Tandem mass tag-based quantitative proteomic profiling identifies candidate serum biomarkers of drug-induced liver injury in humans

Kodihalli C. Ravindra, Vishal S. Vaidya (), Zhenyu Wang, Joel D. Federspiel, Richard Virgen-Slane, Robert A. Everley, Jane I. Grove, Camilla Stephens, Mireia F. Ocana, Mercedes Robles-Díaz, M. Isabel Lucena, Raul J. Andrade, Edmond Atallah, Alexander L. Gerbes, Sabine Weber, Helena Cortez-Pinto, Andrew J. Fowell, Hyder Hussaini, Einar S. Bjornsson, Janisha Patel, Guido Stirnimann, Sumita Verma, Ahmed M. Elsharkawy, William J. H. Griffiths, Craig Hyde, James W. Dear, Guruprasad P. Aithal () and Shashi K. Ramaiah ()
Additional contact information
Kodihalli C. Ravindra: Worldwide Research Development and Medical
Vishal S. Vaidya: Worldwide Research Development and Medical
Zhenyu Wang: Worldwide Research Development and Medical
Joel D. Federspiel: Worldwide Research Development and Medical
Richard Virgen-Slane: Worldwide Research Development and Medical
Robert A. Everley: Worldwide Research Development and Medical
Jane I. Grove: Nottingham University Hospitals NHS Trust and the University of Nottingham
Camilla Stephens: Hospital Universitario Virgen de la Victoria, Universidad de Málaga
Mireia F. Ocana: Worldwide Research Development and Medical
Mercedes Robles-Díaz: Hospital Universitario Virgen de la Victoria, Universidad de Málaga
M. Isabel Lucena: Hospital Universitario Virgen de la Victoria, Universidad de Málaga
Raul J. Andrade: Hospital Universitario Virgen de la Victoria, Universidad de Málaga
Edmond Atallah: Nottingham University Hospitals NHS Trust and the University of Nottingham
Alexander L. Gerbes: University Hospital
Sabine Weber: University Hospital
Helena Cortez-Pinto: Universidade de Lisboa
Andrew J. Fowell: Portsmouth Hospitals University NHS Trust
Hyder Hussaini: Royal Cornwall Hospitals NHS Trust
Einar S. Bjornsson: Landspitali University Hospital Reykjavik
Janisha Patel: University Hospital Southampton
Guido Stirnimann: University Hospital Inselspital and University of Bern
Sumita Verma: Brighton and Sussex Medical School and University Hospitals Sussex NHS Foundation Trust
Ahmed M. Elsharkawy: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
William J. H. Griffiths: Cambridge University Hospitals NHS Foundation Trust
Craig Hyde: Worldwide Research Development and Medical
James W. Dear: University of Edinburgh, The Queen’s Medical Research Institute
Guruprasad P. Aithal: Nottingham University Hospitals NHS Trust and the University of Nottingham
Shashi K. Ramaiah: Worldwide Research Development and Medical

Nature Communications, 2023, vol. 14, issue 1, 1-14

Abstract: Abstract Diagnosis of drug-induced liver injury (DILI) and its distinction from other liver diseases are significant challenges in drug development and clinical practice. Here, we identify, confirm, and replicate the biomarker performance characteristics of candidate proteins in patients with DILI at onset (DO; n = 133) and follow-up (n = 120), acute non-DILI at onset (NDO; n = 63) and follow-up (n = 42), and healthy volunteers (HV; n = 104). Area under the receiver operating characteristic curve (AUC) for cytoplasmic aconitate hydratase, argininosuccinate synthase, carbamoylphosphate synthase, fumarylacetoacetase, fructose-1,6-bisphosphatase 1 (FBP1) across cohorts achieved near complete separation (range: 0.94–0.99) of DO and HV. In addition, we show that FBP1, alone or in combination with glutathione S-transferase A1 and leukocyte cell-derived chemotaxin 2, could potentially assist in clinical diagnosis by distinguishing NDO from DO (AUC range: 0.65–0.78), but further technical and clinical validation of these candidate biomarkers is needed.

Date: 2023
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DOI: 10.1038/s41467-023-36858-6

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