Katugampola R P, Lewis V J, Finlay A Y
Department of Dermatology, School of Medicine, Cardiff University, Heath Park, Cardiff, UK.
Br J Dermatol. 2007 May;156(5):945-50. doi: 10.1111/j.1365-2133.2007.07817.x. Epub 2007 Mar 28.
Clinical trials show improvement in physical and health-related quality of life (HRQoL) measures in patients with psoriasis treated with biologics compared with placebo. However, these reports only give limited interpretation of the meaning of Dermatology Life Quality Index (DLQI) scores and provide limited comparison data.
The aim of this paper is to identify which biological therapy provides the greatest improvement in HRQoL following treatment of patients with chronic plaque psoriasis, as assessed by the DLQI.
We reviewed all data published up to August 2006 of randomized placebo-controlled trials (RCTs) of the four biologics currently licensed in some countries for clinical use in chronic plaque psoriasis (alefacept, efalizumab, etanercept and infliximab) which have used the DLQI as an outcome measure. The DLQI data were assessed based on overall improvement according to the DLQI descriptor bands and on clinically meaningful improvement of > or = 5.
Fifteen peer-reviewed articles and 59 abstracts describing 11 multicentre, double-blind RCTs were reviewed. Treatment with any one of the four biologics led to a clinically meaningful improvement in the DLQI of > or = 5. However, when applying the DLQI banding concept, infliximab and etanercept provided the greatest improvement in the overall HRQoL from a 'very large effect on overall HRQoL' at baseline to 'a small effect on overall HRQoL' following treatment.
The DLQI banding concept provides a further tool to assess the impact of biologics on HRQoL of patients with psoriasis. Based on retrospective application of DLQI bands to published RCT data, infliximab, followed by etanercept, showed the greatest improvement in the overall HRQoL paralleled by a 75% improvement in the Psoriasis Area and Severity Index. However, some publications did not provide absolute baseline DLQI values, making interpretation of data and comparison between the agents difficult. Side-to-side comparative studies between biologics and between biologics and nonbiological psoriasis treatments will aid evidence-based psoriasis management decisions in the future.
临床试验表明，与安慰剂相比，接受生物制剂治疗的银屑病患者在身体和健康相关生活质量（HRQoL）指标方面有所改善。然而，这些报告对皮肤病生活质量指数（DLQI）评分的意义解释有限，且提供的比较数据也有限。
本文旨在确定哪种生物疗法在治疗慢性斑块状银屑病患者后，通过DLQI评估能使HRQoL得到最大程度的改善。
我们回顾了截至2006年8月已发表的所有数据，这些数据来自目前在一些国家被批准用于慢性斑块状银屑病临床治疗的四种生物制剂（阿法赛特、依法利珠单抗、依那西普和英夫利昔单抗）的随机安慰剂对照试验（RCT），这些试验将DLQI作为一项结果指标。根据DLQI描述带的总体改善情况以及临床意义上大于或等于5分的改善情况对DLQI数据进行评估。
共回顾了15篇经过同行评审的文章和59篇摘要，这些文献描述了11项多中心、双盲RCT。使用这四种生物制剂中的任何一种进行治疗都能使DLQI在临床上有意义地改善大于或等于5分。然而，应用DLQI分级概念时，英夫利昔单抗和依那西普在总体HRQoL方面提供了最大的改善，从基线时“对总体HRQoL有非常大的影响”到治疗后变为“对总体HRQoL有较小的影响”。
DLQI分级概念为评估生物制剂对银屑病患者HRQoL的影响提供了进一步的工具。基于对已发表RCT数据进行DLQI分级的回顾性应用，英夫利昔单抗其次是依那西普，在总体HRQoL方面显示出最大的改善，同时银屑病面积和严重程度指数也改善了75%。然而，一些出版物未提供绝对的基线DLQI值，这使得数据解释和制剂间比较变得困难。生物制剂之间以及生物制剂与非生物银屑病治疗方法之间的横向比较研究将有助于未来基于循证的银屑病治疗决策。
