Calin A, Dijkmans B A C, Emery P, Hakala M, Kalden J, Leirisalo-Repo M, Mola E M, Salvarani C, Sanmartí R, Sany J, Sibilia J, Sieper J, van der Linden S, Veys E, Appel A M, Fatenejad S
Royal National Hospital for Rheumatic Disease, Upper Borough Walls, Bath, UK.
Ann Rheum Dis. 2004 Dec;63(12):1594-600. doi: 10.1136/ard.2004.020875. Epub 2004 Sep 2.
A double blind, randomised, placebo controlled study to evaluate the safety and efficacy of etanercept to treat adult patients with ankylosing spondylitis (AS).
Adult patients with AS at 14 European sites were randomly assigned to 25 mg injections of etanercept or placebo twice weekly for 12 weeks. The primary efficacy end point was an improvement of at least 20% in patient reported symptoms, based on the multicomponent Assessments in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20). Secondary end points included ASAS 50 and ASAS 70 responses and improved scores on individual components of ASAS, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), acute phase reactants, and spinal mobility tests. Safety was evaluated during scheduled visits.
Of 84 patients enrolled, 45 received etanercept and 39 received placebo. Significantly more etanercept patients than placebo patients responded at the ASAS 20 level as early as week 2, and sustained differences were evident up to week 12. Significantly more etanercept patients reported ASAS 50 responses at all times and ASAS 70 responses at weeks 2, 4, and 8; reported lower composite and fatigue BASDAI scores; had lower acute phase reactant levels; and had improved spinal flexion. Etanercept was well tolerated. Most adverse events were mild to moderate; the only between-group difference was injection site reactions, which occurred significantly more often in etanercept patients.
Etanercept is a well tolerated and effective treatment for reducing clinical symptoms and signs of AS.
一项双盲、随机、安慰剂对照研究，以评估依那西普治疗成年强直性脊柱炎（AS）患者的安全性和有效性。
欧洲14个地点的成年AS患者被随机分配，接受每周两次25mg依那西普或安慰剂注射，共12周。主要疗效终点是根据强直性脊柱炎多成分评估（ASAS）反应标准（ASAS 20），患者报告的症状改善至少20%。次要终点包括ASAS 50和ASAS 70反应，以及ASAS各单项、巴斯强直性脊柱炎疾病活动指数（BASDAI）、急性期反应物和脊柱活动度测试得分的改善。在预定访视期间评估安全性。
84名入组患者中，45名接受依那西普治疗，39名接受安慰剂治疗。早在第2周，达到ASAS 20水平的依那西普治疗患者显著多于安慰剂治疗患者，直至第12周仍存在持续差异。在所有时间点，报告ASAS 50反应的依那西普治疗患者显著更多，在第2、4和8周报告ASAS 70反应的患者也显著更多；报告的综合和疲劳BASDAI得分更低；急性期反应物水平更低；脊柱前屈改善。依那西普耐受性良好。大多数不良事件为轻至中度；组间唯一差异是注射部位反应，依那西普治疗患者的发生率显著更高。
依那西普是一种耐受性良好且有效的治疗方法，可减轻AS的临床症状和体征。
