Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS

RUAN Cong; DU Qiong; YE Ling; WANG Qiru; HU Weiqiong; QIAN Jiajia; ZHAI Qing; XU Rui

doi:10.13748/j.cnki.issn1007-7693.20233044

RUAN Cong, DU Qiong, YE Ling, WANG Qiru, HU Weiqiong, QIAN Jiajia, ZHAI Qing, XU Rui. Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS[J]. Chinese Journal of Modern Applied Pharmacy, 2025, 42(2): 287-292. DOI: 10.13748/j.cnki.issn1007-7693.20233044

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Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS

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OBJECTIVE To analyze the adverse drug events(ADE) signal mining of CD79b-targeted antibody conjugate drug polatuzumab, and to provide reference for clinical safe drug use.
METHODS ADE reports from January 1, 2019 to June 30, 2023 were extracted from the USA Food and Drug Administration Adverse Event Reporting System(FAERS). Duplicate reports were pooled and eliminated, and ADE signals were screened and analyzed by the proportional imbalance method.
RESULTS A total of 1 037 ADE were reported with polatuzumab, 23 ADE not recorded in the instructions were obtained after screening, including immune effector cell-associated neurotoxicity syndrome, cytokine release syndrome and diffuse intravascular coagulation.
CONCLUSION The excavated real-world ADE report are similar to the instructions, reporting new ADE, and providing reference for clinical monitoring of safe application of polatuzumab.

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Mining and Analysis of Adverse Event Signals of Polatuzumab Based on FAERS

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