Pharmacovigilance evaluation of enfortumab vedotin using the FDA Adverse Event Reporting System

doi:10.5246/jcps.2023.02.011

Abstract

Abstract:

There is still a challenge to comprehensively assess the safety of enfortumab vedotin (EV) in the real world with limited data. In the present study, we aimed to characterize the main features of EV-related adverse drug reactions (ADRs) and identify any potential safety signal using the US Food and Drug Administration Adverse Event Reporting System (FAERS). The evaluation included FAERS reports from Jan. 1, 2004 to Nov. 4, 2021. Standard descriptive statistics were used to summarize the study population characteristics. The chi-square tests for categorical variables were used for between-group comparisons. The disproportionality analysis was conducted by using Bayesian confidence propagation neural network of information component (IC) and reporting odds ratio (ROR). 409 EV-related reports were identified. No significant differences were found in gender, age, reporting year, or reporting region between fatal and non-fatal cases. Potentially serious ADRs were found, including kidney injury (IC₀₂₅ 1.25, ROR₀₂₅2.82, weak signal), urinary tract infection (IC₀₂₅ 0.28, ROR₀₂₅1.44, weak signal), and febrile neutropenia (IC₀₂₅ 0.62, ROR₀₂₅2.22, weak signal). Life-threatening ADRs, including Stevens-Johnson syndrome (SJS, IC₀₂₅ 2.88, ROR₀₂₅15.20, middle signal), toxic epidermal necrolysis (TEN, IC₀₂₅ 2.52, ROR₀₂₅15.52, middle signal), acute kidney injury (IC₀₂₅ 0.47, ROR₀₂₅1.67, weak signal), and multiple organ dysfunction syndrome (MODS, IC₀₂₅ 0.03, ROR₀₂₅2.23, weak signal), were also detected to be significantly associated with EV use. EV could lead to kidney injury, urinary tract infection, and febrile neutropenia. Life-threatening ADRs, including SJS, TEN, acute kidney injury, and MODS, were also significantly associated with EV use.

Key words: Enfortumab vedotin, FAERS, Pharmacovigilance evaluation, Real-word study

Supporting:

Hui Yang, Haozhou Wang, Zhuoling An. Pharmacovigilance evaluation of enfortumab vedotin using the FDA Adverse Event Reporting System[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(2): 130-137.

Figures/Tables 5

Table 1. Characteristics of patients with EV-associated ADRs sourced from the FAERS database (from Jan. 1, 2017 to Nov. 4, 2021).

Table 2. Signal values associated with EV.

Table 3. Signal values of kidney injury associated with EV.

Table 4. Signal values of blood and lymphatic system disorders associated with EV.

Table 5. Signal values of life-threatening ADRs associated with EV.

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