Are We Closer to Finding Biomarkers for Identifying Acute Drug-Induced Liver Injury?

Abstract

Over recent years, there has been a considerable effort to identify and develop new biomarkers of acute drug-induced liver injury (DILI). It is clear that the development and qualification of sensitive and specific hepatic biomarkers that permit quantitative assessment of the translation between preclinical and clinical studies is urgently required. The potential for novel biomarkers to provide enhanced understanding of the fundamental mechanisms that result in clinical DILI is becoming increasingly recognized. Furthermore, there is a great need for mechanistic biomarkers that can bridge between preclinical models and the clinical situation of DILI. These will therefore enable us to understand the human relevance of predictive models of acute DILI and the interpretation of data generated from such models. Such biomarkers would not only accelerate the pace of drug development but also provide a point-of-care test to enable patient and/or DILI-specific treatment stratification once a new drug is licensed. Currently, the number of putative biomarkers that hold some clinical utility is low, mainly because less attention has been placed on the science of drug safety compared with drug efficacy [1].