Publications by authors named "Johan Burisch"

105 Publications

Short and long-term effectiveness and safety of vedolizumab in treatment-refractory patients with ulcerative colitis and Crohn's disease - a real-world two-center cohort study.

Eur J Gastroenterol Hepatol 2021 Jun 7. Epub 2021 Jun 7.

Gastrounit, Medical Division, Copenhagen University Hospital Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Hvidovre Department of Gastroenterology and Hepatology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.

Objectives: Real-world data about sustained clinical remission (SCR) and treatment optimization with vedolizumab for ulcerative colitis (UC) and Crohn's disease (CD) are scarce. We aimed to investigate the short and long-term effectiveness and safety of vedolizumab in a real-world cohort in Denmark.

Methods: A retrospective two-center cohort study was conducted between November 2014 and November 2019 with the primary outcomes of clinical remission (CR) at weeks 14, 30, 52 and 104 and SCR defined as CR at week 14 through week 52.

Results: The study included 182 patients (UC: 97, CD: 85), all previously exposed to at least one biological therapy. Rates of CR at weeks 14, 30, 52 and 104 were 36.6, 35.1, 34.0 and 27.8%, respectively, in UC, and 31.7, 30.1, 26.5 and 22.4% in CD. SCR was achieved in 19.6 and 20.0%, respectively. In UC and CD, optional dosing of vedolizumab at week 10 (odds ratio [OR] = 0.23 (95% confidence interval [CI], 0.03-1.17), and OR = 0.68 (95% CI, 0.22-2.04)), as well as increase of frequency (OR = .26 (95% CI, 0.01-2.86), and OR = 0.19 (95% CI, 0.01-1.45)), were not associated with CR at week 52. Furthermore, combination treatment with azathioprine was not associated with long-term outcomes. However, dose intensification of vedolizumab successfully restored CR in 65.2 and 57.1% of patients with UC and CD experiencing loss of response.

Conclusions: Vedolizumab is effective in achieving and restoring short and long-term CR and SCR in patients with treatment-refractory UC and CD. This study emphasizes that supplementary dosing at week 10, and simultaneous treatment with azathioprine, did not improve long-term outcomes.
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http://dx.doi.org/10.1097/MEG.0000000000002229DOI Listing
June 2021

Validation and update of the Lémann index to measure cumulative structural bowel damage in Crohn's disease.

Gastroenterology 2021 May 27. Epub 2021 May 27.

INSERM U1135 CRESS 'Centre de Recherche Epidémiologie et Statistiques', Equipe ECSTRRA, Université de Paris, Hôpital Saint-Louis, Paris, France.

Background: The Lémann index is a tool measuring cumulative structural bowel damage in Crohn's disease (CD). We here report its validation and updating.

Methods: This was an international, multicenter, prospective, cross-sectional observational study. At each center, 10 inclusions, stratified by CD duration and location, were planned. For each patient, the digestive tract was divided into 4 organs, upper tract, small bowel, colon/rectum, anus, and subsequently into segments, explored systematically by magnetic resonance imaging (MRI), and by endoscopies in relation to disease location. For each segment, investigators retrieved information on previous surgical procedures, identified predefined strictures and penetrating lesions of maximal severity (grades 1-3) at each organ investigational method (gastroenterologist and radiologist for MRI), provided segmental damage evaluation ranging from 0.0 to 10.0 (complete resection). Organ resection-free cumulative damage evaluation was then calculated from the sum of segmental damages. Then, investigators provided a 0-10 global damage evaluation from the 4 organ standardized cumulative damage evaluations. Simple linear regressions of investigator damage evaluations on their corresponding Lémann index were studied, as well as calibration plots. Finally, updated Lémann index was derived through multiple linear mixed models applied to combined development and validation samples.

Results: In 15 centers, 134 patients were included. Correlation coefficients between investigator damage evaluations and Lémann indexes were above 0.80. When analyzing data in 272 patients from both samples and 27 centers, the unbiased correlation estimates were 0.89, 0,97, 0,94, 0.81, 0.91 for the 4 organs and globally, and stable when applied to one sample or the other.

Conclusions: The updated Lémann index is a well-established index to assess cumulative bowel damage in Crohn's disease that can be used in epidemiological studies and disease modification trials.
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http://dx.doi.org/10.1053/j.gastro.2021.05.049DOI Listing
May 2021

Histological Inflammation in the Endoscopically Uninflamed Mucosa is Associated With Worse Outcomes in Limited Ulcerative Colitis.

Inflamm Bowel Dis 2021 May 17. Epub 2021 May 17.

Gastroenterology Division, Hospital Beatriz Ângelo, Loures, Portugal.

Background: The Montreal classification categorizes patients with ulcerative colitis (UC) based on their macroscopic disease extent. Independent of endoscopic extent, biopsies through all colonic segments should be retrieved during index colonoscopy. However, the prognostic value of histological inflammation at diagnosis in the inflamed and uninflamed regions of the colon has never been assessed.

Methods: This was a multicenter retrospective cohort study of newly diagnosed patients with treatment-naïve proctitis and left-sided UC. Biopsies from at least 2 colonic segments (endoscopically inflamed and uninflamed mucosa) were retrieved and reviewed by 2 pathologists. Histological features in the endoscopically inflamed and uninflamed mucosa were scored using the Nancy score. The primary outcomes were disease complications (proximal disease extension, need for hospitalization or colectomy) and higher therapeutic requirements (need for steroids or for therapy escalation).

Results: Overall, 93 treatment-naïve patients were included, with a median follow-up of 44 months (range, 2-329). The prevalence of any histological inflammation above the endoscopic margin was 71%. Proximal disease extension was more frequent in patients with histological inflammation in the endoscopically uninflamed mucosa at diagnosis (21.5% vs 3.4%, P = 0.04). Histological involvement above the endoscopic margin was the only predictor associated with an earlier need for therapy escalation (adjusted hazard ratio, 3.69; 95% confidence interval, 1.05-13.0); P = 0.04) and disease complications (adjusted hazard ratio, 4.79; 95% confidence interval, 1.10-20.9; P = 0.04).

Conclusions: The presence of histological inflammation in the endoscopically uninflamed mucosa at the time of diagnosis was associated with worse outcomes in limited UC.
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http://dx.doi.org/10.1093/ibd/izab069DOI Listing
May 2021

Validation of claims-based indicators used to identify flare-ups in inflammatory bowel disease.

Therap Adv Gastroenterol 2021 31;14:17562848211004841. Epub 2021 Mar 31.

Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.

Background & Aims: There are currently no validated claims-based indicators for identifying a worsening of disease in patients with inflammatory bowel disease (IBD). Therefore, we aimed to develop and validate indicators that identify flare-ups of IBD using data from Danish nationwide registries.

Methods: Using Danish nationwide administrative data, we identified all patients with Crohn's disease (CD) or ulcerative colitis (UC) who had at least one measurement of faecal calprotectin between 1 January 2015 and 31 June 2017. We tested several different claims-based indicators of disease flare-ups against levels of faecal (F-)calprotectin (no flare-up: <250 mg/kg; mild flare-up: 250-1000 mg/kg; severe flare-up: ⩾1000 mg/kg). A generalised estimating equation was used to evaluate whether the proposed indicators could predict disease activity.

Results: A total of 890 children and 4719 adults with CD, and 592 children and 5467 adults with UC were included in the study. During the observation period, 48-61% and 48-55% of the CD and UC patients, respectively, had no flare-up, 26-29% (CD) and 24-26% (UC) experienced a mild flare-up, and 12-23% (CD) and 21-27% (UC) experienced a severe flare-up. Combinations of indicators that could predict a flare-up in CD and UC adults included hospitalisation, surgery, initiation or switch of biological therapy, treatment with systemic steroids, locally acting steroids or topical 5-aminosalicylates, colonoscopy/sigmoidoscopy, and magnetic resonance imaging/computed tomography. In children, only the number of gastroenterology visits was significant as an indicator among UC patients, and none were seen in children with CD. Overall, the indicator combinations resulted in a predictive ability of 0.62-0.67.

Conclusion: Administrative claims data can be useful for identifying patients exhibiting (F-calprotectin defined) flare-ups of their IBD. Clinically relevant events captured in the Danish national patient registry are associated with increased levels of calprotectin and hence increased disease activity, and can be used as valid outcomes in future studies.
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http://dx.doi.org/10.1177/17562848211004841DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8020737PMC
March 2021

Patient Reported Outcomes in Chronic Inflammatory Diseases: Current State, Limitations and Perspectives.

Front Immunol 2021 18;12:614653. Epub 2021 Mar 18.

Department of Internal Medicine I, University Medical Center Schleswig-Holstein, Kiel, Germany.

Chronic inflammatory diseases (CID) are emerging disorders which do not only affect specific organs with respective clinical symptoms but can also affect various aspects of life, such as emotional distress, anxiety, fatigue and quality of life. These facets of chronic disease are often not recognized in the therapy of CID patients. Furthermore, the symptoms and patient-reported outcomes often do not correlate well with the actual inflammatory burden. The discrepancy between patient-reported symptoms and objectively assessed disease activity can indeed be instructive for the treating physician to draw an integrative picture of an individual's disease course. This poses a challenge for the design of novel, more comprehensive disease assessments. In this mini-review, we report on the currently available patient-reported outcomes, the unmet needs in the field of chronic inflammatory diseases and the challenges of addressing these.
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http://dx.doi.org/10.3389/fimmu.2021.614653DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012677PMC
March 2021

Association between 5-aminosalicylates in patients with IBD and risk of severe COVID-19: an artefactual result of research methodology?

Gut 2021 Mar 3. Epub 2021 Mar 3.

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

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http://dx.doi.org/10.1136/gutjnl-2021-324397DOI Listing
March 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

Coronavirus disease 2019, immune-mediated inflammatory diseases and immunosuppressive therapies - A Danish population-based cohort study.

J Autoimmun 2021 03 12;118:102613. Epub 2021 Feb 12.

Gastrounit, Medical Section, Hvidovre University Hospital, Hvidovre, Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Denmark.

Background: Limited data exist regarding the disease course of coronavirus disease 2019 (COVID-19) and its relationship with immunosuppressants among patients with immune-mediated inflammatory diseases (IMIDs). Therefore, this study aims to investigate the association between COVID-19, frequent rheumatological, dermatological, gastrointestinal, and neurological IMIDs and immunosuppressants.

Methods: We conducted a Danish population-based cohort study including all residents living within Capital Region of Denmark and Region Zealand from January 28th, 2020 until September 15th, 2020 with the only eligibility criterion being a test for SARS-CoV-2 via reverse transcription-polymerase chain-reaction. Main outcomes included development of COVID-19, COVID-19-related hospitalization and mortality.

Results: COVID-19 was less common among patients with IMIDs than the background population (n = 328/20,513 (1.60%) and n = 10,792/583,788(1.85%), p < 0.01, respectively). However, those with IMIDs had a significantly higher risk of COVID-19-related hospitalization (31.1% and 18.6%, p < 0.01, respectively) and mortality (9.8% and 4.3%, p < 0.01, respectively), which were associated with patients older than 65 years, and presence of comorbidities. Furthermore, systemic steroids were independently associated with a severe course of COVID-19 (Odds ratio (OR) = 3.56 (95%CI 1.83-7.10), p < 0.01), while biologic therapies were associated with a reduced risk hereof (OR = 0.47 (95%CI 0.22-0.95), p = 0.04). Patients suspending immunosuppressants due to COVID-19 had an increased risk of subsequent hospitalization (OR = 3.59 (95%CI 1.31-10.78), p = 0.02).

Conclusion: This study found a lower occurrence, but a more severe disease course, of COVID-19 among patients with IMIDs, which was associated with the use of systemic steroids for IMIDs and suspension of other immunosuppressants. This study emphasizes the importance of weighing risks before suspending immunosuppressants during COVID-19.
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http://dx.doi.org/10.1016/j.jaut.2021.102613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879155PMC
March 2021

A Danish population-based case series of patients with liver cirrhosis and coronavirus disease 2019.

Scand J Gastroenterol 2021 04 16;56(4):453-457. Epub 2021 Feb 16.

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

Objectives: Coronavirus disease 2019 (COVID-19) is an ongoing major health emergency, but its occurrence and clinical impact on patients withliver cirrhosis is unknown. Therefore, we conducted a population-based study of 2.6 million Danish citizens investigating the occurrence and impact of COVID-19 in patients with liver cirrhosis.

Materials And Methods: A prospective population-based cohort study was conducted in the Capital Region of Denmark and Region Zealand in the study period between 1 March 2020 up until 31 May 2020, with the only eligibility criteria being a reverse-transcriptase polymerase chain reaction for presence of viral genomic material confirming COVID-19. The patients were subsequently stratified according to presence of pre-existing liver cirrhosis.

Results: Among 575,935 individuals tested, 1713 patients had a diagnosis of cirrhosis. COVID-19 occurredsignificantly lessamongpatients with cirrhosis ( = 15; 0.9%,  .01) compared with the population without cirrhosis ( = 10,593; 1.8%). However, a large proportion ( = 6;40.0%) required a COVID-19 related hospitalization which was correlated with higher values of alanine aminotransferase ( .01) and lactate dehydrogenase ( = .04). In addition, one-in-three ( = 2; 13.3%) required intensive therapy. Four patients died (26.7%) and mortality was associated with higher MELD scores, co-existing type 2 diabetes, and bacterial superinfections.

Conclusion: In conclusion, patientswith cirrhosis may have a lower risk of COVID-19; but a higher risk of complications hereto and mortality.
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http://dx.doi.org/10.1080/00365521.2021.1881814DOI Listing
April 2021

The burden of inflammatory bowel disease in Europe in 2020.

J Crohns Colitis 2021 Feb 14. Epub 2021 Feb 14.

Gastro Unit, Medical Division, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.

New data suggest that incidence and prevalence of inflammatory bowel diseases (IBD) are still increasing worldwide, and approximately 0.2% of the European population suffers from IBD at the present time. Medical therapy and disease management have evolved significantly in the last decades with an emphasis on tight objective monitoring of disease progression and treat to target approach in Europe and also worldwide aiming to prevent early bowel damage and disability. Surgery rate declined over time in Europe with 10-30% of CD and 5-10% of UC patients requiring a surgery within five years. The health economic burden associated to IBD is high in Europe. Direct healthcare costs (app. €3500 in CD and €2000 in UC per patient per year) have shifted from hospitalization and surgery towards drug-related expenditures with the increasing use of biological therapy and other novel agents, while substantial indirect costs arise from work productivity loss (app. €1900 per patient yearly). The aim of this paper is to provide an updated review on the burden of IBD in Europe by discussing current data on epidemiology, disease course, risk for surgery, hospitalization, mortality and cancer risks, as well as the economic aspects, patient disability and work impairment by discussing the latest population based studies from the region.
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http://dx.doi.org/10.1093/ecco-jcc/jjab029DOI Listing
February 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 Jan 7. Epub 2021 Jan 7.

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
January 2021

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

J Crohns Colitis 2021 Feb;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

Efficacy of ustekinumab for active perianal fistulizing Crohn's disease: a systematic review and meta-analysis of the current literature.

Scand J Gastroenterol 2021 Jan 2;56(1):53-58. Epub 2020 Dec 2.

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

Background: Although the number of biological therapies for the treatment of Crohn's disease (CD) is rapidly increasing, their efficacy in inducing healing of fistulas in perianal Crohn's disease (pCD) is practically unknown, although they occur in up to 50% of patients with CD.

Objective: We aimed to investigate the clinical effectiveness of ustekinumab for pCD in a systemic review and meta-analysis.

Methods: Studies describing the efficacy of ustekinumab on fistulas in pCD in PubMed and EMBASE database from inception until 22 September 2020, were assessed in a systemic review and meta-analysis. The random-effect model was applied for the meta-analysis.

Results: The systematic review of the current literature yielded 2,243 studies of which nine studies with a total of 396 patients were found eligible for inclusion. The pooled proportions of patients experiencing fistula response were 41.0% (95% CI 23.9-60.6%9), = 85%, 39.7% (95% CI 24.3-57.4%), = 69% and 55.9% (95% CI 40.8-69.9%, = 67% at weeks 8, 24, and 52, respectively. Regarding fistula remission, the pooled proportions were 17.1% (95% CI 8.1-32.7%), = 45%, 17.7% (95% CI 1.8-71.9%), = 68%, and 16.7% (95% CI 3.0-56.5%, = 51% at week 8, 24, and 52, respectively.

Conclusion: In this systematic review with meta-analysis, we found a signal of efficacy of ustekinumab on fistulizing pCD, emphasizing that these patients might benefit from this therapy.
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http://dx.doi.org/10.1080/00365521.2020.1854848DOI Listing
January 2021

Authors' Reply to: "COVID-19 in the IBD Population: The Need for Correct Nomenclature."

J Crohns Colitis 2020 Nov 20. Epub 2020 Nov 20.

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

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http://dx.doi.org/10.1093/ecco-jcc/jjaa240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717207PMC
November 2020

Efficacy of Ustekinumab for Active Perianal Fistulizing Crohn Disease: A Double-Center Cohort Study.

Inflamm Bowel Dis 2021 Feb;27(3):e37-e38

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

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http://dx.doi.org/10.1093/ibd/izaa297DOI 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

Prevalence and Outcomes of COVID-19 Among Patients With Inflammatory Bowel Disease-A Danish Prospective Population-based Cohort Study.

J Crohns Colitis 2021 Apr;15(4):540-550

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

Background And Aims: As no population-based study has investigated the susceptibility and disease course of COVID-19 among patients with inflammatory bowel diseases [IBD], we aimed to investigate this topic in a population-based setting.

Methods: Two cohorts were investigated. First, a nationwide cohort of all IBD patients diagnosed with COVID-19 was prospectively followed to investigate the disease courses of both diseases. Second, within a population-based cohort of 2.6 million Danish citizens, we identified all individuals tested for SARS-CoV-2 to determine the occurrence of COVID-19 among patients with and without IBD and other immune-mediated inflammatory diseases [IMIDs].

Results: Between January 28, 2020 and June 2, 2020, a total of 76 IBD patients with COVID-19 were identified in the national cohort and prospectively followed for 35 days (interquartile range [IQR]: 25-51). A large proportion [n = 19: 25%] required a COVID-19-related hospitalisation for 7 days [IQR: 2-8.5] which was associated with being 65 years or older (odds ratio [OR] = 23].80, 95% confidence interval [CI] 6.32-89.63, p <0.01) and presence of any non-IMID comorbidity [OR = 8.12, 95% CI 2.55-25.87, p <0.01], but not use of immunomodulators [p = 0.52] or biologic therapies [p = 0.14]. In the population-based study, 8476 of 231 601 [3.7%] residents tested positive for SARS-CoV-2; however, the occurrence was significantly lower among patients with IBD [62 of the 2486 patients = 2.5%, p <0.01] and other IMIDs [531 of 16 492 patients = 3.2%, p <0.01] as compared with patients without IMIDs.

Conclusions: Patients with IMIDs, including IBD, had a significantly lower susceptibility to COVID-19 than patients without IMIDs, and neither immunosuppressive therapies nor IBD activity were associated with the disease course of COVID-19.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa205DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7797764PMC
April 2021

Systematic review of the prevalence and development of osteoporosis or low bone mineral density and its risk factors in patients with inflammatory bowel disease.

World J Gastroenterol 2020 Sep;26(35):5362-5374

Gastrounit, Medical Division, Copenhagen University Hospital Hvidovre, Hvidovre 2650, Denmark.

Background: The inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC) are chronic, immune-mediated disorders of the digestive tract. IBD is considered to be a risk factor for developing osteoporosis; however current literature on this matter is inconsistent.

Aim: To assess prevalence and development of osteoporosis and low bone mineral density (BMD), and its risk factors, in IBD patients.

Methods: Systematic review of population-based studies. Studies were identified by electronic (January 2018) and manual searches (May 2018). Databases searched included EMBASE and PubMed and abstracts from 2014-2018 presented at the United European Gastroenterology Week, the European Crohn's and Colitis Organisation congress, and Digestive Disease Week were screened. Studies were eligible for inclusion if they investigated either the prevalence of osteoporosis or osteopenia and/or risk factors for osteoporosis or low BMD in IBD patients. Studies on children under the age of 18 were excluded. Only population-based studies were included. All risk factors for osteoporosis and low BMD investigated in any included article were considered. Study quality and the possibility of bias were analysed using the Newcastle-Ottawa scale.

Results: Twelve studies including 3661 IBD patients and 12789 healthy controls were included. Prevalence of osteoporosis varied between 4%-9% in studies including both CD and UC patients; 2%-9% in studies including UC patients, and 7%-15% in studies including CD patients. Among healthy controls, prevalence of osteoporosis was 3% and 10% in two studies. CD diagnosis, lower body mass index (BMI), and lower body weight were risk factors associated with osteoporosis or low BMD. Findings regarding gender showed inconsistent results. CD patients had an increased risk for osteoporosis or low BMD over time, while UC patients did not. Increased age was associated with decreased BMD, and there was a positive association between weight and BMI and BMD over time. Great heterogeneity was found in the included studies in terms of study methodologies, definitions and the assessment of osteoporosis, and only a small number of population-based studies was available.

Conclusion: This systematic review found a possible increase of prevalence of osteoporosis in CD cohorts when compared to UC and cohorts including both disease types. Lower weight and lower BMI were predictors of osteoporosis or low BMD in IBD patients. The results varied considerably between studies.
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http://dx.doi.org/10.3748/wjg.v26.i35.5362DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7504246PMC
September 2020

Validation of ulcerative colitis and Crohn's disease and their phenotypes in the Danish National Patient Registry using a population-based cohort.

Scand J Gastroenterol 2020 Oct 24;55(10):1171-1175. Epub 2020 Aug 24.

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

Introduction: The Danish National Patient Registry (DNPR) has been the source of several epidemiological studies of inflammatory bowel disease (IBD). However, the validation dates back to 1996 and lacks outpatient records and disease classification. The aim of this study was to update the validation and assess the validity and reliability of using the registry in disease classification.

Methods: Validation of the registry was done using a population-based inception cohort of IBD patients from 2003 to 2011 consisting of 513 patients. Specificity and sensitivity were calculated for the diagnoses of Crohn's disease (CD) and ulcerative colitis (UC), age at diagnosis and disease classification according to the Montreal Classification at both time of diagnosis and end of follow-up.

Results: The registry showed high validity and reliability in identifying CD and UC patients concerning correct age classification and identifying perianal disease. The registry showed inconsistent, unreliable results in further disease classification.

Conclusions: The DNPR has good validity and reliability in identifying patients with CD and UC, and defining the age of patients at diagnosis. However, categorising IBD patients according to the Montreal Classification should not be carried out using DNPR data in their current form, except when identifying CD patients with perianal disease.
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http://dx.doi.org/10.1080/00365521.2020.1807598DOI Listing
October 2020

The Risk of Extraintestinal Cancer in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis of Population-based Cohort Studies.

Clin Gastroenterol Hepatol 2021 Jun 13;19(6):1117-1138.e19. Epub 2020 Aug 13.

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

Background & Aims: Patients with Crohn's disease (CD) and ulcerative colitis (UC) are at increased risk of developing intestinal cancer. However, less is known about the risk of extraintestinal cancers (EICs). The aim of this study was to conduct a systematic review and meta-analysis of population-based cohorts assessing the risk of EICs in inflammatory bowel disease (IBD) patients.

Methods: Only population-based studies reporting on the prevalence or incidence of EICs were included. In total, 884 studies were screened and those included were assessed for quality. Eligible studies were pooled for length of follow-up evaluation, events in the IBD population, and events or expected events in a control population for the meta-analyses.

Results: In total, 40 studies were included in the systematic review and 15 studies were included in the meta-analysis. The overall risk of EICs was found to be increased in both CD (incidence rate ratio [IRR]: 1.43 [CI, 1.26, 1.63]) and UC (IRR: 1.15 [1.02, 1.31]) patients. Both CD and UC patients presented with an increased risk of skin (IRR: CD, 2.22 [1.41-3.48]; UC, 1.38 [1.12-1.71]) and hepatobiliary (IRR: CD, 2.31 [1.25-4.28]; UC, 2.05 [1.52-2.76]) malignancies. Furthermore, CD patients showed an increased risk of hematologic (IRR, 2.40 [1.81-3.18]) and lung (IRR, 1.53 [1.23-1.91]) cancers. These increased risks were present despite treatment with immunosuppressives.

Conclusions: This systematic review and meta-analysis shows that both CD and UC patients are at an increased risk of developing EICs, both overall and at specific sites. However, additional studies with longer follow-up evaluation are needed to assess the true risk of EICs posed by IBD.
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http://dx.doi.org/10.1016/j.cgh.2020.08.015DOI Listing
June 2021

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

Systematic Review with Meta-analysis: The Impact of Co-occurring Immune-mediated Inflammatory Diseases on the Disease Course of Inflammatory Bowel Diseases.

Inflamm Bowel Dis 2021 May;27(6):927-939

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

Background And Aims: Patients with inflammatory bowel diseases (IBDs) are at risk of developing a variety of other immune-mediated inflammatory diseases (IMIDs). The influence of co-occurring IMIDs on the disease course of IBD remains unknown. The aim of this study was therefore to conduct a systematic review and meta-analysis of the impact of IMIDs on phenotypic presentation and outcome in patients with IBD.

Methods: PubMed and Embase were searched from their earliest records through December 2018 and updated in October 2019 for studies reporting proportions or ratios of IBD-related disease outcomes in patients with and without co-occurring IMIDs. Meta-analyses were performed to estimate summary proportions and risks of the main outcomes. PRISMA guidelines were used, and study quality was assessed according to the Newcastle-Ottawa Scale.

Results: A total of 93 studies were identified, comprising 16,064 IBD patients with co-occurring IMIDs and 3,451,414 IBD patients without IMIDs. Patients with IBD and co-occurring IMIDs were at increased risk of having extensive colitis or pancolitis (risk ratio, 1.38; 95% Cl, 1.25-1.52; P < 0.01, I2 = 86%) and receiving IBD-related surgeries (risk ratio, 1.17; 95% Cl, 1.01-1.36; P = 0.03; I2 = 85%) compared with patients without IMIDs. Co-occurrence of IMIDs other than primary sclerosing cholangitis in patients with IBD was associated with an increased risk of receiving immunomodulators (risk ratio, 1.15; 95% Cl, 1.06-1.24; P < 0.01; I2 = 60%) and biologic therapies (risk ratio, 1.19; 95% Cl, 1.08-1.32; P < 0.01; I2 = 53%).

Conclusion: This meta-analysis found that the presence of co-occurring IMIDs influences the disease course of IBD, including an increased risk of surgery and its phenotypical expression.
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http://dx.doi.org/10.1093/ibd/izaa167DOI Listing
May 2021

Cancer Risk in Pediatric-Onset Inflammatory Bowel Disease: A Population-Based Danish Cohort Study.

Gastroenterology 2020 10 19;159(4):1609-1611. Epub 2020 Jun 19.

Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark. Electronic address:

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http://dx.doi.org/10.1053/j.gastro.2020.06.030DOI Listing
October 2020

The Sooner the Better? Cost-effectiveness of Early Biological Therapy in Patients With Crohn's Disease.

J Crohns Colitis 2020 06;14(5):573-574

Gastro Unit, Hvidovre University Hospital, Hvidovre, Denmark.

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http://dx.doi.org/10.1093/ecco-jcc/jjz192DOI Listing
June 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

Risk for development of inflammatory bowel disease under inhibition of interleukin 17: A systematic review and meta-analysis.

PLoS One 2020 27;15(5):e0233781. Epub 2020 May 27.

Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada.

Objective: Cases of inflammatory bowel disease (IBD) during treatment with interleukin (IL)-17 antagonists have been reported from trials in psoriasis, psoriatic arthritis, and ankylosing spondylitis. The aim of this study was to assess the overall risk for development of IBD due to IL-17 inhibition.

Design: Systematic review and meta-analysis of studies conducted 2010-2018 of treatment with IL-17 antagonists in patients with psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. We compared risk of IBD development in anti-IL-17 treated patients compared to placebo treatments. We also computed incident rates of IBD overall. A 'worst case scenario' defining subjects ambiguous for prevalent versus incident cases for the latter was also applied.

Results: Sixty-six studies of 14,390 patients exposed to induction and 19,380 patients exposed to induction and/or maintenance treatment were included. During induction, 11 incident cases of IBD were reported, whereas 33 cases were diagnosed during the entire treatment period. There was no difference in the pooled risk of new-onset IBD during induction studies for both the best-case [risk difference (RD) 0.0001 (95% CI: -0.0011, 0.0013)] and worst-case scenario [RD 0.0008 (95% CI: -0.0005, 0.0022)]. The risk of IBD was not different from placebo when including data from maintenance and long-term extension studies [RD 0.0007 (95% CI: -0.0023, 0.0036) and RD 0.0022 (95% CI: -0.0010, 0.0055), respectively].

Conclusions: The risk for development of IBD in patients treated with IL-17 antagonists is not elevated. Prospective surveillance of patients treated with IL-17 antagonists with symptom and biomarker assessments is warranted to assess for onset of IBD in these patients.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233781PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252630PMC
August 2020

The prevention and management of Crohn's disease postoperative recurrence: results from the Y-ECCO/ClinCom 2019 Survey.

Eur J Gastroenterol Hepatol 2020 08;32(8):1062-1066

Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.

Background: Prevention and management of postoperative recurrence (POR) is a controversial field in Crohn's disease. The aim of this survey was to report common practice in real-life settings.

Methods: An 11-question survey was distributed among gastroenterologists attending the 14th European Crohn's and Colitis Organisation (ECCO) congress.

Results: Postoperative endoscopy to assess recurrence was routinely performed within 12 months by 87% of respondents. Forty-six percent of clinicians reported to maintain endoscopic assessment in routine follow-up even after first negative colonoscopy. Most respondents (60%) considered starting postoperative immunoprophylaxis in naïve patients if one or more known risk factors were present. The number of risk factors was an important driver for prescribing biologics over immunosuppressants for 60% of respondents.In case of fistulizing phenotype, perianal disease, or concomitant colonic involvement, the majority of physicians reported to start an immediate prophylaxis in 85, 98 and 88% of patients, respectively. A significant percentage of clinicians were more prone to an endoscopy-driven treatment in long-standing disease after failure of thiopurines (51%) and elderly (43%).

Conclusion: Endoscopy within the first year after surgery to assess POR has become routine in most centres. The high rate of early prophylaxis with expensive biologics despite missing solid evidence highlights the need for more randomized trials.
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http://dx.doi.org/10.1097/MEG.0000000000001729DOI Listing
August 2020

Current challenges and future needs of clinical and endoscopic training in gastroenterology: a European survey.

Endosc Int Open 2020 Apr 23;8(4):E525-E533. Epub 2020 Mar 23.

Digestive Disease Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

 A universal European training program in gastroenterology and hepatology is currently not available. The European Board of Gastroenterology and Hepatology (EBGH) has produced guidance regarding expected competencies for European gastroenterology trainees but it is unclear whether these have been incorporated in national curricula. The aim of this study was to provide an in-depth assessment of training and research opportunities, professional activities and of socioeconomic aspects of gastroenterology training across Europe through a web-based 90-point questionnaire.  Physicians in their last year or who had recently finished their training, from 16 European countries, were invited to answer the questionnaire.  A total of 144 physicians answered the survey. A minimum number of procedures is required before completing training in nine of 16 countries (56 %). Overall, European trainees dedicate a median of 12 months (IQR 6-25) of their training period to endoscopy and a median of 3 months (IQR 0-6) to ultrasound. Training in interventional endoscopy was not always exhaustive, as about 50 % of participants performed fewer of several interventional procedures than was recommended by EBGH, most participants did not perform endoscopic hemostasis or endoscopic mucosal resection, and nearly a half of participants had no access to pancreatobiliary endoscopy training. Finally, up to 13 % of residents complete their training without the supervision of a mentor.  In this large European survey, deep gaps and considerable differences in several gastroenterology training activities were found both among and within 16 European countries. Homogenization of educational programs and training opportunities across Europe is therefore necessary.
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http://dx.doi.org/10.1055/a-1093-0877DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7089798PMC
April 2020

Outcome of concomitant treatment with thiopurines and allopurinol in patients with inflammatory bowel disease: A nationwide Danish cohort study.

United European Gastroenterol J 2020 02 3;8(1):68-76. Epub 2019 Aug 3.

Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Background: Thiopurine and allopurinol in combination are associated with clinical remission in inflammatory bowel diseases but their influence on subsequent outcomes is unclear. We compared outcomes during exposure to both thiopurines and allopurinol versus thiopurines alone.

Methods: We established a nationwide cohort of patients with inflammatory bowel diseases exposed to thiopurines ± allopurinol during 1999-2014, using registry data. Patients were followed until hospitalization, surgery, anti-TNFα, or death (as a primary composite outcome). We used Poisson regression analyses to calculate incidence rate ratios overall and stratified by calendar period (assuming the combined exposure was unintended before 2009).

Results: A total of 10,367 patients with inflammatory bowel diseases (Crohn's disease,  = 5484; ulcerative colitis,  = 4883) received thiopurines. Of these, 217 (2.1%) also received allopurinol. During 24,714 person years of follow-up, we observed 40 outcomes among thiopurine-allopurinol-exposed patients, and 4745 outcomes among those who were thiopurine exposed; incidence rate ratio, 1.26 (95% confidence interval, 0.92-1.73). The incidence rate ratios decreased over time: 4.88 (95% confidence interval 2.53-9.45) for 1999-2003, 2.19 (95% confidence interval, 1.17-4.09) for 2004-2008 and 0.80 (95% confidence interval, 0.52-1.23) for 2009-2014.

Conclusion: Our nationwide inflammatory bowel disease cohort study shows that concomitant thiopurine-allopurinol is as safe to use as thiopurines alone, with a tendency towards a positive effect on clinical outcomes in recent calendar periods when combined use was intended.
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http://dx.doi.org/10.1177/2050640619868387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006001PMC
February 2020