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

Xenofon Baraliakos¹, Uta Kiltz¹, Kurt de Vlam², Adeline Ruyssen-Witrand³, Julio Ramírez Garcia⁴, Jessica A. Walsh⁵, Denis Poddubnyy⁶, David Nicholls⁷, Marga Oortgiesen⁸, Francesca Maria Ester Castagna⁹, Marie-Alix Bonny¹⁰, Hervé Besson¹¹, Rajan Bajracharya¹², Patrik Öhagen¹³, Christine de La Loge¹⁰ and William Tillett¹⁴, ¹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ²Department of Rheumatology, UZ Leuven, Leuven, Belgium, ³CHU of Toulouse - Pierre-Paul Riquet Hospital (Inflammation, Infection, Immunology and Locomotor Center - Rheumatology Service, Toulouse, France, ⁴Rheumatology Department, Hospital Clinic and IDIBAPS of Barcelona, Barcelona, Spain, ⁵Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, ⁶Division of Rheumatology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, Canada, and Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany; Department of Epidemiology, German Rheumatism Research Centre, Berlin, Germany, ⁷Clinical Trials Unit, University of the Sunshine Coast, Queensland, Australia, ⁸UCB, Raleigh, NC, ⁹UCB SpA, Milano, Italy, ¹⁰UCB, Brussels, Belgium, ¹¹UCB, Breda, Netherlands, ¹²UCB, Slough, England, United Kingdom, ¹³UCB, Stockholm, Sweden, ¹⁴Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom

Meeting: ACR Convergence 2025

Keywords: Ankylosing spondylitis (AS), Disease-Modifying Antirheumatic Drugs (Dmards), spondyloarthritis

Session Information

Date: Sunday, October 26, 2025

Title: (0554–0592) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease with a significant burden on patients’ (pts) health-related quality of life (HRQoL).1 Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated sustained efficacy to 2 years in clinical trials of pts with non-radiographic [nr-] and radiographic [r-]axSpA.2 BKZ has been approved for treatment of axSpA in Europe since June 2023, and the US since September 2024.3,4 SPEAK is the first prospective, observational study in routine clinical practice in Europe evaluating HRQoL and clinical outcomes with BKZ in pts with active axSpA and PsA. We report interim data from SPEAK, describing characteristics of pts with axSpA at BKZ treatment initiation and HRQoL to 24 weeks (wks) in a real-world setting.

Methods: SPEAK is an ongoing 52-wk, multi-country, observational study in Belgium, Czechia, France, Germany, Greece, Spain, and the United Kingdom. Adult pts with active axSpA or PsA who initiated BKZ in routine clinical practice could be included if receiving treatment per label (subcutaneous 160 mg every 4 wks). This planned interim analysis reports data to April 2, 2025 (~50% enrolment). We report Assessment of SpondyloArthritis international Society Health Index (ASAS HI; 0–17), Short Form 36-item Health Survey Physical Component Summary (SF-36 PCS, norm-based T-score with mean [SD]: 50 [10] in the US general population) and Pt Global Assessment of Disease Activity score (PGADA; 0–10) for pts with axSpA to 24 wks. Other clinical outcomes were collected but not available for data cut. Baseline (BL) characteristics and adverse events are also reported.

Results: By April 2025, BL characteristics were available for 197 pts with axSpA (nr-axSpA: 78, r-axSpA: 119; Table). Overall, 38 were biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) naïve, 56 had 1 previous b/tsDMARD and 103 had ≥2 previous b/tsDMARDs. Improvements in ASAS HI score were observed to 24 wks, with mean (SD) CfB at Wk 24 of –1.6 (3.0). SF-36 PCS scores improved to Wk 24 (mean [SD] CfB: +5.7 [7.3]), as did PGADA scores (mean [SD] CfB: –1.0 [2.5]; Figure; BL values in Table).TEAEs were reported in 62.9% of pts; in 33.0% they were deemed drug-related. Three cases of uveitis were reported by 2 pts (1.5%), 15 Candida infections (7.6%), including 12 oral candidiasis (6.1%, 3.0% led to BKZ discontinuation), 1 case of IBD (0.5%) and no suicidal ideation and behavior.

Conclusion: In this first report of HRQoL outcomes in an observational setting for BKZ-treated pts with axSpA in routine clinical practice, BKZ treatment led improved pt-reported outcomes at 24 wks, with changes observed as early as Wk 2, demonstrating rapid HRQoL improvements. The real-world findings complement data from phase 3 trials, for both HRQoL and safety.References: 1. Strand V. J Clin Rheumatol 2017;23:383–91; 2. Baraliakos X. Rheumatology 2025;keaf009; 3. EMA. 2023. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf; 4. FDA. 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s009lbl.pdf.

Table. Baseline characteristics of patients with axSpA in the SPEAK study

Figure. Change from baseline in ASAS HI, SF-36 PCS and PGADA scores to Week 24 (OC)

Disclosures: X. Baraliakos: AbbVie, 2, 5, 6, 12, Paid Instructor, Advanz, 2, 6, 12, Paid instructor, Alexion, 2, 6, 12, Paid instructor, Alphasigma, 2, 6, 12, Paid instructor, Amgen, 2, 6, 12, Paid instructor, BMS, 2, 6, 12, Paid instructor, Celgene, 6, Celltrion, 2, 5, 6, 12, Paid instructor, Cesas, 2, 6, 12, Paid instructor, Chugai, 2, 6, Clarivate, 6, 12, Paid instructor, Galapagos, 2, 6, 12, Paid instructor, J&J, 2, 6, 12, Paid instructor, Janssen, 5, Lilly, 2, 6, 12, Paid instructor, Merck, 6, MoonLake, 2, 5, 6, 12, Paid instructor, MSD, 2, Novartis, 2, 5, 6, 12, Paid instructor, Peervoice, 2, 6, 12, Paid instructor, Pfizer, 2, 6, 12, Paid instructor, Roche, 2, 6, 12, Paid instructor, Sandoz, 2, 6, 12, Paid instructor, Springer, 2, 6, 12, Paid instructor, Stada, 2, 6, 12, Paid instructor, Takeda, 2, 6, 12, Paid instructor, UCB, 2, 6, 12, Paid instructor, Zuellig, 2, 6, 12, Paid instructor; U. Kiltz: AbbVie, 2, 5, Amgen, 2, 5, Biocad, 2, 5, Biogen, 2, 5, BMS, 2, 5, Chugai, 2, 5, Eli Lilly, 2, 5, Fresenius, 2, 5, Gilead, 2, 5, Grünenthal, 2, 5, GSK, 2, 5, Hexal, 2, 5, Janssen, 2, 5, MSD, 2, 5, Novartis, 2, 5, onkowissen.de, 2, 5, Pfizer, 2, 5, Roche, 2, 5, UCB, 2, 5, Viatris, 2, 5; K. de Vlam: AbbVie, 2, 6, Alphasigma, 2, 6, Amgen, 2, 6, BMS, 2, 6, Galapagos, 2, 6, J&J, 2, 6, Lilly, 2, 6, MoonLake, 2, Novartis, 2, 6, Roche, 2, Sandoz, 2, UCB, 6; A. Ruyssen-Witrand: None; J. Ramírez Garcia: AbbVie, 2, 6, Eli Lilly, 6, Johnson & Johnson, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 5, UCB, 2, 6; J. Walsh: AbbVie, 2, 5, Amgen, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Merck, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Spyre, 2, 5, UCB, 2, 5; D. Poddubnyy: AbbVie, 2, 5, 6, Biocad, 2, BMS, 6, Eli Lilly, 2, 5, 6, Gilead, 2, GSK, 2, Moonlake, 2, MSD, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Samsung Bioepis, 6, UCB, 2, 6; D. Nicholls: AbbVie, 1, 5, 6, AstraZeneca, 1, 6, BMS, 5, Eli Lilly, 5, Gilead, 5, Incannex, 5, Janssen, 1, 5, 6, Novartis, 1, 5, 6, Pfizer, 1, 5, 6, Sandoz, 1, 6, Servatus, 5, Sun Pharma, 5, UCB, 1, 5, 6; M. Oortgiesen: UCB, 3, 11; F. Castagna: UCB, 3, 11; M. Bonny: UCB, 3, 11; H. Besson: UCB, 3, 11; R. Bajracharya: UCB, 3, 11; P. Öhagen: UCB, 3, 11; C. de La Loge: UCB, 2; W. Tillett: AbbVie, 2, 5, 6, Amgen, 2, 5, 6, BMS, 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly and Company, 2, 5, 6, GSK, 2, 5, 6, Janssen, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Ono Pharma, 2, 5, 6, Pfizer, 2, 5, 6, Takeda, 2, 5, 6, UCB, 2, 5, 6.

To cite this abstract in AMA style:

Baraliakos X, Kiltz U, de Vlam K, Ruyssen-Witrand A, Ramírez Garcia J, Walsh J, Poddubnyy D, Nicholls D, Oortgiesen M, Castagna F, Bonny M, Besson H, Bajracharya R, Öhagen P, de La Loge C, Tillett W. 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]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/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-clini/. Accessed .

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