Beyond the Label: Evaluating Bimekizumab’s Mental Health Profile in Psoriasis Treatment

Beyond its physical effects on the skin, psoriasis is increasingly recognized for impacting patients’ emotional and psychological health. Individuals with psoriasis are more likely to suffer from depression, anxiety, and suicidal ideation compared with the general population. This burden is multifactorial, stemming from disease visibility, stigma, chronicity, and systemic inflammation.^1,2 

Biologic therapies have transformed the management of psoriasis, and IL-17 inhibitors such as bimekizumab offer targeted control of disease activity. Given the FDA warning for suicidal ideation and behavior (SI/B) listed in bimekizumab’s prescribing information, clinicians may hesitate to use it in patients with a history of mood disorders.³ A closer look at the trial data, however, reveals that bimekizumab not only has a low risk of psychiatric adverse events but may also confer meaningful mental health benefits.⁴

Bimekizumab’s SI/B Label Warning: What the Data Really Say

Despite an FDA warning for potential SI/B, data from 9 phase 2/3 clinical trials involving more than 7166 patient-years (PYs) of exposure paint a reassuring picture⁴:

• Low incidence of SI/B: 0.13 per 100 PYs with suicidal ideation at 0.08/100 PYs, suicide attempts at 0.04/100 PYs, and completed suicide at 0.01/100 PYs.
• Comparison with other therapies: These rates are comparable to or lower than those seen with other anti–IL-17 and IL-23 therapies (0.09-0.54/100 PYs and 0.09-0.19/100 PYs, respectively). For example, brodalumab—a therapy with a boxed SI/B warning—has an SI/B rate of 0.49/100 PYs.
• Enhanced safety protocols: Bimekizumab trials included rigorous psychiatric monitoring via the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) and independent adjudication of cases by a neuropsychiatric adjudication committee.

Depression Outcomes in Clinical Trials

Across the 9 studies, bimekizumab was associated with consistently low depression scores and favorable trends compared with placebo and active comparators⁴:

• Minimal depressive symptoms: At week 16, 92.9% of patients treated with bimekizumab scored 0 to 4 on the Patient Health Questionnaire-9 (PHQ-9) (no/minimal depression) vs 81.1% of patients who received a placebo.
• Fewer moderate to severe cases: Only 1.2% of patients on bimekizumab scored greater than or equal to 10 on the PHQ-9 (moderate to severe depression) compared with 6.3% on placebo; severe depression (PHQ-9 ≥15) occurred in just 0.7% of treated patients vs 4.1% on placebo.
• Long-term stability: Mean PHQ-9 scores remained low through 144 weeks of follow-up, suggesting durable mental health benefits with continued treatment.

Mental Health Benefits of Biologic Therapy in Psoriasis

The positive effects of biologics on mood are not unique to bimekizumab. Biologics offer more than skin-deep benefits—evidence points to direct improvements in mental health, particularly with IL-17 and IL-23 inhibitors:

• Mood-specific effects: Registry data (eg, DermaReg-Pso) show that IL-17 and IL-23 inhibitors are associated with greater reductions in depressive symptoms than TNF-α inhibitors, even after adjusting for disease severity and quality of life.⁵
• Symptom-level improvements: IL-17 inhibitors specifically improved core depressive symptoms, including pessimism, emotional numbness, and even suicidal ideation, suggesting a distinct neuropsychiatric impact.⁵
• Mechanistic rationale: These effects may be mediated by downregulation of neuroinflammatory pathways, underscoring the role of systemic inflammation in mood disorders.¹

Efficacy and Long-Term Safety of Bimekizumab

Bimekizumab has demonstrated durable skin clearance with a manageable safety profile, both in trials and real-world use:

• Superior skin clearance: In head-to-head trials, bimekizumab provided more days of complete clearance (PASI 100) over 52 weeks than secukinumab, ustekinumab, adalimumab, and etanercept.⁶
• Favorable safety data: In pooled clinical trials, serious treatment-emergent adverse events occurred at 5.9/100 PYs, with low rates of major adverse cardiovascular events, malignancy, and inflammatory bowel disease. The most common adverse events included nasopharyngitis, oral candidiasis, and upper respiratory tract infections.⁷
• Real-world alignment: A retrospective analysis (n = 51) showed similar safety signals. Fungal infections were the most frequent adverse event, with a 14% discontinuation rate. No SI/B events were reported; only 1 patient developed new-onset depression.⁸

Clinical Considerations: Counseling and Coordinated Care

Dermatology clinicians play a key role in supporting both the mental and physical health of patients undergoing biologic therapy. Before initiating treatment, clinicians should conduct pretreatment screening using validated tools such as the PHQ-9 and the eC-SSRS to establish a mental health baseline. Open, clear communication is essential, such as addressing the FDA warning for SI/B directly while contextualizing it with supportive clinical trial and real-world data. For patients with a known psychiatric history, collaborative care is recommended, including timely referral to primary care providers or mental health professionals as appropriate.

Conclusion

Although bimekizumab carries a label warning for SI/B, clinical trial evidence supports a low risk and potential improvements in depression symptoms among treated patients. With its strong efficacy profile and favorable long-term safety, bimekizumab remains a valuable treatment for moderate to severe plaque psoriasis. Dermatology clinicians should feel confident in prescribing it while maintaining vigilance around mental health screening.

Jennifer Fisher, MMSc, PA-C, is a board-certified dermatology physician assistant and medical writer in Connecticut.

References

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3. Bimzelx. Prescribing information. UCB Inc; 2024. https://www.ucb-usa.com/bimzelx-prescribing-information.pdf
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7. Gordon KB, Langley RG, Warren RB, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: pooled results from phase 2 and phase 3 randomized clinical trials. JAMA Dermatol. 2022;158(7):735-744. doi:10.1001/jamadermatol.2022.1185
8. Zangenah N, Vazquez-Machado M, Loranger N, Elshaboury S, Hashemi K, LaChance AH. Adverse events associated with bimekizumab for moderate-to-severe plaque psoriasis: a retrospective, multicenter, post-hoc analysis. JAAD Int. 2025;20:54-55. doi:10.1016/j.jdin.2025.02.001