Study: Bimekizumab Not Linked to Higher Depression Risk vs. IL-23 Inhibitors
Key Takeaways
Bimekizumab was not associated with increased risk of depression or suicidal ideation compared with IL-23 inhibitors in a real-world TriNetX analysis of more than 3,700 psoriasis patients.
After exclusion of patients with prior psychiatric diagnoses/psychotropic use, 12% of IL-23 users and 4.9% of bimekizumab users developed depression, suicidal ideation, or initiated antidepressant/antipsychotic therapy.
Findings align with pooled clinical trial safety data suggesting psychiatric adverse events are rare and consistent with background rates in psoriasis populations.
Bimekizumab was not associated with increased risk of depression or suicidal ideation compared with IL-23 inhibitors, a new study from George Washington University indicated.
"Bimekizumab, a dual IL-17A/F inhibitor, has demonstrated robust efficacy in moderate-to-severe psoriasis, but long-term safety regarding psychiatric adverse events remains incompletely characterized," the authors wrote in the study. "Given prior class concerns from the IL-17 receptor blocker brodalumab, we evaluated whether bimekizumab use is associated with increased risk of major depressive disorder (MDD) or suicidal ideation (SI) compared with IL-23 inhibitors in real-world practice using the TriNetX US Collaborative Network."
The IL-23 inhibitors included risankizumab, guselkumab, tildrakizumab, and ustekinumab. Adults aged 18 years and older with psoriasis were included in the analaysis. The investigators assessed outcomes 30 days after biologic initiation and followed for up to 2 years. The primary endpoint was new-onset depression, MDD, or SI, defined by ICD-10 codes and initiation of antidepressant or antipsychotic therapy. Patients with prior depression, SI, or psychotropic use were excluded from the study.
Patients were propensity score-matched (1:1) for demographics, comorbidities, and baseline medications, with a total sampe of 3,792 patients (1,896 per cohort). Following exclusion criteria for psychiatric history, 855 IL-23 inhibitor–treated and 836 bimekizumab-treated patients were included in the outcome analysis. During follow-up, 12% of IL-23 inhibitor users and 4.9% of bimekizumab users developed depression, SI, or initiated psychotropic therapy (RR = 2.43; 95% CI, 1.715 to 3.451). Six-month cumulative incidence was 4.0% for IL-23 inhibitors and 2.7% for bimekizumab (risk difference, 1.3%; 95% CI, −0.004 to 0.031; P = 0.125).
"These data align with pooled clinical-trial safety results for both IL-17 and IL-23 pathways, where psychiatric events occur rarely and at rates consistent with background psoriasis populations," the authors wrote. "Although causality cannot be inferred from observational data, the large multicenter dataset and robust matching strengthen confidence in these results. Routine mental health screening remains essential in patients receiving biologic therapy; however, these findings provide reassurance that bimekizumab does not confer additional psychiatric risk relative to other advanced biologics."
Source: Tolete C, et al. JAAD International. 2026 Doi:10.1016/j.jdin.2026.02.006