Adverse events associated with candida infections in secukinumab treatment

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.

To evaluate the clinical characteristics, severity, onset patterns, and risk factors of Candida infections associated with secukinumab, thereby informing risk stratification and patient management.

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.

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.

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.

Not applicable.