A case of autoimmune hepatitis associated with the PCSK9 inhibitor alirocumab

Ann Clin Biochem. 2025 Jan;62(1):71-74. doi: 10.1177/00045632241269657. Epub 2024 Aug 4.

Abstract

This is a case of a 61-year-old lady who presented to the lipid clinic with possible familial hypercholesterolaemia (Simon Broome Criteria). She was commenced on atorvastatin; however, 4 weeks later, she developed hepatitis, and therefore her atorvastatin was discontinued. Following that, her liver function tests normalized, and she was diagnosed with statin-induced hepatitis. Three years later, she was seen again in the lipid clinic with an uncontrolled lipid profile, and she was commenced on alirocumab, a Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor. A few days later, she developed hepatitis, and subsequently, the alirocumab was discontinued. She underwent a liver biopsy, which confirmed that she had Autoimmune Hepatitis (AIH) with presumed superimposed drug injury. This is the first reported case of autoimmune hepatitis associated with alirocumab.

Keywords: Clinical studies; alirocumab; liver disease.

Publication types

  • Case Reports

MeSH terms

  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Atorvastatin / adverse effects
  • Atorvastatin / therapeutic use
  • Female
  • Hepatitis, Autoimmune* / drug therapy
  • Humans
  • Hyperlipoproteinemia Type II / drug therapy
  • Middle Aged
  • PCSK9 Inhibitors*
  • Proprotein Convertase 9

Substances

  • alirocumab
  • Antibodies, Monoclonal, Humanized
  • PCSK9 Inhibitors
  • PCSK9 protein, human
  • Atorvastatin
  • Proprotein Convertase 9