Signal detection of immune thrombocytopenia associated with immune checkpoint inhibitors.
Humans
Immune Checkpoint Inhibitors
/ adverse effects
Purpura, Thrombocytopenic, Idiopathic
/ chemically induced
Male
Retrospective Studies
Female
Aged
Middle Aged
United States
Bayes Theorem
Adverse Drug Reaction Reporting Systems
Adult
United States Food and Drug Administration
Aged, 80 and over
Programmed Cell Death 1 Receptor
/ antagonists & inhibitors
Neoplasms
/ drug therapy
CTLA-4 Antigen
/ antagonists & inhibitors
Acquired immune thrombocytopenia
FAERS
Immune checkpoint inhibitors
Pharmacovigilance
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
10 10 2024
10 10 2024
Historique:
received:
07
04
2024
accepted:
03
10
2024
medline:
11
10
2024
pubmed:
11
10
2024
entrez:
10
10
2024
Statut:
epublish
Résumé
Immune checkpoint inhibitors (ICIs) have become an important treatment modality for various malignancies. Due to excessive inflammatory and immune responses, immune-related adverse events (irAEs), such as rash, pruritis, pneumonitis, hepatitis, hypothyroidism, hyperthyroidism and fatigue, can occur. Acquired immune thrombocytopenia is a rare irAE that can lead to severe low platelet counts and hemorrhage. A retrospective observational analysis was conducted on data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). We searched for all reports recorded in the FAERS covering the period from 2011 Q1 to 2023 Q4 for target agents. Signal analysis was performed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS) algorithm. Nonparametric tests were used to compare the time to onset of thrombocytopenia-associated fractures between different regimens. There were 404 reports of immune thrombocytopenia in the FAERS database. Immune thrombocytopenia was associated with all ICIs except tremelimumab, and signals were detected by all 4 methods. The median time to the onset of immune thrombocytopenia caused by PD-1, PD-L1 and CTLA-4 inhibitors was 47 days (range: 21-139.2), 21 days (range: 13-131) and 9 days (range: 7-27), respectively. The Weibull shape parameter test revealed that pembrolizumab-, durvalumab-, and ipilimumab-induced thrombocytopenia had a random failure-type profile, and nivolumab- and atezolizumab-induced thrombocytopenia were characterized by an early failure-type profile. There was a significant reporting signal of ICI-induced thrombocytopenia associated with most ICIs. Immune thrombocytopenia has a greater incidence in males, elderly individuals and Asian populations, and PD-1 inhibitors were the most common cause. Clinicians should be aware of the signs of potential serious adverse events.
Identifiants
pubmed: 39390108
doi: 10.1038/s41598-024-75271-x
pii: 10.1038/s41598-024-75271-x
doi:
Substances chimiques
Immune Checkpoint Inhibitors
0
Programmed Cell Death 1 Receptor
0
CTLA-4 Antigen
0
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
23699Subventions
Organisme : Wu Jieping Medical Foundation
ID : 320.6750.2023-6-27
Organisme : Wu Jieping Medical Foundation
ID : 320.6750.2023-6-27
Organisme : Wu Jieping Medical Foundation
ID : 320.6750.2023-6-27
Organisme : Wu Jieping Medical Foundation
ID : 320.6750.2023-6-27
Informations de copyright
© 2024. The Author(s).
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