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. 2022 Jun;44(3):689-697.
doi: 10.1007/s11096-022-01395-7. Epub 2022 Apr 21.

Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system

Chen Chen  1   2 , Chenyu Zhang  1   2 , Ziyan Jin  1   2 , Bin Wu  3 , Ting Xu  4   5
Affiliations

Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system

Chen Chen et al. Int J Clin Pharm. 2022 Jun.

Abstract

Background Although immune-related adverse events (irAEs) have been reported in patients receiving immune checkpoint inhibitor (ICI) therapy, sex differences in irAEs are not known. Aim The present study described, evaluated and compared differences in irAEs between females and males treated with ICIs. Method irAE reports were obtained from the FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2020. Disproportionality analysis and Bayesian analysis were used to explore differences in irAEs between females and males. The onset time and fatality proportion of irAEs in different ICIs between females and males were further evaluated. Results A total of 30,342 irAE cases were obtained, including 11,097 female cases and 19,245 male cases. Consistent disproportionality signals were detected in females and males, including endocrine toxicity, hepatitis, lung toxicity, nervous system toxicity, and ocular toxicity. Renal toxicity was only detected in male patients receiving ICI therapy (PRR 2.37, 95% CI: 2.25-2.51; IC: 1.24, 95% CI: 1.05-1.43). Males had a longer onset time (females 35 days [IQR 14-87] vs. males 39 days [IQR 14-92], P = 0.041) and higher fatality proportion (females 20.5% vs. males 25.6%, P < 0.01). Conclusion This analysis revealed that males had a higher chance of exhibiting ICI-associated renal toxicity, longer median onset time and worse prognosis of irAEs than females. Greater attention to sex differences in ICI therapy is needed.

Keywords: Immune checkpoint inhibitors; Immune-related adverse events; Sex differences.

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References

    1. Klein SL, Flanagan KL. Sex differences in immune responses. Nat Rev Immunol. 2016;16(10):626–38. - DOI
    1. Triggianese P, Novelli L, Galdiero MR, et al. Immune checkpoint inhibitors-induced autoimmunity: The impact of gender. Autoimmun Rev. 2020; 19(8).
    1. Fish EN. The X-files in immunity: sex-based differences predispose immune responses. Nat Rev Immunol. 2008;8(9):737–44. - DOI
    1. Oertelt-Prigione S. The influence of sex and gender on the immune response. Autoimmun Rev. 2012;11(6–7):A479–85. - DOI
    1. Roberts CW, Walker W, Alexander J. Sex-associated hormones and immunity to protozoan parasites. Clin Microbiol Rev. 2001;14(3):476-+. - DOI

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