Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis

Summary

This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids. Furthermore, the effect of adding a second-line immunosuppressive drug, either MMF in steroid-refractory or steroid-dependent cases will be explored and compared.

Timeline

Start

2021-04-07

Primary completion

2025-04-07

Completion

2025-11-07

Publications

• Holmstroem RB, Teisner AS, Sweep MWD, Noringriis IM, Khan S, Aagaard NK, Karlstrom J, Jurlander RS, Sohlin JE, Monberg TJ, Vestergaard C, Stoltenborg Granhoj J, Stenbog P, Toxvaerd A, Hansen AB, Bjerring PN, Lorentzen T, Thielsen P, Bol K, Jonsson G, Ellebaek E, Svane IM. Prospective study of patients with immune checkpoint inhibitor-induced hepatitis; characterization of liver injury, outcome of therapy, and management of steroid-unresponsive and steroid-dependent hepatitis. J Immunother Cancer. 2026 Mar 5;14(3):e013861. doi: 10.1136/jitc-2025-013861.

Drugs

Indications