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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.
Health and Quality of Life Outcomes ( IF 3.2 ) Pub Date : 2020-01-03 , DOI: 10.1186/s12955-019-1260-4
Maxime Dougados , Désirée van der Heijde , Wen-Chan Tsai , Diego Saaibi , Lisa Marshall , Heather Jones , Ron Pedersen , Bonnie Vlahos , Miriam Tarallo

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.

中文翻译:

非放射线轴性脊柱关节炎患者的疾病活动状态或临床反应与患者报告的结局之间的关系:随机对照EMBARK研究的104周结果。

背景我们评估了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)的综合指数的外部有效性,方法是评估一些患者报告了非放射线轴性脊柱关节炎(nr-axSpA)患者的结局(PROs)及其综合指数得分的变化。方法这是对依那西普治疗的nr-axSpA患者的EMBARK研究数据的事后分析。根据ASDAS状态对PRO进行分组(无效[<1.3],低[≥1.3至<2.1],高[≥2.1至≤3.5]和非常高[> 3.5]),患者的BASDAI改善> 50% (BASDAI50个响应者),以及> 104周时,ASAS(ASAS40响应者)改善了40%。对第104周时可观察到的病例进行了分析。使用协方差分析并通过线性对比对基线进行了调整,评估了从基线到104周时PRO的变化。结果104周时,较高的ASDAS疾病活动性与PRO中基线水平的长期改善较低相关(例如,总背痛[视觉类似物评分,cm(95%置信区间):-4.58(-4.95,-4.21),-分别针对无效,低,高和非常高的ASDAS疾病活动分别为3.86(-4.28,-3.43),-2.15(-2.68,-1.61)和1.30(-0.51、3.12);多维疲劳清单(MFI)常规疲劳:-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无反应者与基线相比,从基线到第104周的PRO改善较少(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)。与响应者相比,ASAS40无反应者从基线到第104周的PRO改善也较小(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)。结论综合指数可有效监测治疗反应并充分反映nr-axSpA患者的治疗相关变化。试验注册ClinicalTrials.gov标识符:NCT01258738。2010年12月9日注册。-1.18)--4.43(-4.69,-4.18);MFI一般疲劳:-0.01(-1.12,1.09)对-4.30(-4.98,-3.62); 所有p <0.001)。与响应者相比,ASAS40无反应者从基线到第104周的PRO改善也较小(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)。结论综合指数可有效监测治疗反应并充分反映nr-axSpA患者的治疗相关变化。试验注册ClinicalTrials.gov标识符:NCT01258738。2010年12月9日注册。-1.18)--4.43(-4.69,-4.18);MFI一般疲劳:-0.01(-1.12,1.09)对-4.30(-4.98,-3.62); 所有p <0.001)。与响应者相比,ASAS40无反应者从基线到第104周的PRO改善也较小(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)。结论综合指数可有效监测治疗反应并充分反映nr-axSpA患者的治疗相关变化。试验注册ClinicalTrials.gov标识符:NCT01258738。2010年12月9日注册。反应者(例如总背痛:-1.91(-2.30,-1.52)比-4.75(-5.05,-4.46); MFI一般疲劳:-0.63(-1.56,0.30)比-4.64(-5.37,- 3.91);所有p <0.001)。结论综合指数可有效监测治疗反应并充分反映nr-axSpA患者的治疗相关变化。试验注册ClinicalTrials.gov标识符:NCT01258738。2010年12月9日注册。反应者(例如总背痛:-1.91(-2.30,-1.52)比-4.75(-5.05,-4.46); MFI一般疲劳:-0.63(-1.56,0.30)比-4.64(-5.37,- 3.91);所有p <0.001)。结论综合指数可有效监测治疗反应并充分反映nr-axSpA患者的治疗相关变化。试验注册ClinicalTrials.gov标识符:NCT01258738。2010年12月9日注册。
更新日期:2020-01-04
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