依那西普与柳氮磺吡啶治疗强直性脊柱炎的临床疗效与安全性比较：一项随机双盲研究（ASCEND试验）

原文

译文

Clinical efficacy and safety of etanercept versus sulfasalazine in ankylosing spondylitis patients: A randomized, double-blind study (ASCEND Trial)

1. Juergen Braun¹,

2. Irene E van der Horst-Bruinsma²,

3. Feng Huang³,

4. Ruben Burgos-Vargas⁴,

5. Bonnie Vlahos⁵,

6. Andy S Koenig^5,*,†,

7. Bruce Freundlich⁵

DOI: 10.1002/art.30223

Abstract

Background:

Etanercept, a fully human TNF receptor is an effective treatment in patients with ankylosing spondylitis (AS). Sulfasalazine is frequently used for the treatment of both axial and peripheral symptoms of AS, and it has been recommended for use before anti-TNF agents. Until now, no clinical trial has compared the efficacy and safety of a TNF blocker with sulfasalazine.

Objective:

To compare the efficacy and safety of etanercept versus sulfasalazine after 16 weeks in patients with axial and peripheral manifestations of AS.

Methods:

In this randomized, double-blind study, subjects received etanercept 50 mg once weekly (n=379) or sulfasalazine titrated to a maximum of 3 g/day (n=187) for 16 weeks. The primary endpoint was the proportion of subjects who achieved ASAS20 (20% improvement by the Assessment in AS criteria) at 16 weeks. Last observation carried forward was predefined for imputation of missing values.

Results:

Mean age was 41 years, 74% were male, and average disease duration was 7.6 years. The proportion of ASAS20 responders was greater with etanercept compared with sulfasalazine at Week 16 (75.9% versus 52.9%; P<0.0001). Etanercept was more effective than sulfasalazine (P<0.0001) as early as Week 2 for both axial and peripheral manifestations. Serious adverse events rarely occurred and did not differ between groups.

Conclusions:

In this population of patients with AS, etanercept was significantly more effective than sulfasalazine in improving signs and symptoms of the axial skeleton and of the peripheral joints.

依那西普与柳氮磺吡啶治疗强直性脊柱炎的临床疗效与安全性比较：一项随机双盲研究（ASCEND试验）

Juergen Braun,et al. Arthritis & Rheumatism DOI: 10.1002/art.30223

背景：依那西普是一种全人源化TNF受体，能有效治疗AS患者。柳氮磺吡啶常用于治疗AS的中轴和外周症状，推荐在TNF抑制剂之前使用。目前尚无临床试验比较TNF抑制剂与柳氮磺吡啶的疗效和安全性。

目的：比较依那西普和柳氮磺吡啶治疗AS患者16周的疗效和安全性。

方法：在这项随机双盲研究中，患者使用依那西普50mg/周（n=379）或柳氮磺吡啶逐渐增量至最大剂量3g/天（n=187），共16周。主要终点为第16周达到ASAS20的患者比例。

结果：患者平均年龄41岁，74%为男性，平均病程7.6年。在第16周，依那西普组达到ASAS20的患者比例显著高于柳氮磺吡啶组（75.9% 比52.9%; P<0.0001）。早在第2周，依那西普就显示出比柳氮磺吡啶更为有效地改善中轴和外周症状（P<0.0001）。严重不良事件发生率极低，且两组间没有差异。

结论：在这部分AS患者中，依那西普比柳氮磺吡啶更能有效改善中轴骨骼和外周关节的体征和症状。