Real-World Safety Signals of Bimekizumab Emerge in New FAERS Analysis

Bimekizumab, a dual IL-17A/IL-17F inhibitor used for psoriasis and psoriatic arthritis, is increasingly used in real-world practice, prompting closer evaluation of its long-term safety.¹ In an analysis from the FDA Adverse Event Reporting System (FAERS) covering the third quarter (Q3) of 2021 to the fourth quarter (Q4) of 2024, researchers identified 2780 bimekizumab-related reports and 70 significant safety signals, including both known and newly detected adverse events (AEs).

This retrospective analysis is published in Naunyn-Schmiedeberg's Archives of Pharmacology.

“Given the limited time since its market approval, there is a scarcity of long-term safety data based on real-world studies,” wrote the researchers of the study. “To address this gap, we utilized the FAERS database to identify and analyze bimekizumab-related AEs, thereby enhancing our understanding of its safety profile in routine clinical practice.”

In the US, bimekizumab was first authorized in October 2023 for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, based on phase 3 trial data demonstrating high levels of skin clearance.² Since then, US approvals have expanded to include active psoriatic arthritis, active nonradiographic axial spondyloarthritis with objective signs of inflammation, and active ankylosing spondylitis.³ These indications position bimekizumab as one of the first dual IL-17A/IL-17F inhibitors available for a range of immune-mediated inflammatory disorders.

This study used a retrospective pharmacovigilance design to evaluate AEs associated with bimekizumab using data from the FAERS.¹ All reports submitted between Q3 2021 and Q4 2024 were extracted and screened for cases listing bimekizumab as the primary suspect drug. Analyses were conducted to identify statistically significant safety signals across system organ classes, using established metrics to compare the frequency of reported events with those of the full FAERS database. Time-to-onset analyses were also performed to characterize when adverse events occurred following drug initiation.

Among the 6,037,398 AE reports submitted to FAERS during the study period, 2780 were associated with bimekizumab. The researchers identified 70 significant adverse event signals across 11 System Organ Classes. Many aligned with the drug’s known safety profile, including injection site pain, oral candidiasis, and esophageal candidiasis. However, 29 previously unreported signals also emerged, such as cellulitis, lower respiratory tract infections, Staphylococcus infections, immunodeficiency, and Mycoplasma pneumonia.

Time-to-onset analysis showed a median (IQR) onset of 29 (0, 84.75) days, indicating that many events occurred within the first several weeks of therapy.

However, the researchers acknowledged several limitations. First, FAERS reports are often incomplete, leading to missing data that may bias both AE patterns and time-to-onset findings. Because information on patients taking bimekizumab without AEs was unavailable, true incidence rates could not be calculated. Additionally, the presence of confounders, such as concomitant drugs or underlying conditions, further limited interpretability of this retrospective study, so controlled clinical studies are needed to confirm these safety signals.

Despite these findings, the researchers believe these findings confirm established risks while revealing additional safety signals that warrant further clinical attention in bimekizumab.

References

1. Lin X, Guo L, Lin T, et al. Disproportionality analysis of adverse events associated with bimekizumab: a real-world study based on FDA Adverse Event Reporting System (FAERS) Database. Naunyn Schmiedebergs Arch Pharmacol. doi:10.1007/s00210-025-04894-2

2. Myshko D. Bimekizumab-bkzx, the newest psoriasis treatment, is now available. AJMC®. November 30, 2023. Accessed December 11, 2025. https://www.ajmc.com/view/bimekizumab-bkzx-the-newest-psoriasis-treatment-is-now-available

3. McNulty R. FDA approves bimekizumab for psoriatic arthritis, nonradiographic axSpA, ankylosing spondylitis. AJMC. September 23, 2024. Accessed December 11, 2025. https://www.ajmc.com/view/fda-approves-bimekizumab-for-psoriatic-arthritis-non-radiographic-axspa-ankylosing-spondylitis