Wei James Cheng-Chung, Tsai Wen-Chan, Citera Gustavo, Kotak Sameer, Llamado Lyndon
Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan.
Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
Int J Rheum Dis. 2018 Jul;21(7):1443-1451. doi: 10.1111/1756-185X.12973. Epub 2016 Nov 11.
To evaluate etanercept in patients from Latin America, Central/Eastern Europe, and Asia with non-radiographic axial spondyloarthritis (nr-axSpA).
A subset analysis was performed on nr-axSpA patients from Argentina, Colombia, the Czech Republic, Hungary, Russia and Taiwan who were enrolled in EMBARK (NCT01258738). Patients received either etanercept 50 mg or placebo once weekly. The primary endpoint was proportion of patients achieving 40% improvement from baseline based on Assessment of SpondyloArthritis International Society (ASAS) criteria. Secondary endpoints included other efficacy assessments, health-related quality of life (HRQoL) and safety.
Of the 117 patients in this subset, 59 were treated with etanercept and 58 received placebo. At week 12, numerically greater improvements from baseline were observed for all efficacy endpoints in etanercept-treated patients compared with those receiving placebo. Statistically significant differences between the two treatment groups were observed for proportion of patients achieving ASAS40 (P = 0.0413, at week 8), ASAS5/6 (P = 0.0126), Ankylosing Spondylitis Disease Activity Score - C-reactive protein (CRP) inactive disease (P = 0.0093), Spondyloarthritis Research Consortium of Canada magnetic resonance imaging of sacroiliac joint scores (P = 0.0014), high-sensitivity CRP (P=0.032), and erythrocyte sedimentation rate (P = 0.0082). Statistically significant improvements in the etanercept-treated group compared with placebo group were observed for nocturnal back pain (P = 0.040), total back pain (P = 0.025), physician global assessment of disease (P = 0.023), and Work Productivity and Activity Impairment Questionnaire percent impairment while working (P = 0.047). Adverse events were similar between the two treatment groups.
In this subset of patients with nr-axSpA from Latin America, Central/Eastern Europe, and Asia, treatment with etanercept, compared with placebo, resulted in improved disease symptoms and patient HRQoL. Etanercept was well tolerated.
评估依那西普对来自拉丁美洲、中东欧和亚洲的非放射性中轴型脊柱关节炎（nr-axSpA）患者的疗效。
对来自阿根廷、哥伦比亚、捷克共和国、匈牙利、俄罗斯和台湾地区，纳入EMBARK研究（NCT01258738）的nr-axSpA患者进行亚组分析。患者接受每周一次50mg依那西普或安慰剂治疗。主要终点是根据国际脊柱关节炎评估协会（ASAS）标准，自基线改善40%的患者比例。次要终点包括其他疗效评估、健康相关生活质量（HRQoL）和安全性。
该亚组的117例患者中，59例接受依那西普治疗，58例接受安慰剂治疗。在第12周时，与接受安慰剂治疗的患者相比，依那西普治疗的患者在所有疗效终点上从基线的改善在数值上更大。两个治疗组在达到ASAS40（第8周时P = 0.0413）、ASAS5/6（P = 0.0126）、强直性脊柱炎疾病活动评分- C反应蛋白（CRP）非活动疾病（P = 0.0093）、加拿大脊柱关节炎研究联盟骶髂关节磁共振成像评分（P = 0.0014）、高敏CRP（P = 0.032）和红细胞沉降率（P = 0.0082）的患者比例上观察到统计学显著差异。与安慰剂组相比，依那西普治疗组在夜间背痛（P = 0.040）、总背痛（P = 0.025）、医生对疾病的整体评估（P = 0.023）以及工作时工作效率和活动障碍问卷的损伤百分比（P = 0.047）方面观察到统计学显著改善。两个治疗组的不良事件相似。
在该来自拉丁美洲、中东欧和亚洲的nr-axSpA患者亚组中，与安慰剂相比，依那西普治疗可改善疾病症状和患者的HRQoL。依那西普耐受性良好。
