Adverse reactions of tumor immunotherapy drugs—PD-1/PD-L1 inhibitors

doi:10.19803/j.1672-8629.20210124

Abstract

Abstract: Objective To provide data for rational and safe use of ICI in clinical practice via a comparison of the adverse drug reactions (ADR) caused by four types of PD-1/PD-L1 inhibitors, whose imported immune checkpoint inhibitors (ICI) are marketed in China. Methods The data on PD-1/PD-L1 inhibitors collected between January 21, 2013 and September 30, 2020 was cleaned and summarized by the FDA Adverse Event Reporting System (FAERS) and OpenVigil platform. Signals of ADR were screened, counted and compared using the report odds ratio (ROR). Results A total of 44 220 ADR cases were reported (27 773 cases related to nivolumab, 12 424 cases to pembrolizumab, 2 875 cases to atezolizumab, and 1 148 cases to durvalumab). The ADR covered a wide range according to the system organ classification (SOC). Most of those ADR were immune-related adverse events (irAE), such as colitis, pneumonia, liver dysfunction, hyperthyroidism and type I diabetes. Deeper mining exposed other ADR that were not mentioned in the instructions, including cholangitis, muscle Inflammation, myocarditis, arthritis, neurological diseases (such as cerebral infarction), and cerebral edema. Conclusion The information about ADR of PD-1/PD-L1 has been updated. Most of these ADR are irAE, involving multiple organs and systems of the body, which could be fatal in some cases. It is recommended that medication regimens be optimized to reduce the health care cost and ADR.

Key words: PD-1/PD-L1 inhibitor, adverse drug reaction, immunotherapy, immune-related adverse events (irAE)

CLC Number:

R994.1

CHEN Shuang, ZHENG Shufen, ZHANG Shuyao, ZHONG Shilong. Adverse reactions of tumor immunotherapy drugs—PD-1/PD-L1 inhibitors[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1107-1112.

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