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- Title
Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib: a real-world pharmacovigilance study.
- Authors
Oka, Yurie; Matsumoto, Jun; Takeda, Tatsuaki; Iwata, Naohiro; Niimura, Takahiro; Ozaki, Aya Fukuma; Bekku, Kensuke; Hamano, Hirofumi; Araki, Motoo; Ishizawa, Keisuke; Zamami, Yoshito; Ariyoshi, Noritaka
- 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.
- Subjects
UNITED States. Food &; Drug Administration; WORLD Health Organization; NIVOLUMAB; RENAL cell carcinoma; IPILIMUMAB; IMMUNE checkpoint inhibitors
- Publication
International Journal of Clinical Pharmacy, 2024, Vol 46, Issue 3, p745
- ISSN
2210-7703
- Publication type
Article
- DOI
10.1007/s11096-024-01713-1