4CPS-136 Are cardiovascular adverse events with ibrutinib well considered?

Background Chronic lymphocytic leukaemia and mantle cell lymphoma have a new standard of care: ibrutinib (metabolised by CYP3A4/5 and P-glycoprotein inhibitor). Cardiovascular (CV) adverse events are characterised by atrial fibrillation (AF) (5%–13.8%), bleeding event (BE) (grade 3 or 4 about 3%–4%) and hypertension. CV pre-treatment evaluation is not required in the ibrutinib summary of product characteristics. Purpose Evaluate whether the CV risks are considered regarding the prescription of ibrutinib and measure cardiovascular adverse event occurence during treatment. Material and methods A retrospective analyse was conducted including patients with ibrutinib initiation in our Haematology Department from May 2014 to July 2017. A demographic, clinical and biological database including adverse events, CV evaluation and potential drug interactions was constituted consulting all the medical records. The incidence of AF and BE and the CHA 2 DS 2 -VASc score were calculated. Results Fifty-fivemedical records were analysed. Thirty-six patients (65%) had at least one CV risk factor and 14 patients (25%) had at least one initial cardiac examination (ECG/Holter, echocardiography, cardiology consultation). Twenty-one patients (38%) had CV monitoring during their treatment. Four patients developed AF (1 to 7 months after starting the treatment) and were treated with anti-arrhythmics and anti-coagulants (one patient with CHA 2 DS 2 -VASc Conclusion Our results show that cardiac pre-treatment examinations are rarely performed (25%) despite our patients’ CV risk factors. With 7.2% of AF, this risk is not negligible considering the limited cohort. A part of serious BE could have been prevented, as concomitant drugs, especially CYP3A4 inhibitor, seem to play a role in CV adverse event occurrence. As a result of drug interactions and CV consequences, which can lead to serious outcomes, a multidisciplinary consultation including a haematologist, cardiologist and pharmacist, should be established at the initiation and during treatment by ibrutinib. References and/or Acknowledgements 1. Byrd JC, et al. 2014. 2. Brown JR, et al. 2017. No conflict of interest