| アブストラクト | 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: A retrospective case/non-case study was performed using FAERS reports through Q2 2024. Disproportionality analysis calculated Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) to identify signals (PRR >/=2, lower bound ROR > 1, IC(025) > 0). A meta-analysis calculated risk ratios (RR) for musculoskeletal outcomes. RESULTS: In FAERS, ibrutinib was associated with increased reports of muscle spasms [PRR: 2.2 (chi(2) : 521.9), LB ROR: 2.1, IC(025) = 1.0]. Acalabrutinib showed higher risks 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 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. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/6/16 |
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| 投稿者 | Zuber, Mohammed; Thomas, Christy; Taj, Shifa; Rashid, Muhammed; Undela, Krishna; Ramanarayanan, Jeyanthi; Hernandez-Ilizaliturri, Francisco J; Villa Zapata, Lorenzo |
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| 組織名 | Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia,;Athens, GA, USA.;Department of Pharmacy Practice, National Institute of Pharmaceutical Education;and Research (NIPER) Guwahati, Kamrup, India.;Independent Researcher, Bengaluru, India.;Independent Researcher, Malappuram, India.;Medical Oncology/Hematology, St Joseph's Candler Health System, Nancy N. and J.C.;Lewis Cancer and Research Pavilion at Wayne Memorial Hospital, Jesup, GA, USA.;Department of Medicine, Jacob's School of Medicine and Biomedical Sciences, State;University of New York at Buffalo, Buffalo, NY, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40518694/ |
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