Mease P J, Goffe B S, Metz J, VanderStoep A, Finck B, Burge D J
Minor and James Medical, Seattle, WA 98104, USA.
Lancet. 2000 Jul 29;356(9227):385-90. doi: 10.1016/S0140-6736(00)02530-7.
Etanercept, a tumour-necrosis-factor inhibitor, has shown efficacy in the treatment of rheumatoid arthritis. Psoriatic arthritis and psoriasis are disease states in which tumour necrosis factor, a proinflammatory cytokine, is present in increased concentrations in joints and in the skin. Therefore, psoriatic arthritis and psoriasis may be appropriate therapeutic targets for etanercept.
This randomised, double-blind, placebo-controlled, 12 week study assessed the efficacy and safety of etanercept (25 mg twice-weekly subcutaneous injections) or placebo in 60 patients with psoriatic arthritis and psoriasis. Psoriatic arthritis endpoints included the proportion of patients who met the Psoriatic Arthritis Response Criteria (PsARC) and who met the American College of Rheumatology preliminary criteria for improvement (ACR20). Psoriasis endpoints included improvement in the psoriasis area and severity index (PASI) and improvement in prospectively-identified individual target lesions.
In this 12 week study, 26 (87%) of etanercept-treated patients met the PsARC, compared with seven (23%) of placebo-controlled patients. The ARC20 was achieved by 22 (73%) of etanercept-treated patients compared with four (13%) of placebo-treated patients. Of the 19 patients in each treatment group who could be assessed for psoriasis (> or = 3% body surface area), five (26%) of etanercept-treated patients achieved a 75% improvement in the PASI, compared with none of the placebo-treated patients (p=0.015). The median PASI improvement was 46% in etanercept-treated patients versus 9% in placebo-treated patients; similarly, median target lesion improvements were 50% and 0, respectively. Etanercept was well tolerated.
Etanercept offers patients with psoriatic arthritis and psoriasis a new therapeutic option for control of their disease.
肿瘤坏死因子抑制剂依那西普已显示出对类风湿关节炎的治疗效果。银屑病关节炎和银屑病是这样的疾病状态，其中促炎细胞因子肿瘤坏死因子在关节和皮肤中的浓度升高。因此，银屑病关节炎和银屑病可能是依那西普合适的治疗靶点。
这项随机、双盲、安慰剂对照的12周研究评估了依那西普（每周两次皮下注射25毫克）或安慰剂对60例银屑病关节炎和银屑病患者的疗效和安全性。银屑病关节炎的终点指标包括达到银屑病关节炎反应标准（PsARC）和达到美国风湿病学会改善初步标准（ACR20）的患者比例。银屑病的终点指标包括银屑病面积和严重程度指数（PASI）的改善以及前瞻性确定的单个目标皮损的改善。
在这项12周的研究中，依那西普治疗的患者中有26例（87%）达到了PsARC，而安慰剂对照的患者中有7例（23%）。依那西普治疗的患者中有22例（73%）达到了ACR20，而安慰剂治疗的患者中有4例（13%）。在每个治疗组中可评估银屑病（体表面积≥3%）的19例患者中，依那西普治疗的患者中有5例（26%）PASI改善了75%，而安慰剂治疗的患者中无1例（p = 0.015）。依那西普治疗的患者PASI改善的中位数为46%，而安慰剂治疗的患者为9%；同样，目标皮损改善的中位数分别为50%和0。依那西普耐受性良好。
依那西普为银屑病关节炎和银屑病患者提供了一种控制疾病的新治疗选择。
