BIMZELX® (bimekizumab-bkzx) Data in Moderate-to-Severe Plaque Psoriasis at EADV Showed Complete Skin Clearance Sustained Over Four Years
BIMZELX® (bimekizumab-bkzx) Data in Moderate-to-Severe Plaque Psoriasis at EADV Showed Complete Skin Clearance Sustained Over Four Years
News provided by UCB — Sep 17, 2025, 07:00 ET
- High responses maintained over four years in nearly half of patients: 48.9% of Week 16 PASI 0 responders sustained complete skin clearance of psoriasis, achieving PASI 0 at every study visit from Week 16 to four years*
- Nail psoriasis improvements: 81.8% and 82.7% of patients achieved nail matrix and nail bed mNAPSI 0, respectively (resolution of nail psoriasis) over three years^
- Low occurrence of PsA symptoms: Among patients with psoriasis and four or more baseline risk factors for psoriatic arthritis (PsA), 98.1% maintained PASE <47 (no PsA symptoms) to three years≠
- Unique dual inhibition: BIMZELX® (bimekizumab-bkzx) is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A)
Atlanta, Sept. 17, 2025 — UCB, a global biopharmaceutical company, today announced three- and four-year data from the open-label extension (OLE) Phase 3 trials for BIMZELX® (bimekizumab-bkzx) in moderate-to-severe plaque psoriasis. These data build on evidence that BIMZELX, the first and only medicine approved to selectively inhibit both IL-17A and IL-17F, provides long-term complete skin clearance and symptom relief.1-4
“Achieving complete skin clearance is a key treatment target for all patients with plaque psoriasis, as it prevents the cumulative burden of disease and potentially progression to PsA,” said Richard B. Warren, Professor of Dermatology, University of Manchester. “It is therefore highly relevant to observe complete skin clearance sustained over four years in nearly half of patients who received bimekizumab, demonstrating long-term control of inflammation and the potential to improve patient outcomes.”
Among Week 16 PASI 0 responders who entered the OLE (BIMZELX [BKZ] Total group; N=503), 48.9% maintained PASI 0 at every visit from Week 16 to year four; 72.0% sustained PASI 0 at every visit except up to four visits with PASI >0–≤2, defined in the abstract as remission.2* In the same cohort, 69.4% maintained body surface area (BSA) ≤1% at every visit to year four,2* and 81.7% maintained BSA ≤1% at every visit except up to four visits with BSA >1%–≤3% (high disease control). Separately, 81.8% (383/468) and 82.7% (386/467) of BKZ Total patients achieved nail matrix or nail bed mNAPSI 0, respectively, at year three.3,5-6^
Of BKZ Total patients with ≥4 baseline PsA risk factors (n=68), PASE <47 (no PsA symptoms) was maintained by 98.1% of patients to three years.4≠ In those with ≥4 baseline PsA risk factors (n=417), only 2.6% (0.9/100 PY) reported incidence of PsA treatment-emergent adverse events over four years. These data support long-term BIMZELX treatment to achieve complete skin clearance in psoriasis and to reduce PsA risk factors.2-4
“The presentation of this new three- and four-year data is further evidence of the depth and durability of response achieved with bimekizumab treatment in psoriasis, even at highly stringent measures of disease control,” said Donatello Crocetta, Head of Medical & Chief Medical Officer, UCB. “These results reinforce UCB’s commitment to developing evidence-driven solutions that aim to improve care for people living with chronic inflammatory diseases and reduce the risk of disease progression.”
UCB’s BIMZELX data in plaque psoriasis were presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France (September 17–20). The abstracts are part of 19 presentations from UCB across BIMZELX in psoriasis, hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis, and include an abstract for the investigational therapy galvokimig in atopic dermatitis.†
Analysis notes
*mNRI-LOCF: Modified non-responder imputation last responder carried forward – patients who discontinued due to lack of efficacy or treatment-related adverse events were considered non-responders at subsequent timepoints; last observation carried forward was used for other missing data. Data were pooled from the 52-week BE VIVID, 56-week BE SURE and BE READY Phase 3 trials and their 144-week open-label extension (OLE) BE BRIGHT. Reported data are for patients who received continuous BIMZELX and entered the OLE (BKZ Total).
^OC: Analyses were conducted post hoc for patients with baseline nail involvement (mNAPSI >0) using observed cases. Data were pooled from the BE VIVID, BE SURE, BE READY trials, 96 weeks of their OLE (BE BRIGHT), and the BE RADIANT Phase 3b trial. Reported data are for patients who received continuous BKZ and entered the OLE (BKZ Total).
≠ mNRI: Patients discontinuing due to lack of efficacy or treatment-related adverse events were considered non-responders; multiple imputation was used for other missing data. Proportions reported from BE RADIANT (data available from that trial). Included patients received BKZ 320 mg Q4W to Week 16, then Q4W or Q8W into the OLE.
† Galvokimig is investigational and is not approved by any regulatory authority worldwide.
Notes to editors
- PASI 0: Psoriasis Area and Severity Index (PASI) – PASI 0 (PASI 100) is complete skin clearance. PASI 0 at every visit except up to 2/3/4 visits with PASI >0–≤2 was defined as remission in the abstract.2
- BSA: Body surface area. BSA ≤1% means one percent or less of the body surface is affected. BSA ≤1% at every visit except up to 2/3/4 visits with BSA >1%–≤3% was defined as complete skin clearance control.2
- mNAPSI 0: Complete nail clearance in the nail matrix using the modified Nail Psoriasis Severity Index (mNAPSI).5
- PASE <47: Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire – PASE <47 indicates no PsA symptoms.4
About plaque psoriasis
Psoriasis is a common, chronic inflammatory disease primarily affecting the skin. It affects men and women of all ages and ethnicities. Signs and symptoms can include red, scaly patches that itch or burn; dry, cracked skin that may bleed; and thickened, pitted, or ridged nails. Psoriasis affects 2–3% of the global population (about 125 million people worldwide).8–11
About psoriatic arthritis
Psoriatic arthritis (PsA) is a chronic, systemic inflammatory condition affecting joints and skin, with a global prevalence of approximately 0.02%–0.25%. Approximately 30% of people with psoriasis develop PsA. Symptoms include joint pain and stiffness, skin plaques, dactylitis (swollen toes/fingers), and enthesitis (inflammation where tendons/ligaments insert into bone). PsA carries a burden beyond physical symptoms, including comorbidities such as hypertension, cardiovascular disease, and depression.12–15
About BIMZELX® (bimekizumab-bkzx)
BIMZELX is a humanized monoclonal IgG1 antibody designed to selectively inhibit both IL-17A and IL-17F, two cytokines that drive inflammatory processes. IL-17A and IL-17F contribute to chronic inflammation across multiple tissues; IL-17F can increase over time and is over-expressed in skin and elevated in serum of patients with psoriasis, PsA, nr-axSpA, ankylosing spondylitis, and hidradenitis suppurativa.1,16–19
Approved U.S. indications for BIMZELX include:
- Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
- Active psoriatic arthritis in adults
- Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults
- Active ankylosing spondylitis in adults
- Moderate-to-severe hidradenitis suppurativa in adults
BIMZELX U.S. Important Safety Information
Suicidal Ideation and Behavior
BIMZELX may increase the risk of suicidal ideation and behavior (SI/B). A causal association has not been definitively established. Prescribers should weigh risks and benefits in patients with a history of severe depression or SI/B. Monitor for emergence or worsening of depression, suicidal ideation, or other mood changes and seek appropriate care if they occur.
Infections
BIMZELX may increase risk of infections, including serious infections. Do not initiate treatment in patients with clinically important active infection until resolved or adequately treated. Monitor patients and do not administer BIMZELX until infection resolves.
Tuberculosis
Evaluate for TB infection prior to initiating BIMZELX. Avoid use in active TB. Treat latent TB prior to initiating BIMZELX when indicated and monitor for signs of active TB during and after treatment.
Liver biochemical abnormalities
Elevated serum transaminases were reported in clinical trials. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline and periodically. Interrupt or discontinue BIMZELX if drug-induced liver injury is suspected; avoid use in acute liver disease or cirrhosis.
Inflammatory bowel disease
Cases of IBD have been reported with IL-17 inhibitors, including BIMZELX. Avoid BIMZELX in patients with active IBD and monitor for new or worsening signs of IBD.
Immunizations
Complete age-appropriate vaccinations prior to initiating therapy. Avoid live vaccines during treatment with BIMZELX.
Most common adverse reactions
Common (≥1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. For other indications see prescribing information.
Please see full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX.
For further information, contact UCB
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About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or the central nervous system. With ~9,000 people in ~40 countries, the company generated revenue of €6.1 billion in 2024. Follow us on X: @UCBUSA.
Forward-looking statements
This document contains forward-looking statements based on current plans, estimates and beliefs of management and are subject to risks and uncertainties that may cause actual results to differ materially. Important factors include geopolitical events, pandemics, economic conditions, regulatory approvals, R&D costs, clinical results, data integrity, manufacturing issues, supply chain disruption, data security breaches, competition, and changes in laws, among others. The public is cautioned not to place undue reliance on forward-looking statements, which are made only as of the date of this document. UCB disclaims any obligation to update such statements unless required by law.
References
1. BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX.
2. Warren RB, Strober B, Jullien D, et al. Bimekizumab remission and high disease control over 4 years in patients with psoriasis achieving complete skin clearance at Week 16: Results from four phase 3 trials. [abstract]. EADV 2025. #P2120.
3. Rich P, Valenzuela F, Rigopoulos DG, et al. Bimekizumab response in the nail matrix and nail bed through 3 years in patients with moderate to severe plaque psoriasis. [abstract]. EADV 2025. #P2530.
4. Merola JF, Pinter A, Yamanaka K, et al. Bimekizumab long-term incidence of psoriatic arthritis symptoms and psoriatic arthritis adverse events in patients with psoriasis and risk factors for disease progression. [abstract]. EADV 2025. #P2785.
5–19. (Additional references as listed in the original data.)
US-BK-2501218
Date of preparation: September 2025
BIMZELX® is a registered trademark of the UCB Group of Companies.
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