Evidence map›Paper›PMID 33538994›Full record

ArticleDrug safety2021

Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry.

Eline L Giraud, Pepijn W A Thomas, Jette A van Lint, Eugene P van Puijenbroek, Tessa E H Römkens, Rachel L West, Maurice G V M Russel, Jeroen M Jansen, Naomi T Jessurun, Frank Hoentjen and 1 more

Open access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. The Impact of Genetic Variation on Drug Response in Adult IBD: A Systematic Review.JGH open : an open access journal of gastroenterology and hepatology · 2025
    Review
  3. Article
  4. Safety of corticosteroid therapy in sarcoidosis treatment.Frontiers in drug safety and regulation · 2023
    Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Eline L Giraud *Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Pepijn W A Thomas *Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands. pepijn.thomas@radboudumc.nl.ORCID 0000-0002-1353-4509
Jette A van LintNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Eugene P van PuijenbroekNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Tessa E H RömkensDepartment of Gastroenterology and Hepatology, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, The Netherlands.
Rachel L WestDepartment of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands.
Maurice G V M RusselDepartment of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands.
Jeroen M JansenDepartment of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Naomi T JessurunNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Frank HoentjenDepartment of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
IBDREAM registry
Radboud University Nijmegen · NLNetherlands Pharmacovigilance Centre Lareb · NLMedisch Spectrum Twente · NLOLVG · NLSint Franciscus Gasthuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInflammatory bowel disease (IBD) frequently requires chronic immunosuppressive treatment and active involvement from patients during treatment decision making. Information about the risk of developing adverse drug reactions (ADRs) to IBD therapies is required in this process.

objectiveThe aim of this study was to describe the ADRs reported in IBD patients from real-world data, using the Dutch nationwide IBDREAM registry, and compare the occurrence and cumulative incidences with the Summary of Product Characteristics (SmPC) of the associated drugs.

methodsIn this retrospective multicentre study, ADRs related to IBD medication were assessed. Only reports associated with the use of drugs used for the maintenance treatment of IBD were included. All ADRs were verified by healthcare professionals and coded by trained pharmacovigilance assessors.

resultsIn total, 3080 ADRs were reported in 1179 patients. Twenty-three new drug-ADR associations related to the use of azathioprine, mercaptopurine, infliximab, oral mesalamine and thioguanine were reported in the IBDREAM registry that were not mentioned in the corresponding SmPCs. The most frequently reported new association was pyrexia for azathioprine (3.1%) and mercaptopurine (4.9%). In addition, there were seven ADRs with a higher cumulative incidence in IBDREAM compared with the SmPC, and included, among others, arthralgia during mercaptopurine use (2.5%), and diarrhoea (1.4%), alopecia (1.2%) and infections (1.6%) during azathioprine use.

conclusionsBased on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients.

Indexed as

Drug-Related Side Effects and Adverse ReactionsInflammatory Bowel DiseasesAdverse Drug Reaction Reporting SystemsAzathioprineHumansMercaptopurinePharmacovigilanceRegistriesRetrospective StudiesAzathioprineMercaptopurine

Identifiers

PMID33538994
PMCPMC8053178
OpenAlexW3127947920

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.