综合多中心研究数据库评价依那西普治疗银屑病的有效性

作     者：Gordon K. Korman N. Frankel E. 朱国兴 

作者机构：Division of Dermatology Evanston Northwestern Healthcare 9977Woods Dr Skokie IL 60077 United States Dr. 

出 版 物：《世界核心医学期刊文摘（皮肤病学分册）》 (Digest of the World Core Medical JOurnals:Dermatology)

年 卷 期：2006年第2卷第5期

页      面：9-9页

学科分类：1002[医学-临床医学] 100206[医学-皮肤病与性病学] 10[医学] 

主　　题：银屑病 依那西普 研究数据库 临床试验研究 大样本量 次要终点 皮肤科医师 严重度 肿瘤坏死因子 安 

摘      要：Background: The tumor necrosis factor (TNF) inhibitor etanercept has been demonstrated to be safe and effective for treating chronic plaque psoriasis in 3 clinical trials. Objectives: To refine efficacy results for etanercept on the basis of a larger population size through the integration of the 3 studies, and to determine if the efficacy profile across all 3 studies is consistent with efficacy profiles observed for individual trials. Methods: In these integrated analyses, data for 1187 patients from 3 blinded treatment groups were pooled to compare efficacy at 12 weeks: etanercept 50 mg weekly (equivalent to 25 mg twice weekly) subcutaneously, etanercept 50 mg twice weekly subcutaneously, and placebo. The primary efficacy end point in all 3 studies was at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75). Other measurements included PASI 50, PASI 90, patient’ s and dermatologist’ s global assessments, and Dermatology Life Quality Index. Results: In the integrated analyses, statistically significant, dosede-pendent improvements in PASI 75 at 12weeks were observed in patients treated with etanercept 50 mg weekly (33% ) and 50 mg twice weekly (49% ), comparedwith the placebo group (3% ; P .05). Significant improvements also were seen in all secondary end points (PASI 50 and PASI 90 responses, patient’ s and dermatologist’ s global assessments, and Dermatology Life Quality Index) at 12 weeks. Subgroup analyses of baseline patient characteristics demonstrated that there were no statistically significant treatment-by-covariate interactions. Limitations: A limitation of these integrated analyses is the relatively short (12-week) time frame. Conclusion: The efficacy profile of etanercept in patients with psoriasis was consistent across multiple studies as shown in the integrated analyses of the primary and secondary end points. Etanercept demonstrated rapid,dosedependent improvements in disease severity and quality of life consistently over all