- Ibrutinib is associated with significantly higher infection risk in patients with B-cell malignancies.
Why this matters
- Findings support increased vigilance for infection in patients receiving ibrutinib for B-cell malignancies.
- Meta-analysis of 7 phase 3 randomized controlled trials of ibrutinib vs other agents (5 trials) or placebo (2 trials) in 2167 patients with B-cell malignancies, pooling point estimates using the Der Simonian and Laird method.
- Treatment duration ranged from 9.4 to 38.7 months.
- Funding: None disclosed.
- Overall, infections occurred in 514 (46%) of patients receiving ibrutinib vs 393 (37%) of those in control groups.
- Ibrutinib was associated with significantly increased risk for infection:
- Any grade: pooled risk ratio (RR), 1.34; 95% CI, 1.06-1.69; P=.015.
- Grades 3-5: pooled RR, 1.35; 95% CI, 1.05-1.74; P=.018.
- In a subset of patients with chronic lymphocytic leukemia, ibrutinib was associated with significantly increased risk for grade 3-5 infection (pooled RR, 1.24; 95% CI, 1.02-1.50; P=.028).
- Ibrutinib was not associated with significantly more pneumonia or upper respiratory tract infections in any study.
- Study heterogeneity may limit generalizability.