Signal mining and risk analysis of tisotumab vedotin adverse events based on the FAERS database

Area of Science:

• Oncology
• Pharmacovigilance
• Drug Safety

Background:

• Tisotumab vedotin (TV) is an antibody-drug conjugate (ADC) approved for recurrent or metastatic cervical cancer.
• Clinical trial data on TV's adverse events (AEs) are limited; real-world evidence is needed.
• Understanding real-world AEs is crucial for safe and effective TV utilization.

Purpose of the Study:

• To analyze real-world AEs associated with Tisotumab vedotin using the FDA Adverse Event Reporting System (FAERS).
• To identify significant AE signals and compare them with existing clinical trial data.
• To provide updated safety information for clinicians managing cervical cancer patients on TV therapy.

Main Methods:

• Retrospective analysis of the FAERS database for TV-related AE reports from July 2021 to September 2024.
• Utilized four statistical algorithms (ROR, PRR, IC, EBGM) to assess AE signal strength.
• Focused on system organ class (SOC) and individual AE reporting.

Main Results:

• Eye disorders (ROR=11.53) and blood/lymphatic system disorders (ROR=2.31) were significantly associated with TV.
• Peripheral neuropathy (ROR=23.03) was the most common AE; symblepharon (ROR=1094.23) showed the strongest signal.
• New safety signals included cataract (ROR=8.8) and Stevens-Johnson syndrome (ROR=9.91).
• Median AE onset was 21 days, with most occurring within the first month.

Conclusions:

• Real-world data reveal significant associations between TV and eye/blood/lymphatic AEs, including previously unreported signals.
• The findings supplement clinical trial data, highlighting the importance of monitoring for specific AEs like peripheral neuropathy, symblepharon, cataracts, and SJS.
• This analysis offers valuable insights for optimizing TV's clinical application and patient safety in cervical cancer treatment.