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

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Beyond its physical effects on the skin, psoriasis is increasingly recognized for its impact on patients’ emotional and psychological health. Individuals with psoriasis are more likely to suffer from depression, anxiety, and suicidal ideation compared to 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 interleukin (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 over 7166 patient-years (PY) of exposure paint a reassuring picture:⁴

• Low incidence of SI/B: 0.13 per 100 PY with suicidal ideation at 0.08/100 PY, suicide attempts at 0.04/100 PY, and completed suicide at 0.01/100 PY.
• 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 to 0.54/100PY and 0.09 to 0.19/100PY, respectively). For example, brodalumab—a therapy with a boxed SI/B warning—has an SI/B rate of 0.49/100 PY.
• Enhanced safety protocols: Bimekizumab trials included rigorous psychiatric monitoring via the 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 to placebo and active comparators:⁴

• Minimal depressive symptoms: At week 16, 92.9% of bimekizumab-treated patients scored 0 to 4 on the Patient Health Questionnaire-9 (PHQ-9) (no/minimal depression), vs 81.1% of placebo patients.
• Fewer moderate to severe cases: Only 1.2% of patients on bimekizumab scored ≥10 on the PHQ-9 (moderate to severe depression), compared to 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 IL-17 and IL-23 inhibitors are associated with greater reductions in depressive symptoms than TNF-alpha 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 TEAEs occurred at 5.9/100 PY, with low rates of MACE, malignancy, and IBD. The most common AEs 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 AE, with a 14% discontinuation rate. No SI/B events were reported; only one 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 pre-treatment screening using validated tools such as the PHQ-9 and the eC-SSRS to establish a mental health baseline. Open, clear communication is essential—addressing the FDA warning for suicidal ideation and behavior (SI/B) directly, while also 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. UCB. (2024). BIMZELX (bimekizumabbkzx) prescribing information. U.S. Food and Drug Administration. https://www.ucb-usa.com
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5. Svedbom A, Ståhle M. Interleukin-17 and - 23 inhibitors associated with direct effects on depressive symptoms in psoriasis: results from a register study. Acta Derm Venereol. 2023;103:adv7138. doi:10.2340/actadv.v103.7138
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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