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

• Published in: Multiple sclerosis and related disorders 2020-05, Vol.40, p.101948, Article 101948
• Main Authors: Michels, Sebastian, Zizer, Eugen, Barth, Thomas FE, Wassner, Anette, Fangerau, Tanja, Taranu, Daniela, Bachhuber, Franziska, Tumani, Hayrettin, Senel, Makbule
• Format: Article
• Language: English
• Subjects: Adult; Biosimilar Pharmaceuticals - adverse effects; Biosimilars; Chemical and Drug Induced Liver Injury; Clift; Disease-modifying therapy; Drug-induced liver injury; Female; Glatiramer acetate; Glatiramer Acetate - adverse effects; Humans; Immunologic Factors - adverse effects; Multiple sclerosis; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Young Adult
• ISSN: 2211-0348; 2211-0356
• DOI: 10.1016/j.msard.2020.101948

•Glatiramer acetate is a well-known drug in the long-term treatment of MS.•After the administration of Clift, an increase in liver enzymes was noticed.•Histological work-up of a liver biopsy indicates a drug-induced liver injury.•This case highlights the importance of tight monitoring of liver function. 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.