Mechanism-based reporting patterns of infection-related adverse events with systemic psoriasis therapies in FAERS

<p>Infection-related adverse events are an important safety concern in psoriasis therapy.</p> <p>To compare infection-related adverse-event reporting across mechanism-based therapy groups.</p> <p>We analyzed psoriasis-indicated US Food and Drug Administration Adverse Event Reporting System (FAERS) reports from 2014 Q3 through 2025 Q3. Sixteen therapies were grouped as TNF, IL-12/23, IL-17, and IL-23 inhibitors and immunosuppressive or non-immunosuppressive nonbiologics.

Primary exposure was a primary- or secondary-suspect listing; sensitivity analysis required drug-sequence linkage to psoriatic disease. Reporting odds ratios (RORs) and information-component lower bounds (IC₀₂₅) were calculated.</p> <p>Among 357,728 reports, 67,827 contained an infection term. Signals were strongest for immunosuppressive nonbiologics (ROR 2.51; IC₀₂₅ 0.88) and IL-12/23 inhibition (2.43; 0.83), followed by IL-17 inhibitors (1.82; 0.47).