Publications

@article{Bjornsson2023-vk,

title = {A new framework for advancing in drug-induced liver injury 

 research. The Prospective European DILI Registry},

author = {Einar S Bj\"{o}rnsson and Camilla Stephens and Edmond Atallah and Mercedes Robles-Diaz and Ismael Alvarez-Alvarez and Alexander Gerbes and Sabine Weber and Guido Stirnimann and Gerd Kullak-Ublick and Helena Cortez-Pinto and Jane I Grove and M Isabel Lucena and Raul J Andrade and Guruprasad P Aithal},

year  = {2023},

date = {2023-01-01},

journal = {Liver Int.},

volume = {43},

number = {1},

pages = {115\textendash126},

publisher = {Wiley},

abstract = {BACKGROUND \& AIMS: No 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. METHODS: Patients 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. RESULTS: Of 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. CONCLUSIONS: In 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.},

keywords = {drug aetiologies, drug-induced autoimmune-like hepatitis, Drug-induced liver injury, outcomes, prospective study},

pubstate = {published},

tppubtype = {article}

}