UCB's long-term Phase III clinical trial data has revealed remarkable sustained efficacy for Bimzelx (bimekizumab-bkzx) in patients with moderate-to-severe plaque psoriasis, with the majority of patients maintaining complete skin clearance after five years of treatment.
Among 153 patients who completed a five-year open-label extension study, 67.7% achieved complete skin clearance (PASI 100) at the five-year mark, while 84.9% achieved near-complete clearance (PASI 90). These results demonstrate the durability of response with Bimzelx, which is the first and only approved medicine designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F).
"A primary treatment goal for people living with psoriasis is durable, high rates of complete skin clearance. These five-year results for bimekizumab-bkzx provide valuable evidence for clinical decision-making," said Dr. Andrew Blauvelt, Chair of the Medical Board at the National Psoriasis Foundation. "The sustained complete skin clearance offers important insights into the potential of bimekizumab-bkzx's dual inhibition to provide long-term management of this chronic inflammatory condition."
Consistent Efficacy Across Patient Subgroups
The data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting demonstrated Bimzelx's efficacy across various patient populations, including those with different baseline characteristics:
Weight Stratification
- In patients weighing less than 90 kg (198 lbs): 88.5% achieved PASI 90 and 67.4% achieved PASI 100 at four years
- In patients weighing 90 kg or more: 83.0% achieved PASI 90 and 61.6% achieved PASI 100 at four years
Cardiometabolic Comorbidities
- Patients with baseline hypertension: 82.8% achieved PASI 90 and 59.3% achieved PASI 100 at four years
- Patients with elevated BMI: 82.5% achieved PASI 90 and 60.7% achieved PASI 100 at four years
- Patients with hyperglycemia: 80.4% achieved PASI 90 and 56.9% achieved PASI 100 at four years
Psoriatic Arthritis Risk
Notably, patients at risk of progressing to psoriatic arthritis (PsA) showed high rates of complete skin clearance after three years of treatment (68.7%-71.6% achieved PASI 100), which was consistent with the overall treated population. Similar outcomes were observed in patients who had only psoriasis at baseline.
Safety Profile
Throughout the five-year period, Bimzelx was generally well tolerated with no unexpected safety findings. The most common treatment-emergent adverse events were nasopharyngitis (9.7/100 patient-years), oral candidiasis (7.6/100 patient-years), coronavirus infection (6.1/100 patient-years), and upper respiratory tract infection (5.8/100 patient-years).
Disease Burden and Treatment Impact
Psoriasis affects approximately 125 million people globally, including around eight million in the United States. The chronic inflammatory condition can significantly impact quality of life, with 60% of people with psoriasis reporting that it affects their daily living. Additionally, about 30% of patients with psoriasis will eventually develop psoriatic arthritis.
"Psoriasis is a chronic condition that increases the risk of developing other serious health issues," said Fiona du Monceau, Executive Vice President and Head of Patient Evidence at UCB. "These five-year results highlight the robust potential of bimekizumab-bkzx in transforming patient outcomes by offering the possibility of lasting, complete skin clearance. Bimekizumab-bkzx is aiming to set a new standard for treatment success, and our belief in its innovative dual inhibition approach is reflected in our dedication to head-to-head trials, including the BE BOLD Phase III trial in psoriatic arthritis."
Expanding Indications
Beyond plaque psoriasis, Bimzelx has received approval for multiple indications in the United States, including:
- Psoriatic arthritis
- Non-radiographic axial spondyloarthritis
- Ankylosing spondylitis
- Hidradenitis suppurativa
The comprehensive data presented at AAD 2025 included six posters on Bimzelx in moderate-to-severe plaque psoriasis, along with additional data for hidradenitis suppurativa, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, underscoring UCB's commitment to addressing unmet needs in immune-mediated inflammatory diseases.
Clinical Significance
The sustained efficacy demonstrated by Bimzelx over five years represents a significant advancement in the management of moderate-to-severe plaque psoriasis. Complete skin clearance is a primary treatment goal for patients with psoriasis, and the ability to maintain this response long-term addresses a critical unmet need in this patient population.
The dual inhibition mechanism of Bimzelx, targeting both IL-17A and IL-17F, appears to provide a durable therapeutic effect across diverse patient populations, including those with comorbidities or risk factors for disease progression. These findings suggest that Bimzelx may offer a valuable long-term treatment option for patients with moderate-to-severe plaque psoriasis, potentially setting a new standard for treatment success in this chronic inflammatory condition.
