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"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 3 trial in psoriatic arthritis."

UCB's data for BIMZELX in moderate-to-severe PSO will be presented as six posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, U.S., March 7–11.^1-6 These abstracts complement other BIMZELX data presented at AAD in hidradenitis suppurativa,^7-13 psoriatic arthritis,^14-16 ankylosing spondylitis, and non-radiographic axial spondyloarthritis,^17-18 emphasizing UCB's leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.

⁺PASI100: 100% improvement from baseline in Psoriasis Area and Severity Index, indicating complete skin clearance.^1,4

^*All patients received BIMZELX every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.

Notes to Editors:
Further detail on selected BIMZELX data in PSO presented at AAD 2025: 

• Five-year efficacy and safety: 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. BIMZELX 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:¹

  • 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

  • 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).

• Weight stratification: BIMZELX demonstrated long-term efficacy across four years regardless of patients' weight subgroup at baseline (either <90 kg or ≥90 kg):²*^†≠

  • Of the 420 patients analyzed who were <90 kg, 88.5%/67.4% achieved PASI90/PASI100 at four years

  • Of the 351 patients analyzed who were ≥90 kg, 83.0%/61.6% achieved PASI90/PASI100 at four years

• Skin clearance rates in patients with cardiometabolic comorbidities: High and durable levels of complete or near-complete skin clearance were achieved after four years of BIMZELX treatment in 771 patients with PSO, regardless of baseline hypertension, elevated BMI, or hyperglycemia:³*^†≠

  • Of the 375 patients with baseline hypertension, 82.8%/59.3%, respectively, achieved PASI90/PASI100 at four years

  • Of the 344 patients with baseline elevated BMI, 82.5%/60.7%, respectively, achieved PASI90/PASI100 at four years

  • Of the 62 patients with baseline hyperglycemia, 80.4%/56.9%, respectively, achieved PASI90/PASI100 at four years

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

^*All patients received BIMZELX every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.

^†Modified non‑responder imputation.

^≠Data were pooled from the 52/56-week Phase 3 trials: BE VIVID, BE SURE, BE READY, and their open-label extension (OLE) BE BRIGHT.

^¥Data were pooled from BE VIVID, BE SURE, BE READY, the first 96 weeks of their open-label extension (OLE) BE BRIGHT, and BE RADIANT (48-week double-blinded period, plus 96-week OLE).

About Plaque Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.¹⁹ This skin condition affects men and women of all ages and ethnicities.²⁰ 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.²¹ Psoriasis affects nearly three percent of the total population, or about 125 million people worldwide.²²

About Psoriatic Arthritis
Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.²³ Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.²⁴ 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).²⁵ The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety, and depression.²⁶

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.²⁷ IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.^27-30 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). ^27-31

The approved indications for BIMZELX in the U.S. are:²⁷

• 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 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 Important Safety Information below and full U.S. Prescribing Information at http://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 €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements 
This press release may contain forward-looking statements including, without limitation, statements containing the words "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 guarantees of 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 differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: 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; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval 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 differences 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, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, 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. 

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

References

1. Blauvelt A, et al. 2025. AAD 2025. #62275

2. Gkini M-A, Lambert J, López-Ferrer A, et al. Bimekizumab efficacy in patients with plaque psoriasis: A post hoc stratification by weight over 4 years in BE BRIGHT [abstract]. AAD 2025. #62020

3. Armstrong A, et al. 2025. AAD 2025. #63300

4. Langley R, et al. 2025. AAD 2025. #63312

5. Lebwohl M, Langley R, Strober B, et al. Bimekizumab achievement of 'super response' using a previously published definition in moderate to severe plaque psoriasis: Results from four phase 3/3b trials [abstract]. AAD 2025. #62276

6. Cutcutache I, et al. 2025. AAD 2025. #61802

7. Tzellos T, Sayed C, Gottlieb A, et al. Bimekizumab impact on draining tunnel reduction over 2 years in moderate to severe hidradenitis suppurativa: Results from BE HEARD EXT [abstract]. AAD 2025. #64414

8. Orenstein L, Shi V, Gottlieb A, et al. Bimekizumab effect on pain severity and impact in moderate to severe hidradenitis suppurativa: 2-year results from BE HEARD EXT [abstract]. AAD 2025. #63286

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10. Ingram J, Naik H, Zouboulis C, et al. Bimekizumab safety and tolerability in patients with moderate to severe hidradenitis suppurativa: 2-year results from BE HEARD EXT [abstract]. AAD 2025. #63331

11. Schneeweiss M, Anand P, Mostaghimi A, et al. Development and Validation of a Claims-Based Algorithm for Hidradenitis Suppurativa Severity [abstract]. AAD 2025. #63547

12. Kimball A, Garg A, Lev-Tov H, et al. Bimekizumab clinical efficacy responses translate into improvements in patient outcomes to Week 48 in patients with moderate to severe hidradenitis suppurativa: Results from BE HEARD I&II [abstract]. AAD 2025. #63370

13. Chovatiya R, Forman S, Alavi A, et al. Bimekizumab efficacy by disease duration in moderate to severe hidradenitis suppurativa: 2-year phase 3 results from BE HEARD EXT [abstract]. AAD 2025. #61888

14. Gottlieb A, Asahina A, Thaçi D, et al. Bimekizumab treatment resulted in sustained improvements in pain and fatigue in patients with active psoriatic arthritis and baseline psoriasis: 2-year results from two phase 3 studies [poster]. AAD 2025. #62763

15. Merola J, McInnes I, Mease P, et al. Head-to-head study of bimekizumab, an IL-17A/IL-17F inhibitor, and risankizumab, an IL-23 inhibitor, in patients with active psoriatic arthritis: Study design and rationale of BE BOLD, a phase 3b, randomized, parallel-group study. [poster]. AAD 2025. #62767

16. Merola J, Tillett W, Warren R, et al. Achieving early skin clearance was associated with cumulative benefits on disease impact up to 2 years in patients with psoriatic arthritis and psoriasis treated with bimekizumab [oral presentation]. AAD 2025.

17. Gottlieb A, Proft F, van der Heijde D, et al. Maintenance of stringent clinical responses with bimekizumab in patients with axial spondyloarthritis: 2-year outcomes from two phase 3 studies [poster]. AAD 2025. #62156

18. Merola J, Mease P, Poddubnyy D, et al. Long-term safety and tolerability of bimekizumab in patients with axial spondyloarthritis and psoriatic arthritis: Updated results from phase 2b/3 studies and their open-label extensions [poster]. AAD 2025. #62152

19. Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.

20. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590. doi:10.1136/bmj.m1590.

21. Griffiths C, Armstrong A, Gudjonsson J, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.

22. Griffiths CEM, van der Walt JM, Ashcroft DM, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4-e7.

23. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):545–68.

24. 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.

25. 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.

26. 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.

27. BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed January 2025.

28. 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.

29. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

30. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498.

31. Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973.

US-BK-2500314
Date of preparation: March 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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