Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib: a real-world pharmacovigilance study.
Int J Clin Pharm
; 46(3): 745-750, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38632203
ABSTRACT
BACKGROUND:
No head-to-head clinical trials have compared the differences in adverse events (AEs) between nivolumab plus ipilimumab (NIVO-IPI) and nivolumab plus cabozantinib (NIVO-CABO) in the treatment of metastatic renal cell carcinoma (mRCC).AIM:
We analysed the two largest real-world databases, the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the World Health Organization's VigiBase, to elucidate the differences in AEs between NIVO-IPI and NIVO-CABO.METHOD:
In total, 40,376 and 38,022 records were extracted from FAERS and VigiBase, and 193 AEs were analysed. The reporting odds ratios (ROR) with 95% confidence interval were calculated using a disproportionality analysis (NIVO-CABO/NIVO-IPI).RESULTS:
The reported numbers of immune-related AEs, including myocarditis, colitis, and hepatitis, were significantly higher with NIVO-IPI (ROR = 0.18 for FAERS and 0.13 for VigiBase). Contrarily, the reported numbers of other AEs, including gastrointestinal disorders (ROR = 2.68 and 2.92) and skin and subcutaneous tissue disorders (ROR = 2.94 and 3.55), considered to be potentiated by the combination of NIVO and CABO, were higher with NIVO-CABO.CONCLUSION:
Our findings contribute to the selection and clinical management of NIVO-IPI and NIVO-CABO, which minimizes the risk of AEs for individual patients with mRCC by considering distinctive differences in the AE profiles.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pyridines
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Carcinoma, Renal Cell
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Antineoplastic Combined Chemotherapy Protocols
/
Adverse Drug Reaction Reporting Systems
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Pharmacovigilance
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Ipilimumab
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Nivolumab
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Kidney Neoplasms
/
Anilides
Limits:
Adult
/
Aged
/
Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Journal:
Int J Clin Pharm
Year:
2024
Document type:
Article
Affiliation country:
Japón