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Cited by 267

The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.

Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials

Open access
Brown, Jennifer R., Moslehi, Javid, O’Brien, Susan, Ghia, Paolo, Hillmen, Peter, Cymbalista, Florence, Shanafelt, Tait D., Fraser, Graeme, Rule, Simon, Kipps, Thomas J., Coutre, Steven, Dilhuydy, Marie-Sarah, Cramer, Paula, Tedeschi, Alessandra, Jaeger, Ulrich, Dreyling, Martin, Byrd, John C., Howes, Angela, Todd, Michael, Vermeulen, Jessica, James, Danelle F., Clow, Fong, Styles, Lori, Valentino, Rudy, Wildgust, Mark, Mahler, Michelle, Burger, Jan A.·2017·Haematologica

Abstract

The first-in-class Bruton’s tyrosine kinase inhibitor ibrutinib has proven clinical benefit in B-cell malignancies; however, atrial fibrillation (AF) has been reported in 6–16% of ibrutinib patients. We pooled data from 1505 chronic lymphocytic leukemia and mantle cell lymphoma patients enrolled in four large, randomized, controlled studies to characterize AF with ibrutinib and its management. AF incidence was 6.5% [95% Confidence Interval (CI): 4.8, 8.5] for ibrutinib at 16.6-months versus 1.6% (95%CI: 0.8, 2.8) for comparator and 10.4% (95%CI: 8.4, 12.9) at the 36-month follow up; estimated cumulative incidence: 13.8% (95%CI: 11.2, 16.8). Ibrutinib treatment, prior history of AF and age 65 years or over were independent risk factors for AF. Multiple AF events were more common with ibrutinib (44.9%; comparator, 16.7%) among patients with AF. Most (85.7%) patients with AF did not discontinue ibrutinib, and more than half received common anticoagulant/antiplatelet medications on study. Low-grade bleeds were more frequent with ibrutinib, but serious bleeds were uncommon (ibrutinib, 2.9%; comparator, 2.0%). Although the AF rate among older non-trial patients with comorbidities is likely underestimated by this dataset, these results suggest that AF among clinical trial patients is generally manageable without ibrutinib discontinuation (clinicaltrials.gov identifier: 01578707, 01722487, 01611090, 01646021).

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Metadata

Authors
Brown, J. R., Moslehi, J., O’Brien, S., Ghia, P., Hillmen, P., Cymbalista, F., Shanafelt, T. D., Fraser, G., Rule, S., Kipps, T. J., Coutre, S., Dilhuydy, M.-S., Cramer, P., Tedeschi, A., Jaeger, U., Dreyling, M., Byrd, J. C., Howes, A., Todd, M., Vermeulen, J., James, D. F., Clow, F., Styles, L., Valentino, R., Wildgust, M., Mahler, M., & Burger, J. A.
Venue
Haematologica
Published
2017-07-27
Volume
102
Issue
10
Pages
1796-1805
ISSN
  • 0390-6078 (ISSN-L)
  • 1592-8721
OpenAlex
W2739393823
Cited by
267
References
25
FWCI
13.38
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. https://app.cochat.ai/papers/10.3324/haematol.2017.171041
The paper
Brown, J. R., Moslehi, J., O’Brien, S., Ghia, P., Hillmen, P., Cymbalista, F., Shanafelt, T. D., Fraser, G., Rule, S., Kipps, T. J., Coutre, S., Dilhuydy, M.-S., Cramer, P., Tedeschi, A., Jaeger, U., Dreyling, M., Byrd, J. C., Howes, A., Todd, M., . . . Burger, J. A. (2017). Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. https://doi.org/10.3324/haematol.2017.171041

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.