Brown, Jennifer R., Moslehi, Javid, O'Brien, Susan, Ghia, Paolo ORCID: 0000-0003-3750-7342, 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 and Burger, Jan A. (2017). Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica, 102 (10). S. 1796 - 1806. PAVIA: FERRATA STORTI FOUNDATION. ISSN 0390-6078

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Brown, Jennifer R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moslehi, JavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
O'Brien, SusanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghia, PaoloUNSPECIFIEDorcid.org/0000-0003-3750-7342UNSPECIFIED
Hillmen, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cymbalista, FlorenceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shanafelt, Tait D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fraser, GraemeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rule, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kipps, Thomas J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Coutre, StevenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dilhuydy, Marie-SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tedeschi, AlessandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jaeger, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Byrd, John C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Howes, AngelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Todd, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vermeulen, JessicaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
James, Danelle F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Clow, FongUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Styles, LoriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Valentino, RudyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wildgust, MarkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahler, MichelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burger, Jan A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-216626
DOI: 10.3324/haematol.2017.171041
Journal or Publication Title: Haematologica
Volume: 102
Number: 10
Page Range: S. 1796 - 1806
Date: 2017
Publisher: FERRATA STORTI FOUNDATION
Place of Publication: PAVIA
ISSN: 0390-6078
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CHRONIC LYMPHOCYTIC-LEUKEMIA; OPEN-LABEL; FOLLOW-UP; RISK; CLL; INHIBITOR; MORTALITY; COLLAGEN; THERAPYMultiple languages
HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21662

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