Evidence map›Paper›PMID 35899490›Full record

ArticleLiver international : official journal of the International Association for the Study of the Liver2023

A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry.

Einar S Björnsson, Camilla Stephens, Edmond Atallah, Mercedes Robles-Diaz, Ismael Alvarez-Alvarez, Alexander Gerbes, Sabine Weber, Guido Stirnimann, Gerd Kullak-Ublick, Helena Cortez-Pinto and 4 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Liver international : official journal of the International Association for the Study of the Liver, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06446609 (Understanding the Natural History and Impact of Itching), which is not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
10.6field-weighted citation impact, top 1% 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.

NCT06446609 recruitingnot on this mapstarted 2025, after this paper: background citation

Understanding the Natural History and Impact of Itching (Pruritus) in Patients With Drug-induced Liver Injury (DILI)

TypeobservationalSponsorUniversity of NottinghamRan2025 to 2028Enrolled50ConditionsDrug Induced Liver Injury, Pruritus
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 60 citations in OpenAlex.

  1. Review
  2. Common Causes of Drug-Induced Liver Injury in 2025.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026
    Review
  3. Liver Injury From Medications Used for Treating Inflammatory Bowel Disease: The Drug-Induced Liver Injury Network Experience.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Unmet needs in autoimmune liver diseases.Current opinion in immunology · 2025
    Review
  12. Article
  13. Article
  14. Drug-Induced Liver Injury Caused by Metamizole: Identification of a Characteristic Injury Pattern.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Observational
  15. Mechanisms and aetiology-dependent treatment of acute liver failure.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Review
  16. Methods for causality assessment of idiosyncratic drug-induced liver injury.Liver international : official journal of the International Association for the Study of the Liver · 2025
    Review
  17. Article
  18. Impact of Traditional Chinese Medicine Antioxidants on Oxidative Stress and Drug-Induced Liver Injury: A Review.Medical science monitor : international medical journal of experimental and clinical research · 2024
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 6 countries.

Einar S BjörnssonFaculty of Medicine, University of Iceland, Reykjavík, Iceland.ORCID 0000-0002-8392-0632
Camilla StephensServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain.
Edmond AtallahNottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.ORCID 0000-0002-7341-9174
Mercedes Robles-DiazServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain.ORCID 0000-0002-2365-2787
Ismael Alvarez-AlvarezServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain.ORCID 0000-0001-6271-0604
Alexander GerbesDepartment of Medicine II, LMU Klinikum Munich, Munich, Germany.ORCID 0000-0003-0440-7417
Sabine WeberDepartment of Medicine II, LMU Klinikum Munich, Munich, Germany.ORCID 0000-0001-7077-8078
Guido StirnimannDepartment of Visceral Surgery and Medicine, Inselspital University Hospital and University of Bern, Bern, Switzerland.ORCID 0000-0003-3447-264X
Gerd Kullak-UblickDepartment of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Helena Cortez-PintoClínica Universitária de Gastrenterologia, Faculdade de Medicina de Lisboa, Universidade de Lisboa, Centro Hospitalar Lisboa Norte, HSM, Lisbon, Portugal.ORCID 0000-0002-8537-8744
Jane I GroveNottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.ORCID 0000-0002-9950-7201
M Isabel LucenaServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain.ORCID 0000-0001-9586-4896
Raul J AndradeServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain.ORCID 0000-0002-1565-0757
Guruprasad P AithalNottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.ORCID 0000-0003-3924-4830
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESNottingham University Hospitals NHS Trust · GBLMU Klinikum · DEReykjavík University · ISUniversity of Bern · CHUniversity of Lisbon · PTUniversity of Zurich · CH

Funding

Department of Health IS-BRC-1215-20003
6 · The paper itself

Abstract

BACKGROUND &

aimsNo multi-national prospective study of drug-induced liver injury (DILI) has originated in Europe. The design of a prospective European DILI registry, clinical features and short-term outcomes of the cases and controls is reported.

methodsPatients with suspected DILI were prospectively enrolled in the United Kingdom, Spain, Germany, Switzerland, Portugal and Iceland, 2016-2021. DILI cases or non-DILI acute liver injury controls following causality assessment were enrolled.

resultsOf 446 adjudicated patients, 246 DILI patients and 100 had acute liver injury due to other aetiologies, mostly autoimmune hepatitis (n = 42) and viral hepatitis (n = 34). DILI patients (mean age 56 years), 57% women, 60% with jaundice and 3.6% had pre-existing liver disease. DILI cases and non-DILI acute liver injury controls had similar demographics, clinical features and outcomes. A single agent was implicated in 199 (81%) DILI cases. Amoxicillin-clavulanate, flucloxacillin, atorvastatin, nivolumab/ipilimumab, infliximab and nitrofurantoin were the most commonly implicated drugs. Multiple conventional medications were implicated in 37 (15%) and 18 cases were caused by herbal and dietary supplements. The most common single causative drug classes were antibacterials (40%) and antineoplastic/immunomodulating agents (27%). Overall, 13 (5.3%) had drug-induced autoimmune-like hepatitis due to nitrofurantoin, methyldopa, infliximab, methylprednisolone and minocycline. Only six (2.4%) DILI patients died (50% had liver-related death), and another six received liver transplantation.

conclusionsIn this first multi-national European prospective DILI Registry study, antibacterials were the most commonly implicated medications, whereas antineoplastic and immunomodulating agents accounted for higher proportion of DILI than previously described. This European initiative provides an important opportunity to advance the study on DILI.

Indexed as

Chemical and Drug Induced Liver InjuryNitrofurantoinAnti-Bacterial AgentsFemaleHumansImmunomodulating AgentsInfliximabMaleMiddle AgedProspective StudiesRegistriesAnti-Bacterial AgentsImmunomodulating AgentsInfliximabNitrofurantoindrug aetiologiesdrug-induced autoimmune-like hepatitisdrug-induced liver injuryoutcomesprospective study

Identifiers

PMID35899490
PMCPMC7614006
OpenAlexW4288080965

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Registered trials

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.