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补骨脂素加紫外线 A 疗法与生物制剂治疗中重度慢性斑块状银屑病的疗效比较:患者登记处的回顾性数据分析。

Efficacy of psoralen plus ultraviolet A therapy vs. biologics in moderate to severe chronic plaque psoriasis: retrospective data analysis of a patient registry.

机构信息

Research Unit for Photodermatology, Department of Dermatology, Medical University of Graz, Auenbrugger Platz 8, A-8036 Graz, Austria.

出版信息

Br J Dermatol. 2011 Sep;165(3):640-5. doi: 10.1111/j.1365-2133.2011.10396.x. Epub 2011 Jul 11.

DOI:10.1111/j.1365-2133.2011.10396.x
PMID:21564068
Abstract

BACKGROUND

Few studies have directly compared the clinical efficacy of psoralen plus ultraviolet A (PUVA) vs. biologics in the treatment of psoriasis.

OBJECTIVES

To compare the clinical efficacy of PUVA and biologic therapies for psoriasis under daily life conditions.

METHODS

Data from a psoriasis registry (http://www.psoriasis-therapieregister.at) of 172 adult patients with moderate to severe chronic plaque psoriasis treated between 2003 and 2010 were analysed retrospectively. These patients had received oral PUVA [118 treatment courses including 5-methoxypsoralen (5-MOP; n = 32) and 8-methoxypsoralen (8-MOP; n = 86)] and/or biologic agents [130 treatment courses including adalimumab (n = 18), alefacept (n = 32), efalizumab (n = 17), etanercept (n = 38), infliximab (n = 7) and ustekinumab (n = 18)]. Treatment responses were analysed in terms of Psoriasis Area and Severity Index (PASI) improvement, including complete remission (CR) and reduction of PASI by at least 90% (PASI 90) or 75% (PASI 75), at treatment completion for PUVA (median time 10·3 and 9·2 weeks, for 8-MOP and 5-MOP, respectively) and at week 12 for biologics.

RESULTS

Intention-to-treat-as observed CR, PASI 90 and PASI 75 rate was 22%, 69% and 86% for PUVA compared with 6%, 22% and 56% for adalimumab (P = 0·0034 by adapted Wilcoxon test), 3%, 3% and 25% for alefacept (P = 0·000000002), 6%, 6% and 59% for efalizumab (P = 0·000053), 6%, 29% and 39% for etanercept (P = 0·0000086), 29%, 71% and 100% for infliximab (P = 0·36) and 6%, 39% and 67% for ustekinumab (P = 0·028). When applying a more conservative post-hoc modified worst-case scenario analysis, with CR of 15%, PASI 90 of 58% and PASI 75 of 69%, PUVA was superior only to alefacept (P = 0·000013), efalizumab (P = 0·015) and etanercept (P = 0·0037). There were no statistically significant differences in PASI reduction rates between PUVA and infliximab.

CONCLUSIONS

Retrospective analysis of registry data revealed that the primary efficacy of PUVA was superior to that of certain biologics. Prospective head-to-head studies of PUVA and biologics are warranted to confirm these observations.

摘要

背景

很少有研究直接比较补骨脂素加紫外线 A(PUVA)与生物制剂在治疗银屑病中的临床疗效。

目的

在日常生活条件下比较 PUVA 和生物疗法治疗银屑病的临床疗效。

方法

对 2003 年至 2010 年间接受中重度慢性斑块型银屑病治疗的 172 例成年患者的银屑病登记处(http://www.psoriasis-therapieregister.at)的数据进行回顾性分析。这些患者接受了口服 PUVA [包括 5-甲氧基补骨脂素(5-MOP;n = 32)和 8-甲氧基补骨脂素(8-MOP;n = 86)的 118 个疗程]和/或生物制剂[包括阿达木单抗(n = 18)、阿法赛普(n = 32)、依那西普(n = 38)、英夫利昔单抗(n = 7)和乌司奴单抗(n = 18)的 130 个疗程]。根据治疗完成时的银屑病面积和严重程度指数(PASI)改善情况,包括完全缓解(CR)和 PASI 至少减少 90%(PASI 90)或 75%(PASI 75),分析 PUVA 的治疗反应(中位数时间分别为 10.3 和 9.2 周,8-MOP 和 5-MOP)和生物制剂的第 12 周。

结果

意向治疗-观察到的 CR、PASI 90 和 PASI 75 率分别为 22%、69%和 86%的 PUVA 与阿达木单抗的 6%、22%和 56%(经适应性 Wilcoxon 检验,P = 0.0034)、3%、3%和 25%的阿法赛普(P = 0.000000002)、6%、6%和 59%的依那西普(P = 0.000053)、6%、29%和 39%的英夫利昔单抗(P = 0.0000086)、29%、71%和 100%的英夫利昔单抗(P = 0.36)和 6%、39%和 67%的乌司奴单抗(P = 0.028)。当应用更保守的事后修改最差情况情景分析时,CR 为 15%,PASI 90 为 58%,PASI 75 为 69%,PUVA 仅优于阿法赛普(P = 0.000013)、依那西普(P = 0.015)和英夫利昔单抗(P = 0.0037)。PUVA 和英夫利昔单抗在 PASI 降低率方面无统计学差异。

结论

对登记处数据的回顾性分析显示,PUVA 的主要疗效优于某些生物制剂。需要进行前瞻性的 PUVA 和生物制剂头对头研究来证实这些观察结果。

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