Department of Rheumatology, La Paz University Hospital, Madrid, Spain
Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.
RMD Open. 2024 Apr 10;10(2):e004040. doi: 10.1136/rmdopen-2023-004040.
To assess how achievement of increasingly stringent clinical response criteria and disease activity states at week 52 translate into changes in core domains in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA).
Patients in BE MOBILE 1 and 2 achieving different levels of response or disease activity (Assessment of SpondyloArthritis International Society (ASAS) and Ankylosing Spondylitis Disease Activity Score (ASDAS) response criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50)) at week 52 were pooled, regardless of treatment arm. Associations between achievement of these endpoints and change from baseline (CfB) in patient-reported outcomes (PROs) measuring core axSpA domains, including pain, fatigue, physical function, overall functioning and health, and work and employment, were assessed.
Achievement of increasingly stringent clinical efficacy endpoints at week 52 was generally associated with sequentially greater improvements from baseline in all PROs. Patients with nr-axSpA achieving ASAS40 demonstrated greater improvements (CfB) than patients who did not achieve ASAS40 but did achieve ASAS20, in total spinal pain (-5.3 vs -2.8, respectively), Functional Assessment of Chronic Illness-Fatigue subscale (12.7 vs 6.7), Bath Ankylosing Spondylitis Function Index (-3.9 vs -1.8), European Quality of Life 5-Dimension 3-Level Version (0.30 vs 0.16), Work Productivity and Activity Impairment-axSpA presenteeism (-35.4 vs -15.9), overall work impairment (-36.5 vs -12.9), activity impairment (-39.0 vs -21.0) and sleep (9.0 vs 3.9). Results were similar for ASDAS and BASDAI50. Similar amplitudes of improvement were observed between patients with nr-axSpA and r-axSpA.
Patients treated with bimekizumab across the full axSpA disease spectrum, who achieved increasingly stringent clinical response criteria and lower disease activity at week 52, reported larger improvements in core axSpA domains.
评估在第 52 周时，越来越严格的临床缓解标准和疾病活动状态的达标情况如何转化为非放射学（nr-）和放射学（r-）轴性脊柱关节炎（axSpA）患者的核心领域的变化。
将 BE MOBILE 1 和 2 中达到不同缓解或疾病活动水平（ASAS 和 ASDAS 缓解标准，BASDAI50）的患者进行汇总，无论治疗组如何。评估这些终点的达标情况与从基线（CfB）开始的患者报告的结局（PROs）变化之间的关联，这些 PROs 测量核心 axSpA 领域，包括疼痛、疲劳、身体功能、整体功能和健康以及工作和就业。
在第 52 周时，达到越来越严格的临床疗效终点通常与所有 PROs 从基线开始的逐渐改善相关。达到 ASAS40 的 nr-axSpA 患者在总脊柱疼痛（-5.3 与-2.8）、慢性疾病疲劳量表（12.7 与 6.7）、Bath 强直性脊柱炎功能指数（-3.9 与-1.8）、欧洲五维健康量表 3 级版（0.30 与 0.16）、工作生产力和活动障碍-axSpA 出席障碍（-35.4 与-15.9）、整体工作障碍（-36.5 与-12.9）、活动障碍（-39.0 与-21.0）和睡眠（9.0 与 3.9）方面的改善均大于未达到 ASAS40 但达到 ASAS20 的患者。ASDAS 和 BASDAI50 也得到了类似的结果。在 nr-axSpA 和 r-axSpA 患者之间观察到相似的改善幅度。
在整个 axSpA 疾病谱中接受 bimekizumab 治疗的患者，在第 52 周时达到越来越严格的临床缓解标准和较低的疾病活动度，报告了核心 axSpA 领域的更大改善。
