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.