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

Rheumatology and Therapy · 10 authors, 8 centres

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TL;DR

This randomized controlled trial compared upadacitinib to placebo in 313 patients with active non-radiographic axial spondyloarthritis. Upadacitinib treatment led to significantly greater improvements in health-related quality of life and work productivity at 14 weeks.

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This is a phase 3, randomized, placebo-controlled trial (SELECT-AXIS 2) assessing upadacitinib in 313 adult patients with active non-radiographic axial spondyloarthritis. Outcomes included mean change from baseline through 14 weeks for health-related quality of life (HRQoL) measures (ASQoL, ASAS HI, SF-36 PCS) and work productivity (WPAI). At week 14, upadacitinib resulted in statistically significant improvements versus placebo in ASQoL, ASAS HI, SF-36 PCS, and WPAI overall work impairment. A greater proportion of upadacitinib-treated patients achieved clinically meaningful improvements (≥MCID) in ASQoL, ASAS HI, and SF-36 PCS, with numbers needed to treat <10 for all. Improvements were observed as early as weeks 2-4. The results suggest upadacitinib provides clinically meaningful improvements in HRQoL and work productivity for this patient population.

STUDY TYPE

RCT

SPECIALTY

rheumatology

SUMMARISED BY

AI pipeline

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100% · A

ORIGINAL PAPER

PMC10186301

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

Rheumatology and Therapy

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ABSTRACT

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. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-023-00550-4. Keywords: Non-radiographic axial spondyloarthritis, Patient-reported outcomes, Quality of life, Upadacitinib

CITATION EXPORT

Uta Kiltz, Mitsumasa Kishimoto, Jessica A Walsh et al.. 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. Rheumatology and Therapy. (2023). https://doi.org/10.1007/s40744-023-00550-4

AUTHORS

10 · 8 CENTRES

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

1Ruhr-Universität Bochum, Bochum, Germany
2Rheumazentrum Ruhrgebiet, Department of Rheumatology, Claudiusstr. 45, 44649 Herne, Germany
3Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan
4University of Utah and Salt Lake City Veterans Affairs Health, Salt Lake City, UT USA
5Division of Rheumatology, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil
6AbbVie Inc, North Chicago, IL USA
7Department of Gastroenterology, Infectious Diseases and Rheumatology (Including Nutrition Medicine), Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
8Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany