与布鲁顿酪氨酸激酶抑制剂相关的肌肉骨骼疾病风险：FAERS数据库的歧化分析和荟萃分析。

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-06-18 DOI:10.1080/14740338.2025.2521358

Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata

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引用次数: 0

摘要

背景：随机对照试验（RCTs）报道BTK抑制剂（BTKis）增加肌肉骨骼疾病的风险。我们使用FDA不良事件报告系统（FAERS）进行了歧化分析，并对随机对照试验进行了荟萃分析以进一步研究。研究设计和方法：使用FAERS报告进行回顾性案例/非案例研究，直至2024年第二季度。歧化分析计算报告比值比（ROR）、比例报告比（PRR）和信息分量（IC）来识别信号（PRR≥2，下限ROR > 1, IC025 > 1）。荟萃分析计算了肌肉骨骼结果的风险比（RR）。结果：在FAERS中，伊鲁替尼与肌肉痉挛报告增加相关[PRR: 2.2 (χ2: 521.9), LB ROR: 2.1, IC025 = 1.0]。阿卡拉布替尼出现肌痛[PRR: 2.4, LB ROR: 2.0, IC025 = 0.9]和骨痛[PRR: 2.2, LB ROR: 1.6, IC025 = 0.6]的风险较高。在荟萃分析中，伊鲁替尼与关节痛（RR: 1.46, 95% CI 1.21-1.76）、肌肉痉挛（RR: 2.32, 95% CI 1.72-3.12）和背部疼痛（RR: 1.22, 95% CI 0.75-1.96）的高风险相关。结论：FAERS和荟萃分析的结果表明，BTKis（尤其是依鲁替尼）与肌肉骨骼不良事件之间存在更强的关联。

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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: 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, IC₀₂₅ > 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 (χ² : 521.9), LB ROR: 2.1, IC₀₂₅ = 1.0]. Acalabrutinib showed higher risks for myalgia [PRR: 2.4, LB ROR: 2.0, IC₀₂₅ = 0.9] and bone pain [PRR: 2.2, LB ROR: 1.6, IC₀₂₅ = 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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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.