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

INTRODUCTIONInfection-related adverse events are an important safety concern in psoriasis therapy.

OBJECTIVETo compare infection-related adverse-event reporting across mechanism-based therapy groups.

METHODSWe 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.

RESULTSAmong 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). TNF inhibitors showed a modest signal (1.17; 0.11), whereas IL-23 inhibitors were near null (0.99; -0.04). Indication linkage attenuated the immunosuppressive-nonbiologic signal to ROR 1.14 (IC025 0.09), while IL-12/23 and IL-17 signals persisted. IL-17 inhibitors showed a Candida signal (ROR 8.67; IC025 1.55).

CONCLUSIONReporting estimates varied by mechanism, and exposure attribution materially influenced the immunosuppressive-nonbiologic result.

Abstract from PubMed