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.

Details

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
Author
Kiltz, Uta 1   VIAFID ORCID Logo  ; Kishimoto, Mitsumasa 2 ; Walsh, Jessica A. 3 ; Sampaio-Barros, Percival 4 ; Mittal, Manish 5 ; Saffore, Christopher D. 5 ; Wung, Peter 5 ; Ganz, Fabiana 5 ; Biljan, Ana 5 ; Poddubnyy, Denis 6 

1  Ruhr-Universität Bochum, Bochum, Germany (GRID:grid.5570.7) (ISNI:0000 0004 0490 981X); Department of Rheumatology, Rheumazentrum Ruhrgebiet, Herne, Germany (GRID:grid.476674.0) (ISNI:0000 0004 0559 133X) 
2  Kyorin University School of Medicine, Department of Nephrology and Rheumatology, Tokyo, Japan (GRID:grid.411205.3) (ISNI:0000 0000 9340 2869) 
3  University of Utah and Salt Lake City Veterans Affairs Health, Salt Lake City, USA (GRID:grid.223827.e) (ISNI:0000 0001 2193 0096) 
4  Universidade de São Paulo, Division of Rheumatology, Faculdade de Medicina, Hospital das Clinicas HCFMUSP, São Paulo, Brazil (GRID:grid.11899.38) (ISNI:0000 0004 1937 0722) 
5  AbbVie Inc, North Chicago, USA (GRID:grid.431072.3) (ISNI:0000 0004 0572 4227) 
6  Charité, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Gastroenterology, Infectious Diseases and Rheumatology (Including Nutrition Medicine), Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662); German Rheumatism Research Centre, Epidemiology Unit, Berlin, Germany (GRID:grid.418217.9) (ISNI:0000 0000 9323 8675) 
Pages
887-899
Publication year
2023
Publication date
Aug 2023
Publisher
Springer Nature B.V.
ISSN
21986576
e-ISSN
21986584
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1007/s40744-023-00550-4
ProQuest document ID
2867131639
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.