TY - JOUR
T1 - Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis
T2 - results from two phase 3 studies
AU - Dubreuil, Maureen
AU - Navarro-Compan, Victoria
AU - Boonen, Annelies
AU - Gaffney, Karl
AU - Gensler, Lianne S.
AU - de la Loge, Christine
AU - Vaux, Thomas
AU - Fleurinck, Carmen
AU - Massow, Ute
AU - Taieb, Vanessa
AU - Morup, Michael F.
AU - Deodhar, Atul
AU - Rudwaleit, Martin
PY - 2024/6/1
Y1 - 2024/6/1
N2 - 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.
AB - 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.
KW - Spondylitis, Ankylosing
KW - Health-Related Quality Of Life
KW - Patient Reported Outcome Measures
KW - Biological Therapy
KW - ANKYLOSING-SPONDYLITIS
KW - VALIDITY
KW - BURDEN
U2 - 10.1136/rmdopen-2024-004202
DO - 10.1136/rmdopen-2024-004202
M3 - Article
SN - 2056-5933
VL - 10
JO - RMD Open
JF - RMD Open
IS - 2
M1 - e004202
ER -