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Rheumatology and Therapy
Published in: Rheumatology and Therapy 4/2023

Open Access 16-05-2023 | Ankylosing Spondylitis | Original Research

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

Authors: Uta Kiltz, Mitsumasa Kishimoto, Jessica A. Walsh, Percival Sampaio-Barros, Manish Mittal, Christopher D. Saffore, Peter Wung, Fabiana Ganz, Ana Biljan, Denis Poddubnyy

Published in: Rheumatology and Therapy | Issue 4/2023

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Abstract

Introduction

To evaluate the effect of upadacitinib vs. placebo on health-related quality of life (HRQoL) and work productivity in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) enrolled in the SELECT-AXIS 2 phase 3 randomized controlled trial.

Methods

Adult patients with active nr-axSpA and an inadequate response to non-steroidal anti-inflammatory drugs were randomized 1:1 to receive upadacitinib 15 mg once daily or placebo. Mean changes from baseline in measures of HRQoL (Ankylosing Spondylitis QoL [ASQoL], Assessment of SpondyloArthritis international Society Health Index [ASAS HI], Short-Form 36 Physical Component Summary [SF-36 PCS] score) and Work Productivity and Activity Impairment (WPAI) were assessed through 14 weeks based on mixed-effects repeated measures or analysis of covariance models. The proportions of patients with improvements ≥ minimum clinically important differences (MCID) were assessed in HRQoL measures at week 14 using non-responder imputation with multiple imputation.

Results

At week 14, upadacitinib- vs. placebo-treated patients reported greater improvements from baseline in ASQoL and ASAS HI (ranked, P < 0.001) and in SF-36 PCS and WPAI overall work impairment (nominal P < 0.05). Improvements were observed as early as week 2 in ASAS HI. Greater proportions of upadacitinib vs. placebo-treated patients reported improvements ≥ MCID in ASQoL (62.6 vs. 40.9%), ASAS HI (44.8 vs. 28.8%), and SF-36 PCS (69.3 vs. 52.0%), with numbers needed to treat < 10 for all (nominal P ≤ 0.01). Improvements ≥ MCID were consistently observed irrespectively of prior exposure to tumor necrosis factor inhibitors.

Conclusions

Upadacitinib provides clinically meaningful improvements in HRQoL and work productivity in patients with active nr-axSpA.

Clinical Registration Number

NCT04169373, SELECT-AXIS 2.
Appendix
Available only for authorised users
Literature
1.
Garcia-Montoya L, Gul H, Emery P. Recent advances in ankylosing spondylitis: understanding the disease and management. F1000Res. 2018;7(F1000 Faculty Rev):1512CrossRef
2.
Richard N, Haroon N, Tomlinson GA, et al. FRI0208 Ankylosing spondylitis quality of life: defining minimal clinically important change. Ann Rheum Dis. 2018;77(Suppl 2):645.
3.
4.
Baraliakos X, Braun J. Non-radiographic axial spondyloarthritis and ankylosing spondylitis: what are the similarities and differences? RMD Open. 2015;1(Suppl 1): e000053.CrossRefPubMedPubMedCentral
5.
Rudwaleit M, van der Heijde D, Landewé R, et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68(6):777–83.CrossRefPubMed
6.
Poddubnyy D, Sieper J. Similarities and differences between nonradiographic and radiographic axial spondyloarthritis: a clinical, epidemiological and therapeutic assessment. Curr Opin Rheumatol. 2014;26(4):377–83.CrossRefPubMed
7.
López-Medina C, Ramiro S, van der Heijde D, et al. Characteristics and burden of disease in patients with radiographic and non-radiographic axial spondyloarthritis: a comparison by systematic literature review and meta-analysis. RMD Open. 2019;5(2): e001108.CrossRefPubMedPubMedCentral
8.
Robinson PC, Sengupta R, Siebert S. Non-radiographic axial spondyloarthritis (nr-axSpA): advances in classification, imaging and therapy. Rheumatol Ther. 2019;6(2):165–77.CrossRefPubMedPubMedCentral
9.
Nikiphorou E, Ramiro S, van der Heijde D, et al. Association of comorbidities in spondyloarthritis with poor function, work disability, and quality of life: results from the Assessment of SpondyloArthritis International Society Comorbidities in Spondyloarthritis Study. Arthritis Care Res (Hoboken). 2018;70(8):1257–62.CrossRefPubMed
10.
Mease PJ, Heijde DV, Karki C, et al. Characterization of patients with ankylosing spondylitis and nonradiographic axial spondyloarthritis in the US-Based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70(11):1661–70.CrossRefPubMed
11.
Kiltz U, Essers I, Hiligsmann M, et al. Which aspects of health are most important for patients with spondyloarthritis? A Best Worst Scaling based on the ASAS Health Index. Rheumatology (Oxford). 2016;55(10):1771–6.CrossRefPubMed
12.
Walsh JA, Song X, Kim G, Park Y. Healthcare utilization and direct costs in patients with ankylosing spondylitis using a large US administrative claims database. Rheumatol Ther. 2018;5(2):463–74.CrossRefPubMedPubMedCentral
13.
Kiltz U, Baraliakos X, Karakostas P, et al. Do patients with non-radiographic axial spondylarthritis differ from patients with ankylosing spondylitis? Arthritis Care Res (Hoboken). 2012;64(9):1415–22.CrossRefPubMed
14.
van der Heijde D, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978–91.CrossRefPubMed
15.
Ward MM, Deodhar A, Gensler LS, et al. 2019 update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Care Res. 2019;71(10):1285–99.CrossRef
16.
Ramiro S, Nikiphorou E, Sepriano A et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis 2023;82(1):19–34.
17.
Deodhar A, Van den Bosch F, Poddubnyy D, et al. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10349):369–79.CrossRefPubMed
18.
van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984;27(4):361–8.CrossRefPubMed
19.
Doward LC, Spoorenberg A, Cook SA, et al. Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann Rheum Dis. 2003;62(1):20–6.CrossRefPubMedPubMedCentral
20.
Kiltz U, van der Heijde D, Boonen A, et al. Development of a health index in patients with ankylosing spondylitis (ASAS HI): final result of a global initiative based on the ICF guided by ASAS. Ann Rheum Dis. 2015;74(5):830–5.CrossRefPubMed
21.
Braun J, Brandt J, Listing J, et al. Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet. 2002;359(9313):1187–93.CrossRefPubMed
22.
Reilly MC, Gooch KL, Wong RL, Kupper H, van der Heijde D. Validity, reliability and responsiveness of the Work Productivity and Activity Impairment Questionnaire in ankylosing spondylitis. Rheumatology (Oxford). 2010;49(4):812–9.CrossRefPubMed
23.
Kiltz U, van der Heijde D, Boonen A, et al. Measurement properties of the ASAS Health Index: results of a global study in patients with axial and peripheral spondyloarthritis. Ann Rheum Dis. 2018;77(9):1311–7.CrossRefPubMed
24.
Strand V, Boers M, Idzerda L, et al. It’s good to feel better but it’s better to feel good and even better to feel good as soon as possible for as long as possible. Response criteria and the importance of change at OMERACT 10. J Rheumatol. 2011;38(8):1720–7.CrossRefPubMed
25.
Siwek J, Newman DH. Introducing medicine by the numbers: A collaboration of The NNT Group and AFP. Am Fam Physician. 2015;91(7):434–5.PubMed
26.
27.
Kishimoto M, Ono K, Fukui S, et al. Clinical characteristics of non-radiographic versus radiographic axial spondyloarthritis in Asia and non-radiographic axial spondyloarthritis in other regions: results of the cross-sectional ASAS-COMOSPA study. RMD Open. 2021;7(3): e001752.CrossRefPubMedPubMedCentral
28.
Deodhar A, Mease P, Rahman P, et al. Ixekizumab improves patient-reported outcomes in non-radiographic axial spondyloarthritis: results from the Coast-X trial. Rheumatol Ther. 2021;8(1):135–50.CrossRefPubMed
29.
Walsh JA, Magrey MN, Baraliakos X, et al. Improvement of functioning and health with ixekizumab in the treatment of active nonradiographic axial spondyloarthritis in a 52-week, randomized, controlled trial. Arthritis Care Res (Hoboken). 2022;74(3):451–60.CrossRefPubMed
30.
van der Heijde D, Joshi A, Pangan AL, et al. ASAS40 and ASDAS clinical responses in the ABILITY-1 clinical trial translate to meaningful improvements in physical function, health-related quality of life and work productivity in patients with non-radiographic axial spondyloarthritis. Rheumatology (Oxford). 2016;55(1):80–8.CrossRefPubMed
31.
Sieper J, Kivitz A, van Tubergen A, et al. Long-term maintenance of improvements in patient-reported outcomes with certolizumab pegol in patients with axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis: 96-week results of the RAPID-axSpA study. Value Health. 2014;17(7):A385–6.CrossRefPubMed
32.
Sieper J, van der Heijde D, Dougados M, et al. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015;67(10):2702–12.CrossRefPubMedPubMedCentral
33.
Mease P, Walsh JA, Baraliakos X, et al. Translating improvements with ixekizumab in clinical trial outcomes into clinical practice: ASAS40, pain, fatigue, and sleep in ankylosing spondylitis. Rheumatol Ther. 2019;6(3):435–50.CrossRefPubMedPubMedCentral
34.
Stebbings SM, Treharne GJ, Jenks K, Highton J. Fatigue in patients with spondyloarthritis associates with disease activity, quality of life and inflammatory bowel symptoms. Clin Rheumatol. 2014;33(10):1467–74.CrossRefPubMed
35.
Dougados M, van der Heijde D, Tsai WC, et al. Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study. Health Qual Life Outcomes. 2020;18(1):4.CrossRefPubMedPubMedCentral
36.
van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441–51.CrossRefPubMed
37.
van der Heijde D, Baraliakos X, Sieper J, et al. 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;81(11):1515–23.CrossRefPubMed
Metadata
Title
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
Authors
Uta Kiltz
Mitsumasa Kishimoto
Jessica A. Walsh
Percival Sampaio-Barros
Manish Mittal
Christopher D. Saffore
Peter Wung
Fabiana Ganz
Ana Biljan
Denis Poddubnyy
Publication date
16-05-2023
Publisher
Springer Healthcare
Published in
Rheumatology and Therapy / Issue 4/2023
Print ISSN: 2198-6576
Electronic ISSN: 2198-6584
DOI
https://doi.org/10.1007/s40744-023-00550-4

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