Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis
Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis
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DOI：
10.1093/rheumatology/keh475
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发表时间：
2005-03-01
期刊：
影响因子：
5.5
通讯作者：
Braun, J
中科院分区：
文献类型：
--
作者：
Brandt, J;Listing, J;Braun, J
目标.在有限时期的随机对照试验（RCT）中，肿瘤坏死因子α（TNF-α）受体融合蛋白依那西普治疗强直性脊柱炎（AS）在活动性疾病患者中显示出疗效。本研究的目的是评估依那西普治疗1年以上的长期疗效和安全性，包括停药和再给药。在这项为期54周的开放性观察性研究中，26例AS患者在使用相同药物进行6个月RCT后停药数月后接受25 mg依那西普皮下注射，每周两次。所有在依那西普停药后发生高疾病活动的患者，定义为巴斯强直性脊柱炎疾病活动指数（BASDAI）大于或等于4，疼痛大于或等于4的数字评定量表，进入研究。使用标准评估工具，如Bath强直性脊柱炎功能指数（BASFI）。进行了意向治疗（ITT）和完成者分析。将结果与开放研究的基线值进行比较。在最初的30例患者中，26例（87%）在平均约27周后有资格参加开放扩展研究。第54周时，23/26例患者（88%）仍在接受依那西普治疗。ITT分析显示，58%（95%置信区间39-74%）的患者在第54周时BASDAI改善50%。根据强直性脊柱炎评估工作组标准，8/26例患者（31%）在第54周时部分缓解。功能、计量和生活质量显著改善。仅1例患者发生严重不良事件导致停药。这项研究表明，在未服用DMARD或类固醇的活动性AS患者中，依那西普治疗在重新给药1年后有效且安全。
Objectives. Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor alpha (TNF-alpha) receptor fusion protein etanercept has shown efficacy in patients with active disease in randomized controlled trials (RCTs) for limited periods. The objective of the study was to assess the long-term efficacy and safety of etanercept over 1 yr, including discontinuation and readministration.Methods. In this 54-week open observational study, 26 AS patients received 25 mg etanercept subcutaneously twice weekly after several months of discontinuation following a 6-month RCT with the same agent. All patients who developed high disease activity after cessation of etanercept, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater than or equal to4 and pain greater than or equal to4 on a numerical rating scale, entered the study. Standard assessment tools, such as the Bath Ankylosing Spondylitis functional index (BASFI), were used. An intention-to-treat (ITT) and a completer analysis were performed. The results were compared with the baseline values of the open study.Results. Out of the initial 30 patients, 26 (87%) were eligible for the open extension study after a mean of about 27 weeks. At week 54, 23/26 patients (88%) were still on treatment with etanercept. The ITT analysis showed that 58% (95% confidence interval 39-74%) of the patients achieved a 50% improvement of BASDAI at week 54. According to the Assessments in Ankylosing Spondylitis working group criteria, 8/26 patients (31%) were in partial remission at week 54. Function, metrology and quality of life improved significantly. Only one patient had a serious adverse event that resulted in discontinuation.Conclusions. This study shows that treatment with etanercept is efficacious and safe after readministration over 1 yr in patients with active AS not taking DMARDs or steroids.