The following is a summary of “Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials,” published in the July 2024 issue of Dermatology by Blauvelt, et al.

Patients with moderate to severe psoriasis are at increased risk of suicidal ideation and behavior (SIB) and depression. Bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, received regulatory approval in 2023 by the Food and Drug Administration, following approval by the European Medicines Agency in 2021. For a study, researchers sought to report on the occurrence of SIB and depression in patients with moderate to severe psoriasis treated in clinical trials with bimekizumab.

Mental health outcomes, including neuropsychiatric events, were actively monitored across 9 phase 2/3 clinical trials of bimekizumab in psoriasis. The electronic Columbia-Suicide Severity Rating Scale (measuring SIB) and Patient Health Questionnaire-9 (measuring depression) were administered, and an independent Neuropsychiatric Adjudication Committee adjudicated outcomes.

Over 7,166 patient-years (PY) of bimekizumab exposure, the adjudicated rate of SIB was 0.13 per 100 PY. Comparable SIB rates in the general psoriasis population and among patients receiving anti-IL-17A/anti-IL-23 therapies ranged from 0.09 to 0.54 per 100 PY and 0.09 to 0.19 per 100 PY, respectively. At week 16, a significantly higher proportion of patients treated with bimekizumab (92.9%) compared to placebo (81.1%) reported no/minimal depression. New-onset positive responses on the electronic Columbia-Suicide Severity Rating Scale and mean Patient Health Questionnaire-9 scores remained low among bimekizumab-treated patients. Patients with significant or severe pre-existing SIB or depression histories were excluded from the trials.

The long-term adjudicated rate of SIB with bimekizumab was low and consistent with rates reported in the general psoriasis population and among patients treated with anti-IL-17A/anti-IL-23 biologics. Screening and monitoring with validated questionnaires indicated low levels of SIB and depression in patients treated with bimekizumab.

Reference: sciencedirect.com/science/article/pii/S0190962224004389