Risk of musculoskeletal disorders associated with Bruton’s tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis

BACKGROUND: Randomized controlled trials (RCTs) have reported an increased risk of musculoskeletal disorders with BTK inhibitors (BTKis). We conducted a disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) and a meta-analysis of RCTs to further investigate. RESEARCH DESIGN AND METHODS: > 0). A meta-analysis calculated risk ratios (RR) for musculoskeletal outcomes. In the meta-analysis, ibrutinib was associated with higher risks of arthralgia (RR: 1.46, 95% CI 1.21-1.76), muscle spasm (RR: 2.32, 95% CI 1.72-3.12), and back pain (RR: 1.22, 95% CI 0.75-1.96). CONCLUSIONS: Findings from FAERS and meta-analysis suggest a stronger association between BTKis, particularly ibrutinib, and musculoskeletal adverse events.