Psychiatric Adverse Events Associated With Bimekizumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Background and objectiveBimekizumab, a dual inhibitor of interleukin-17A and interleukin-17F, carries a US label warning for suicidal ideation and behavior.Whether postmarketing reporting is consistent with that warning has not been examined as a primary objective.In this study, we aimed to quantify the reporting of depression, suicidality, anxiety, and insomnia and to test whether any signal depended on the comparator and reporting channel. MethodsWe conducted a case/non-case disproportionality analysis of the FDA Adverse Event Reporting System (FAERS), accessed through openFDA, covering reports received from October 18, 2023, to June 30, 2026.Ten psychiatric preferred terms were assessed using reporting odds ratios (RORs) under four analyses: against all other FAERS reports, restricted to physician and pharmacist reports, against 11 other biologic agents indicated for the same diseases, and with both sides restricted to spontaneous reports.A signal required a lower 95% confidence limit above 1 and at least three exposed reports. ResultsAmong 20,939 bimekizumab-associated reports, 702 (3.4%) contained a target term.Depression (349 reports (1.7%); ROR: 2.38; 95% confidence interval (CI): 2.14 to 2.65) met the signal criterion in all four analyses and survived Bonferroni correction for 40 comparisons in each.Suicidal ideation (142 reports (0.7%); ROR: 1.93; 95% CI: 1.63 to 2.28) met the criterion in all four analyses but survived correction in only three, not surviving in the analysis restricted to spontaneous reports (ROR: 1.27; 95% CI: 1.01 to 1.59).The magnitude of the signal depended on the comparator: when compared with other biologic agents, the ROR for depression fell to 1.24 (95% CI: 1.10 to 1.38) and that for suicidal ideation rose to 3.81 (95% CI: 3.14 to 4.63). ConclusionsBimekizumab was associated with disproportionate reporting of depression and suicidal ideation in FAERS.The association depended on both the comparator and the reporting channel, was concordant with the labeled warning, was equally compatible with that warning having shaped reporting, and does not establish causation.