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Incidence of and risk factors for major haemorrhage in patients treated with ibrutinib: An integrated analysis
- Source :
- British Journal of Haematology
- Publication Year :
- 2018
- Publisher :
- John Wiley and Sons Inc., 2018.
-
Abstract
- Summary 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 (~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.
- Subjects :
- Male
Time Factors
clinical results in lymphomas
law.invention
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
B-cell neoplasm
Piperidines
law
Risk Factors
B‐cell neoplasms
signalling therapie
Randomized Controlled Trials as Topic
education.field_of_study
biology
Haematological Malignancy
Incidence (epidemiology)
Incidence
Hematology
Middle Aged
lymphoid leukaemia
030220 oncology & carcinogenesis
Ibrutinib
Hematologic Neoplasms
Female
Research Paper
medicine.medical_specialty
clinical results in lymphoma
Population
Hemorrhage
03 medical and health sciences
Internal medicine
medicine
Bruton's tyrosine kinase
Humans
education
Aged
business.industry
Adenine
Confidence interval
lymphoid leukaemias
Discontinuation
Pyrimidines
chemistry
Relative risk
biology.protein
Pyrazoles
business
signalling therapies
030215 immunology
Subjects
Details
- Language :
- English
- ISSN :
- 13652141 and 00071048
- Volume :
- 184
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- British Journal of Haematology
- Accession number :
- edsair.doi.dedup.....dcd1cc53a072c32988be1ceeff84f2db