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28-Oct-2025

BIMZELX® (bimekizumab-bkzx) three year rheumatology data at ACR 2025 demonstrated sustained inflammation control in psoriatic arthritis and axial spondyloarthritis

  • Sustained improvements across stringent measures of disease in patients with psoriatic arthritis (PsA): One-year improvements were sustained to three years across strict measures of peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis – indicating sustained inflammation control

 

·         Sustained clinical response to highly stringent endpoints in half of patients with axial spondyloarthritis (axSpA): From Week 16 to three years, 50% of patients never lost ASDAS low disease activity (LDA) (<2.1) status at any assessed visit – indicating sustained inflammation control

 

·         First real-world findings demonstrate rapid quality of life (HRQoL) improvements in patients with PsA and axSpA: Improvements in outcomes in routine clinical practice were reported at 24 weeks, with benefits as early as Week 2 in some patients

Brussels (Belgium), October 24, 2025 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX® (bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) (non-radiographic [nr-]axSpA and radiographic [r-]axSpA). Bimekizumab-bkzx, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),1 continued to demonstrate sustained control of inflammation and deep efficacy in patients living with PsA and axSpA.2,3,4,5,6

Sustained improvements across stringent measures of disease in patients with PsA2

“The diverse, multi-faceted nature of PsA can make it challenging to treat, as therapy should ideally address multiple disease domains,” said Professor Laura Coates, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford, United Kingdom. “These compelling data show sustained improvements over three years across key PsA disease domains. This demonstrates that bimekizumab-bkzx has potential to benefit a broad range of patients, and may improve long-term inflammation control and prevent structural damage.”

In patients with PsA, one-year improvements were sustained to three years across the following GRAPPA domains:* peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis.2 Individual domain responses were consistent between bDMARD‑naïve and TNFi-IR patients.2 Further, exposure-adjusted incidence rates per 100 patient years for uveitis and definite or probable adjudicated Inflammatory Bowel Disease (IBD) to Week 156 were 0.2 (95% confidence interval 0.1, 0.6) and 0.3 (0.1, 0.7) in BE OPTIMAL and 0 and 0.1 (0.0, 0.6) in BE COMPLETE, respectively.2 (See Appendix for further details).

Sustained clinical response to highly stringent endpoints in half of patients with axial spondyloarthritis4

“In clinical practice, ASDAS LDA is an important treatment target for disease control for people living with axSpA, as it is a highly stringent measure of low disease activity,” said Professor Fabian Proft, MD from Universitätsmedizin Berlin, Germany. “It is therefore meaningful that in this study of bimekizumab‑bkzx, half of the patients never lost their ASDAS LDA response at any assessed visit over three years, while over three quarters of patients maintained this response over three years. This suggests long-term disease control, which is paramount in treating both nr-axSpA and r-axSpA.”

A high proportion of bimekizumab-bkzx-randomized patients who achieved clinical responses at Week 16 maintained these to Week 164 across the full disease spectrum of axSpA, including nr-axSpA and r-axSpA.4 From Week 16 through to Week 164, 50% of patients never lost their ASDAS LDA (<2.1) status at any assessed visit (MI), with a further 22.4% only losing their ASDAS LDA status at one visit, and 6.1% at two visits, respectively (MI).4 Of the 152 patients (43.6%; NRI) who achieved ASDAS LDA at Week 16, 78.8% still achieved ASDAS LDA at Week 164 (MI).4 (Proportion of patients who achieved ASDAS LDA at Week 16 and Week 164 in patients randomized to bimekizumab-bkzx 160 mg Q4W at baseline).4

Real-world findings demonstrate rapid HRQoL improvements in patients with PsA and axSpA5,6

Interim, post-hoc data analysis (observed case, OC) of patient-reported outcomes from the SPEAK study in routine clinical practice showed that:5,6

For bimekizumab-bkzx-treated PsA patients, improvements in PsAID-12 total score were observed to 24 weeks, with mean (SD) change from baseline (CfB) at Week 24 of −1.9 (2.0).5 SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +4.6 [7.9]), as did PGADA scores (Mean [SD] CfB: −17.5 [23.8]).5 At Week 2, mean (SD) change from baseline (CfB) in PsAID-12 total score and PGADA score were -0.8 (1.6) and -7.1 (19.3), respectively.5

For bimekizumab-bkzx-treated nr-axSpA and r-axSpA patients, improvements in ASAS HI score were observed to 24 weeks, with mean (SD) CfB at Week 24 of –1.6 (3.0).6 SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +5.7 [7.3]), as did PGADA scores (mean [SD] CfB: –1.0 [2.5].6 At Week 2, mean (SD) change from baseline (CfB) in ASAS HI score and PGADA score were –0.7 (2.3) and –0.8 (2.1), respectively.6

“This data presented at ACR shows that bimekizumab-bkzx continues to demonstrate long-term improvement in inflammation control and deep efficacy in patients living with PsA and axSpA, and emphasizes that this effect is consistent across a spectrum of patients with these psoriatic diseases,” said Donatello Crocetta, Chief Medical Officer, UCB. “This underlines the robust potential of bimekizumab-bkzx to help prevent long-term, irreversible structural damage and improve quality of life for many patients living with these debilitating rheumatic conditions.” 

UCB will present 16 abstracts on bimekizumab-bkzx at ACR 2025 in Chicago, Illinois, 24–29 October, across axSpA, PsA, and psoriasis. These will complement seven other presentations from UCB across their rheumatology portfolio. This data underscores UCB’s ambition to be a leader in rheumatology, commitment to advancing clinical research and innovation, and focus on developing meaningful solutions across the spectrum of rheumatic diseases.

*Core domains of PsA according to GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) recommendations.7

Study methodology

PsA abstract:2 Included patients who were randomized to subcutaneous bimekizumab-bkzx 160 mg or placebo every 4 weeks (Q4W) in BE OPTIMAL (biologic DMARD [bDMARD]‑naïve patients with PsA), BE COMPLETE (patients with PsA with inadequate response or intolerance to TNF inhibitors [TNFi‑IR]), BE MOBILE 1 (non‑radiographic axSpA) and BE MOBILE 2 (radiographic axSpA, i.e., AS).2 From Week 16, all placebo-randomized patients received bimekizumab-bkzx 160 mg Q4W.2 Week 52/16 BE OPTIMAL/BE COMPLETE completers were eligible for BE VITAL open-label extension; BE MOBILE 1 and 2 Week 52 completers could enter BE MOVING.2

AxSpA abstract:4 BE MOBILE 1 (nr-axSpA) and 2 from Week 16, all patients received subcutaneous bimekizumab-bkzx 160 mg every 4 weeks. At Week 52, eligible patients could enroll in the OLE (BE MOVING).4

Real-world study: 5,6 SPEAK is an ongoing 52-week, multi-country, observational study in Belgium, Czechia, France, Germany, Greece, Spain and the United Kingdom. 5,6 This planned interim analysis reports data to April 2, 2025 (approx. 50% enrollment). 5,6 Adult patients with active PsA or axSpA who initiated bimekizumab-bkzx in routine clinical practice could be included if receiving treatment per label (bimekizumab-bkzx 160 mg every 4 weeks).5,6 

References

  1. BIMZELX® (bimekizumab) U.S. PI. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Last accessed: October 2025.
  2. Merola J. Sustained Efficacy up to 3 Years with Bimekizumab Treatment Across GRAPPA Core Domains in Patients with Psoriatic Arthritis: Long-Term Results from Two Phase 3 Trials. 2025 [abstract]. ACR. #2129566.
  3. Rudwaleit M. Long-Term Uveitis Rates with Bimekizumab Treatment Across Pooled Phase 2b and Phase 3 Studies in Patients with Axial Spondyloarthritis or Psoriatic Arthritis: 3-Year Update [abstract]. ACR 2025. #2129301.
  4. Proft F. Bimekizumab Treatment Resulted in Patients with Axial Spondyloarthritis Maintaining Their Clinical Responses Over 3 Years: Results from Two Phase 3 Studies and Their Open-Label Extension [abstract].ACR 2025. #2129239.
  5. Baraliakos X. An Interim Analysis of Health-Related Quality of Life Outcomes from an International Multicentre Observational Study in Patients with Psoriatic Arthritis Initiating Bimekizumab in Real-World Clinical Practice [abstract]. ACR 2025. #2127676.
  6. Baraliakos X. An Interim Analysis of Health-Related Quality of Life Outcomes from an International Multicentre Observational Study in Patients with Axial Spondyloarthritis Initiating Bimekizumab in Real-World Clinical Practice. [abstract]. ACR 2025. #2127714.
  7. Coates LC, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): Updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465–79.
  8. Garcia-Magallón B et al. Is the new ASDAS nomenclature in agreement with therapeutic decision making in patients with axial spondyloarthritis? Semin Arthritis Rheum. 2020;50(5):854-57.
  9. Dactylitis. Oxford Concise Medical Dictionary (10 ed). https://www.oxfordreference.com/display/10.1093/acref/9780198836612.001.0001/acref-9780198836612-e-2446. Last accessed: October 2025.
  10. Enthesitis. Spondylitis Org. https://spondylitis.org/spondylitis-plus/enthesitis-a-closer-look/. Last accessed: October 2025.
  11. What is uveitis? American Academy of 0pthalmology. https://www.aao.org/eye-health/diseases/what-is-uveitis. Last accessed: October 2025.
  12. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):545–68.
  13. National Psoriasis Foundation. https://www.psoriasis.org/about-psoriatic-arthritis/. Last accessed: October 2025.
  14. Mease PJ, Armstrong A. 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. P T. 2010;35(12):680–89.
  16. Kwok T, Sutton M, Cook R, et al. Musculoskeletal Surgery in Psoriatic Arthritis: Prevalence and Risk Factors. J Rheumatol. 2023;50(4):497–503.
  17. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023;82(11);1404–14.
  18. Coates L, Landewé R, McInnes I, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10(1):e003855.
  19. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25(1):S319–30.
  20. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012;64(6):905–10.
  21. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Disord. 2015;16:392.
  22. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024;83(2):199–213.
  23. BIMZELX® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: October 2025.

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Last Updated: 28-Oct-2025