{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T06:05:03Z","timestamp":1790057103792,"version":"4.0.1"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Candida-related events are established labelled events during IL-17 pathway inhibition. The remaining pharmacovigilance question is how\n                      <jats:italic>Candida<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a phenotype-focused, dual-database disproportionality study using FAERS 2023Q4\u20132026Q1 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 \u2265 5), with n11 \u2265 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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\u20136.60); JADER showed a directionally consistent reporting contrast (ROR 7.73, 95% CI 4.09\u201314.62). In FAERS, oral candidiasis,\n                      <jats:italic>Candida<\/jats:italic>\n                      infection, and oesophageal candidiasis met both n11 \u2265 5 and n11 \u2265 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats: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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1931368","type":"journal-article","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T05:39:39Z","timestamp":1790055579000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Postmarketing reporting patterns of Candida-related events associated with bimekizumab and selective IL-17A inhibitors in psoriasis: a FAERS and JADER pharmacovigilance study"],"prefix":"10.3389","volume":"17","author":[{"given":"Hao","family":"Zhong","sequence":"first","affiliation":[{"name":"Department of Pharmacy, The Third Affiliated Hospital of Sun Yat-Sen University","place":["Guangzhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongjian","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Huizhou Central People\u2019s Hospital","place":["Huizhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingyu","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shantou Central Hospital","place":["Shantou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yige","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University","place":["Wenzhou, Zhejiang, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guihao","family":"Hou","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, The Third Affiliated Hospital of Sun Yat-Sen University","place":["Guangzhou, Guangdong, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,22]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1016\/j.it.2017.01.006","article-title":"IL-17 signaling: the yin and the yang","volume":"38","author":"Amatya","year":"2017","journal-title":"Trends Immunol."},{"key":"B2","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1007\/s002280050466","article-title":"A Bayesian neural network method for adverse drug reaction signal generation","volume":"54","author":"Bate","year":"1998","journal-title":"Eur. 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