| アブストラクト | BACKGROUND: Rilonacept, an interleukin-1 (IL-1) "trap," is FDA-approved for recurrent pericarditis, but research on its adverse reactions is limited due to its recent introduction. AIM: This study aimed to identify potential adverse reactions associated with rilonacept using the FDA Adverse Event Reporting System (FAERS) and to evaluate long-term effects through Mendelian randomization (MR) analysis. METHOD: We analyzed all adverse event reports related to rilonacept from the FAERS database between January 2021 and June 2024. Positive signals for adverse reactions were extracted using reporting odds ratios (ROR) and information components (IC). MR analysis was conducted using genetic variants as instrumental variables to explore causal relationships between rilonacept and identified adverse reactions, with sensitivity analyses performed for robustness. RESULTS: A total of 419 adverse event reports were analyzed, documenting 1847 AEs. Common events included COVID-19, injection site rash, pain, and injection site reaction, categorized into 27 System Organ Classes (SOCs). Notable frequencies were found in Infections and Infestations, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders. Disproportionality analysis identified positive signals primarily in Skin and Subcutaneous Tissue Disorders, Cardiac Disorders, and Immune System Disorders, with 11 AEs showing positive signals in both Preferred Terms (PTs) and SOCs. MR analysis revealed significant associations between IL-1RN (rilonacept) and allergic urticaria (OR: 1.56), rash (OR: 0.64), and myocarditis (OR: 2.26). CONCLUSION: Rilonacept is effective for certain inflammatory conditions, but careful monitoring for adverse reactions, particularly involving the immune system, skin, and cardiac issues, is essential. |
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| ジャーナル名 | International journal of clinical pharmacy |
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| Pubmed追加日 | 2025/7/2 |
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| 投稿者 | Liu, Lihong; Chi, Zhenfei; Zhang, Zhe |
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| 組織名 | Liaoning University of Traditional Chinese Medicine, The Third Affiliated;Hospital of Jinzhou Medical University, Shenyang, China.;Shengjing Hospital of China Medical University, Liaoning University of;Traditional Chinese Medicine, Shenyang, China.;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,;Liaoning University of Traditional Chinese Medicine, No. 79, Chongshandong Road,;Huanggu District, Shenyang City, Liaoning Province, China. in-mind@foxmail.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40601088/ |
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