients with IBD in the era of biologicals has been done in Europe. We aimed to investigate cost profiles of a pan-European, community-based inception cohort during 5 years of follow-up.

Methods: The Epi-IBD cohort is a community-based, prospective inception cohort of unselected patients with IBD diagnosed in 2010 at centres in 20 European countries plus Israel. Incident patients who were diagnosed with IBD according to the Copenhagen Diagnostic Criteria between Jan 1, and Dec 31, 2010, and were aged 15 years or older the time of diagnosis were prospectively included. Data on clinical characteristics and direct costs (investigations and outpatient visits, blood tests, treatments, hospitalisations, and surgeries) were collected prospectively using electronic case-report forms. Patient-level costs incorporated procedures leading to the initial diagnosis of IBD and costs of IBD management during the 5-year follow-up period. Costs incurred by comorbidities and unrelated to IBD were excluded. We grouped direct costs into the following five categories: investigations (including outpatient visits and blood tests), conventional medical treatment, biological therapy, hospitalisation, and surgery.

Findings: The study population consisted of 1289 patients with IBD, with 1073 (83%) patients from western Europe and 216 (17%) from eastern Europe. 488 (38%) patients had Crohn's disease, 717 (56%) had ulcerative colitis, and 84 (6%) had IBD unclassified. The mean cost per patient-year during follow-up for patients with IBD was €2609 (SD 7389; median €446 [IQR 164-1849]). The mean cost per patient-year during follow-up was €3542 (8058; median €717 [214-3512]) for patients with Crohn's disease, €2088 (7058; median €408 [133-1161]) for patients with ulcerative colitis, and €1609 (5010; median €415 [92-1228]) for patients with IBD unclassified (p<0·0001). Costs were highest in the first year and then decreased significantly during follow-up. Hospitalisations and diagnostic procedures accounted for more than 50% of costs during the first year. However, in subsequent years there was a steady increase in expenditure on biologicals, which accounted for 73% of costs in Crohn's disease and 48% in ulcerative colitis, in year 5. The mean annual cost per patient-year for biologicals was €866 (SD 3056). The mean yearly costs of biological therapy were higher in patients with Crohn's disease (€1782 [SD 4370]) than in patients with ulcerative colitis (€286 [1427]) or IBD unclassified (€521 [2807]; p<0·0001).

Interpretation: Overall direct expenditure on health care decreased over a 5-year follow-up period. This period was characterised by increasing expenditure on biologicals and decreasing expenditure on conventional medical treatments, hospitalisations, and surgeries. In light of the expenditures associated with biological therapy, cost-effective treatment strategies are needed to reduce the economic burden of inflammatory bowel disease.

Funding: Kirsten og Freddy Johansens Fond and Nordsjællands Hospital Forskningsråd.
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http://dx.doi.org/10.1016/S2468-1253(20)30012-1DOI Listing
May 2020

Societal costs attributable to Crohn's disease and ulcerative colitis within the first 5 years after diagnosis: a Danish nationwide cost-of-illness study 2002-2016.

Scand J Gastroenterol 2020 Jan 21;55(1):41-46. Epub 2020 Jan 21.

Gastroenterology Department, North Zealand University Hospital, Frederikssund, Denmark.

There is little information on cost-of-illness among patients diagnosed with Crohn's disease (CD) and ulcerative colitis (UC) in Denmark. The objective of this study was to estimate the average 5-year societal costs attributable to CD or UC patients in Denmark with incidence in 2003-2015, including costs related to health care, prescription medicine, home care and production loss. A national register-based, cost-of-illness study was conducted using an incidence-based approach to estimate societal costs. Incident patients with CD or UC were identified in the National Patient Registry and matched with a non-IBD control from the general population on age and sex. Attributable costs were estimated applying a difference-in-difference approach, where the total costs among individuals in the control group were subtracted from the total costs among patients. CD and UC incidence fluctuated but was approximately 14 and 31 per 100,000 person years, respectively. The average attributable costs were highest the first year after diagnosis, with costs equalling €12,919 per CD patient and €6,501 per UC patient. Hospital admission accounted for 36% in the CD population and 31% in the UC population, the first year after diagnosis. Production loss exceeded all other costs the third-year after diagnosis (CD population: 52%; UC population: 83%). We found that the societal costs attributable to incident CD and UC patients are substantial compared with the general population, primarily consisting of hospital admission costs and production loss. Appropriate treatment at the right time may be beneficial from a societal perspective.
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http://dx.doi.org/10.1080/00365521.2019.1707276DOI Listing
January 2020

Cost Burden of Crohn's Disease and Ulcerative Colitis in the 10-Year Period Before Diagnosis-A Danish Register-Based Study From 2003-2015.

Inflamm Bowel Dis 2020 08;26(9):1377-1382

Gastroenterology Department, North Zealand University Hospital, Frederikssund, Capital Region, Denmark.

Background: The diagnostic delay in inflammatory bowel disease (IBD) is well known, yet the costs associated with diagnoses before IBD diagnosis have not yet been reported. This study explored societal costs and disease diagnoses 10 years before Crohn's disease (CD) and ulcerative colitis (UC) diagnosis in Denmark.

Methods: This national register study included patients diagnosed between 2003 and 2015 identified in the Danish National Patient Registry (NPR) and controls who were individually matched on age and sex from the general population. Societal costs included health care services, prescription medicine, home care services, and labor productivity loss. Prediagnostic hospital contact occurring before CD or UC diagnosis was identified using the NPR. Average annual costs per individual were calculated before the patient's first CD or UC diagnosis. A 1-sample t test was then applied to determine significance in differences between cases and controls.

Results: Among CD (n = 9019) and UC patients (n = 20,913) the average societal costs were higher throughout the entire 10-year period before the diagnosis date compared with the general population. The difference increased over time and equaled €404 for CD patients and €516 for UC patients 10 years before diagnosis and €3377 and €2960, respectively, in the year before diagnosis. Crohn's disease and UC patients had significantly more diagnoses before their CD and UC diagnosis compared with the general population.

Conclusions: Compared with the general population, the societal costs and number of additional diagnoses among CD and UC patients were substantially higher in the 10-year period before diagnosis.
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http://dx.doi.org/10.1093/ibd/izz265DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7441097PMC
August 2020

Individualized home-monitoring of disease activity in adult patients with inflammatory bowel disease can be recommended in clinical practice: A randomized-clinical trial.

World J Gastroenterol 2019 Oct;25(40):6158-6171

Department of Gastroenterology, North Zealand University Hospital, Frederikssund 3600, Capital region, Denmark.

Background: The optimal way to home-monitor patients with inflammatory bowel disease (IBD) for disease progression or relapse remains to be found.

Aim: To determine whether an electronic health (eHealth) screening procedure for disease activity in IBD should be implemented in clinical practice, scheduled every third month (3M) or according to patient own decision, on demand (OD).

Methods: Adult IBD patients were consecutively randomized to 1-year open-label eHealth interventions (3M OD). Both intervention arms were screening for disease activity, quality of life and fatigue and were measuring medical compliance with the constant care web-application according to the screening interventions OD or 3M. Disease activity was assessed using home measured fecal calprotectin (FC) and a disease activity score.

Results: In total, 102 patients were randomized ( = 52/50 3M/OD) at baseline, and 88 patients completed the 1-year study ( = 43 3M; = 45 OD). No difference in the two screening procedures could be found regarding medical compliance ( = 0.58), fatigue ( = 0.86), quality of life ( = 0.17), mean time spent in remission ( > 0.32), overall FC relapse rates ( = 0.49), FC disease courses ( = 0.61), FC time to a severe relapse ( = 0.69) and remission ( = 0.88) during 1 year. Median (interquartile range) numbers of FC home-monitoring test-kits used per patient were significantly different, 3M: 6.0 (5.0-8.0) and OD: 4.0 (2.0-9.0), = 0.04.

Conclusion: The two eHealth screening procedures are equally good in capturing a relapse and bringing about remission. However, the OD group used fewer FC home test-kits per patient. Individualized screening procedures can be recommended for adult IBD patients in clinical web-practice.
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http://dx.doi.org/10.3748/wjg.v25.i40.6158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824278PMC
October 2019

Ethnic differences in inflammatory bowel disease: Results from the United Kingdom inception cohort epidemiology study.

World J Gastroenterol 2019 Oct;25(40):6145-6157

Gastroenterology, St. Mark's Hospital and Academic Institute, London HA1 3UJ, United Kingdom.

Background: The current epidemiology of inflammatory bowel disease (IBD) in the multi-ethnic United Kingdom is unknown. The last incidence study in the United Kingdom was carried out over 20 years ago.

Aim: To describe the incidence and phenotype of IBD and distribution within ethnic groups.

Methods: Adult patients (> 16 years) with newly diagnosed IBD (fulfilling Copenhagen diagnostic criteria) were prospectively recruited over one year in 5 urban catchment areas with high South Asian population. Patient demographics, ethnic codes, disease phenotype (Montreal classification), disease activity and treatment within 3 months of diagnosis were recorded onto the Epicom database.

Results: Across a population of 2271406 adults, 339 adult patients were diagnosed with IBD over one year: 218 with ulcerative colitis (UC, 64.3%), 115 with Crohn's disease (CD, 33.9%) and 6 with IBD unclassified (1.8%). The crude incidence of IBD, UC and CD was 17.0/100000, 11.3/100000 and 5.3/100000 respectively. The age adjusted incidence of IBD and UC were significantly higher in the Indian group (25.2/100000 and 20.5/100000) compared to White European (14.9/100000, = 0.009 and 8.2/100000, < 0.001) and Pakistani groups (14.9/100000, = 0.001 and 11.2/100000, = 0.007). The Indian group were significantly more likely to have extensive disease than White Europeans (52.7% 41.7%, = 0.031). There was no significant difference in time to diagnosis, disease activity and treatment.

Conclusion: This is the only prospective study to report the incidence of IBD in an ethnically diverse United Kingdom population. The Indian ethnic group showed the highest age-adjusted incidence of UC (20.5/100000). Further studies on dietary, microbial and metabolic factors that might explain these findings in UC are underway.
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http://dx.doi.org/10.3748/wjg.v25.i40.6145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824277PMC
October 2019

Disease course of inflammatory bowel disease unclassified in a European population-based inception cohort: An Epi-IBD study.

J Gastroenterol Hepatol 2019 Jun 21;34(6):996-1003. Epub 2019 Jan 21.

Department of Gastroenterology, University Hospital of Ioannina, Ioannina, Greece.

Background And Aim: A definitive diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) is not always possible, and a proportion of patients will be diagnosed as inflammatory bowel disease unclassified (IBDU). The aim of the study was to investigate the prognosis of patients initially diagnosed with IBDU and the disease course during the following 5 years.

Methods: The Epi-IBD study is a prospective population-based cohort of 1289 IBD patients diagnosed in centers across Europe. Clinical data were captured prospectively throughout the follow-up period.

Results: Overall, 476 (37%) patients were initially diagnosed with CD, 701 (54%) with UC, and 112 (9%) with IBDU. During follow-up, 28 (25%) IBDU patients were changed diagnoses to either UC (n = 20, 71%) or CD (n = 8, 29%) after a median of 6 months (interquartile range: 4-12), while 84 (7% of the total cohort) remained IBDU. A total of 17 (15%) IBDU patients were hospitalized for their IBD during follow-up, while 8 (7%) patients underwent surgery. Most surgeries (n = 6, 75%) were performed on patients whose diagnosis was later changed to UC; three of these colectomies led to a definitive diagnosis of UC. Most patients (n = 107, 96%) received 5-aminosalicylic acid, while 11 (10%) patients received biologicals, of whom five remained classified as IBDU.

Conclusions: In a population-based inception cohort, 7% of IBD patients were not given a definitive diagnosis of IBD after 5 years of follow-up. One in four patients with IBDU eventually was classified as CD or UC. Overall, the disease course and medication burden in IBDU patients were mild.
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http://dx.doi.org/10.1111/jgh.14563DOI Listing
June 2019

Natural Disease Course of Ulcerative Colitis During the First Five Years of Follow-up in a European Population-based Inception Cohort-An Epi-IBD Study.

J Crohns Colitis 2019 Feb;13(2):198-208

IBD Clinical and Research Centre, ISCARE, Prague, Czech Republic.

Background And Aims: Few population-based cohort studies have assessed the disease course of ulcerative colitis [UC] in the era of biological therapy and widespread use of immunomodulators. The aim of this study was to assess the 5-year outcome and disease course of patients with UC in the Epi-IBD cohort.

Methods: In a prospective, population-based inception cohort of unselected patients with UC, patients were followed up from the time of their diagnosis, which included the collection of their clinical data, demographics, disease activity, medical therapy, and rates of surgery, cancers, and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis.

Results: A total of 717 patients were included in the study. During follow-up, 43 [6%] patients underwent a colectomy and 163 [23%] patients were hospitalised. Of patients with limited colitis [distal to the left flexure], 90 [21%] progressed to extensive colitis. In addition, 92 [27%] patients with extensive colitis experienced a regression in disease extent, which was associated with a reduced risk of hospitalisation (hazard ratio [HR]: 0.5 95% CI: 0.3-0.8]. Overall, patients were treated similarly in both geographical regions; 80 [11%] patients needed biological therapy and 210 [29%] patients received immunomodulators. Treatment with immunomodulators was found to reduce the risk of hospitalisation [HR: 0.5 95% CI: 0.3-0.8].

Conclusions: Although patients in this population-based cohort were treated more aggressively with immunomodulators and biological therapy than in cohorts from the previous two decades, their disease outcomes, including colectomy rates, were no different. However, treatment with immunomodulators was found to reduce the risk of hospitalisation.
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http://dx.doi.org/10.1093/ecco-jcc/jjy154DOI Listing
February 2019

Vitamin D deficiency in a European inflammatory bowel disease inception cohort: an Epi-IBD study.

Eur J Gastroenterol Hepatol 2018 11;30(11):1297-1303

Pekka Collin Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.

Background: Serum vitamin D level is commonly low in patients with inflammatory bowel disease (IBD). Although there is a growing body of evidence that links low vitamin D level to certain aspects of IBD such as disease activity and quality of life, data on its prevalence and how it varies across disease phenotype, smoking status and treatment groups are still missing.

Materials And Methods: Patients diagnosed with IBD between 2010 and 2011 were recruited. Demographic data and serum vitamin D levels were collected. Variance of vitamin D level was then assessed across different treatment groups, disease phenotype, disease activity and quality of life scores.

Results: A total of 238 (55.9% male) patients were included. Overall, 79% of the patients had either insufficient or deficient levels of vitamin D at diagnosis. Patients needing corticosteroid treatment at 1 year had significantly lower vitamin D levels at diagnosis (median 36.0 nmol/l) (P=0.035). Harvey-Bradshaw Index (P=0.0001) and Simple Clinical Colitis Activity Index scores (P=0.0001) were significantly lower in patients with higher vitamin D level. Serum vitamin D level correlated significantly with SIBQ score (P=0.0001) and with multiple components of SF12. Smokers at diagnosis had the lowest vitamin D levels (vitamin D: 34 nmol/l; P=0.053).

Conclusion: This study demonstrates the high prevalence of low vitamin D levels in treatment-naive European IBD populations. Furthermore, it demonstrates the presence of low vitamin D levels in patients with IBD who smoke.
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http://dx.doi.org/10.1097/MEG.0000000000001238DOI Listing
November 2018

The sensitivity of fecal calprotectin in predicting deep remission in ulcerative colitis.

Scand J Gastroenterol 2018 Jun - Jul;53(7):825-830. Epub 2018 Jul 3.

g Department of Gastroenterology , North Zealand Hospital, University of Copenhagen , Frederikssund , Denmark.

Background: Mucosal healing is proposed as treat-to-target in ulcerative colitis (UC), even though the definition of mucosal healing remains contested as it has been suggested to be assessed by either endoscopy, histology or both. However, all definitions require an endoscopic evaluation of the mucosa. As endoscopies are invasive and uncomfortable to the patient we aimed to calibrate noninvasive predictors of mucosal inflammatory status defined by both endoscopy and histology.

Methods: UC patients (n = 106) undergoing a sigmoid-/colonoscopy were prospectively included. Feces (fecal calprotectin, FC), blood samples (hemoglobin, C-reactive protein, orosomucoid, erythrocyte sedimentation rate, albumin) and symptom scores (Simple Clinical Colitis Activity Index, SSCAI) were collected and analyzed. The colonic mucosa was assessed by the Mayo endoscopic sub score and biopsies were obtained for a histologic grading by Geboes score. Predictive cutoff values were analyzed by receiver operating characteristics (ROC). A combined endoscopic and histologic assessment defined deep remission (Mayo =0 and Geboes ≤1) and activity (Mayo ≥2 and Geboes >3).

Results: Only FC showed a significant ROC curve (p < .05). We suggest FC (mg/kg) cutoffs for detection of following: Deep remission: FC ≤25; Indeterminate: FC 25-230 - an endoscopy is recommended if a comprehensive status of both endoscopic and histologic assessed activity is needed; Active disease: FC >230. The complete ROC data is presented, enabling extraction of an FC cutoff value's sensitivity and specificity.

Conclusions: FC predicts endoscopic and histologic assessed deep remission and inflammatory activity of colon mucosa. Neither the markers in blood nor the SCCAI performed significant ROC results.
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http://dx.doi.org/10.1080/00365521.2018.1482956DOI Listing
November 2018

Epidemiology of inflammatory bowel disease in racial and ethnic migrant groups.

World J Gastroenterol 2018 Jan;24(3):424-437

Department of Gastroenterology, St. Marks Academic Institute, London HA1 3UJ, United Kingdom.

Aim: To summarise the current literature and define patterns of disease in migrant and racial groups.

Methods: A structured key word search in Ovid Medline and EMBASE was undertaken in accordance with PRISMA guidelines. Studies on incidence, prevalence and disease phenotype of migrants and races compared with indigenous groups were eligible for inclusion.

Results: Thirty-three studies met the inclusion criteria. Individual studies showed significant differences in incidence, prevalence and disease phenotype between migrants or race and indigenous groups. Pooled analysis could only be undertaken for incidence studies on South Asians where there was significant heterogeneity between the studies [95% for ulcerative colitis (UC), 83% for Crohn's disease (CD)]. The difference between incidence rates was not significant with a rate ratio South Asian: Caucasian of 0.78 (95%CI: 0.22-2.78) for CD and 1.39 (95%CI: 0.84-2.32) for UC. South Asians showed consistently higher incidence and more extensive UC than the indigenous population in five countries. A similar pattern was observed for Hispanics in the United States. Bangladeshis and African Americans showed an increased risk of CD with perianal disease.

Conclusion: This review suggests that migration and race influence the risk of developing inflammatory bowel disease. This may be due to different inherent responses upon exposure to an environmental trigger in the adopted country. Further prospective studies on homogenous migrant populations are needed to validate these observations, with a parallel arm for in-depth investigation of putative drivers.
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http://dx.doi.org/10.3748/wjg.v24.i3.424DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5776404PMC
January 2018

Natural disease course of Crohn's disease during the first 5 years after diagnosis in a European population-based inception cohort: an Epi-IBD study.

Gut 2019 03 23;68(3):423-433. Epub 2018 Jan 23.

IBD Clinical and Research Centre, ISCARE, Prague, Czech Republic.

Objective: The Epi-IBD cohort is a prospective population-based inception cohort of unselected patients with inflammatory bowel disease from 29 European centres covering a background population of almost 10 million people. The aim of this study was to assess the 5-year outcome and disease course of patients with Crohn's disease (CD).

Design: Patients were followed up prospectively from the time of diagnosis, including collection of their clinical data, demographics, disease activity, medical therapy, surgery, cancers and deaths. Associations between outcomes and multiple covariates were analysed by Cox regression analysis.

Results: In total, 488 patients were included in the study. During follow-up, 107 (22%) patients received surgery, while 176 (36%) patients were hospitalised because of CD. A total of 49 (14%) patients diagnosed with non-stricturing, non-penetrating disease progressed to either stricturing and/or penetrating disease. These rates did not differ between patients from Western and Eastern Europe. However, significant geographic differences were noted regarding treatment: more patients in Western Europe received biological therapy (33%) and immunomodulators (66%) than did those in Eastern Europe (14% and 54%, respectively, P<0.01), while more Eastern European patients received 5-aminosalicylates (90% vs 56%, P<0.05). Treatment with immunomodulators reduced the risk of surgery (HR: 0.4, 95% CI 0.2 to 0.6) and hospitalisation (HR: 0.3, 95% CI 0.2 to 0.5).

Conclusion: Despite patients being treated early and frequently with immunomodulators and biological therapy in Western Europe, 5-year outcomes including surgery and phenotype progression in this cohort were comparable across Western and Eastern Europe. Differences in treatment strategies between Western and Eastern European centres did not affect the disease course. Treatment with immunomodulators reduced the risk of surgery and hospitalisation.
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http://dx.doi.org/10.1136/gutjnl-2017-315568DOI Listing
March 2019

The Natural History of IBD: Lessons Learned.

Curr Treat Options Gastroenterol 2018 Mar;16(1):101-111

Department of Gastroenterology, North Zealand University Hospital, Frederikssundsvej 30, 3600, Frederikssund, Denmark.

Purpose Of Review: Inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), are chronic, relapsing diseases with unknown etiologies. The purpose of this review is to present the natural disease course evidenced in the latest epidemiology data.

Recent Findings: The prevalence of IBD is rapidly increasing, affecting five million patients worldwide with the highest incidence observed in Northern Europe and Northern America. It has been shown that both CD and UC patients are at an increased risk for developing cancer of the gastrointestinal tract compared to the general population. Though the disease course of IBD is unpredictable, the rate of surgical treatment has declined potentially as a consequence of the introduction of immunomodulators and new biologic treatment options. Treatments with biological agents and/or immunosuppressive drugs as well as disease monitoring with eHealth devices seem to have a positive impact on the disease course. However, long-term follow-up studies are still lacking and therefore no reliable conclusions can be drawn as of yet. Medical compliance is paramount in the treatment of IBD, and continuous research focusing on approaches that increase compliance is also necessary.
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http://dx.doi.org/10.1007/s11938-018-0173-3DOI Listing
March 2018

The complexity of evaluating and increasing adherence in inflammatory bowel disease.

Rev Esp Enferm Dig 2017 08;109(8):539-541

Department of Gastroenterology, North Zealand University Hospital.

Inflammatory bowel diseases (IBDs), due to their chronic and progressive nature, require lifelong treatment to relief and/or prevent inflammation and symptoms, obtaining mucosal healing at best. Therefore, adherence to treatment is an essential topic to address when treating patients with IBD. Nonetheless, adherence remains a common and complex issue in IBD care. Patient characteristics such as young age, male sex and employment has previously been verified as possible predictors of non-adherence. Additionally, evaluating adherence in itself is a challenge since both accurate and easy-to-use screening tools as well as golden standards are lacking.
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http://dx.doi.org/10.17235/reed.2017.5143/2017DOI Listing
August 2017

Individualized Infliximab Treatment Guided by Patient-managed eHealth in Children and Adolescents with Inflammatory Bowel Disease.

Inflamm Bowel Dis 2017 09;23(9):1473-1482

*Department of Pediatrics, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark; †Department of Auto-immunology and Biomarkers, Statens Serum Institut, Copenhagen, Denmark; ‡Department of Orthopaedic Surgery, Clinical Research Centre, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark; §Department of Pathology, Herlev Hospital, University of Copenhagen, Herlev, Denmark; and ‖Department of Gastroenterology, Danish Centre for eHealth & Epidemiology, North Zealand Hospital, University of Copenhagen, Frederikssund, Denmark.

Background: To individualize timing of infliximab (IFX) treatment in children and adolescents with inflammatory bowel disease (IBD) using a patient-managed eHealth program.

Methods: Patients with IBD, 10 to 17 years old, treated with IFX were prospectively included. Starting 4 weeks after their last infusion, patients reported a weekly symptom score and provided a stool sample for fecal calprotectin analysis. Based on symptom scores and fecal calprotectin results, the eHealth program calculated a total inflammation burden score that determined the timing of the next IFX infusion (4-12 wk after the previous infusion). Quality of Life was scored by IMPACT III. A control group was included to compare trough levels of IFX antibodies and concentrations and treatment intervals. Patients and their parents evaluated the eHealth program.

Results: There were 29 patients with IBD in the eHealth group and 21 patients with IBD in the control group. During the control period, 94 infusions were provided in the eHealth group (mean interval 9.5 wk; SD 2.3) versus 105 infusions in the control group (mean interval 6.9 wk; SD 1.4). Treatment intervals were longer in the eHealth group (P < 0.001). Quality of Life did not change during the study. Appearance of IFX antibodies did not differ between the 2 groups. Eighty percent of patients reported increased disease control and 63% (86% of parents) reported an improved knowledge of the disease.

Conclusions: Self-managed, eHealth-individualized timing of IFX treatments, with treatment intervals of 4 to 12 weeks, was accompanied by no significant development of IFX antibodies. Patients reported better control and improved knowledge of their IBD.
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http://dx.doi.org/10.1097/MIB.0000000000001170DOI Listing
September 2017
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