Bimekizumab: No Increased Risk for Depression or Suicidal Ideation in Psoriasis Patients

Bimekizumab Shows No Increased Risk of Depression or Suicidal Ideation Compared to Other Psoriasis Treatments

New data offer reassurance regarding the safety profile of bimekizumab, a relatively new biologic medication used to treat psoriasis. An analysis of real-world data suggests that individuals prescribed bimekizumab do not experience a higher risk of developing depression or suicidal thoughts compared to those taking alternative IL-23 inhibitors, another class of biologic drugs commonly used for psoriasis. This finding addresses concerns raised by a warning on the drug’s label regarding potential psychiatric risks.

Psoriasis, a chronic autoimmune condition affecting the skin, is increasingly recognized for its significant psychological impact. Research has demonstrated a strong link between psoriasis and an increased risk of depression and other mental health challenges. Given this established connection, and the initial warning associated with bimekizumab, clinicians and patients understandably approached the medication with caution.

Study Details and Findings

The retrospective study, published in JAAD International, analyzed data from the TriNetX database, a large, real-world observational database. Researchers examined the records of 1,691 adults diagnosed with psoriasis who had no prior history of depression or suicidal ideation. The cohort was divided into two groups: 836 patients who initiated bimekizumab treatment and 855 patients who began treatment with an IL-23 inhibitor. The average age of participants was 51, with approximately 62% being female.

Researchers tracked the incidence of new-onset depression, major depressive disorder, or suicidal ideation, as well as the initiation of antidepressant or antipsychotic medications, for up to two years following the start of treatment. To account for potential differences between the groups, the researchers employed propensity score matching, adjusting for factors like age, sex, obesity, diabetes, hypertension, inflammatory bowel disease, psoriatic arthritis, and pre-existing medication use (glucocorticoids, methotrexate, and cyclosporine).

The results indicated that 4.9% of patients prescribed bimekizumab and 12% of those prescribed an IL-23 inhibitor experienced a new diagnosis of depression, suicidal ideation, or started antidepressant/antipsychotic medication. This translated to a risk ratio of 2.43 (95% CI, 1.715-3.451), suggesting a significantly lower risk in the bimekizumab group. Further analysis focusing on the first six months of treatment showed a 6-month cumulative incidence of depression or suicidal ideation of 4% in the IL-23 inhibitor group and 2.7% in the bimekizumab group, a risk difference of 1.3% (95% CI, –0.004-0.031. P = 0.125).

Understanding the Implications

“The [drug] label says that this IL-17 inhibitor can potentially increase your risk for depression and suicidal ideation, so a lot of clinicians and patients, rightfully so, become very nervous when it comes to prescribing or starting it,” explained Leonardo Tjahjono, MD, assistant professor of dermatology at the George Washington University School of Medicine, in an interview with Healio. “We want to make sure that all patients with any type of psoriasis or HS have a chance to try this medication.”

These findings suggest that, at least within the first six to twelve months of treatment, bimekizumab does not appear to elevate the risk of depressive symptoms or suicidal ideation as initially suggested by the drug’s warning. Here’s particularly important as bimekizumab has demonstrated efficacy in treating psoriasis and, increasingly, hidradenitis suppurativa (HS), a chronic inflammatory skin condition. Recent data suggest bimekizumab is often preferred as a first-line biologic option for psoriasis patients.

The Importance of Continued Mental Health Screening

Despite these reassuring findings, researchers emphasize that routine mental health screenings remain crucial for all patients prescribed biologic therapies. The study provides reassurance that bimekizumab does not appear to carry an *additional* psychiatric risk compared to other advanced biologics, but it does not negate the need for ongoing monitoring. Psoriasis itself is associated with psychological distress, and any new medication should be accompanied by careful assessment of a patient’s mental well-being.

Dr. Tjahjono also highlighted the need for further research in the context of hidradenitis suppurativa. “This [type of analysis] will be especially important to conduct for people with hidradenitis supperativa,” he stated. “The medication is too new … So there is not enough data to power that analysis at this point. But it is going to be important. This drug has been helpful for me in clinic for patients with severe HS.”

Looking Ahead: Ongoing Surveillance and Research

The findings from this study contribute to a growing body of evidence informing the safe and effective use of bimekizumab. Ongoing post-market surveillance will be essential to continue monitoring the long-term psychiatric effects of the medication in diverse patient populations. Further research, particularly focusing on individuals with hidradenitis suppurativa, is warranted to fully understand the drug’s safety profile across different conditions. UNCW is currently monitoring weather conditions, which highlights the importance of ongoing vigilance in all areas of health and safety.

Clinicians should remain aware of the potential for psychiatric side effects with all biologic therapies and engage in open communication with their patients about any changes in mood or mental health. Patients should promptly report any concerning symptoms to their healthcare provider.

Leonardo Tjahjono, MD, can be reached at [email protected].