Rheumatology Department, Hospital Universitario Virgen Macarena, Avenida Dr Fedriani 3, 41009 Sevilla, Spain.
Rheumatology (Oxford). 2011 Oct;50(10):1828-37. doi: 10.1093/rheumatology/ker083. Epub 2011 Jun 23.
Etanercept 50 mg a week is approved in the treatment of AS. Increasing the etanercept dose to 100 mg/week improves efficacy in cutaneous psoriasis, a clinical manifestation related to the spondylarthritis family, while maintaining its safety profile. The purpose of this study was to evaluate the efficacy and safety of etanercept 100 vs 50 mg/week in patients with AS.
Adult patients with AS were randomized to receive etanercept 50 mg twice a week (biw), or etanercept 50 mg once a week (qw) for 12 weeks. The primary efficacy endpoint was Ankylosing Spondylitis Assessment Study (ASAS20) response at Week 12; secondary endpoints included ASAS40, ASAS50, ASAS70 and ASAS5/6 responses, partial remission and quality of life. Safety was assessed until 15 days after the last visit.
A total of 108 patients were randomly selected and treated, 54 in each arm. At 12 weeks, ASAS20 response was achieved by 34 (71%) out of 48 patients of the etanercept 50 mg biw group and by 37 (76%) out of 49 patients of the etanercept 50 mg qw group (not statistically significant differences). Other efficacy variables improved significantly over time, but not between treatment groups. Fifty-six patients experienced at least one adverse event (generally, infections and infestations, gastrointestinal disorders and injection site reactions), most of them mild or moderate.
High-dose (100 mg/week) etanercept in the treatment of AS for 12 weeks is as safe as the standard dose (50 mg/week). However, it does not significantly increase its efficacy. Trial Registration. Clinicaltrials.gov, http://clinicaltrials.gov/, NCT00873730.
依那西普每周 50mg 已被批准用于治疗 AS。增加依那西普剂量至每周 100mg 可改善与脊柱关节病家族相关的皮肤银屑病的疗效，同时保持其安全性。本研究旨在评估依那西普 100mg/周与 50mg/周治疗 AS 患者的疗效和安全性。
成年 AS 患者随机分为接受依那西普 50mg 每周两次（biw）或每周一次（qw）治疗 12 周。主要疗效终点为第 12 周时的强直性脊柱炎评估研究（ASAS20）应答；次要终点包括 ASAS40、ASAS50、ASAS70 和 ASAS5/6 应答、部分缓解和生活质量。安全性评估直至末次就诊后 15 天。
共随机选择和治疗了 108 例患者，每组 54 例。在 12 周时，依那西普 50mg biw 组的 48 例患者中有 34 例（71%）和依那西普 50mg qw 组的 49 例患者中有 37 例（76%）达到 ASAS20 应答（无统计学显著差异）。其他疗效变量随时间显著改善，但两组间无差异。56 例患者发生至少 1 次不良事件（一般为感染和寄生虫病、胃肠道疾病和注射部位反应），大多数为轻度或中度。
依那西普高剂量（100mg/周）治疗 12 周与标准剂量（50mg/周）一样安全。然而，它并没有显著增加其疗效。试验注册。Clinicaltrials.gov，http://clinicaltrials.gov/，NCT00873730。
