Upadacitinib in Active Non-radiographic Axial Spondyloarthritis: 1-Year Data From a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial

Filip Van den Bosch; Atul Deodhar; Denis Poddubnyy; Walter P Maksymowych; Désirée van der Heijde; Tae-Hwan Kim; Mitsumasa Kishimoto; Xenofon Baraliakos; Yihan Li; Kristin D'Silva; Peter Wung; In-Ho Song

doi:10.1002/acr2.11669

Upadacitinib in Active Non-radiographic Axial Spondyloarthritis: 1-Year Data From a Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial

ACR Open Rheumatol. 2024 May 15. doi: 10.1002/acr2.11669. Online ahead of print.

Authors

Affiliations

¹ Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium.
² Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
³ Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin, Berlin, Germany.
⁴ Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
⁵ Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
⁶ Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
⁷ Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.
⁸ Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.
⁹ AbbVie Inc, North Chicago, Illinois.

PMID: 38747163
DOI: 10.1002/acr2.11669

Abstract

Objective: Upadacitinib improved the signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) versus placebo over 14 weeks in the primary analysis of the SELECT-AXIS 2 nr-axSpA study. Here, we evaluated the efficacy and safety of upadacitinib through 1 year in patients with nr-axSpA in SELECT-AXIS 2.

Methods: Patients aged at least 18 years diagnosed with nr-axSpA who fulfilled the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria and were receiving stable background therapy were randomized to upadacitinib 15 mg once daily or placebo for the 52-week double-blind period. Efficacy was assessed using non-responder imputation incorporating multiple imputation (NRI-MI) and as-observed analyses for binary endpoints, and mixed-effects model repeated measures for continuous endpoints.

Results: Of 314 randomized patients, 259 (upadacitinib, n = 129; placebo, n = 130) completed 52 weeks of treatment. More patients receiving upadacitinib versus placebo achieved ≥40% improvement in ASAS at week 52 (63% vs 43%, NRI-MI; nominal P < 0.001). Similar treatment effects were observed for the achievement of axSpA Disease Activity Score inactive disease (33% v 11%, NRI-MI; nominal P < 0.001). Overall, patients receiving upadacitinib versus placebo showed greater improvement in disease activity, inflammation, pain, function, enthesitis, and quality of life through 52 weeks. Adverse events were generally comparable between the treatment groups. No opportunistic infections, malignancies, major adverse cardiovascular events, venous thromboembolic events, inflammatory bowel disease, or deaths were reported in those receiving upadacitinib.

Conclusion: Treatment with upadacitinib showed sustained efficacy versus placebo with no new safety findings identified through 1 year. These results support the continued favorable benefit-risk profile of upadacitinib treatment for nr-axSpA.

Grants and funding

AbbVie