Risk of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis.
Mohammed Zuber, Christy Thomas, Shifa Taj et al.
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In 30 seconds
This study examined musculoskeletal adverse events associated with Bruton's tyrosine kinase inhibitors (BTKis) using a retrospective case/non-case disproportionality analysis of FAERS reports through Q2 2024 and a meta-analysis of randomised controlled trials. FAERS signals included muscle spasms with ibrutinib and myalgia and bone pain with acalabrutinib. In the trial meta-analysis, ibrutinib was associated with higher risks of arthralgia (RR: 1.46, 95% CI 1.21-1.76) and muscle spasm (RR: 2.32, 95% CI 1.72-3.12); the estimate for back pain was imprecise and included no difference.
Key findings
- FAERS reports showed a muscle-spasm signal for ibrutinib (PRR: 2.2; LB ROR: 2.1; IC 025 = 1.0).
- Acalabrutinib had FAERS signals for myalgia (PRR: 2.4; LB ROR: 2.0; IC 025 = 0.9) and bone pain (PRR: 2.2; LB ROR: 1.6; IC 025 = 0.6).
- In the meta-analysis, ibrutinib was associated with arthralgia (RR: 1.46, 95% CI 1.21-1.76) and muscle spasm (RR: 2.32, 95% CI 1.72-3.12).
- The back-pain estimate for ibrutinib was RR: 1.22, 95% CI 0.75-1.96.
Why it matters
Musculoskeletal symptoms may be relevant when assessing adverse events during BTKi treatment. The combination of spontaneous-report signals and trial data identifies particular symptoms and agents for clinical awareness, while the differing evidence sources require cautious interpretation: disproportionality indicates reporting patterns, not incidence or causation.
What to keep in mind
FAERS disproportionality analysis relies on spontaneous reports and cannot establish incidence or causality. The abstract does not provide the number of trials or participants included in the meta-analysis.