Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials

Background Patients with psoriasis have increased risk of suicidal ideation/behavior (SIB) and depression. Bimekizumab, a biologic that inhibits interleukin (IL)-17A and IL-17F, received FDA approval in 2023 for moderate to severe plaque psoriasis, following 2021 EMA approval. Objective To report SIB and depression in patients with moderate to severe psoriasis treated in bimekizumab clinical trials. Methods Mental health changes, including neuropsychiatric events, were actively monitored across nine bimekizumab in psoriasis phase 2/3 trials. The patient-reported electronic Columbia-Suicide Severity Rating Scale (eC-SSRS; measuring SIB) and Patient Health Questionnaire-9 (PHQ-9; measuring depression) were administered, monitored by an independent Neuropsychiatric Adjudication Committee. Results Throughout 7,166 patient-years (PY) of bimekizumab exposure, the adjudicated SIB rate was 0.13/100PY; SIB ranges for the general psoriasis population and patients receiving anti-IL-17A/anti-IL-23 therapies are 0.09-0.54/100PY and 0.09-0.19/100PY, respectively. At Week 16, 92.9% vs. 81.1% of bimekizumab- vs. placebo-treated patients had no/minimal depression. New-onset positive eC-SSRS responses and mean PHQ-9 scores were low for bimekizumab-treated patients. Limitations Patient exclusion for significant/severe pre-specified SIB/depression history. Conclusion The long-term adjudicated SIB rate with bimekizumab was low and within ranges reported in the general psoriasis patient population and psoriasis patients treated with anti-IL-17A/anti-IL-23 biologics. Screening/monitoring questionnaires reported low SIB and depression levels.