Cohort profile: design and first results of the Dutch IBD Biobank: a prospective, nationwide biobank of patients with inflammatory bowel disease

Spekhorst, Lieke M.; Imhann, Floris; Festen, Eleonora A. M.; Bodegraven, Ad A. van; Boer, Nanne K. H. de; Bouma, Gerd; Fidder, Herma H.; D’Haens, G; Hoentjen, Frank; Hommes, Daan W.; Jong, Dirk J. de; Löwenberg, Mark; Maljaars, P W J; Jong, Andrea E. van der Meulen–de; Oldenburg, Bas; Pierik, Marieke; Ponsioen, Cyriel Y.; Stokkers, Pieter; Verspaget, Hein W.; Visschedijk, Marijn C.; Woude, C. Janneke van der; Dijkstra, Gerard; Weersma, Rinse K.

doi:10.1136/bmjopen-2017-016695

Cited by 44 publications

(40 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Another limitation of our study was that we strongly depend on the strength of data documentation at the site level. The information in the Dutch IBD Biobank is updated regularly (ie data are automatically uploaded from the local database to the central database at least once a month), still missing data or information bias might have been introduced in our study . Moreover, we only investigated the prevalence of off‐label IBD prescriptions and the proportion of patients exposed to these drugs, but we were not able to assess further questions about the reasons for initiation and withdrawal of off‐label drugs.…”

Section: Discussionmentioning

confidence: 99%

“…This is a nationwide biobank in which data and biomaterial of adult IBD patients are routinely collected from all seven Dutch university medical centres in the Netherlands since 2007 (ie Erasmus Medical Centre, Leiden University Medical Centre, Maastricht University Medical Centre, Radboud University Nijmegen Medical Centre, University Medical Centre Groningen, University Medical Centre Utrecht and Amsterdam University Medical Centre (locations VU University Medical Centre and Academical Medical Centre). The Dutch IBD Biobank is part of the Parelsnoer Institute (PSI) (http://www.parelsnoer.org) and is initiated and maintained by the Initiative on Crohn's and Colitis (ICC) working party from the Netherlands …”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis

Simsek

Lissenberg‐Witte

Riswijk

et al. 2019

Aliment Pharmacol Ther

Self Cite

View full text Add to dashboard Cite

Background Off‐label prescribing is encountered across various fields of medicine and creates alternative treatment options, but is associated with unknown safety risks. The use of off‐label drugs for the treatment of patients with inflammatory bowel diseases (IBD) has not been characterised before. Aim To assess the proportion and characteristics of off‐label prescribing for IBD in tertiary care centres in the Netherlands. Methods A prospective database of IBD patients from all Dutch university hospitals was used to collect data on drug prescriptions for IBD and demographics. Drugs were classified as off‐label if they were unlicensed for Crohn's disease and/or ulcerative colitis by the Medicines Evaluation Board. Uni‐ and multivariable analyses were used to identify patient‐specific characteristics predictive of increased off‐label use. Results For the induction and/or maintenance treatment of 4583 IBD patients, 12 651 historical and current drug records were available in the database. Of these, 2374 (19%) were considered off‐label prescriptions. Out of 4583 IBD patients, 1477 (32%) were exposed to off‐label drugs. Commonly prescribed off‐label IBD drugs were mercaptopurine (18%), beclomethasone (12%), thioguanine (4%) and allopurinol (3%). Non‐thiopurine/methotrexate off‐label drugs were prescribed in 243 patients (6%), including biological agents or tofacitinib in 47 IBD patients (1%). Off‐label prescriptions were more common in ulcerative colitis than Crohn's disease (37% vs 29%, P < 0.001). Smokers and patients that received ≥5 drug types during their disease course were more likely to be exposed to off‐label drugs (smoking 33% vs 27% and multiple drug use 66% vs 22%, both P < 0.001). Conclusion About one‐fifth of prescriptions for IBD were off‐label and one‐third of IBD patients, especially ulcerative colitis patients, were exposed to off‐label drugs.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis

Simsek

Lissenberg‐Witte

Riswijk

et al. 2019

Aliment Pharmacol Ther

Self Cite

View full text Add to dashboard Cite

show abstract

“…In precision medicine era, many national and international collaborative efforts are under way aimed at improving clinical research (figure 3). 72–84…”

Section: Current Paradigm Of Ibd Disease Management and Its Limitationsmentioning

confidence: 99%

Big data in IBD: big progress for clinical practice

Tabib

Madgwick

Sudhakar³

et al. 2020

Gut

139

108

View full text Add to dashboard Cite

IBD is a complex multifactorial inflammatory disease of the gut driven by extrinsic and intrinsic factors, including host genetics, the immune system, environmental factors and the gut microbiome. Technological advancements such as next-generation sequencing, high-throughput omics data generation and molecular networks have catalysed IBD research. The advent of artificial intelligence, in particular, machine learning, and systems biology has opened the avenue for the efficient integration and interpretation of big datasets for discovering clinically translatable knowledge. In this narrative review, we discuss how big data integration and machine learning have been applied to translational IBD research. Approaches such as machine learning may enable patient stratification, prediction of disease progression and therapy responses for fine-tuning treatment options with positive impacts on cost, health and safety. We also outline the challenges and opportunities presented by machine learning and big data in clinical IBD research.

show abstract

“…12 Although there are an increasing number of reports and reviews for clinical and biochemical biomarkers at onset of disease, none have been able to predict future clinical outcome with great certainty . [13][14][15][16][17][18] In our research group we have published reports on mucosal transcript levels of tumor necrosis factor (TNF) as a biomarker for response to and when to stop anti-TNF thereapy, [19][20][21] However, most of the studies are of retrospective design and there is a lack of validated studies of prognostic biomarkers to predict the clinical outcome in IBD with high reliability. Moreover, a personalized therapy approach initiated at the time of disease diagnosis, may have an impact on the natural course of IBD.…”

Section: Introductionmentioning

confidence: 99%

Discovery and validation of mucosal TNF expression combined with histological score - a biomarker for personalized treatment in ulcerative colitis

Florholmen

Johnsen

Renate

et al. 2020

Preprint

View full text Add to dashboard Cite

BackgroundThere are no accurate markers that can predict clinical outcome in ulcerative colitis at time of diagnosis. The aim of this study was to explore a comprehensive data set to identify and validate predictors of clinical outcome in the first year following diagnosis. MethodsTreatment naive-patients with ulcerative colitis were included at time of initial diagnosis from 2004-2014, followed by a validation study from 2014-2018. Patients were treated according to clinical guidelines following a standard step-up regime. Patients were categorized according to the treatment level necessary to achieve clinical remission: mild, moderate and severe. The biopsies were assessed by Robarts histopathology index (RHI) and TNF gene transcripts. ResultsWe included 66 patients in the calibration cohort and 89 patients in the validation. Mucosal TNF transcripts showed high test reliability for predicting severe outcome in UC . When combined with histological activity (RHI) scores the test improved its diagnostic reliability. Based on the cut-off values of mucosal TNF and RHI scores from the calibration cohort, the combined test had still high reliability in the validation cohort (specificity 0.99, sensitivity 0.44, PPV 0.89, NPV 0.87) and a diagnostic odds-ratio (DOR) of 54.ConclusionsThe combined test using TNF transcript and histological score at debut of UC can predict severe outcome and the need for anti-TNF therapy with a high level of precision. These validated data may be of great clinical utility and contribute to a personalized medical approach with the possibility of top-down treatment for selected patients.

show abstract

Cohort profile: design and first results of the Dutch IBD Biobank: a prospective, nationwide biobank of patients with inflammatory bowel disease

Cited by 44 publications

References 29 publications

Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis

Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis

Big data in IBD: big progress for clinical practice

Discovery and validation of mucosal TNF expression combined with histological score - a biomarker for personalized treatment in ulcerative colitis

Contact Info

Product

Resources

About