Comparative safety of nivolumab plus ipilimumab versus nivolumab plus relatlimab in advanced melanoma: a pharmacovigilance study based on the FDA adverse event reporting system (FAERS).

ABSTRACT:

Background

Nivolumab combined with ipilimumab (NIVO-IPI) and nivolumab combined with relatlimab (NIVO-RELA) are approved treatments for advanced melanoma. However, the data on the differential adverse event (AE) risks associated with these two regimens are lacking.

Methods

We performed a disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) database for NIVO-IPI and NIVO-RELA from the fourth quarter (Q4) of 2015 to Q4 of 2024. We calculated the reporting odds ratios (ROR) and information component (IC) with 95% confidence intervals (CIs).

Results

A total of 7,482 records for NIVO-IPI and 185 records for NIVO-RELA were extracted from FAERS. NIVO-IPI showed significantly higher risks for gastrointestinal (ROR = 1.39), endocrine (ROR = 3.10), h

SUBMITTER: Xu S 

PROVIDER: S-EPMC12275244 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature