Baseline factors that influence ASAS 20 response in patients with ankylosing spondylitis treated with etanercept.
Baseline factors that influence ASAS 20 response in patients with ankylosing spondylitis treated with etanercept.
复制标题
DOI：
--
复制
发表时间：
2005-09
期刊：
影响因子：
--
通讯作者：
John C. Davis;D. van der Heijde;M. Dougados;J. Braun;J. Cush;D. Clegg;R. Inman;T. de Vries;W. Tsuji
中科院分区：
文献类型：
--
作者：
John C. Davis;D. van der Heijde;M. Dougados;J. Braun;J. Cush;D. Clegg;R. Inman;T. de Vries;W. Tsuji
目的 通过强直性脊柱炎（AS）患者的强直性脊柱炎反应标准评估（ASAS 20）来检查可能影响改善的基线人口和疾病特征。方法进行了一项多中心 3 期研究，比较 AS 患者每周两次皮下注射依那西普 25 mg (n = 138) 和安慰剂 (n = 139) 24 周的安全性和有效性。在多个时间点测量 ASAS 20。使用 0.05 的显着性水平，使用重复测量逻辑回归模型来确定在试验的 24 周双盲部分期间哪些基线因素影响依那西普治疗的患者的反应。模型中使用了以下基线因素：人口统计学和疾病严重程度变量、伴随药物、关节外表现和 HLA-B27 状态。然后在接受开放标签依那西普治疗后接受安慰剂的患者身上测试该模型的预测能力。结果 在依那西普治疗的患者中，作为 ASAS 20 反应显着预测因子的基线因素是 C 反应蛋白 (CRP)、背痛评分和巴斯强直性脊柱炎功能指数 (BASFI) 评分。尽管在所有基线疾病活动水平上均观察到依那西普的临床反应，但随着 CRP 水平或背痛评分的升高，反应的可能性始终较高，而随着基线 BASFI 评分的增加，反应的可能性较小。结论 基线时较高的 CRP 值和背痛评分以及较低的 BASFI 评分是接受依那西普的 AS 患者较高 ASAS 20 反应的显着预测因子，但预测值不足以确定个体患者的治疗。
OBJECTIVE To examine the baseline demographic and disease characteristics that might influence improvement as measured by the Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) in patients with ankylosing spondylitis (AS). METHODS A multicenter Phase 3 study was performed to compare the safety and efficacy of 24 weeks of etanercept 25 mg subcutaneous injection twice weekly (n = 138) and placebo (n = 139) in patients with AS. The ASAS 20 was measured at multiple time points. Using a significance level of 0.05, a repeated measures logistic regression model was used to determine which baseline factors influenced response in the etanercept-treated patients during the 24-week double blind portion of the trial. The following baseline factors were used in the model: demographic and disease severity variables, concomitant medications, extra-articular manifestations, and HLA-B27 status. The predictive capability of the model was then tested on the patients receiving placebo after they had received open-label etanercept treatment. RESULTS Baseline factors that were significant predictors of an ASAS 20 response in etanercept-treated patients were C-reactive protein (CRP), back pain score, and Bath Ankylosing Spondylitis Functional Index (BASFI) score. Although clinical response to etanercept was seen at all levels of baseline disease activity, responses were consistently more likely with higher CRP levels or back pain scores and less likely with increased BASFI scores at baseline. CONCLUSIONS Higher CRP values and back pain scores and lower BASFI scores at baseline were significant predictors of a higher ASAS 20 response in patients with AS receiving etanercept but predictive value was of insufficient magnitude to determine treatment in individual patients.