BIMZELX® (bimekizumab-bkzx) Data in Moderate-to-Severe Plaque Psoriasis at EADV Showed Complete Skin Clearance Sustained Over Four Years

Rhea-AI Summary

UCB (OTC:UCBJY) announced significant long-term efficacy data for BIMZELX® (bimekizumab-bkzx) in treating moderate-to-severe plaque psoriasis. The data, presented at EADV 2025, showed that 48.9% of Week 16 PASI 0 responders maintained complete skin clearance over four years.

Key findings include 81.8% and 82.7% of patients achieving nail matrix and nail bed mNAPSI 0 respectively over three years, and 98.1% of high-risk patients maintaining no PsA symptoms over three years. BIMZELX, as the first and only approved dual IL-17A and IL-17F inhibitor, demonstrated sustained efficacy in preventing disease progression and maintaining complete skin clearance.

Positive

• 48.9% of Week 16 PASI 0 responders maintained complete skin clearance for four years
• 81.8% and 82.7% of patients achieved complete nail psoriasis resolution over three years
• 98.1% of high-risk patients maintained no PsA symptoms over three years
• Only 2.6% reported incidence of PsA TEAEs over four years
• First and only approved medicine to selectively inhibit both IL-17A and IL-17F

Negative

• None.

• 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 risk factors for PsA at baseline, 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 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced three- and four-year data from across the open-label extension (OLE) Phase 3 trials for BIMZELX^® (bimekizumab-bkzx) in moderate-to-severe plaque psoriasis. These new data build on established evidence that BIMZELX, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),¹ provides long-term complete skin clearance and symptom relief.^2-4

"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 and Northern Care Alliance NHS Foundation Trust. "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 this abstract as remission.^2* In the same study, among Week 16 PASI 0 responders, 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%, defined in this abstract as high disease control.^2* 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≠ Similarly, in those with ≥4 baseline PsA risk factors (n=417), only 2.6% (0.9/100 PY) reported incidence of PsA TEAEs over four years.^≠ These data support long-term BIMZELX treatment to achieve complete skin clearance in psoriasis and 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 data on BIMZELX in plaque psoriasis will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, September 17-20. These abstracts are part of the 19 presentations from UCB across BIMZELX in PSO, hidradenitis suppurativa, PsA, and axial spondyloarthritis, as well as the abstract for the investigational therapy galvokimig in atopic dermatitis.^†  

*mNRI-LOCF: Modified non-responder imputation last responder carried forward – patients who discontinued treatment due to lack of efficacy/treatment-related adverse events were considered non-responders at subsequent timepoints; the 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. Data reported here are only for patients who received continuous BIMZELX (BKZ) and entered the OLE, regardless of dosing regimen (BKZ Total). 

^OC: Analyses were conducted post hoc for patients with baseline nail involvement (mNAPSI >0) using observed cases. Data are also reported for patients with psoriasis only at baseline (Psoriatic Arthritis Screening and Evaluation [PASE] <47 and no medical history of PsA). Data were pooled from the 52-week BE VIVID, 56-week BE SURE, and BE READY Phase 3 trials, 96 weeks of their open-label extension (OLE), BE BRIGHT, and the BE RADIANT Phase 3b trial. Data reported here are only for patients who received continuous BKZ and entered the OLE, regardless of dosing regimen (BKZ Total).

^≠mNRI: Patients discontinuing due to lack of efficacy, treatment-related AEs were considered non-responder; multiple imputation was used for other missing data. Proportion of patients reported from the BE RADIANT Phase 3b trial (data only available from BE RADIANT). Included patients who received BKZ 320 mg every 4 weeks (Q4W) to Week 16, then Q4W or Q8W into the open-label extension. Data are reported for patients who received continuous BKZ and entered the OLE, regardless of dosing regimen (BKZ Total).

†Galvokimig is currently under clinical investigation and is not approved by any regulatory authority worldwide.

Notes to Editors:

• PASI 0: Psoriasis Area and Severity Index (PASI) is a tool used to measure the severity and extent of psoriasis. PASI 0 is the same measure as PASI 100 and is considered complete skin clearance. PASI 0 at every visit except up to 2/3/4 visits with PASI >0–≤2 was defined as remission of psoriasis in the abstract.²
• BSA: Body surface area. BSA ≤1% entails one percent or less of the body surface area 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 in the abstract.²
• mNAPSI 0: Patients achieving complete nail clearance in the nail matrix using the modified Nail Psoriasis Severity Index (mNAPSI).⁵
• PASE <47: The Psoriatic Arthritis Screening and Evaluation (PASE) is a questionnaire that aids the early detection of PsA and intervention,⁷ helping to delay/halt progression and prevent long-term complications; PASE <47 indicates no PsA symptoms.⁴

About plaque psoriasis 
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.⁸ This skin condition affects men and women of all ages and ethnicities.⁹ Psoriasis signs and symptoms can vary, but may include patches of thick, red skin covered with silvery-white scales that itch or burn; dry, cracked skin that may bleed; and thickened, pitted, or ridged nails.¹⁰ Psoriasis affects two to three percent of the total population, or about 125 million people worldwide.¹¹

About psoriatic arthritis
Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a global prevalence of 0.02 percent to 0.25 percent of the population.¹² Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.¹³ It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).¹⁴ The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, and depression.¹⁵

About BIMZELX^® (bimekizumab-bkzx)
BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.¹ IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.^1,16-18 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).^1,16-19

The approved indications for BIMZELX in the U.S. are:¹

• Plaque psoriasis: BIMZELX is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
• Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
• Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
• Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
• Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa

BIMZELX U.S. IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Suicidal Ideation and Behavior
BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.

Infections
BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.

Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.

Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.

Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.  

Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.  

Most Common Adverse Reactions 
Most 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.

Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection.

Please see full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX.

For further information, contact UCB:

Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com 

Brand Communications
Nicole Herga
T +1.773.960.5349
email: nicole.herga@ucb.com 

About UCB 
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 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, including, without limitation, statements containing the words "potential", "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document.

Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB's information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.

UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

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. Kaeley GS, Eder L, Aydin SZ, et al. Nail Psoriasis: Diagnosis, Assessment, Treatment Options, and Unmet Clinical Needs. J Rheumatol. 2021;48(8):1208–20.
6. Tillet W, Egeberg A, Sonkoly E, et al. Nail psoriasis dynamics during biologic treatment and withdrawal in patients with psoriasis who may be at high risk of developing psoriatic arthritis: a post hoc analysis of the VOYAGE 2 randomized trial. Arthritis Res Ther. 2023;25(1):169.
7. Husni ME, Meyer KH, Cohen DS, et al. The PASE questionnaire: pilot-testing a psoriatic arthritis screening and evaluation tool. J Am Acad Dematol. 2007;57(4):581–7.
8. Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.
9. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590.
10. Griffiths C, Armstrong A, Gudjonsson J, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.
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12. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):545–68.
13. Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023.
14. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423–41.
15. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: A literature review from a global health systems perspective. PT. 2010;35(12):680–89.
16. Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523–32.
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US-BK-2501218
Date of preparation: September 2025
BIMZELX^® is a registered trademark of the UCB Group of Companies.
©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved

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FAQ

What are the 4-year efficacy results for BIMZELX in treating plaque psoriasis?

48.9% of Week 16 PASI 0 responders maintained complete skin clearance (PASI 0) at every visit from Week 16 to year four, with 72% sustaining PASI 0 at every visit except up to four visits.

How effective is BIMZELX in treating nail psoriasis over the long term?

After three years of treatment, 81.8% and 82.7% of patients achieved complete resolution of nail matrix and nail bed psoriasis (mNAPSI 0) respectively.

What makes BIMZELX (bimekizumab-bkzx) unique in psoriasis treatment?

BIMZELX is the first and only approved medicine designed to selectively inhibit both interleukin 17F (IL-17F) and interleukin 17A (IL-17A), offering a unique dual inhibition mechanism.

How effective is BIMZELX in preventing psoriatic arthritis (PsA) symptoms?

Among patients with 4 or more risk factors for PsA at baseline, 98.1% maintained no PsA symptoms (PASE <47) for up to three years, with only 2.6% reporting PsA-related adverse events over four years.

What percentage of BIMZELX patients maintain long-term skin clearance?

69.4% of Week 16 PASI 0 responders maintained body surface area (BSA) ≤1% at every visit to year four, and 81.7% maintained high disease control with minimal flares.