Long-Term Safety Data Highlight Potential of Bimekizumab in Plaque Psoriasis

Kenneth Gordon, MD
Credit: International Psoriasis Council

Leveraging data from nearly half a dozen clinical trials, results of a study from Maui Dermatology NP+PA Fall 2024 meeting is shedding new light on the effects of bimekizumab (Bimzelx) in patients with moderate to severe plaque psoriasis.

With more than 6300 person-years of follow-up data, results of the study provide an overview of the safety of the IL-17A and IL-17F inhibitor, with investigators detailing the safety data from more than 2100 patients throughout duration of the follow-up and broken down by year.¹

“[Bimekizumab] demonstrated good tolerability and a consistent safety profile over 4 years in patients with plaque psoriasis,” wrote investigators.¹

Developed and marketed by UCB, bimekizumab received its initial approval from the US Food and Drug Administration for the treatment of moderate to severe plaque psoriasis in patients in adults who are candidates for systemic therapy or phototherapy in October 2023. As of September 17, 2024, UCB had filed 5 additional supplemental Biologics License Applications with the FDA in 2024 for multiple new indications, including moderate to severe hidradenitis suppurativa, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and for a 2mL presentation.^2,3

The current study, which was presented at Maui Dermatology NP+PA Fall 2024 by Kenneth Gordon, MD, chair of Dermatology at the Medical College of Wisconsin, sought to evaluate the safety of bimekizumab use from the BE READY, BE VIVID, BE SURE, BE BRIGHT, and BE RADIANT trials. The primary aim of the study was to describe the incidence of treatment emergent adverse events per 100 patient-years for patients who received at least 1 dose of bimekizumab, with a secondary interest in stratification by year of treatment.¹

From the studies, investigators obtained 6324.3 patient-years of follow-up data from involving 2186 patients. The breakdown of patient-years of follow-up from each year were as follows:¹

• 2053.3 patient-years in Year 1 from 2186 patients
• 1904.3 patient-years in Year 2 from 2013 patients
• 1521.1 patient-years in Year 3 from 1803 patients
• 819.5 patient-years in Year 4 from 1309 patients

Results of the investigators’ analysis suggested the overall incidence rate of treatment-emergent adverse events with use bimekizumab was 170.5 per 100 patient-years. Analysis stratified according to time on treatment suggested the incidence of events decreased over time, with rates falling from 230.9 per 100 patient-years in year 1 to 99.9 per 100 patient-years in year 4.¹

Further analysis revealed rates of 5.5 and 2.9 per 100 patient-years of treatment for serious treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation, respectively. Investigators pointed out the most common treatment-emergent adverse events were nasopharyngitis (12.7 per 100 patient-years), oral candidiasis (8.9 per 100 patient-years), and upper respiratory tract infections (5.7 per 100 patient-years). Investigators also highlighted fewer treatment-emergent adverse events were observed with bimekizumab every 8 weeks relative to bimekizumab every 4 weeks, including a pronounced effect on oral candidiasis (6.5 per 100 patient-years vs 16.7 per 100 patient-years).¹

“[Exposure-adjusted incidence rates] of [treatment-emergent adverse events] remained consistent/decreased with longer [bimekizumab] exposure,” investigators concluded.¹

References:

1. ^{KB Gordon, D Thaci, M Gooderham. Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials . Abstract presented at Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024.}
2. ^{UCB. BIMZELX[®] approved by the U.S. FDA for the treatment of adults with moderate to severe plaque psoriasis. UCB. October 13, 2023. Accessed September 17, 2024. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis.}
3. ^{UCB. FDA accepts supplemental biologics license applications for BIMZELX[®] (bimekizumab-BKZX) for moderate to severe hidradenitis suppurativa and additional 2ML device presentations. UCB. April 4, 2024. Accessed September 17, 2024. https://www.ucb.com/stories-media/Press-Releases/article/FDA-Accepts-Supplemental-Biologics-License-Applications-for-BIMZELXR-bimekizumab-bkzx-for-Moderate-to-Severe-Hidradenitis-Suppurativa-and-Additional-2mL-Device-Presentations.}