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Review
. 2023 Mar;12(5):5181-5194.
doi: 10.1002/cam4.5394. Epub 2022 Dec 12.

Allograft rejection following immune checkpoint inhibitors in solid organ transplant recipients: A safety analysis from a literature review and a pharmacovigilance system

Xiangli Cui  1   2 , Cilin Yan  3 , Ye Xu  1 , Dandan Li  1 , Mingxing Guo  1 , Liying Sun  2 , Zhijun Zhu  2
Affiliations
Review

Allograft rejection following immune checkpoint inhibitors in solid organ transplant recipients: A safety analysis from a literature review and a pharmacovigilance system

Xiangli Cui et al. Cancer Med. 2023 Mar.

Abstract

Aim: This study aimed to systematically characterize transplant rejection after immune checkpoint inhibitors (ICIs) initiation in solid organ transplant recipients (SOTRs).

Methods: Data were extracted from the US FDA Adverse Event Reporting System (FAERS) database and case reports in the literature. Disproportionality analysis including information component and reported odds ratio (ROR) was performed to access potential risk signals.

Results: A total of 168 patients with transplant rejection after ICIs usage were identified in the FAERS database, and 89 cases were identified in the literature review. ICIs were significantly associated with transplant rejection (ROR025 : 2.2). A strong risk signal was found for combination therapy with pembrolizumab and ipilimumab compared to monotherapy.

Conclusion: Immune checkpoint inhibitors were significantly associated with transplant rejection in SOTRs.

Keywords: adverse event reporting system; immune checkpoint inhibitors; solid organ transplant; transplant rejection.

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Conflict of interest statement

All authors declare that they have no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Association of transplant rejection with different types of ICI regimens.
FIGURE 2
FIGURE 2
Association of transplant rejection with different types of ICIs (Anti‐PD‐1 vs. anti‐PD‐L1 vs. anti‐CTLA4).
FIGURE 3
FIGURE 3
Time (days) to event onset of transplant rejection following different anti‐PD‐1 regimens.
FIGURE 4
FIGURE 4
Fatality proportion of liver or kidney transplant rejection following different ICI regimens.
See this image and copyright information in PMC

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