ArticleFrontiers in pharmacology2026
Postmarketing reporting patterns of Candida-related events associated with bimekizumab and selective IL-17A inhibitors in psoriasis: a FAERS and JADER pharmacovigilance study.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Candida-related events are established labelled events during IL-17 pathway inhibition. The remaining pharmacovigilance question is how Methods: We performed a phenotype-focused, dual-database disproportionality study using FAERS 2023Q4-2026Q1 as the primary source and the JADER May 2026 release as a complementary consistency source. Analyses were restricted to psoriasis-associated reports/cases. Candida-related events were the core infection phenotype; inflammatory bowel disease (IBD) and eczema/dermatitis were prespecified mechanism-related contextual domains. Reporting odds ratios (RORs) were interpreted as exploratory relative reporting contrasts. PT-level signal interpretation required at least five bimekizumab event reports (n11 ≥ 5), with n11 ≥ 10 examined as a sensitivity threshold. Age- and sex-stratified complete-case analyses and descriptive time-to-onset (TTO) sensitivity analyses were performed where data permitted. Results: The analysis included 7,850 bimekizumab and 10,971 selective IL-17A-comparator FAERS reports, and 104 bimekizumab and 890 comparator JADER cases. In FAERS, any Candida-related event was reported in 514/7,850 and 139/10,971 reports, respectively (ROR 5.46, 95% CI 4.52-6.60); JADER showed a directionally consistent reporting contrast (ROR 7.73, 95% CI 4.09-14.62). In FAERS, oral candidiasis, Conclusion: Candida-related phenotypes showed a reproducible disproportional reporting pattern across FAERS and JADER, whereas IBD and eczema/dermatitis findings were less consistent. The results support phenotype-focused pharmacovigilance follow-up and clinical awareness without ranking drug safety. These findings characterize spontaneous reporting patterns and should not be interpreted as estimates of incidence or comparative clinical risk.
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