Patterns of use and safety of ibrutinib inreal-life practice in onco-hematology
Language
EN
Article de revue
This item was published in
Fundamental & Clinical Pharmacology. 2024-06-01, vol. 38, n° S1, p. 43-44
English Abstract
Despite being a standard of care in B-cell
malignancies, a benefit–risk assessment in real-life set-
tings of ibrutinib, the first-in-class Bruton tyrosine
kinase (BTK) inhibitor, was still needed. This work
aimed to ...Read more >
Despite being a standard of care in B-cell
malignancies, a benefit–risk assessment in real-life set-
tings of ibrutinib, the first-in-class Bruton tyrosine
kinase (BTK) inhibitor, was still needed. This work
aimed to provide real-life data on patterns of use and
safety of ibrutinib through two data sources, VigiBase®
and SNDS. Firstly, co-administration of ibrutinib and
anticoagulants was associated with a 2.5-fold
increased risk of clinically relevant bleeding, without
any difference between vitamin K antagonists and
direct oral anticoagulants. Secondly, 1-year incidence
of fungal invasive infections was 1.3% in ibrutinib-
treated patients, with the following predictive factors:
stem cell transplantation, neutropenia, corticosteroids,
and chronic respiratory diseases, previous treatment
and combination with anti-CD20 agents. Lastly, rele-
vant safety signals emerged from VigiBase®, mainly
cardiovascular and ocular reactions. Taken together,
these findings contributed to providing essential
information about monitoring and management of
ibrutinib-treated patients and crucial insights for real-
world surveillance of next-generation BTK inhibitorsRead less <
English Keywords
Ibrutinib
Pharmacoepidemiology
Pharma-Covigilance
Targeted Therapy