Frontiers in pharmacology · 2026
Postmarketing reporting patterns of Candida-related events associated with bimekizumab and selective IL-17A inhibitors in psoriasis: a FAERS and JADER pharmacovigilance study.
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Zhong Hao, Liu Yongjian, Yu Yingyu, Yu Yige, Hou Guihao
Аннотация
BACKGROUND: Candida-related events are established labelled events during IL-17 pathway inhibition. The remaining pharmacovigilance question is how Candida phenotypes are represented in spontaneous reports for bimekizumab and selective IL-17A inhibitors within psoriasis, while accounting for the interpretive limits of reporting-system data.
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, Candida infection, and oesophageal candidiasis met both n11 ≥ 5 and n11 ≥ 10 thresholds. Complete-case age and sex strata showed the same direction, although missing demographic data, particularly FAERS sex, limited interpretation. Strict TTO was evaluable for 74/514 and 45/139 Candida-positive FAERS reports.
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.
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, Candida infection, and oesophageal candidiasis met both n11 ≥ 5 and n11 ≥ 10 thresholds. Complete-case age and sex strata showed the same direction, although missing demographic data, particularly FAERS sex, limited interpretation. Strict TTO was evaluable for 74/514 and 45/139 Candida-positive FAERS reports.
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.