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• W2892052114 abstract "e19559 Background: Patients taking ibrutinib are at increased risk of bleeding and atrial fibrillation / flutter (AFF). Data regarding safety of ibrutinib is mostly based on information from clinical trials. We aimed through this analysis to evaluate the real-life toxicity of ibrutinib. Methods: We reviewed data from FDA Adverse Event Reporting System (FAERS) for adverse events (AEs) associated with the use of ibrutinib between January 2010 and November 2017. We restricted our analysis to patients aged ≥ 18 years (y) and to reports that included only ibrutinib as an agent suspected as the cause of the AE. We performed a descriptive analysis of hospitalization and death outcomes, as well as select adverse events including bleeding and atrial fibrillation/flutter (AFF). We examined the associations between clinicodemographic variables, such as age and bleeding, and primary outcome variables with Chi-square tests of homogeneity. Results: A total of 11,801 FAERS safety reports were included in this analysis after exclusion of 2,426. Rates of hospitalization and death were 4,831 (41%) and 1,751 (15%) respectively. No significant difference in hospitalization (p = 0.389) or death (p = 0.072) rates were seen across age groups. A bleeding event was reported in 1,344 (11%). AFF was reported in 553 (5%). A minimal but statistically significant increased prevalence of bleeding (p = 0.004) and AFF (p = 0.031) was seen in older patients. Higher rate of hospitalization was noted in patients with AFF (p < 0.001). Bleeding was associated with higher prevalence of hospitalization in older adults (p = 0.047) but not in the general population (p = 0.144). An increased rate of death was seen in patients with bleeding (p < 0.001) or AFF (p = 0.002) who required hospitalization. Conclusions: Our analysis suggests that among patients with ibrutinib-related toxicity, older adults had an increased prevalence of bleeding and a higher rate of hospitalization secondary to a bleeding event. Although AFF was observed at a higher prevalence in older patients, it was not associated with an increased hospitalization prevalence. Clinicians prescribing ibrutinib should be diligent in monitoring patients, especially those aged ≥ 65 years, and decreasing the risk of treatment-related adverse events." @default.
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• W2892052114 date "2018-05-20" @default.
• W2892052114 modified "2023-10-16" @default.
• W2892052114 title "Ibrutinib: A post-marketing safety analysis." @default.
• W2892052114 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.e19559" @default.
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