非放射性轴性脊柱关节炎患者的疾病活动状态或临床应答与患者报告结局的关系：来自随机对照 EMBARK 研究的 104 周结果。
Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study.
机构信息
Paris Descartes University, Department of Rheumatology, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, INSERM (U1153), Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité, Paris, France.
Leiden University Medical Center, Leiden, The Netherlands.
出版信息
Health Qual Life Outcomes. 2020 Jan 3;18(1):4. doi: 10.1186/s12955-019-1260-4.
BACKGROUND
We assessed the external validity of composite indices Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Assessment in SpondyloArthritis international Society (ASAS) 40 response (ASAS40) by evaluating the correlations between the changes in some patient reported outcomes (PROs) for patients with non-radiographic axial spondyloarthritis (nr-axSpA) and the changes in the scores of the composite indices.
METHODS
This was a post-hoc analysis of data from the EMBARK study in patients with nr-axSpA treated with etanercept. PROs were grouped according to ASDAS status (inactive [< 1.3], low [≥ 1.3 to < 2.1], high [≥ 2.1 to ≤3.5], and very high [> 3.5]), patient achievement of > 50% improvement in BASDAI (BASDAI50 responders), and > 40% improvement in ASAS (ASAS40 responders) at 104 weeks. Analyses were conducted on observed cases available at Week 104. Changes in PROs from Baseline to Week 104 were assessed using analysis of covariance with adjustment for baseline with linear contrast.
RESULTS
Higher ASDAS disease activity at 104 weeks was associated with lower long-term improvement from baseline in PROs (e.g., total back pain [visual analog scale, cm (95% confidence interval): - 4.58 (- 4.95, - 4.21), - 3.86 (- 4.28, - 3.43), - 2.15 (- 2.68, - 1.61), and 1.30 (- 0.51, 3.12) for inactive, low, high, and very high ASDAS disease activity, respectively; Multidimensional Fatigue Inventory (MFI) general fatigue: - 4.77 (- 5.70, - 3.84), - 2.96 (- 4.04, - 1.87), - 1.00 (- 2.32, 0.31), and 2.14 (- 2.10, 6.38); all p < 0.001)]. BASDAI50 non-responders had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: - 1.61 (- 2.05, - 1.18) vs. -4.43 (- 4.69, - 4.18); MFI general fatigue: - 0.01 (- 1.12, 1.09) vs. -4.30 (- 4.98, - 3.62); all p < 0.001). ASAS40 non-responders also had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: - 1.91 (- 2.30, - 1.52) vs. -4.75 (- 5.05, - 4.46); MFI general fatigue: - 0.63 (- 1.56, 0.30) vs. -4.64 (- 5.37, - 3.91); all p < 0.001).
CONCLUSION
Composite indices are valid for monitoring treatment response and adequately reflect treatment-related changes experienced by patients with nr-axSpA.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT01258738. Registered 9 December 2010.
背景
我们评估了复合指标强直性脊柱炎疾病活动评分（ASDAS）、巴斯强直性脊柱炎疾病活动指数（BASDAI）和脊柱关节炎国际协会（ASAS）40 反应（ASAS40）的外部有效性，方法是评估非放射性轴性脊柱关节炎（nr-axSpA）患者的一些患者报告结果（PROs）的变化与复合指标评分的变化之间的相关性。
方法
这是一项对接受依那西普治疗的 nr-axSpA 患者的 EMBARK 研究数据的事后分析。PROs 根据 ASDAS 状态（无活动 [<1.3]、低 [≥1.3 至 <2.1]、高 [≥2.1 至 ≤3.5] 和非常高 [>3.5]）、患者在 104 周时实现 BASDAI 改善 >50%（BASDAI50 应答者）和 ASAS 改善 >40%（ASAS40 应答者）进行分组。在第 104 周可观察到的病例上进行了分析。使用协方差分析，根据基线进行调整，用线性对比评估从基线到第 104 周 PROs 的变化。
结果
104 周时 ASDAS 疾病活动度较高与 PROs 从基线的长期改善程度较低相关（例如，总背痛[视觉模拟量表，cm（95%置信区间）：-4.58（-4.95，-4.21）、-3.86（-4.28，-3.43）、-2.15（-2.68，-1.61）和 1.30（-0.51，3.12），分别用于无活动、低、高和非常高的 ASDAS 疾病活动度；多维疲劳量表（MFI）一般疲劳：-4.77（-5.70，-3.84）、-2.96（-4.04，-1.87）、-1.00（-2.32，0.31）和 2.14（-2.10，6.38）；所有 p<0.001）]。BASDAI50 非应答者与应答者相比，PROs 从基线到第 104 周的改善程度较低（例如，总背痛：-1.61（-2.05，-1.18）与-4.43（-4.69，-4.18）；MFI 一般疲劳：-0.01（-1.12，1.09）与-4.30（-4.98，-3.62）；所有 p<0.001）。ASAS40 非应答者与应答者相比，PROs 从基线到第 104 周的改善程度也较低（例如，总背痛：-1.91（-2.30，-1.52）与-4.75（-5.05，-4.46）；MFI 一般疲劳：-0.63（-1.56，0.30）与-4.64（-5.37，-3.91）；所有 p<0.001）。
结论
复合指标可有效监测治疗反应，充分反映患者对 nr-axSpA 的治疗反应。
试验注册
ClinicalTrials.gov 标识符：NCT01258738。注册于 2010 年 12 月 9 日。
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