Jiménez-Puya R, Gómez-García F, Amorrich-Campos V, Moreno-Giménez J C
Service of Dermatology, University Hospital of Cordoba, Cordoba, Spain.
J Eur Acad Dermatol Venereol. 2009 Apr;23(4):402-5. doi: 10.1111/j.1468-3083.2008.03063.x.
To evaluate the efficacy and safety of etanercept in the treatment of patients with moderate to severe plaque psoriasis.
An observational, longitudinal, and retrospective study involving two groups of dose of treatment with etanercept (50 vs. 100 mg/week). The selected patients presented moderate to severe plaque psoriasis, and they had received treatment with the mentioned drug. A total of 58 patients were included in the study. The efficacy of the drug was evaluated by measuring the psoriasis area and severity index (PASI), body surface area (BSA) and physician's global assessment (PGA) in weeks 8, 16, 24, 32, 40 and 48.
A statistically significant improvement was observed in the PASI, BSA and PGA indexes after 24 and 48 weeks of therapy. As for PASI, and after 48 weeks of treatment, PASI 50, 75 and 90 were 100.0%, 92.3% and 69.2%, respectively. In our series, etanercept 50 mg/week reached the same results after 48 weeks as etanercept 100 mg/week, though the initial response was faster in the last group. The PASI, BSA and PGA indexes diminished significantly with the treatment, though without statistically significant differences between both groups. As for the safety, etanercept was well tolerated, and no serious adverse events were recorded. There were no cases of tuberculosis or opportunistic infections.
Our study confirms the efficacy and safety outcomes of the clinical trials of etanercept in psoriasis with both doses of treatment. As for the safety, etanercept was well tolerated, and all the recorded adverse events coincided with the known potential side-effects of treatment.
评估依那西普治疗中度至重度斑块状银屑病患者的疗效和安全性。
一项观察性、纵向、回顾性研究，涉及两组依那西普治疗剂量（50 与 100 毫克/周）。所选患者患有中度至重度斑块状银屑病，且已接受上述药物治疗。共有 58 名患者纳入研究。在第 8、16、24、32、40 和 48 周通过测量银屑病面积和严重程度指数（PASI）、体表面积（BSA）和医生整体评估（PGA）来评估药物疗效。
治疗 24 周和 48 周后，PASI、BSA 和 PGA 指数有统计学意义的改善。就 PASI 而言，治疗 48 周后，PASI 改善 50%、75%和 90%的比例分别为 100.0%、92.3%和 69.2%。在我们的研究系列中，依那西普 50 毫克/周在 48 周后达到了与依那西普 100 毫克/周相同的结果，尽管后一组的初始反应更快。随着治疗，PASI、BSA 和 PGA 指数显著降低，但两组之间无统计学显著差异。至于安全性，依那西普耐受性良好，未记录到严重不良事件。无结核病或机会性感染病例。
我们的研究证实了依那西普两种治疗剂量在银屑病临床试验中的疗效和安全性结果。至于安全性，依那西普耐受性良好，所有记录的不良事件均与已知的潜在治疗副作用相符。
