Key result
Ibrutinib-based regimens carry ~4.5-fold higher odds of pericardial events than standard chemoimmunotherapy.
Why the study?
Cardiovascular toxicities of ibrutinib, including pericardial events, have not been well characterized in randomized controlled trials for treatment-naïve CLL/SLL patients.
Does ibrutinib-based therapy increase the risk of pericardial events compared to conventional chemoimmunotherapy in patients with treatment-naïve chronic lymphocytic leukemia?
Meta-Analysis (n=1,057)
Yes
Does ibrutinib-based therapy increase the risk of pericardial events compared to conventional chemoimmunotherapy in patients with treatment-naïve chronic lymphocytic leukemia?
Odds Ratio: 4.5 (95% CI 1.1–19.6)
Absolute Event Rate: 2.5% vs 0.9%
p-value: p=0.043
Ibrutinib-based therapy for chronic lymphocytic leukemia is associated with a significantly increased risk of pericardial events compared to standard chemoimmunotherapy.
Supports closer pericardial surveillance with ibrutinib in CLL; extends cardiac safety data for BTK inhibitors beyond atrial fibrillation.
In the past decade, ibrutinib has transformed the treatment landscape for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Two pivotal US Intergroups trials (E1912 and A041202) have established ibrutinib as the frontline treatment option for patients with treatment-naïve CLL in both young and fit, and old and frail populations. The cardiovascular side effect profile such as cardiac dysrhythmias, ischemic events and hypertension continues to be meticulously reported in all trials investigating ibrutinib and all other Bruton tyrosine kinase inhibitors for CLL/SLL. Herein, we utilized pooled data from two pivotal US Intergroup trials (A041202 and E1912) to report and evaluate ibrutinib associated pericardial events (including pericardial effusion, pericarditis, and tamponade).
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Fakhri et al. (2024) conducted a meta-analysis in Chronic lymphocytic leukemia (CLL) (n=1,057). Ibrutinib-based regimens vs. Chemoimmunotherapy (FCR or BR) was evaluated on Pericardial events (pericardial effusion, pericarditis, and tamponade) (OR 4.5, 95% CI 1.1-19.6, p=0.043). Ibrutinib-based regimens significantly increased the risk of pericardial events compared to standard chemoimmunotherapy (2.5% vs 0.9%, OR 4.5).
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