Brown, Jennifer R., Moslehi, Javid, Ewer, Michael S., O'Brien, Susan M., Ghia, Paolo ORCID: 0000-0003-3750-7342, Cymbalista, Florence, Shanafelt, Tait D., Fraser, Graeme, Rule, Simon, Coutre, Steven E., Dilhuydy, Marie-Sarah, Cramer, Paula, Jaeger, Ulrich, Dreyling, Martin, Byrd, John C., Treon, Steven, Liu, Emily Y., Chang, Stephen, Bista, Amulya, Vempati, Rama, Boornazian, Lisa, Valentino, Rudolph, Reddy, Vijay, Mahler, Michelle, Yang, Huiying, Graef, Thorsten and Burger, Jan A. (2019). Incidence of and risk factors for major haemorrhage in patients treated with ibrutinib: An integrated analysis. Br. J. Haematol., 184 (4). S. 558 - 570. HOBOKEN: WILEY. ISSN 1365-2141

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Abstract

Ibrutinib, a Bruton tyrosine kinase inhibitor, is approved for treatment of various B-cell malignancies. In ibrutinib clinical studies, low-grade haemorrhage was common, whereas major haemorrhage (MH) was infrequent. We analysed the incidence of and risk factors for MH from 15 ibrutinib clinical studies (N = 1768), including 4 randomised controlled trials (RCTs). Rates of any-grade bleeding were similar for single-agent ibrutinib and ibrutinib combinations (39% and 40%). Low-grade bleeding was more common in ibrutinib-treated than comparator-treated patients (35% and 15%), and early low-grade bleeding was not associated with MH. The proportion of MH in RCTs was higher with ibrutinib than comparators (4.4% vs. 2.8%), but after adjusting for longer exposure with ibrutinib (median 13 months vs. 6 months), the incidence of MH was similar (3.2 vs. 3.1 per 1000 person-months). MH led to treatment discontinuation in 1% of all ibrutinib-treated patients. Use of anticoagulants and/or antiplatelets (AC/AP) during the study was common (similar to 50% of patients) and had an increased exposure-adjusted relative risk for MH in both the total ibrutinib-treated population (1.9; 95% confidence interval, 1.2-3.0) and RCT comparator-treated patients (2.4; 95% confidence interval, 1.0-5.6), indicating that ibrutinib may not alter the effect of AC/AP on the risk of MH in B-cell malignancies.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Brown, Jennifer R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moslehi, JavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ewer, Michael S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
O'Brien, Susan M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghia, PaoloUNSPECIFIEDorcid.org/0000-0003-3750-7342UNSPECIFIED
Cymbalista, FlorenceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shanafelt, Tait D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fraser, GraemeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rule, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Coutre, Steven E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dilhuydy, Marie-SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jaeger, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dreyling, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Byrd, John C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Treon, StevenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Liu, Emily Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chang, StephenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bista, AmulyaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vempati, RamaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boornazian, LisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Valentino, RudolphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reddy, VijayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mahler, MichelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yang, HuiyingUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graef, ThorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burger, Jan A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-158042
DOI: 10.1111/bjh.15690
Journal or Publication Title: Br. J. Haematol.
Volume: 184
Number: 4
Page Range: S. 558 - 570
Date: 2019
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1365-2141
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SINGLE-AGENT IBRUTINIB; ATRIAL-FIBRILLATION; ADVERSE EVENTS; TARGETING BTK; FOLLOW-UP; MANAGEMENT; COLLAGEN; CLLMultiple languages
HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/15804

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