TY - JOUR
T1 - Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib
T2 - a real-world pharmacovigilance study
AU - Oka, Yurie
AU - Matsumoto, Jun
AU - Takeda, Tatsuaki
AU - Iwata, Naohiro
AU - Niimura, Takahiro
AU - Ozaki, Aya Fukuma
AU - Bekku, Kensuke
AU - Hamano, Hirofumi
AU - Araki, Motoo
AU - Ishizawa, Keisuke
AU - Zamami, Yoshito
AU - Ariyoshi, Noritaka
N1 - Publisher Copyright:
© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2024.
PY - 2024/6
Y1 - 2024/6
N2 - 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.
AB - 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.
KW - Adverse event
KW - FDA Adverse Event Reporting System
KW - Immune-checkpoint inhibitor
KW - Renal cell carcinoma
KW - Tyrosine kinase inhibitor
KW - VigiBase
UR - http://www.scopus.com/inward/record.url?scp=85190807385&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85190807385&partnerID=8YFLogxK
U2 - 10.1007/s11096-024-01713-1
DO - 10.1007/s11096-024-01713-1
M3 - Article
C2 - 38632203
AN - SCOPUS:85190807385
SN - 2210-7703
VL - 46
SP - 745
EP - 750
JO - International Journal of Clinical Pharmacy
JF - International Journal of Clinical Pharmacy
IS - 3
ER -