UCB presents new BIMZELX[®] (bimekizumab-bkzx) data at AAD demonstrating high rates of durable and complete skin clearance in moderate-to-severe plaque psoriasis

Brussels (Belgium), March 27, 2026 – 15:00 (CET) – UCB, a global biopharmaceutical company, today announced new data in moderate-to-severe plaque psoriasis (PSO) at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, US, March 27–31. These data assess bimekizumab-bkzx in providing on-treatment remission, as defined by the National Psoriasis Foundation (NPF), and complete skin clearance up to four years with retreatment after stopping treatment.^1,2

“The recent National Psoriasis Foundation definition of on-treatment remission provides clinicians with a benchmark in routine practice, helping them feel confident that those living with psoriasis can reach and maintain minimal or no disease,” said Dr. April Armstrong, Professor and Chief of Dermatology at The University of California, Los Angeles (UCLA), US. “Achieving complete skin clearance can ease the significant burden of symptoms and meaningfully improve daily life for those affected by this chronic condition.”

“Achieving sustained inflammation control and complete skin clearance is our goal for people living with psoriasis, and generating the evidence to support that progress is fundamental to advancing care,” said Donatello Crocetta, Chief Medical Officer, UCB. “At the same time, continuity of treatment may not always be possible in real-world clinical practice. These findings show high response rates following retreatment with bimekizumab and indicate potential to re-establish disease control without meaningfully impacting long-term outcomes.”

In a post-hoc analysis of the first year of BE RADIANT and BE VIVID, 62.6% and 64.9% (N=289/N=242, respectively) of PSO patients treated with bimekizumab-bkzx achieved NPF-defined on-treatment remission during any ≥6-month period.^1* At Week 28, the earliest timepoint at which remission could be observed across both BE RADIANT and BE VIVID, 10.4% and 12.4% of patients in BE RADIANT and BE VIVID, respectively, treated with bimekizumab-bkzx¬ achieved NPF-defined remission.^1* 

In a separate post hoc analysis, data reported from the BE READY Phase 3 trial and the BE BRIGHT open-label extension (OLE) showed that among patients treated with bimekizumab-bkzx 320mg Q4W who achieved PASI 90 at Week 16 and stopped treatment (N=105), 31.4% (33/105) maintained at least a PASI 75 response to Week 56.^2** In those who lost PASI 75 response (66/105) before Week 56, 63.1% (41/65) achieved complete skin clearance (PASI 100) after 12 weeks of retreatment with bimekizumab-bkzx.2** At four years, complete skin clearance was maintained by 83.6% (46/55) of patients who were retreated with bimekizumab-bkzx.^2** 

These data form part of UCB’s broader presence at the 2026 AAD Annual Meeting, where a total of eleven abstracts will be presented across the bimekizumab-bkzx portfolio in psoriasis, hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis. 

*Observed case (OC): Data are reported as observed case. The data reported are from a post-hoc analyses of two Phase 3 trials, BE VIVID and BE RADIANT.¹ Patients who completed the double-blinded periods of BE VIVID (52 weeks) and BE RADIANT (48 weeks) were included.¹ In BE VIVID, patients were randomized to bimekizumab-bkzx 320mg every 4 weeks (Q4W) or ustekinumab 45/90mg (≤100kg/>100kg) at Week 0, Week 4, then Q12W.³ In BE RADIANT, patients were randomized to bimekizumab-bkzx Q4W to Week 16, then Q4W or Q8W thereafter, or secukinumab 300mg weekly to Week 4 then Q4W;⁴ bimekizumab-bkzx Q4W and Q8W data were pooled. Proportions achieving NPF-defined remission (either continuous BSA=0% for ≥6 months or IGA=0 for ≥6 months) during the first year of BE VIVID/BE RADIANT, with no missing BSA/IGA measurements, are reported (observed case).¹ These data were post hoc analyses and should be interpreted with caution as the analyses were not prespecified in the original protocols.

^**Observed case (OC): Data are reported as observed case. Data are reported from the BE READY Phase 3 trial/BE BRIGHT open-label extension (OLE).² Patients randomized to bimekizumab bkzx 320mg every 4 weeks (Q4W), who achieved PASI90 at Week 16, were then rerandomized to placebo for a 40-week randomized-withdrawal period before OLE entry.² Patients maintaining at least PASI75 continued placebo to Week 56, switching to bimekizumab-bkzx Q4W in the OLE.² Relapsing patients (<PASI75 during Week 20-56) entered a 12-week open-label bimekizumab-bkzx Q4W arm before OLE entry (required ≥PASI50).² PASI90 and PASI100 responses in placebo-rerandomized patients who lost PASI75 response and were retreated with bimekizumab-bkzx are reported through OLE Week 144 (Year 4; observed case (11 patients missing)).² These data were post hoc analyses and should be interpreted with caution as the analyses were not prespecified in the original protocols.

Notes to Editors:

• On-treatment remission: A National Psoriasis Foundation (NPF) consensus definition of on-treatment remission in psoriasis has recently emerged: continuous maintenance of either body surface area (BSA)=0% for ≥6 months or Investigator’s Global Assessment (IGA)=0 for ≥6 months while on treatment¹
• BSA (body surface area): Widely known and used measure of the extent of psoriasis severity in clinical practice (mild 0%–<3%, moderate 3%–<10%, severe ≥10%, as used by the National Psoriasis Foundation)⁵
• IGA (Investigator’s Global Assessment): A 5-point scale typically used in clinical trials, gauging psoriasis severity according to the patient’s degree of skin redness, thickening and scaling (clear/almost clear (0–1), mild (2), moderate (3) and severe (4))⁶
• PASI100 (Psoriasis Area and Severity Index 100): A tool used to assess response to treatment in psoriasis. PASI 100, the same measure as PASI 0, is 100% improvement from baseline in Psoriasis Area and Severity Index (PASI) and indicates complete skin clearance.^7,8

About Plaque Psoriasis

Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.⁹ This skin condition affects men and women of all ages and ethnicities.¹⁰ Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery-white scales; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.¹¹ Psoriasis affects 2–3 percent of the total population, or about 125 million people worldwide.¹²

About BIMZELX^® (bimekizumab-bkzx) in the U.S.

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.¹³ Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.¹³

The approved indications for BIMZELX in the U.S. are:¹³ 

• Plaque psoriasis: BIMZELX is approved 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 adults 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 Important Safety Information below and full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX.

About BIMZELX^®▼(bimekizumab) in the European Union (EU)/European Economic Area (EEA)

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.¹⁴ 

About BIMZELX^®▼(bimekizumab) EU/EEA*

The approved indications for bimekizumab▼ in the European Union are:¹⁴ 

• Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy 
• Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) 
• Axial spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy
• Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy

The label information may differ in other countries where approved. Please check local Prescribing Information.

BIMZELX^®▼(bimekizumab) EU/EEA* Important Safety Information

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions (injection site erythema, reaction, edema, pain, swelling, hematoma), fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).

Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.

Live vaccines should not be given in patients treated with bimekizumab.

Please consult the Summary of Product Characteristics in relation to other side effects, full safety and prescribing information.

European SmPC date of revision: April 2025. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

*EU/EEA means European Union/European Economic Area.

Last accessed: March 2026.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

For further information, contact UCB: 

Investor Relations

Antje Witte 

T +32.2.559.94.14 

antje.witte@ucb.com 

Sahar Yazdian 

T +32.2.559.94.37 

sahar.yazdian@ucb.com 

Yvonne Naughton 

T +44.175.344.7521 

yvonne.naughton@ucb.com 

Corporate Communications

Laurent Schots 

T +32.2.559.92.64 

email laurent.schots@ucb.com

Brand Communications

Amy Cheshire

T +44 7786 743 577

email amy.cheshire@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. UCB is listed on Euronext Brussels (symbol: UCB).

Forward looking statements 

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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

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