Gottlieb Alice B, Kircik Leon, Eisen Drore, Jackson J Mark, Boh Erin E, Strober Bruce E, Frankel Ellen, Xia H Amt, Stevens Seth R
Department of Dermatology, Tufts-New England Medical Center, Boston, MA 02111-1533, USA.
J Dermatolog Treat. 2006;17(6):343-52. doi: 10.1080/09546630600967166.
To assess the efficacy and tolerability of etanercept to treat psoriatic arthritis.
A total of 1,122 patients who had active psoriatic arthritis were enrolled in a Phase 4, non-randomized, open-label, single-arm, 24-week study. These patients had clinically stable, plaque psoriasis involving >or=10% body surface area and joint disease (either >or=two swollen and >or=two tender/painful joints for >or=3 months, or >or=one joint with sacroiliitis or spondylitis). They received etanercept therapy 50 mg subcutaneously once weekly for 24 weeks.
After 24 weeks of treatment, 865 patients (77.1%; 95% CI: 74.64-79.55%) achieved a 'mild or better' score on the physician global assessment of psoriasis and were improved from baseline. Mean improvement in body surface area involvement was 16.9 percentage points (15.89-17.91). Patient global assessment of psoriasis, joint pain, and joint disease scores were improved by means of 2.2 (2.15-2.34), 2.7 (2.53-2.84), and 1.5 (1.39-1.55), respectively. Thirty-five patients (3.1%) experienced at least one serious adverse event. No patient died during the study.
These results support the effectiveness and tolerability of etanercept treatment in patients with psoriatic arthritis being treated at dermatology clinics.
评估依那西普治疗银屑病关节炎的疗效和耐受性。
共1122例活动性银屑病关节炎患者纳入一项4期、非随机、开放标签、单臂、为期24周的研究。这些患者临床病情稳定，斑块状银屑病累及体表面积≥10%且有关节病变（≥2个关节肿胀且≥2个关节压痛/疼痛≥3个月，或≥1个关节有骶髂关节炎或脊柱炎）。他们接受依那西普治疗，皮下注射50mg，每周一次，共24周。
治疗24周后，865例患者（77.1%；95%可信区间：74.64 - 79.55%）在医生对银屑病的整体评估中达到“轻度或更好”评分，且较基线有所改善。体表面积受累的平均改善为16.9个百分点（15.89 - 17.91）。患者对银屑病的整体评估、关节疼痛和关节疾病评分分别改善了2.2（2.15 - 2.34）、2.7（2.53 - 2.84）和1.5（1.39 - 1.55）。35例患者（3.1%）经历了至少一次严重不良事件。研究期间无患者死亡。
这些结果支持在皮肤科诊所接受治疗的银屑病关节炎患者中，依那西普治疗的有效性和耐受性。
