Immune checkpoint inhibitors increase the risk of kidney transplant rejection: a real-world pharmacovigilance study

ABSTRACT

Background

Kidney transplant recipients with cancer are at higher risk of kidney transplant rejection (KTR), and the safety of immune checkpoint inhibitors (ICIs) is unclear. The present study investigates the relationship between ICIs and KTR using data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Research design and methods

Case reports of KTR inducted by ICIs in FAERS from 1 January 2011, to 30 June 2021, were collected, and a disproportionate analysis was performed to assess the correlation between ICIs and KTR.

Results

A total of 99 cases of ICI-related KTR were reported in the FAERS database. Most of them were male patients (n = 63, 84.0%), and more than half of patients suffered from malignant melanoma (n = 46, 52.9%). The median onset time after the medication was 22 days, the withdrawal rates of ICIs were 78.0%, and the overall death rate was 29.3%. In general, there was a significant relevance between ICIs and KTR (ROR = 3.92[3.21–4.79] IC025 = 1.56), of which PD-1 was the most prominent (n = 81 ROR = 5.26[4.22–6.57] IC025 = 1.86).

Conclusions

ICIs may increase the risk of KTR in organ transplant recipients with cancer.

KEYWORDS:

• Immune checkpoint inhibitor
• Food and Drug Administration adverse events reporting system
• kidney transplant rejection
• adverse events

Author contributions

J Wu, J Zhu, and J Huang were responsible for the conception and design of the research. J Huang and J Zhu were responsible for collecting data. J Wu, J Huang, J Zhu, Z He, M Chen, S Gao, D Liang, X Yu and C Lu were responsible for interpreting and analyzing data. All authors participated in the drafting and revision of the intellectual content of the manuscript, provided detailed feedback, reviewed and agreed to submit the final version.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability statement

The datasets generated and analysed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

This paper was not funded.