Mease Philip J, Kivitz Alan J, Burch Francis X, Siegel Evan L, Cohen Stanley B, Ory Peter, Salonen David, Rubenstein Joel, Sharp John T, Dunn Meleana, Tsuji Wayne
Seattle Rheumatology Associates, Seattle, Washington 98104, USA.
J Rheumatol. 2006 Apr;33(4):712-21. Epub 2006 Feb 1.
Clinical and radiographic responses were evaluated in patients with psoriatic arthritis (PsA) treated for up to 2 years with etanercept.
Patients were previously randomized to receive placebo or etanercept in a double-blind study and chose to participate in the current open-label extension phase. All patients received etanercept 25 mg twice weekly. Radiographic progression was determined at baseline, 1 year, and 2 years using the Sharp method modified to include joints frequently affected in PsA. Arthritis and psoriasis responses were determined using American College of Rheumatology 20% (ACR20) improvement criteria, PsA response criteria (PsARC), and the psoriasis area severity index (PASI).
Of 205 patients randomized, 169 entered open-label, and 141 [71 randomized to receive placebo (placebo/etanercept) and 70 randomized to receive etanercept (etanercept/etanercept)] had radiographic data available for analysis at 2 years. ACR20 criteria, PsARC, and PASI 50 criteria were met by 64%, 84%, and 62%, respectively, of etanercept/etanercept patients at the end of the 48-week open-label period. Placebo/etanercept patients achieved comparable results within 12 weeks that were sustained at 48 weeks (63%, 80%, and 73%). Radiographic progression was inhibited in the etanercept/ etanercept patients (mean adjusted change in total Sharp score of -0.38 from baseline to 2 yrs). In placebo/etanercept patients, disease progression was inhibited once patients began receiving etanercept (mean adjusted change of -0.22 from 1 year to 2 years). Adverse event rates were similar to those observed during randomized phase, with only one serious adverse event deemed possibly related to etanercept.
These data demonstrate a sustained benefit of etanercept treatment, including inhibition of radiographic progression, in patients with PsA.
评估接受依那西普治疗长达2年的银屑病关节炎（PsA）患者的临床和影像学反应。
在一项双盲研究中，患者先前被随机分配接受安慰剂或依那西普，且选择参与当前的开放标签延长期。所有患者接受依那西普25mg，每周两次。使用改良的Sharp方法在基线、1年和2年时确定影像学进展，该方法纳入了PsA中经常受累的关节。使用美国风湿病学会20%改善标准（ACR20）、PsA反应标准（PsARC）和银屑病面积严重程度指数（PASI）确定关节炎和银屑病反应。
在随机分组的205例患者中，169例进入开放标签阶段，141例[71例随机接受安慰剂（安慰剂/依那西普）和70例随机接受依那西普（依那西普/依那西普）]在2年时有可供分析的影像学数据。在48周开放标签期结束时，依那西普/依那西普组分别有64%、84%和62%的患者达到ACR20标准、PsARC和PASI 50标准。安慰剂/依那西普组患者在12周内取得了类似结果，并在48周时得以维持（63%、80%和73%）。依那西普/依那西普组患者的影像学进展受到抑制（从基线到2年，总Sharp评分的平均校正变化为-0.38）。在安慰剂/依那西普组患者中，一旦患者开始接受依那西普，疾病进展就受到抑制（从1年到2年的平均校正变化为-0.22）。不良事件发生率与随机阶段观察到的相似，只有1例严重不良事件被认为可能与依那西普有关。
这些数据表明依那西普治疗对PsA患者有持续益处,包括抑制影像学进展。
