Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib: a real-world pharmacovigilance study

Yurie Oka, Jun Matsumoto, Tatsuaki Takeda, Naohiro Iwata, Takahiro Niimura, Aya Fukuma Ozaki, Kensuke Bekku, Hirofumi Hamano, Motoo Araki, Keisuke Ishizawa, Yoshito Zamami, Noritaka Ariyoshi

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)745-750
Number of pages6
JournalInternational Journal of Clinical Pharmacy
Volume46
Issue number3
DOIs
Publication statusPublished - Jun 2024

Keywords

  • Adverse event
  • FDA Adverse Event Reporting System
  • Immune-checkpoint inhibitor
  • Renal cell carcinoma
  • Tyrosine kinase inhibitor
  • VigiBase

ASJC Scopus subject areas

  • Pharmacy
  • Toxicology
  • Pharmacology
  • Pharmaceutical Science
  • Pharmacology (medical)

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