Prevalence, clinical course, and predictive factors of immune checkpoint inhibitor monotherapy-associated hepatitis in Japan.
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ adverse effects
Antineoplastic Agents, Immunological
/ adverse effects
Chemical and Drug Induced Liver Injury
/ epidemiology
Female
Forecasting
Humans
Ipilimumab
/ adverse effects
Japan
/ epidemiology
Male
Middle Aged
Nivolumab
/ adverse effects
Prevalence
Retrospective Studies
Severity of Illness Index
adverse events
female
hepatitis
immune checkpoint inhibitor
immune system
irAE
risk factor
Journal
Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
received:
17
01
2020
revised:
03
03
2020
accepted:
09
03
2020
pubmed:
19
3
2020
medline:
24
11
2020
entrez:
19
3
2020
Statut:
ppublish
Résumé
Immune checkpoint inhibitors (ICI) have revolutionized anti-malignancy therapy and thus have been increasingly used. Although ICI may cause immune-related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clarified. In this retrospective study, consecutive patients who had malignancies and were treated with ICI without other chemotherapeutic agents at Hokkaido University Hospital between 2014 and 2019 were screened. Patients were excluded if they were < 20 years old and had insufficient clinical data. Of the 233 patients screened, 202 patients met the inclusion criteria and were included in the analysis. The patients were aged 25-92 years, and 60.9% were male. The patients received nivolumab (n = 137), pembrolizumab (n = 45), ipilimumab (n = 17), atezolizumab (n = 2), and avelumab (n = 1). The prevalence of any grade and grade ≥ 3 irAE hepatitis was 8.4% (17/202) and 4.0% (8/202), respectively. irAE hepatitis occurred at a median duration of 42 days in any grade and 36 days in grade ≥ 3 after ICI initiation. The clinical course of grade ≥ 3 irAE hepatitis was generally favorable; however, 50% required corticosteroid treatment and two patients required additional mycophenolate mofetil. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis. Grade ≥ 3 irAE hepatitis was observed in 4.0% of the patients who were treated with ICI. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
Immune checkpoint inhibitors (ICI) have revolutionized anti-malignancy therapy and thus have been increasingly used. Although ICI may cause immune-related adverse events (irAE) in various organs, including the liver, the prevalence and predictive factors of irAE have not been clarified.
METHODS
METHODS
In this retrospective study, consecutive patients who had malignancies and were treated with ICI without other chemotherapeutic agents at Hokkaido University Hospital between 2014 and 2019 were screened. Patients were excluded if they were < 20 years old and had insufficient clinical data.
RESULTS
RESULTS
Of the 233 patients screened, 202 patients met the inclusion criteria and were included in the analysis. The patients were aged 25-92 years, and 60.9% were male. The patients received nivolumab (n = 137), pembrolizumab (n = 45), ipilimumab (n = 17), atezolizumab (n = 2), and avelumab (n = 1). The prevalence of any grade and grade ≥ 3 irAE hepatitis was 8.4% (17/202) and 4.0% (8/202), respectively. irAE hepatitis occurred at a median duration of 42 days in any grade and 36 days in grade ≥ 3 after ICI initiation. The clinical course of grade ≥ 3 irAE hepatitis was generally favorable; however, 50% required corticosteroid treatment and two patients required additional mycophenolate mofetil. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.
CONCLUSIONS
CONCLUSIONS
Grade ≥ 3 irAE hepatitis was observed in 4.0% of the patients who were treated with ICI. Female sex and history of ICI treatment were significantly associated with the incidence of grade ≥ 3 irAE hepatitis.
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents, Immunological
0
Ipilimumab
0
Nivolumab
31YO63LBSN
atezolizumab
52CMI0WC3Y
pembrolizumab
DPT0O3T46P
avelumab
KXG2PJ551I
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1782-1788Subventions
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210022h0103, 19fk0210018h0003, 19fk0310101s05
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210048s0501, 19fk0210058h0001, and 19fk021004
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210047s0401
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210058h0001
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210048s0501
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0310101s0503
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210018h0003
Organisme : Japan Agency for Medical Research and Development
ID : 19fk0210022h0103
Organisme : SPS KAKENHI
ID : 19K08458
Informations de copyright
© 2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
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