Pharmacovigilance insights into antibody-drug conjugates: a multi-database analysis of adverse events in leukemia treatment.

Abstract

Background: Gemtuzumab ozogamicin and inotuzumab ozogamicin play a crucial role in leukemia treatment. This study aims to explore multiple databases to identify adverse event (AE) signals that could enhance the safe use of these drugs.

Methods design and methods: The FDA Adverse Event Reporting System (FAERS) database ASCII packages, covering 83 quarters from Q1 2004 to Q3 2024, were imported into SAS software (version 9.4) for data cleaning and analysis. Signal detection methods included the ROR, PRR, BCPNN and MGPS. The Japanese Adverse Drug Event Report database (JADER) and WHO Adverse Drug Event Report database (VigiAccess) were used to validate the results.

Results: In FAERS and VigiAccess, the most frequent positive PT signal for gemtuzumab ozogamicin was 'febrile neutropenia.' In FAERS, the most frequent positive PT signal for inotuzumab ozogamicin was 'death.' The top five PTs with the highest signal intensity for both drugs across the three databases consistently included 'fibrin degradation products increased' and 'veno-occlusive liver disease.'

Conclusion: Mining multiple databases enabled the identification of SOCs and AEs strongly associated with frequent adverse reactions to gemtuzumab ozogamicin and inotuzumab ozogamicin, offering valuable insights for clinical dosing guidance.