25rhk166 10.3205/25rhk166 urn:nbn:de:0183-25rhk1662 Meeting Abstract Kiltz Kiltz Uta U

Ruhr-Universität Bochum, Bochum Rheumazentrum Ruhrgebiet, Herne

author Weiner Weiner Stefan S

Krankenhaus der Barmherzigen Brüder, Department of Rheumatology, Immunology and Nephrology, Medical Campus of the Johannes Gutenberg-University Mainz, Trier

author Bühring Bühring Björn B

Ruhr-Universität Bochum, Bochum

author Klemm Klemm Philipp P

Department of Rheumatology, Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim

author Adolf Adolf Daniela D

StatConsult GmbH Biometrie und Datenmanagement, Magdeburg

author Kabelitz Kabelitz Maria M

StatConsult GmbH Biometrie und Datenmanagement, Magdeburg

author Sartingen Sartingen Sabine S

AbbVie Deutschland GmbH & Co. KG, Wiesbaden

author Stemmler Stemmler Edgar E

AbbVie Deutschland GmbH & Co. KG, Wiesbaden

author Baraliakos Baraliakos Xenofon X

Ruhr-Universität Bochum, Bochum Rheumazentrum Ruhrgebiet, Herne

author German Medical Science GMS Publishing House

Düsseldorf

610 20250917 engl This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). M0627 166 Deutsche Gesellschaft für Rheumatologie Deutsche Gesellschaft für Orthopädische Rheumatologie 53. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 39. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh) Deutscher Rheumatologiekongress 2025 Spondyloarthritiden Wiesbaden 20250917 20250920 SpA.29 TextMethods: In this interim analysis alleviation of symptoms was evaluated at weeks 4 and 12 considering the following outcomes: i) ASADAS inactive disease (ID) or low disease activity (LDA) states, ii) ASAS40 response, iii) BASDAI response, and iiii) total back pain. Safety was assessed by collection of adverse event (AE) data.Results: Mean age of 198 patients (59.6% male) was 44.3 (11.8) years, symptom duration was 13.7 (10.5) years and disease duration 9.5 (10.1) years. 39.4% of patients were bDMARD-naïve and 60.6% were bDMARD-IR. Initial ASDAS was 3.4 (0.9) for bDMARD-naïve (n = 63) and 3.2 (0.8) for bDMARD-IRs (n = 108) patients. Baseline CRP-level was 1.2 (2.2) mg/l and decreased to 0.8 (2.0) mg/dl and 0.6 (1.0) mg/dl after 4 and 12 weeks.ASDAS-ID or ASDAS-LDA increased from 0.6% and 7.0% at baseline to 7.3% and 42.0% at week 4, and to 12.0% and 45.8% at week 12. (Figures 1a & b). 23.1% and 26.6% of all patients achieved ASAS40 at weeks 4 and 12 (Figure 1c). The average BASDAI score of 5.4 (1.9) changed to 3.7 (2.1) at week 4 and week 12, each. (Figure 1d) . Alleviation of total back pain at week 4 was ∆ BL = -2.0 [95%CI: -2.4 to -1.6]) with further pain reduction by week 12 (∆ BL = -2.5 [95%CI: -2.9 to -2.0]) (Figure 1e) . Outcomes for bDMARD-naïve and bDMARD-IR patients were mostly comparable (Figures 1a-e ). Adverse events did not indicate any new safety signals.Conclusion: Treatment with UPA led to meaningful improvement of axSpA symptoms demonstrated as early as week 4. Outcomes were comparable for bDMARD-naïve and bDMARD-IR patients. No new safety signals were identified. van der Heijde D Deodhar A Maksymowych WP Sieper J Van den Bosch F Kim TH Kishimoto M Östör AJ Combe B Sui Y Duan Y Wung PK Song IH Upadacitinib in active ankylosing spondylitis: results of the 2-year, double-blind, placebo-controlled SELECT-AXIS 1 study and open-label extension 2022 RMD Open e002280 van der Heijde D, Deodhar A, Maksymowych WP, Sieper J, Van den Bosch F, Kim TH, Kishimoto M, Östör AJ, Combe B, Sui Y, Duan Y, Wung PK, Song IH. Upadacitinib in active ankylosing spondylitis: results of the 2-year, double-blind, placebo-controlled SELECT-AXIS 1 study and open-label extension. RMD Open. 2022 Jul;8(2):e002280. DOI: 10.1136/rmdopen-2022-002280 http://dx.doi.org/10.1136/rmdopen-2022-002280 Baraliakos X van der Heijde D Sieper J Inman RD Kameda H Maksymowych WP Lagunes-Galindo I Bu X Wung P Kato K Shmagel A Deodhar A Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study 2024 Arthritis Res Ther 197 Baraliakos X, van der Heijde D, Sieper J, Inman RD, Kameda H, Maksymowych WP, Lagunes-Galindo I, Bu X, Wung P, Kato K, Shmagel A, Deodhar A. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study. Arthritis Res Ther. 2024 Nov 12;26(1):197. DOI: 10.1186/s13075-024-03412-8 http://dx.doi.org/10.1186/s13075-024-03412-8 Van den Bosch F Deodhar A Poddubnyy D Maksymowych WP van der Heijde D Kim TH Kishimoto M Baraliakos X Li Y D'Silva K Wung P Song IH Upadacitinib in Active Non-radiographic Axial Spondyloarthritis: 1-Year Data From a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial 2024 ACR Open Rheumatol 470-80 Van den Bosch F, Deodhar A, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Baraliakos X, Li Y, D'Silva K, Wung P, Song IH. Upadacitinib in Active Non-radiographic Axial Spondyloarthritis: 1-Year Data From a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial. ACR Open Rheumatol. 2024 Aug;6(8):470-80. DOI: 10.1002/acr2.11669 http://dx.doi.org/10.1002/acr2.11669 Kviatkovsky MJ Ramiro S Landewé R Dougados M Tubach F Bellamy N Hochberg M Ravaud P Martin-Mola E Awada H Bombardier C Felson D Hajjaj-Hassouni N Logeart I Matucci-Cerinic M van de Laar M van der Heijde D The Minimum Clinically Important Improvement and Patient-acceptable Symptom State in the BASDAI and BASFI for Patients with Ankylosing Spondylitis 2016 J Rheumatol 1680-6 Kviatkovsky MJ, Ramiro S, Landewé R, Dougados M, Tubach F, Bellamy N, Hochberg M, Ravaud P, Martin-Mola E, Awada H, Bombardier C, Felson D, Hajjaj-Hassouni N, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D. The Minimum Clinically Important Improvement and Patient-acceptable Symptom State in the BASDAI and BASFI for Patients with Ankylosing Spondylitis. J Rheumatol. 2016 Sep;43(9):1680-6. DOI: 10.3899/jrheum.151244 http://dx.doi.org/10.3899/jrheum.151244 Tubach F Ravaud P Martin-Mola E Awada H Bellamy N Bombardier C Felson DT Hajjaj-Hassouni N Hochberg M Logeart I Matucci-Cerinic M van de Laar M van der Heijde D Dougados M Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study 2012 Arthritis Care Res (Hoboken) 1699-707 Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bombardier C, Felson DT, Hajjaj-Hassouni N, Hochberg M, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1699-707. DOI: 10.1002/acr.21747 http://dx.doi.org/10.1002/acr.21747 0

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