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Development and Validation of a Clinical Risk Score to Predict Immune-mediated Liver Injury Caused by Sintilimab:
Caiyun Zheng1,2, Shunmin Huang1,3, Meimei Lin1
1Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Journal of Clinical and Translational Hepatology
|September 18, 2023
Summary
Immune-mediated liver injury from sintilimab is a serious risk. Hypoproteinemia, dyslipidemia, and thyroid peroxidase antibodies are key predictors of this hepatotoxicity, aiding early intervention.
Area of Science:
- Oncology
- Immunology
- Hepatology
Background:
- Immune-mediated liver injury is a critical adverse event associated with sintilimab, a checkpoint inhibitor.
- Identifying risk factors is crucial for managing this potentially fatal side effect.
Purpose of the Study:
- To investigate the incidence, risk factors, and outcomes of sintilimab-induced immune-mediated liver injury.
- To develop a predictive model for sintilimab-related hepatotoxicity.
Main Methods:
- Retrospective review of 772 patients treated with sintilimab.
- Utilized the Roussel Uclaf Causality Assessment Method (RUCAM) for case identification.
- Logistic regression analysis to identify risk factors and clinical characteristics.
Main Results:
- 12.1% of 585 patients developed liver injury.
- Hypoproteinemia, dyslipidemia, and thyroid peroxidase antibodies were significant risk factors.
- A nomogram model demonstrated good predictive value (C-index 0.713) for liver injury.
Conclusions:
- Hypoproteinemia, dyslipidemia, and thyroid peroxidase antibodies serve as feasible prognostic biomarkers for sintilimab-induced liver injury.
- The developed nomogram aids in predicting patients at higher risk.
- Early identification and intervention, including steroid treatment, can improve outcomes.
