| アブストラクト | BACKGROUND: Voclosporin, a novel oral calcineurin inhibitor (CNI), is increasingly used in clinical practice. The relationship between voclosporin and psychiatric disorders remains unclear. METHODS: Adverse events (AEs) associated with voclosporin were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering the period from first quarter of 2021 to the third quarter of 2024. Disproportionality analysis including reporting odds ratio (ROR) and Medicines and Healthcare Products Regulatory Agency (MHRA) was employed to identify potential psychotic safety signals associated with voclosporin. Furthermore, drug target Mendelian randomization (MR) was utilized to assess the causal association between voclosporin and psychiatric disorders. RESULTS: A total of 313 cases of psychiatric disorders associated with voclosporin were recorded among 260 patients. In the pharmacovigilance analysis, insomnia (N = 64, ROR = 1.39, 95% CI: 1.09-1.77) emerged as the most frequently reported psychiatric disorders and showed a positive signal. Specifically, the insomnia signal for voclosporin is more pronounced than that of traditional CNIs, and persists despite restriction to indications (SLE and LN) and other CNIs as control groups. In the drug target MR analysis, genetically predicted voclosporin was associated with a higher risk of insomnia (OR=1.37,95%CI:1.16-1.62, P < 0.001) and sleep disorder (OR=1.64,95%CI:1.17-2.29, P = 0.004). CONCLUSION: This study underscores a positive correlation between voclosporin and increased insomnia. Physicians should pay more attention to insomnia during administering voclosporin and implement timely measures such as monitoring sleep quality, adjusting drug dosages or treatment regimens, or adding insomnia agents. |
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| ジャーナル名 | Psychiatry research |
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| Pubmed追加日 | 2026/10/27 |
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| 投稿者 | Wang, Jingjing; Yang, Yongli; Wang, Shijia; Fan, Jingwen; Xia, Xudong; Jia, Xiaocan |
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| 組織名 | Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou;University, Zhengzhou, Henan, 450001, China.;University, Zhengzhou, Henan, 450001, China; Center for Drug Evaluation of Henan,;Zhengzhou, Henan, 450000, China. Electronic address: hmpaxxd@126.com.;University, Zhengzhou, Henan, 450001, China. Electronic address: jxc@zzu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42945861/ |
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