Lecluse L L A, Naldi L, Stern R S, Spuls P I
Department of Dermatology, A0-252, Academic Medical Center, University of Amsterdam, PO Box 22700, Amsterdam NL-1100 DE, The Netherlands.
Dermatology. 2009;218(4):347-56. doi: 10.1159/000183757. Epub 2008 Dec 11.
About 11 million people suffer from psoriasis in Europe. This chronic condition may have a dramatic impact on quality of life. About 20% of patients may need systemic treatment to effectively control their disease activity. The introduction of biological agents greatly increased the options of systemic therapies for psoriasis. However, clinical experience with newer systemic therapies is relatively limited, and available data are mostly derived from short-term phase III trials. Except for PUVA and ciclosporin, long-term safety data from formal postmarketing studies are also largely lacking conventional treatment options. Registries provide one mechanism to monitor the long-term safety and effectiveness of treatment in the 'natural environment'. Several European countries have established registries to collect data on systemic psoriasis treatment. Even though different in some aspects of study design and monitoring, the registries share a number of common features: they include all the biological drugs and sometimes all the licensed systemic agents for psoriasis, and they observe the patients for a defined period of time irrespective of the drug given. Combining the results from these registries would increase their power and impact. We are developing an international collaboration called 'Psonet' that will perform a joint analysis of data from 9 individual national psoriasis registries.
在欧洲，约有1100万人患有银屑病。这种慢性病可能会对生活质量产生巨大影响。约20%的患者可能需要进行全身治疗，以有效控制疾病活动。生物制剂的引入极大地增加了银屑病全身治疗的选择。然而，新型全身治疗的临床经验相对有限，现有数据大多来自短期III期试验。除了补骨脂素紫外线A光化学疗法（PUVA）和环孢素外，传统治疗方案也大多缺乏来自正规上市后研究的长期安全性数据。注册登记是在“自然环境”中监测治疗长期安全性和有效性的一种机制。几个欧洲国家已经建立了注册登记系统，以收集银屑病全身治疗的数据。尽管这些注册登记系统在研究设计和监测的某些方面存在差异，但它们有许多共同特征：它们涵盖了所有生物药物，有时还包括所有已获许可的银屑病全身用药，并且无论给予何种药物，都会对患者进行一定时期的观察。整合这些注册登记系统的结果将增强其影响力。我们正在开展一项名为“Psonet”的国际合作项目，该项目将对来自9个国家银屑病个体注册登记系统的数据进行联合分析。
