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Acute liver injury in three patients receiving Cardiomab for giant cell arteritis: a case series

Martinez R., Chen L., Okafor B., Singh P. ยท Journal of Hepatology Reports ยท 2026-07-22 ยท PMID: 38956789 ยท DOI: 10.1016/j.hepj.2026.07.045

โ†’ ICSR Workbench

Case Structure

๐Ÿ“„ Article
๐Ÿ“Š Aggregate Safety Finding

Human Controls

โš ๏ธAI-extracted data must be verified against source text by a qualified reviewer.

Patient Candidate 1

confirmed
AI confidence: 94%Publication ID: 38956789

Body weight, exact dates of onset and resolution, R-factor

Age / Age GroupAI
64 years
SexAI
Female
Medical HistoryAI
Giant cell arteritis. No history of liver disease or alcohol use.
Suspect ProductAI
Cardiomab 10 mg/kg IV monthly
DoseAI
10 mg/kg
RouteAI
Intravenous
IndicationAI
Giant cell arteritis
Treatment DatesAI
Started 2026-06 (first dose)
Concomitant MedicinesAI
Prednisolone 20mg daily
Reported EventAI
Acute liver injury (hepatocellular) โ€” ALT 847, AST 623, bilirubin 4.2
Event OnsetAI
2 weeks after first dose
Seriousness IndicatorsAI
Required hospitalization; Required intervention to prevent permanent impairment
OutcomeAI
Recovered โ€” liver enzymes normalized within 6 weeks after discontinuation
DechallengeAI
Positive
RechallengeAI
Not performed
Laboratory FindingsAI
ALT 847 U/L, AST 623 U/L, total bilirubin 4.2 mg/dL, ALP within normal range
Author CausalityAI
Probable (per Naranjo scale)
CountryAI
United States
Missing InformationAI
Body weight, exact dates of onset and resolution, R-factor

Source Locations

Page 3, Paragraph 1-3Page 4, Paragraph 1-2
๐Ÿ“Š

Aggregate Safety Finding

Elevated liver enzymes in the broader cohort

An aggregate safety finding of elevated liver enzymes was observed in the cohort but no individual patient-level data was available for Patient 3.

Source: Abstract, last sentence