Drug-induced liver injury associated with the biosimilar glatiramer acetate (Clift®)

Mult Scler Relat Disord. 2020 May:40:101948. doi: 10.1016/j.msard.2020.101948. Epub 2020 Jan 13.

Abstract

A 23-year old female was diagnosed with relapsing-remitting multiple sclerosis with two symptomatic attacks. Immunomodulatory treatment with Clift® (Glatiramer Acetate biosimilar) was initiated. Shortly after administration, an asymptomatic increase in liver enzymes was noticed, and therapy was paused. However, we observed an enormous increase in liver enzymes within a few days. Histological work up of a liver biopsy showed microfocal liver necrosis accompanied with increased numbers of CD38-positive lymphocytes as shown by immunohistology, indicating a drug-induced liver injury. Subsequently, under oral prednisolone treatment, liver enzymes normalized. This case highlights the importance of tight monitoring of liver function in the initial phase of a new immunotherapy to unravel asymptomatic hepatotoxicity in time and prevent further damage.

Keywords: Biosimilars; Clift®; Disease-modifying therapy; Drug-induced liver injury; Glatiramer acetate; Multiple sclerosis.

Publication types

  • Case Reports

MeSH terms

  • Adult
  • Biosimilar Pharmaceuticals / adverse effects*
  • Chemical and Drug Induced Liver Injury
  • Female
  • Glatiramer Acetate / adverse effects*
  • Humans
  • Immunologic Factors / adverse effects*
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Young Adult

Substances

  • Biosimilar Pharmaceuticals
  • Immunologic Factors
  • Glatiramer Acetate