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
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..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Rheumatology and therapy - 10(2023), 4 vom: 16. Mai, Seite 887-899 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kiltz, Uta [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
Non-radiographic axial spondyloarthritis |
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| Anmerkungen: |
© The Author(s) 2023 |
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| doi: |
10.1007/s40744-023-00550-4 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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OLC2144344620 |
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| 520 | |a 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. | ||
| 650 | 4 | |a Non-radiographic axial spondyloarthritis | |
| 650 | 4 | |a Patient-reported outcomes | |
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| 700 | 1 | |a Kishimoto, Mitsumasa |4 aut | |
| 700 | 1 | |a Walsh, Jessica A. |4 aut | |
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| 700 | 1 | |a Mittal, Manish |4 aut | |
| 700 | 1 | |a Saffore, Christopher D. |4 aut | |
| 700 | 1 | |a Wung, Peter |4 aut | |
| 700 | 1 | |a Ganz, Fabiana |4 aut | |
| 700 | 1 | |a Biljan, Ana |4 aut | |
| 700 | 1 | |a Poddubnyy, Denis |4 aut | |
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