Table 2_Postmarketing reporting patterns of Candida-related events associated with bimekizumab and selective IL-17A inhibitors in psoriasis: a FAERS and JADER pharmacovigilance study.xlsx

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.</p>Results<p>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.</p>Conclusion<p>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.</p>