Department of Rheumatology, Boston University School of Medicine, Boston, Massachusetts, USA
Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain.
RMD Open. 2024 Jun 4;10(2):e004202. doi: 10.1136/rmdopen-2024-004202.
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.
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).
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.
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.
NCT03928704; NCT03928743.
评估比美吉单抗对非放射性（nr-）和放射性（r-）轴性脊柱关节炎（axSpA）患者的身体功能、睡眠、工作生产力和总体健康相关生活质量（HRQoL）的影响，这些患者在 3 期研究 BE MOBILE 1 和 2 中。
患者被随机分配接受皮下注射比美吉单抗 160mg 或安慰剂，每 4 周一次；从第 16 周开始，所有患者每 4 周接受一次比美吉单抗 160mg。我们报告以下结果至第 52 周： Bath 强直性脊柱炎功能指数（BASFI）、医学结果研究睡眠量表修订版（MOS-Sleep-R）指数 II、工作生产力和活动障碍：axSpA（WPAI:axSpA）、36 项简短形式健康调查物理和精神成分综合评分（SF-36 PCS/MCS）和强直性脊柱炎生活质量（ASQoL）。
在第 16 周，与安慰剂相比，比美吉单抗治疗的患者在 BASFI、SF-36 PCS 和 ASQoL 方面从基线显著改善（p<0.001），MOS-Sleep-R 指数 II 和 WPAI:axSpA 评分也有数值上的改善。与安慰剂相比，更多的比美吉单抗治疗的患者在第 16 周达到了 BASFI（从基线下降 0 到≤4）、SF-36 PCS（从基线增加≥5 分）和 ASQoL（从基线下降≥4 分）的严格改善标准。反应持续或进一步改善至第 52 周，60%-70%的比美吉单抗治疗的患者实现了 BASFI≤4 和 SF-36 PCS 和 ASQoL 的有意义改善，无论最初是随机接受比美吉单抗还是安慰剂。
在整个 axSpA 疾病谱的患者中，比美吉单抗治疗在第 16 周时就导致了身体功能、睡眠、工作生产力和总体 HRQoL 的早期改善。这些改善持续到第 52 周。
NCT03928704；NCT03928743。
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