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从依那西普转换至阿达木单抗是有效且安全的:结果显示在 30 例对依那西普原发性失效、继发性失效或不耐受的银屑病患者中。

Switching from etanercept to adalimumab is effective and safe: results in 30 patients with psoriasis with primary failure, secondary failure or intolerance to etanercept.

机构信息

Department of Dermatology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6525 GL Nijmegen, the Netherlands.

出版信息

Br J Dermatol. 2010 Oct;163(4):838-46. doi: 10.1111/j.1365-2133.2010.09950.x. Epub 2010 Sep 2.

Abstract

BACKGROUND

Knowledge on the sequential treatment of psoriasis with biologics with regard to efficacy and safety is sparse. This also applies to the efficacy and safety of adalimumab in patients previously treated with etanercept. The relationship between the reasons for discontinuation of etanercept and the response to adalimumab is not clear in psoriasis.

OBJECTIVES

To evaluate the efficacy and safety of adalimumab in patients with psoriasis with primary failure, secondary failure or intolerance to etanercept in daily practice.

METHODS

Data were extracted from two prospective registries from all patients with psoriasis with failure on etanercept treatment, who switched to adalimumab therapy. Thirty patients fulfilled these criteria. All patients were naive to biologics when etanercept was initiated. Primary endpoints were the percentage of patients achieving a 50% or 75% improvement of the baseline Psoriasis Area and Severity Index (PASI) score (PASI 50 and PASI 75, respectively) at weeks 12, 24 and 48. Secondary endpoints were the percentage of patients achieving PASI 90, the mean percentage improvement in the PASI score from baseline and the adverse event rate.

RESULTS

Compared with the baseline PASI score before the start of etanercept, the mean percentage improvement in PASI and the PASI 50/75/90 response rates to adalimumab until week 48 were comparable to those achieved with etanercept. In the patients failing on etanercept, PASI 75 was achieved by 27%, 36% and 54% at weeks 12, 24 and 48 of adalimumab treatment, respectively. The majority of patients showed a beneficial response to adalimumab, irrespective of the reason for discontinuation of etanercept. Previous treatment with etanercept did not increase the adverse event rate nor change the nature of the side-effects.

CONCLUSIONS

Adalimumab seems to be an effective and safe treatment option for patients with psoriasis who failed on etanercept treatment irrespective of the reason for discontinuation.

摘要

背景

关于生物制剂序贯治疗银屑病的疗效和安全性的知识相对较少。这同样适用于依那西普治疗失败的患者中阿达木单抗的疗效和安全性。在银屑病中,依那西普停药的原因与阿达木单抗的反应之间的关系尚不清楚。

目的

评估阿达木单抗在依那西普治疗失败的银屑病患者中的疗效和安全性,这些患者对依那西普治疗原发性失效、继发性失效或不耐受。

方法

从所有依那西普治疗失败的银屑病患者的两个前瞻性登记处提取数据,这些患者转为阿达木单抗治疗。符合这些标准的患者有 30 名。当开始依那西普治疗时,所有患者均对生物制剂无经验。主要终点是在第 12、24 和 48 周时达到基线银屑病面积和严重程度指数(PASI)评分改善 50%或 75%的患者比例(分别为 PASI 50 和 PASI 75)。次要终点是达到 PASI 90 的患者比例、从基线开始 PASI 评分的平均百分比改善和不良反应发生率。

结果

与依那西普开始前的基线 PASI 评分相比,阿达木单抗治疗直至第 48 周时 PASI 的平均百分比改善和 PASI 50/75/90 反应率与依那西普相当。在依那西普治疗失败的患者中,阿达木单抗治疗第 12、24 和 48 周时 PASI 75 的实现率分别为 27%、36%和 54%。大多数患者对阿达木单抗有良好的反应,无论依那西普停药的原因如何。先前使用依那西普并未增加不良反应发生率,也未改变副作用的性质。

结论

对于依那西普治疗失败的银屑病患者,阿达木单抗似乎是一种有效且安全的治疗选择,无论停药原因如何。

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