The University of Toledo Translation Journal of Medical Sciences 
Internal Medicine Abstract, Department of Medicine Research Symposium UTJMS 2023 May 5; 11(1):e1-e1 

Steroid-unresponsive Immune-mediated 
Hepatitis Induced by Durvalumab: A Case 
Report 
Omar Sajdeya, MD1*, Saif Malhas, MD1, Wasef Alsayeh, MD1, Mohammad Alqadi, MD1, Ragheb Assaly, MD2 

1Division of Internal Medicine, Department of Medicine, The University of Toledo, 
Toledo, OH 43614 
2Division of Pulmonary and Critical Care Medicine, Department of Medicine, The 
University of Toledo, Toledo, OH 43614 

*Corresponding author:

Published: 05 May 2023 

Introduction: Lung cancer is the leading cause of cancer death in the United States. Durvalumab 
is a monoclonal antibody against programmed cell death ligand (PD-L1) and CD80 used for the 
treatment of stage III non-small cell lung cancer. Immune-mediated hepatitis is a common side 
effect of durvalumab, which is reported in 12% of patients. However, most durvalumab-induced 
hepatitis is mild and progression to severe (grade 4) immune-mediated hepatitis is rare and seen 
in only 0.4% of patients. Of these patients, only 1.7% required corticosteroids, and 
mycophenolate was required in 0.1%. We report a case of grade 4 immune-mediated hepatitis 
induced by durvalumab, which was unresponsive to high-dose corticosteroids and needed 
treatment with mycophenolate. 

Case Presentation: A 78-year-old female with a history of lung adenocarcinoma presented with 
abnormal liver function tests on routine screening after two cycles of durvalumab. The patient reported 
jaundice, pale stools, dark-colored urine, and pruritus. On admission, her vitals were normal. Initial labs 
revealed a significant elevation in total bilirubin, alkaline phosphatase, alanine aminotransferase, and 
aspartate aminotransferase. She was started on high-dose steroids for grade 4 immune-mediated 
hepatitis. Initially, she showed temporary improvement on steroids but declined on day 2 of admission 
with an increase in total bilirubin and alkaline phosphatase. Mycophenolate was added on day 4, and 
magnetic resonance cholangiopancreatography was done and ruled out obstruction. The administration 
of mycophenolate provided a gradual improvement of hepatitis. However, on day 6, a sharp decline in 
her pulmonary function prompted a transfer to the intensive care unit (ICU) for acute respiratory failure, 
which was likely secondary to immunotherapy. On day 9, the patient elected to withdraw her treatment 
and be admitted to hospice. 

Conclusion: We describe a rare case of steroid-unresponsive severe immune-mediated hepatitis 
induced by durvalumab. As the use of durvalumab is rising following FDA approval, physician 
cognizance of immune-mediated hepatitis induced by durvalumab is important. This requires careful 
monitoring of liver function tests in cancer patients on immune checkpoint inhibitors such as 
durvalumab, and demonstration of acute liver injury should be evaluated and managed promptly.  

https://dx.doi.org/10.46570/utjms.vol11-2023-718 

https://dx.doi.org/10.46570/utjms.vol11-2023-718