From the FDA Drug Label
An increased incidence of new onset or worsening suicidal ideation and behavior was observed in subjects treated with BIMZELX. A causal association between treatment with BIMZELX and increased risk of suicidal ideation and behavior has not been definitively established Suicidal ideation and behavior were prospectively monitored using the Columbia Suicide Severity Rating Scale (C-SSRS) in clinical trials Pooled analysis of C-SSRS data indicated that 12/670 (1.8%) BIMZELX-treated subjects and 1/169 (0. 6%) subjects receiving placebo reported passive suicidal ideation with an estimated relative risk of 3.0 (95% confidence interval: 0.39,22.74). During the open-label extension trial, one completed suicide was reported in a BIMZELX-treated subject Analysis of pooled C-SSRS data from the first 16 weeks of the placebo-controlled clinical trials indicated that 16/861 (1.9%) BIMZELX-treated subjects and 1/146 (0. 7%) subjects receiving placebo reported suicidal ideation with an estimated relative risk of 2.70 (95% confidence interval: 0.36,20.12).
The suicide risk with Bimzelx is as follows:
- Suicidal ideation was reported in 1.8% of BIMZELX-treated subjects and 0.6% of subjects receiving placebo in clinical trials for plaque psoriasis.
- Suicidal ideation was reported in 1.9% of BIMZELX-treated subjects and 0.7% of subjects receiving placebo in clinical trials for hidradenitis suppurativa.
- One completed suicide was reported in a BIMZELX-treated subject during the open-label extension trial.
- The estimated relative risk of suicidal ideation was 3.0 (95% confidence interval: 0.39,22.74) in clinical trials for plaque psoriasis and 2.70 (95% confidence interval: 0.36,20.12) in clinical trials for hidradenitis suppurativa. It is essential to monitor patients for the emergence or worsening of depression, suicidal ideation, or other mood changes, and to refer them to a mental health professional if such events occur 1 1.
From the Research
There is no established or reported association between Bimzelx (bimekizumab) and increased suicide risk or suicidal ideation, as evidenced by the most recent and highest quality study 2.
Key Points
- Bimzelx is a monoclonal antibody that targets IL-17A and IL-17F cytokines and is approved for treating plaque psoriasis.
- The clinical trials and post-marketing surveillance for Bimzelx have not identified suicide risk as a safety concern in the drug's profile, with a low adjudicated suicidal ideation and behavior (SIB) rate of 0.13/100 patient-years 2.
- The most common side effects reported with Bimzelx include upper respiratory infections, oral candidiasis, headache, injection site reactions, and tinea infections.
- If patients experience any changes in mood or thoughts of self-harm while taking Bimzelx, they should contact their healthcare provider immediately, as this would be considered an unexpected adverse event that should be evaluated.
- Healthcare providers should continue to follow standard monitoring practices for patients with psoriasis, who may have higher baseline rates of depression and anxiety compared to the general population.
Considerations
- The study by 2 provides the most recent and highest quality evidence on the topic, and its findings should be prioritized in clinical decision-making.
- While other studies, such as 3, 4, 5, and 6, provide valuable information on medication-related adverse events and preventable harm, they do not specifically address the association between Bimzelx and suicide risk.
- The low SIB rate reported in the study by 2 suggests that Bimzelx is not associated with an increased risk of suicidal ideation or behavior.
- However, as with any medication, patients should be monitored for unexpected side effects, and healthcare providers should be vigilant for signs of depression, anxiety, or suicidal ideation in patients with psoriasis.