Bimzelx Shows Long-Term Efficacy in Psoriasis

Dual inhibition with bimekizumab-bkzx demonstrated high efficacy and sustained clinical benefits across different adult patient populations living with this common inflammatory skin condition.

“A primary treatment goal for people living with psoriasis is durable, high rates of complete skin clearance. These five-year bimekizumab-bkzx results provide valuable evidence for clinical decision-making,” said Dr Andrew Blauvelt, MD, MBA, Chair, Medical Board, 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.”

Among patients with PSO only at baseline, who were at risk of progression to psoriatic arthritis, 68.7–71.6% achieved complete skin clearance (Psoriasis Area and Severity Index, [PASI]100) at three years, generally consistent with the overall treated group, who achieved 72%. Similar results were seen in all patients with PSO, including those with PsA at baseline. Among the 153 US/Canadian patients who completed an open-label extension period to five years, 67.7% achieved PASI100, while 84.9% achieved PASI90. In this subgroup over the five-year period, bimekizumab-bkzx was generally well tolerated with no unexpected safety findings.

“Psoriasis is a chronic condition that increases the risk of developing other serious health issues,” said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, 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.”

UCB’s data for bimekizumab-bkzx in moderate-to-severe PSO was presented as six posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. These abstracts complement other bimekizumab-bkzx data presented at AAD in hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthrits, emphasizing UCB’s leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.

Further detail on selected bimekizumab-bkzx data in PSO presented at AAD 2025:

1. Five-year efficacy and safety: i) A US/Canadian subgroup of 153 patients completing BE VIVID/BE SURE/BE READY and the BE BRIGHT open-label extension could enter a second 48-week extension (OLE2), where all patients received Q8W. Bimekizumab-bkzx demonstrated high rates of clinical and health-related quality of life responses, which were highly durable to Year 5. It was generally well tolerated in this patient subgroup, with no unexpected safety findings, over five years: a) Of the 153 patients analyzed, 75.2% and 67.7% patients achieved PASI100 at one year and five years, respectively. Similarly, 92.8% and 84.9% achieved PASI90 at one year and five years, respectively; b) Over five years, in the subgroup of 153 patients, the four most common treatment emergent adverse events (TEAEs) were: nasopharyngitis (9.7/100PY), oral candidiasis (7.6/100PY), coronavirus infection (6.1/100PY) and upper respiratory tract infection (5.8/100PY).

2. Weight stratification: i) Bimekizumab-bkzx demonstrated long-term efficacy across four years regardless of patients’ weight subgroup at baseline (either <90 kg or ≥90 kg):

a) Of the 420 patients analyzed who were <90 kg, 88.5%/67.4% achieved PASI90/PASI100 at four years; b) Of the 351 patients analyzed who were ≥90 kg, 83.0%/61.6% achieved PASI90/PASI100 at four years.

3. Skin clearance rates in patients with cardiometabolic comorbidities: i) High and durable levels of complete or near-complete skin clearance were achieved after four years of bimekizumab-bkzx treatment in 771 patients with PSO, regardless of baseline hypertension, elevated BMI, or hyperglycemia: a) Of the 375 patients with baseline hypertension, 82.8%/59.3%, respectively, achieved PASI90/PASI100 at four years; b) Of the 344 patients with baseline elevated BMI, 82.5%/60.7%, respectively, achieved PASI90/PASI100 at four years; c) Of the 62 patients with baseline hyperglycemia, 80.4%/56.9%, respectively, achieved PASI90/PASI100 at four years.

4. Patients at risk of progressing to psoriatic arthritis (PsA): i) The rates of complete skin clearance (PASI100) were high after three years in bimekizumab-bkzx-treated patients with PSO and risk factors for progression to PsA, or who screened PsA-positive, consistent with the overall bimekizumab-bkzx-treated group. Outcomes were similar when the analysis was restricted to patients with only psoriasis at baseline.