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Dubreuil, Maureen, Navarro-Compán, Victoria, Boonen, Annelies, Gaffney, Karl 
ORCID: https://orcid.org/0000-0002-7863-9176, Gensler, Lianne S., de la Loge, Christine, Vaux, Thomas, Fleurinck, Carmen, Massow, Ute, Taieb, Vanessa, Mørup, Michael F., Deodhar, Atul and Rudwaleit, Martin
(2024)
Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: Results from two phase 3 studies.
RMD Open, 10 (2).
ISSN 2056-5933
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Abstract
Objective To assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2. Methods Patients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL). Results At Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%-70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo. Conclusion Bimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52. Trial registration numbers NCT03928704; NCT03928743.
| Item Type: | Article |
|---|---|
| Additional Information: | Funding Information: This article was based on the original studies BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743) which were sponsored by UCB Pharma. Support for third-party writing assistance for this article, provided by Chloe Foulds, MBiol, and Kaity McCafferty, BSc, Costello Medical, UK, was funded by UCB Pharma in accordance with Good Publication Practice 2022 guidelines (https://www.ismpp.org/gpp-2022). |
| Uncontrolled Keywords: | biological therapy,health-related quality of life,patient reported outcome measures,spondylitis, ankylosing,rheumatology,immunology and allergy,immunology ,/dk/atira/pure/subjectarea/asjc/2700/2745 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 02 Sep 2024 08:31 |
| Last Modified: | 25 Sep 2024 18:04 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/96408 |
| DOI: | 10.1136/rmdopen-2024-004202 |
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