An evaluation of polatuzumab vedotin for the treatment of patients with diffuse large B-cell lymphoma

Walji, Moneeza; Assouline, Sarit

doi:10.1080/17474086.2020.1795828

Cited by 4 publications

(3 citation statements)

References 51 publications

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“…In order to assess the time of occurrence of AEs to polatuzumab vedotin, we carried out an analysis on the time of occurrence of AEs to polatuzumab vedotin. The results indicated that the median time for detecting AEs with polatuzumab vedotin was 18.5 (5∼57.75) days, and most AEs occurred within 162 days, but AEs may still occur within 1 year ( Walji and Assouline, 2020 ). As per these results, it is recommended that we pay special attention to AEs occurring in patients within the first month.…”

Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of polatuzumab vedotin based on the FDA adverse event reporting system (FAERS)

Liu,

Mao,

et al. 2024

Front. Pharmacol.

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BackgroundPolatuzumab vedotin, the first FDA-approved antibody-drug conjugate (ADC) targeting CD79b, is utilized in the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL), as well as relapsed or refractory (R/R) DLBCL. Despite its approval, concerns persist regarding the long-term safety profile of polatuzumab vedotin. This study aims to evaluate the adverse events (AEs) associated with polatuzumab vedotin since its approval in 2019, utilizing data mining strategies applied to the FDA Adverse Event Reporting System (FAERS).MethodsSignal detection employed four methodologies, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS), to evaluate and quantify the signals of polatuzumab vedotin-associated AEs. Additionally, subgroup analyses based on patients age, gender, and fatal cases were conducted to investigate AEs occurrences in specific subpopulations.ResultsA total of 1,521 reports listing polatuzumab vedotin as a “principal suspect (PS)” drug were collected from the FAERS database. Through concurrent compliance with four algorithms, 19 significant Standardized MedDRA Query (SMQ) AEs and 92 significant Preferred Term (PT) AEs were detected. Subgroup analyses revealed a higher incidence of PTs in male patients compared to female patients, increased likelihood of polatuzumab vedotin-associated AEs in elder patients (>65 years), and AEs with a high risk of fatal cases include: blood lactate dehydrogenase increased, cytopenia, and hydronephrosis. The median time to AEs occurrence following polatuzumab vedotin initiation was 18.5 (5∼57.75) days, with 95% of AEs occurred within 162 days.ConclusionThis study identified various AEs associated with polatuzumab vedotin, offering critical insights for clinical monitoring and risk identification in patients receiving polatuzumab vedotin therapy.

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Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of polatuzumab vedotin based on the FDA adverse event reporting system (FAERS)

Liu,

Mao,

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

show abstract

“…In order to assess the time of occurrence of AEs to polatuzumab vedotin, we carried out an analysis on the time of occurrence of AEs to polatuzumab vedotin. The results indicated that the median time for detecting AEs with polatuzumab vedotin was 18.5 (5~57.75) days, and most AEs occurred within 162 days, but AEs may still occur within 1 year (Walji and Assouline, 2020). As per these results, it is recommended that we pay special attention to AEs occurring in patients within the first month.…”

Section: Discussionmentioning

confidence: 84%

Table1.DOCX

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“…In order to assess the time of occurrence of AEs to polatuzumab vedotin, we carried out an analysis on the time of occurrence of AEs to polatuzumab vedotin. The results indicated that the median time for detecting AEs with polatuzumab vedotin was 18.5 (5~57.75) days, and most AEs occurred within 162 days, but AEs may still occur within 1 year (Walji and Assouline, 2020). As per these results, it is recommended that we pay special attention to AEs occurring in patients within the first month.…”

Section: Discussionmentioning

confidence: 84%

Table4.XLSX

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An evaluation of polatuzumab vedotin for the treatment of patients with diffuse large B-cell lymphoma

Cited by 4 publications

References 51 publications

A real-world pharmacovigilance study of polatuzumab vedotin based on the FDA adverse event reporting system (FAERS)

A real-world pharmacovigilance study of polatuzumab vedotin based on the FDA adverse event reporting system (FAERS)

Table1.DOCX

Table4.XLSX

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