First use of a global pharmacovigilance dataset to examine the safety profiles of the antibody-drug conjugates EV and SG.

Main reports of EV - dermatological and neurological, effects unfavorable laboratory test results.

Main reports of SG - gastrointestinal effects, unfavorable laboratory test results.

Antibody-drug conjugates (ADC), enfortumab-vedotin (EV) and sacituzumab-govitecan are new drugs in the treatment of urologic tumors, whose safety profile has not been fully investigated. Therefore, the aim of our study was to evaluate adverse events related to both agents reported to VigiBase, the World Health Organization’s global pharmacovigilance database.

We employed Bayesian disproportionality analysis based on the information component (IC) to explore the safety profile associated with both therapies. Additionally, we used the proportional reporting ratio approach to examine the safety profile further.

We identified 41,752 reports connected to ADC therapy (EV: n=5359; SG: n=36,393). In the EV subgroup, most reports were associated with dermatologic (38.6 %), neurologic adverse events (16.5 %), or adverse laboratory assessments (19.4 %). In contrast, reports in the SG subgroup were mainly associated with gastrointestinal adverse events (24.2 %) and adverse laboratory assessments (39.0 %). Adverse laboratory assessments in both cohorts were often based on haematotoxic adverse events.

We could provide a comprehensive real-world safety profile of EV and SG using a global pharmacovigilance database. Based on the safety signals explored in this study, further research regarding the impact of these side effects on patient outcomes is justified.

Bladder cancer

Metastatic disease

Antibody-drug Conjugate

Toxicity

Adverse Events

© 2024 The Authors. Published by Elsevier Ltd.