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

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 treate...
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Autor*in:	Chen, Chen [verfasserIn] Zhang, Chenyu Jin, Ziyan WU, Bin XU, Ting

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	Immune checkpoint inhibitors Immune-related adverse events Sex differences

Anmerkung:	© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022

Übergeordnetes Werk:	Enthalten in: Pharmacy world & science - Dordrecht [u.a.] : Springer Science + Business Media B.V., 1979, 44(2022), 3 vom: 21. Apr., Seite 689-697
Übergeordnetes Werk:	volume:44 ; year:2022 ; number:3 ; day:21 ; month:04 ; pages:689-697

Links:	Volltext

DOI / URN:	10.1007/s11096-022-01395-7

Katalog-ID:	SPR047289406

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520			\|a 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.
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allfields	10.1007/s11096-022-01395-7 doi (DE-627)SPR047289406 (SPR)s11096-022-01395-7-e DE-627 ger DE-627 rakwb eng Chen, Chen verfasserin aut Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022 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. Immune checkpoint inhibitors (dpeaa)DE-He213 Immune-related adverse events (dpeaa)DE-He213 Sex differences (dpeaa)DE-He213 Zhang, Chenyu aut Jin, Ziyan aut WU, Bin (orcid)0000-0001-5313-5193 aut XU, Ting aut Enthalten in Pharmacy world & science Dordrecht [u.a.] : Springer Science + Business Media B.V., 1979 44(2022), 3 vom: 21. Apr., Seite 689-697 (DE-627)320474054 (DE-600)2008911-9 1573-739X nnns volume:44 year:2022 number:3 day:21 month:04 pages:689-697 https://dx.doi.org/10.1007/s11096-022-01395-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 AR 44 2022 3 21 04 689-697
spelling	10.1007/s11096-022-01395-7 doi (DE-627)SPR047289406 (SPR)s11096-022-01395-7-e DE-627 ger DE-627 rakwb eng Chen, Chen verfasserin aut Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022 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. Immune checkpoint inhibitors (dpeaa)DE-He213 Immune-related adverse events (dpeaa)DE-He213 Sex differences (dpeaa)DE-He213 Zhang, Chenyu aut Jin, Ziyan aut WU, Bin (orcid)0000-0001-5313-5193 aut XU, Ting aut Enthalten in Pharmacy world & science Dordrecht [u.a.] : Springer Science + Business Media B.V., 1979 44(2022), 3 vom: 21. Apr., Seite 689-697 (DE-627)320474054 (DE-600)2008911-9 1573-739X nnns volume:44 year:2022 number:3 day:21 month:04 pages:689-697 https://dx.doi.org/10.1007/s11096-022-01395-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 AR 44 2022 3 21 04 689-697
allfields_unstemmed	10.1007/s11096-022-01395-7 doi (DE-627)SPR047289406 (SPR)s11096-022-01395-7-e DE-627 ger DE-627 rakwb eng Chen, Chen verfasserin aut Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022 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. Immune checkpoint inhibitors (dpeaa)DE-He213 Immune-related adverse events (dpeaa)DE-He213 Sex differences (dpeaa)DE-He213 Zhang, Chenyu aut Jin, Ziyan aut WU, Bin (orcid)0000-0001-5313-5193 aut XU, Ting aut Enthalten in Pharmacy world & science Dordrecht [u.a.] : Springer Science + Business Media B.V., 1979 44(2022), 3 vom: 21. Apr., Seite 689-697 (DE-627)320474054 (DE-600)2008911-9 1573-739X nnns volume:44 year:2022 number:3 day:21 month:04 pages:689-697 https://dx.doi.org/10.1007/s11096-022-01395-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 AR 44 2022 3 21 04 689-697
allfieldsGer	10.1007/s11096-022-01395-7 doi (DE-627)SPR047289406 (SPR)s11096-022-01395-7-e DE-627 ger DE-627 rakwb eng Chen, Chen verfasserin aut Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022 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. Immune checkpoint inhibitors (dpeaa)DE-He213 Immune-related adverse events (dpeaa)DE-He213 Sex differences (dpeaa)DE-He213 Zhang, Chenyu aut Jin, Ziyan aut WU, Bin (orcid)0000-0001-5313-5193 aut XU, Ting aut Enthalten in Pharmacy world & science Dordrecht [u.a.] : Springer Science + Business Media B.V., 1979 44(2022), 3 vom: 21. Apr., Seite 689-697 (DE-627)320474054 (DE-600)2008911-9 1573-739X nnns volume:44 year:2022 number:3 day:21 month:04 pages:689-697 https://dx.doi.org/10.1007/s11096-022-01395-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 AR 44 2022 3 21 04 689-697
allfieldsSound	10.1007/s11096-022-01395-7 doi (DE-627)SPR047289406 (SPR)s11096-022-01395-7-e DE-627 ger DE-627 rakwb eng Chen, Chen verfasserin aut Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022 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. Immune checkpoint inhibitors (dpeaa)DE-He213 Immune-related adverse events (dpeaa)DE-He213 Sex differences (dpeaa)DE-He213 Zhang, Chenyu aut Jin, Ziyan aut WU, Bin (orcid)0000-0001-5313-5193 aut XU, Ting aut Enthalten in Pharmacy world & science Dordrecht [u.a.] : Springer Science + Business Media B.V., 1979 44(2022), 3 vom: 21. Apr., Seite 689-697 (DE-627)320474054 (DE-600)2008911-9 1573-739X nnns volume:44 year:2022 number:3 day:21 month:04 pages:689-697 https://dx.doi.org/10.1007/s11096-022-01395-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 AR 44 2022 3 21 04 689-697
language	English
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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. 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author	Chen, Chen
spellingShingle	Chen, Chen misc Immune checkpoint inhibitors misc Immune-related adverse events misc Sex differences Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system
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topic_title	Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system Immune checkpoint inhibitors (dpeaa)DE-He213 Immune-related adverse events (dpeaa)DE-He213 Sex differences (dpeaa)DE-He213
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title	Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system
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title_full	Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system
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title_sort	sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the fda adverse event reporting system
title_auth	Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system
abstract	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. © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022
abstractGer	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. © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022
abstract_unstemmed	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. © The Author(s), under exclusive licence to Springer Nature Switzerland AG 2022
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title_short	Sex differences in immune-related adverse events with immune checkpoint inhibitors: data mining of the FDA adverse event reporting system
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