简化强直性脊柱炎疾病活动度评分 (SASDAS) 与 ASDAS 的比较：一项随机对照试验的事后分析。
Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) Versus ASDAS: A Post Hoc Analysis of a Randomized Controlled Trial.
机构信息
E.E. Schneeberger, MD, G. Citera, MD, Department of Rheumatology, Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina;
E.E. Schneeberger, MD, G. Citera, MD, Department of Rheumatology, Instituto de Rehabilitación Psicofísica, Buenos Aires, Argentina.
出版信息
J Rheumatol. 2022 Oct;49(10):1100-1108. doi: 10.3899/jrheum.211075. Epub 2022 Jul 15.
OBJECTIVE
To compare the Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) against the Ankylosing Spondylitis Disease Activity Score (ASDAS) for measuring and categorizing disease activity using data from the EMBARK trial (ClinicalTrials.gov: NCT01258738), a randomized controlled trial of etanercept (ETN) for axial spondyloarthritis (axSpA).
METHODS
Patients with early active axSpA received ETN 50 mg once weekly (n = 106) or placebo (PBO; n = 109) for 12 weeks in a double-blind manner; they then received open-label ETN for 92 weeks. For this analysis, ASDAS-C-reactive protein (CRP) and SASDAS-CRP were calculated at baseline, week 12, and week 24. The SASDAS was calculated by the linear addition of the ASDAS components without adjustment.
RESULTS
A very strong correlation, as determined by the Spearman correlation coefficient, was observed between the ASDAS and SASDAS for continuous variables at baseline and during treatment. For pooled categorical data at baseline, the SASDAS placed 69.9% of patients in the same disease categories as the ASDAS but overestimated for 17.8% of patients and underestimated for 12.2% of patients. A similar pattern was seen postbaseline. Cohen weighted [Formula: see text] statistics for all individual and pooled treatments and timepoints (0.54-0.73) reflected moderate to substantial agreement. The capacity to differentiate between treatments (ie, ETN and PBO/ETN) was higher with the ASDAS (effect size -0.74, 95% CI -1.03 to -0.46) compared with the SASDAS (effect size -0.51, 95% CI -0.79 to -0.23), but sensitivity to change was generally similar.
CONCLUSION
A very strong correlation between the SASDAS and ASDAS was observed when considering continuous variables; however, moderate to substantial agreement was observed for categorical data, and the SASDAS classified a lower proportion of patients as being in the inactive and low disease activity categories.
目的
使用 EMBARK 试验（ClinicalTrials.gov：NCT01258738）的数据，比较简化强直性脊柱炎疾病活动评分（SASDAS）与强直性脊柱炎疾病活动评分（ASDAS），以衡量和分类疾病活动度，该试验为依那西普（ETN）治疗轴性脊柱关节炎（axSpA）的随机对照试验。
方法
12 周双盲期内，106 例早期活动性 axSpA 患者接受 ETN 50mg 每周一次（n=106）或安慰剂（PBO；n=109）治疗，随后接受 92 周的开放标签 ETN 治疗。在此分析中，基线时、第 12 周及第 24 周时计算 ASDAS-C 反应蛋白（CRP）和 SASDAS-CRP。SASDAS 通过不调整的 ASDAS 成分的线性加和计算。
结果
基线时和治疗期间，Spearman 相关系数确定了 ASDAS 和 SASDAS 之间的高度相关，在基线时和治疗期间，连续性变量的相关性非常强。对于基线时的汇总分类数据，SASDAS 将 69.9%的患者置于与 ASDAS 相同的疾病类别中，但高估了 17.8%的患者，低估了 12.2%的患者。在基线后也出现了类似的模式。所有个体和汇总治疗及时间点的 Cohen 加权[公式：见文本]统计（0.54-0.73）反映了中度至高度一致性。与 SASDAS 相比（效应量-0.51，95%CI-0.79 至-0.23），ASDAS 更能区分治疗效果（即 ETN 和 PBO/ETN）（效应量-0.74，95%CI-1.03 至-0.46），但对变化的敏感性通常相似。
结论
考虑连续性变量时，SASDAS 与 ASDAS 之间存在高度相关，但分类数据的一致性为中度至高度，SASDAS 将较低比例的患者归类为处于不活动和低疾病活动类别。
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