Abstract 855P
Background
Recent studies suggested any cardio-cerebrovascular and thromboembolic events in BCR-ABL1-negative MPN (essential thrombocythemia (ET), polycythaemia vera (PV), and myelofibrosis) patients treated with ruxolitinib (RUX), a Janus kinase (JAK) inhibitor, although the results were still inconsistent. This study aims to compare the cardio-cerebrovascular events and thromboembolic incidences in BCR-ABL1-negative neoplasms patients treated with RUX and the best available therapy (BAT).
Methods
We performed comprehensive searching in several online databases to include all relevant studies from 2000 until 2021. We followed the PRISMA guideline for conducting this study. We included all randomized controlled trials (RCTs) that compare the cardio-cerebrovascular events and thromboembolic incidences in ET, PV, and myelofibrosis, treated with RUX compared with BAT. We used the Cochrane Risk-of-bias instrument for accessing bias risks. We performed analysis to provide pooled risk ratio (RR) with 95% confidence interval (CI) using random-effect heterogeneity test.
Results
We included 12 RCTs met our inclusion criteria. The RUX group has non-significant increased risks of myocardial infarction RR=1.91, 95%CI 0.71-5.16, p=0.20, I2=0%), new-onset hypertension (RR=1.58, 95%CI 0.69-3.61, p=0.28, I2=0%), ischemic stroke (RR=2.01, 95%CI 0.38-10.73, p=0.41, I2=0%), haemorrhagic stroke (RR=2.17, 95%CI 0.33-14.22, p=0.42, I2=0%), but has decreased arrhythmia risk (RR=0.64, 95%CI 0.22-1.85, p=0.41, I2=0%) compared with BAT. There are no significant differences between RUX and BAT groups for the pulmonary embolism, thrombosis of the deep vein, retinal vein, portal vein, and spleen, also thrombophlebitis. The overall analysis showed that RUX has increased thromboembolism risks although not statistically significant (RR=1.24, 95%CI 0.57-2.69, p=0.58, I2=20%).
Conclusions
Ruxolitinib tends to increase the cardio-cerebrovascular events and thromboembolism risks in BCR-ABL1-negative MPN patients. Nevertheless, further studies are needed to establish the outcomes and comparisons.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.