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

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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.

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Acknowledgements

We thank Editage (www.editage.jp) for English language editing.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Author notes

  1. Yurie Oka and Tatsuaki Takeda have contributed equally.

Authors and Affiliations

  1. Department of Personalized Medicine and Preventive Healthcare Sciences, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

    Yurie Oka, Jun Matsumoto & Noritaka Ariyoshi

  2. Department of Education and Research Centre for Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

    Jun Matsumoto, Tatsuaki Takeda & Noritaka Ariyoshi

  3. Department of Pharmacy, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

    Jun Matsumoto, Tatsuaki Takeda, Naohiro Iwata, Hirofumi Hamano & Yoshito Zamami

  4. Department of Clinical Pharmacology and Therapeutics, Graduate School of Biomedical Sciences, Tokushima University, 2-50-1 Kuramoto-cho, Tokushima, 700-8503, Japan

    Takahiro Niimura & Keisuke Ishizawa

  5. Department of Clinical Pharmacy Practice, School of Pharmacy & Pharmaceutical Sciences, University of California Irvine, 101 Theory Ste 100, Irvine, CA, 92697, USA

    Aya Fukuma Ozaki

  6. Department of Urology, Faculty of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

    Kensuke Bekku & Motoo Araki

Authors
  1. Yurie Oka
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  2. Jun Matsumoto
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Correspondence to Jun Matsumoto.

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Oka, Y., Matsumoto, J., Takeda, T. et al. Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib: a real-world pharmacovigilance study. Int J Clin Pharm (2024). https://doi.org/10.1007/s11096-024-01713-1

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  • DOI: https://doi.org/10.1007/s11096-024-01713-1

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