A real-world pharmacovigilance analysis of the FDA adverse event reporting system events for polatuzumab vedotin

ABSTRACT

Background

Polatuzumab vedotin is the first antibody-drug conjugate approved by the US Food and Drug Administration (FDA) for patients with diffuse large B-cell lymphoma. This study evaluated adverse events (AEs) associated with polatuzumab vedotin by data mining of the FDA Adverse Event Reporting System (FAERS).

Methods

This study included AEs registered in FAERS between 2019 Q2 and 2023 Q2. Four algorithms were used to quantify the signals of polatuzumab vedotin-associated AEs, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.

Results

A total of 7,609,450 reports were collected from the FAERS database, and 1,388 reports of polatuzumab vedotin were identified as primary suspected AEs. Polatuzumab vedotin-associated AEs involved 26 organ systems. According to the four algorithms, 108 significant disproportionality AEs were retained simultaneously. Unexpected significant AEs included gastrointestinal hemorrhage, ileus, gastrointestinal perforation, cholecystitis, hypogammaglobulinemia, hepatitis B reactivation, hypercalcemia, hydronephrosis, cystitis hemorrhagic, interstitial lung disease, and thrombophlebitis. The median time to onset of polatuzumab vedotin-associated AEs was 20 (interquartile range 4–56) days.

Conclusions

Our study identified significant new AE signals for polatuzumab vedotin through real-world disproportionality analysis data and may provide additional evidence for risk identification of polatuzumab vedotin.

KEYWORDS:

• Polatuzumab vedotin
• adverse event
• FAERS
• pharmacovigilance
• data mining

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions statement

Z Xu, D Huang, J Liu, and Z Shen contributed to the conception and study design, and took responsibility for the collection, integrity and accuracy of the data. All authors drafted the manuscript, participated in data analysis and interpretation, revised the manuscript and approved the final version.

Acknowledgments

This study was conducted using the FDA Adverse Event Reporting System (FAERS) database provided by the FDA. The information, findings, and interpretations in this study do not represent the views of the FDA.

Ethics statement

The FAERS database contains anonymized patient information. The Hospital Ethics Committee has confirmed that ethical approval was not required.

Data availability statement

The original data could be obtained from FAERS (https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html). This manuscript contains data presented as electronic supplementary material.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2348572

Additional information

Funding

This manuscript was funded by the CQMU Program for Youth Innovation in Future Medicine [No. w0067], the Chongqing Science and Health Joint Medical Research Project [No. 2022MSXM047], and the Chongqing Clinical Pharmacy Key Specialties Construction Project.