ArticleBMC cancer2025
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).
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- The Cardio-Onco-Immune Axis: immunopathological mechanisms in the cardiac microenvironment of checkpoint inhibitor-induced myocarditis.Acta pharmacologica Sinica · 2026Review
- Advances in Cancer Immunotherapy for Solid Tumors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Evidence of Cardiotoxic Immune Activation by Triple Immune Checkpoint Blockade: A Translational Alert for Clinical Surveillance in Patients With Cancer.Journal of cardiovascular pharmacology · 2026Article
- Safety profile of ipilimumab in elderly patients: a disproportionate analysis based on the FDA Adverse Event Reporting System database.Frontiers in oncology · 2026Article
- Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.Frontiers in endocrinology · 2026Article
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Authors and funding
5 authors.
Funding
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Abstract
backgroundNivolumab 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.
methodsWe 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).
resultsA 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), hepatobiliary (ROR = 2.32), metabolism and nutrition (ROR = 1.44), and respiratory, thoracic, and mediastinal disorders (ROR = 1.18), particularly in preferred terms (PTs) such as colitis, hypophysitis, pneumonia, and hepatitis. NIVO-RELA was associated with increased risks for cardiac (ROR = 2.84) and vascular disorders (ROR = 2.04), notably in PTs like myocarditis, troponin elevation, and myasthenia gravis. 80% of AEs occurred within three months for both regimens. The median time-to-onset was 42 days for NIVO-IPI compared to 57 days for NIVO-RELA, with no statistically significant difference (p = 0.66).
conclusionNIVO-IPI is linked with a broader range of immune-related toxicities, whereas NIVO-RELA presents higher cardiac-specific risks. These findings emphasize the need for tailored AE monitoring based on treatment selection.
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