Signal Mining and Analysis of ICIs-Associated Thrombocytopenia Adverse Events Based on FAERS Database

doi:10.19803/j.1672-8629.20240875

Abstract

Abstract: Objective To explore the immune checkpoint inhibitors (ICIs)-associated thrombocytopenia adverse events (AE) based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database in order to provide a reference for the safe use of ICIs in clinic. Methods AE reports on ICIs-related thrombocytopenia collected from the first quarter of 2011 to the second quarter of 2024 in the FAERS database were retrieved. Signals were mined using the reporting odds ratio (ROR) and information component (IC) methods. Results A total of 2 050 AE reports with ICIs as the primary suspected drug (PS) associated with thrombocytopenia were obtained, involving a higher percentage of males (52.29%) and elders (44.73%). The country that submitted the largest number of reports was Japan (19.95%). Indications were prevalent in the lungs (33.41%) and skin (13.41%). Except for cytotoxic T lymphocyte associated antigen-4 (CTLA-4) inhibitors, positive signals related to programmed death receptor 1 (PD-1) inhibitors and programmed death receptor ligand 1 (PD-L1) inhibitors were detected in both thrombocytopenia and immune thrombocytopenia. The positive signals of thrombocytopenia were classified as weak ones according to the information component (IC₀₂₅) while those of immune thrombocytopenia were moderate except for cemiplimab (IC₀₂₅=0.07) and avelumab (IC₀₂₅=0.57), and the combination of PD-L1 inhibitor and CTLA-4 inhibitor had the highest ROR value [RR=26.15 (13.04~52.45)]. Conclusion Clinicians should be alert to the potential AE of thrombocytopenia caused by ICIs and promptly implement prevention or treatment strategies to improve the safety of ICIs in clinical application.

Key words: Immune Checkpoint Inhibitors, Thrombocytopenia, Post-Marketing Pharmacovigilance, Signal Mining, FAERS

CLC Number:

R994.1
R978

SUN Ximu, ZHOU Han, LI Yanming, GUO Peng, NIE Xiaolu. Signal Mining and Analysis of ICIs-Associated Thrombocytopenia Adverse Events Based on FAERS Database[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 23-28.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240875

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I1/23

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