The risk of atrial fibrillation is higher among patients treated with single-agent ibrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in the real-world setting than in clinical trials, according to an abstract presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
These results were presented by Jiajia Liu, MD, University of Toronto, Canada.
“Ibrutinib has been increasingly used in the frontline and relapsed/refractory setting for CLL as it compares favorably to chemoimmunotherapy and immunotherapy alone in phase 3 clinical trials,” said Dr Liu during her presentation.
“Observational studies suggest that the rate of ibrutinib related adverse events may be higher in the real world and in clinical trials and that those reduction and drug discontinuation is more common,” she continued.
Using Joanna-Briggs Institute checklists, prospective and retrospective cohort studies and case series of patients with CLL treated with single agent ibrutinib as a first or subsequent line treatment outside of clinical trials were critically reviewed.
The qualitative analysis revealed that the rates of any bleeding ranged from 5.4 to 54.1 events/100 person-years and rates of severe bleeding ranged from 0 to 6.4 events/100 person-years. The rate of infection was 9.2 to 49.8 infections/100 person-years. Rate of atrial fibrillation varied from 2.5 to 26.0 events/100 person-years.
Meta-analysis of data Pooled from moderate quality studies estimated the risk of atrial fibrillation per 100 person-years to be 7.0 (95% CI 5.8, 8.2). The authors also found that the rate of dose reductions varied from 15.1 to 26.8 events/100 person-years, and dose reductions did not affect outcomes. The rate of drug discontinuation varied from 6.4 to 55.2 events/100 person-years.
The study revealed that the real-world adverse event rates were higher than reported from clinical trials and were the leading cause of dose reduction and discontinuation.
“This highlights the need for standardized post-marketing studies of new drugs and for inclusive criteria for inclusion into randomized controlled trials,” concluded Dr Liu.—Lisa Kuhns
Cheung MC, Amitai I, and Liu J. Real-World Outcomes of Patients Treated with Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): A Systematic Review and Meta-Analysis. Presented at: the 62nd ASH Annual Meeting and Exposition; Dec 5-8, 2020. Abstract 1661.
