A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Summary
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: * To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). * To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). * To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). * To evaluate the maintenance of disease control after withdrawal of upadacitinib.
Timeline
- Start
- 2019-11-26
- Primary completion
- 2021-09-02
- Completion
- 2025-02-28
Outcome
Met primary endpoint
registry analysis (superiority test); Study 1: Placebo vs Study 1: Upadacitinib 15 mg; p <0.0001; Response Rate Difference 26.4 (95% CI 17.9 to 34.9); Cochran-Mantel-Haenszel NCT04169373 ↗
registry analysis (superiority test); Study 2: Placebo vs Study 2: Upadacitinib 15 mg; p <0.0001; Response Rate Difference 22.2 (95% CI 12.1 to 32.3); Cochran-Mantel-Haenszel NCT04169373 ↗
release “adults with active non-radiographic axial spondyloarthritis (nr-axSpA), showing upadacitinib (RINVOQ ® ; 15 mg, once daily) met the primary endpoint” abbvie.com ↗
release “In the SELECT-AXIS 2 trial (Study 2), evaluating the efficacy and safety of upadacitinib in adult patients with nr-axSpA, upadacitinib met its primary” abbvie.com ↗
release “In the SELECT-AXIS 2 nr-axSpA study, significantly more nr-axSpA patients achieved the primary endpoint of ASAS40 at week 14” abbvie.com ↗
Publications
- Baraliakos X, Bessette L, de Vlam K, Taylor PC, Biljan A, Urbanik J, Gao T, Jasion VS, Kato K, Lippe R, Magrey M. Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies. Rheumatol Ther. 2026 Jun;13(3):611-628. doi: 10.1007/s40744-026-00834-5. Epub 2026 Mar 13.
- Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
- Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.
- Navarro-Compan V, Van den Bosch F, Sampaio-Barros PD, Ostor AJK, Parikh B, Kato K, Gao T, Stigler J, Ramiro S. Efficacy of upadacitinib in subgroups of patients with axial spondyloarthritis with early versus established disease. RMD Open. 2025 Mar 4;11(1):e005110. doi: 10.1136/rmdopen-2024-005110.
- Van den Bosch F, Deodhar A, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Baraliakos X, Bu X, Lagunes-Galindo I, Song IH, Wung P, Kato K, Shmagel A. Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study. Arthritis Res Ther. 2025 Feb 4;27(1):23. doi: 10.1186/s13075-024-03441-3.
- 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.
- Burmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.
- Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.
- Kiltz U, Kishimoto M, Walsh JA, Sampaio-Barros P, Mittal M, Saffore CD, Wung P, Ganz F, Biljan A, Poddubnyy D. Effect of Upadacitinib on Quality of Life and Work Productivity in Active Non-radiographic Axial Spondyloarthritis: Results From Randomized Phase 3 Trial SELECT-AXIS 2. Rheumatol Ther. 2023 Aug;10(4):887-899. doi: 10.1007/s40744-023-00550-4. Epub 2023 May 16.
- Navarro-Compan V, Baraliakos X, Magrey M, Ostor A, Saffore CD, Mittal M, Song IH, Ganz F, Stigler J, Deodhar A. Effect of Upadacitinib on Disease Activity, Pain, Fatigue, Function, Health-Related Quality of Life and Work Productivity for Biologic Refractory Ankylosing Spondylitis. Rheumatol Ther. 2023 Jun;10(3):679-691. doi: 10.1007/s40744-023-00536-2. Epub 2023 Feb 23.
- Deodhar A, Van den Bosch F, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Blanco R, Duan Y, Li Y, Pangan AL, Wung P, Song IH. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Jul 30;400(10349):369-379. doi: 10.1016/S0140-6736(22)01212-0.
- van der Heijde D, Baraliakos X, Sieper J, Deodhar A, Inman RD, Kameda H, Zeng X, Sui Y, Bu X, Pangan AL, Wung P, Song IH. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022 Nov;81(11):1515-1523. doi: 10.1136/ard-2022-222608. Epub 2022 Jul 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Upadacitinib | Small molecule | 15 mg | Oral |