Adverse events associated with candida infections in secukinumab treatment

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 β < 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.