2026-10-14T05:33:53Z https://api.figshare.com/v2/oai

oai:figshare.com:article/34022076 2026-09-29T08:32:38Z category_146 category_7 category_19 category_21 category_873 category_46 category_734 category_122 category_132 portal_87 item_type_3 month_year_09_2026

Mechanism-based reporting patterns of infection-related adverse events with systemic psoriasis therapies in FAERS Shinwon Hwang (13822820) Yerim Kwak (25136082) Yeon Woo Jung (24509015) Se Yong Jung (13969456) Jae Il Shin (8112179) Tae-Gyun Kim (11893628) Space Science Medicine Pharmacology Biotechnology Chemical Sciences not elsewhere classified Immunology Biological Sciences not elsewhere classified Mental Health Infectious Diseases Psoriasis FAERS systemic therapy biologics pharmacovigilance infection <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). 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).</p> <p>Reporting estimates varied by mechanism, and exposure attribution materially influenced the immunosuppressive-nonbiologic result.</p> 2026-09-29T08:32:38Z Dataset Dataset 10.6084/m9.figshare.34022076.v1 https://figshare.com/articles/dataset/Mechanism-based_reporting_patterns_of_infection-related_adverse_events_with_systemic_psoriasis_therapies_in_FAERS/34022076 CC BY 4.0