Davis John C, Van Der Heijde Désirée, Braun Jurgen, Dougados Maxime, Cush John, Clegg Daniel O, Kivitz Alan, Fleischmann Roy, Inman Robert, Tsuji Wayne
University of California, San Francisco, CA 94143, USA.
Arthritis Rheum. 2003 Nov;48(11):3230-6. doi: 10.1002/art.11325.
To determine the safety and efficacy of etanercept in a multicenter, randomized, placebo-controlled, double-blind trial of adults with moderate to severe active ankylosing spondylitis (AS).
Patients (n = 277) were treated with either etanercept 25 mg (n = 138) or placebo (n = 139) subcutaneously twice weekly for 24 weeks. The primary outcome measures were the percentages of patients achieving the Assessments in Ankylosing Spondylitis 20% response (ASAS20) at weeks 12 and 24. Other outcome measures included the percentage of patients achieving higher ASAS responses, and the safety of etanercept in patients with AS. All outcome measures were assessed at 2, 4, 8, 12, and 24 weeks.
Treatment with etanercept resulted in dramatic improvement. The ASAS20 was achieved by 59% of patients in the etanercept group and by 28% of patients in the placebo group (P < 0.0001) at week 12, and by 57% and 22% of patients, respectively, at week 24 (P < 0.0001). All individual ASAS components, acute-phase reactant levels, and spinal mobility measures were also significantly improved. The safety profile of etanercept was similar to that reported in studies of patients with rheumatoid arthritis or psoriatic arthritis. The only adverse events that occurred significantly more often in the etanercept group were injection-site reactions, accidental injuries, and upper respiratory tract infections.
Etanercept is a highly effective and well tolerated treatment in patients with active AS.
在一项针对中重度活动性强直性脊柱炎（AS）成人患者的多中心、随机、安慰剂对照、双盲试验中确定依那西普的安全性和有效性。
277例患者分别接受皮下注射依那西普25mg（138例）或安慰剂（139例），每周两次，共24周。主要结局指标为在第12周和第24周达到强直性脊柱炎评估20%反应（ASAS20）的患者百分比。其他结局指标包括达到更高ASAS反应的患者百分比以及依那西普在AS患者中的安全性。所有结局指标在第2、4、8、12和24周进行评估。
依那西普治疗带来显著改善。在第12周，依那西普组59%的患者达到ASAS20，安慰剂组为28%（P<0.0001）；在第24周，依那西普组和安慰剂组分别为57%和22%（P<0.0001）。所有ASAS单项指标、急性期反应物水平和脊柱活动度指标也均有显著改善。依那西普的安全性与类风湿关节炎或银屑病关节炎患者研究中报告的相似。依那西普组中显著更常发生的不良事件仅为注射部位反应、意外伤害和上呼吸道感染。
依那西普对活动性AS患者是一种高效且耐受性良好的治疗方法。
