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Bleeding risk with concurrent use of anticoagulants and ibrutinib: A population-based nested case-control study
Marion Allouchery1,2,3, Cécile Tomowiak4,5, Allison Singier3
1Pharmacologie Clinique et Vigilances, CHU de Poitiers, Poitiers, France.
British Journal of Haematology
|July 24, 2023
Summary
Ibrutinib combined with anticoagulants significantly increases the risk of clinically relevant bleeding (CRB) by 2.5-fold in real-world patient populations. This finding highlights crucial safety considerations for concurrent use of these medications.
Area of Science:
- Pharmacovigilance
- Hematology
- Oncology
Background:
- Real-world data on the safety of combining ibrutinib with anticoagulants are limited.
- Assessing the risk of clinically relevant bleeding (CRB) is crucial for patient safety.
Purpose of the Study:
- To evaluate the risk of CRB in patients using ibrutinib concurrently with anticoagulants.
- To compare bleeding risks across different anticoagulant classes.
Main Methods:
- A nested case-control study was conducted using a nationwide database.
- 614 cases of CRB were matched with up to 2407 controls.
- Conditional logistic regression models were used to estimate adjusted odds ratios (aOR).
Main Results:
- Patients receiving both ibrutinib and anticoagulants had a 2.54-fold increased risk of CRB (aOR 2.54, 95% CI [1.94; 3.32]).
- Increased risks were observed for all anticoagulant classes: VKAs (aOR 1.99), DOACs (aOR 2.48), and parenteral anticoagulants (aOR 3.40).
Conclusions:
- Concurrent use of ibrutinib and anticoagulants is associated with a significantly higher risk of CRB in real-world settings.
- The increased bleeding risk applies across various anticoagulant types, emphasizing the need for careful monitoring.
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