| アブストラクト | BACKGROUND: Secukinumab, an interleukin-17 A inhibitor widely used in psoriasis and related disorders, has been linked to opportunistic infections. Candida infections are a key safety concern, yet their real-world clinical profiles, risk distribution, and onset patterns remain insufficiently characterized. OBJECTIVES: To evaluate the clinical characteristics, severity, onset patterns, and risk factors of Candida infections associated with secukinumab, thereby informing risk stratification and patient management. METHODS: A retrospective pharmacovigilance analysis was performed using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from Q1 2004 to Q1 2025. Secukinumab reports were retrieved, and Candida-related adverse events were identified using a predefined Candida-specific MedDRA Preferred Term dictionary. Disproportionality analyses were conducted using reporting odds ratios (RORs) with 95% confidence intervals (CIs). Event severity, subgroup characteristics, and time-to-onset were assessed, and Weibull shape parameter modeling was used to characterize risk patterns. RESULTS: We identified 1,075 Candida events (0.8% of all secukinumab reports). Oral, esophageal, and vulvovaginal candidiasis predominated. All eight focal PTs showed significant disproportionality, with genital candidiasis yielding the strongest signal (ROR 19.85; 95% CI 12.91-30.53). Over half of events met criteria for serious outcomes. Stronger reporting signals were observed in females and adults aged 18-64 years. Median onset was 2-3 months, and Weibull beta < 1 indicated an early-failure pattern, suggesting heightened risk shortly after treatment initiation. CONCLUSIONS: Candida infections during secukinumab therapy are uncommon but often severe, particularly in defined high-risk groups. Early onset highlights the importance of vigilant monitoring during initial treatment months. Real-world pharmacovigilance remains essential for optimizing biologic safety. CLINICAL TRIAL NUMBER: Not applicable. |
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| ジャーナル名 | BMC infectious diseases |
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| Pubmed追加日 | 2026/6/13 |
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| 投稿者 | Yu, Chongli; Ma, Tian; Wu, Nan; Li, Chengxin; Wang, Rui |
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| 組織名 | School of Medicine, Nankai University, Tianjin, 300071, China.;Department of Dermatology, First Medical Centre of Chinese PLA General Hospital,;28 Fuxing Rd, Beijing, 100853, China.;Department of Dermatology, Fourth Medical Centre of Chinese PLA General Hospital,;51 Fucheng Rd, Beijing, 100089, China.;chengxinderm@163.com.;28 Fuxing Rd, Beijing, 100853, China. chengxinderm@163.com.;28 Fuxing Rd, Beijing, 100853, China. wangruiderm@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42286536/ |
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