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阿达木单抗治疗依那西普应答不佳的斑块状银屑病患者的疗效和安全性。

Efficacy and safety of adalimumab in patients with plaque psoriasis who have shown an unsatisfactory response to etanercept.

机构信息

Innovaderm Research Inc, Montreal, Quebec, Canada.

出版信息

J Am Acad Dermatol. 2010 Aug;63(2):228-34. doi: 10.1016/j.jaad.2009.08.040. Epub 2010 May 21.

DOI:10.1016/j.jaad.2009.08.040
PMID:20494479
Abstract

BACKGROUND

The safety and efficacy of adalimumab in patients who have shown an unsatisfactory response to etanercept are unknown.

OBJECTIVE

We sought to evaluate the safety and efficacy of adalimumab in patients who failed to show a satisfactory response or lost their satisfactory response to etanercept.

METHODS

This multicenter study enrolled patients who either failed to reach a physician global assessment (PGA) score of 0 or 1 after 12 weeks of etanercept (group A; 50 patients) or who lost their PGA score of 0 or 1 at any time after etanercept dose decrease from 50 mg twice a week to 50 mg every week (group B; 35 patients). Patients received adalimumab 40 mg every other week without loading dose for 12 weeks followed by 40 mg every week for an additional 12 weeks if they did not reach a PGA score of 0 or 1.

RESULTS

After 12 weeks of adalimumab, 34.0% (n = 17; 95% confidence interval [CI] 20.4-47.6) and 31.4% (n = 11; 95% CI 15.2-47.6) of patients from groups A and B, respectively, reached a PGA score of 0 or 1. A total of 46.0% (n = 23; 95% CI 31.7-60.3) and 45.7% (n = 16; 95% CI 28.4-63.1) of patients from group A and B, respectively, achieved a PGA score of 0 or 1 after 24 weeks of adalimumab. Adalimumab was well tolerated and no serious adverse events were reported.

LIMITATIONS

This was an open-label uncontrolled study.

CONCLUSIONS

Adalimumab should be considered as an alternative in patients with psoriasis who have not shown an adequate response or who lost their response to etanercept after a dose decrease.

摘要

背景

阿达木单抗在对依那西普反应不佳的患者中的安全性和疗效尚不清楚。

目的

我们旨在评估阿达木单抗在对依那西普反应不佳或失去反应的患者中的安全性和疗效。

方法

这项多中心研究纳入了以下患者:12 周依那西普治疗后未能达到医生整体评估(PGA)评分 0 或 1(组 A;50 例),或依那西普剂量从每周 50mg 两次减至每周 50mg 后任何时间PGA 评分降至 0 或 1(组 B;35 例)的患者。患者接受阿达木单抗 40mg,每两周 1 次,无负荷剂量,治疗 12 周,如果未达到 PGA 评分 0 或 1,则再接受阿达木单抗 40mg,每周 1 次,治疗 12 周。

结果

阿达木单抗治疗 12 周后,组 A 和组 B 分别有 34.0%(n=17;95%置信区间[CI]20.4-47.6)和 31.4%(n=11;95% CI 15.2-47.6)的患者达到 PGA 评分 0 或 1。阿达木单抗治疗 24 周后,组 A 和组 B 分别有 46.0%(n=23;95% CI 31.7-60.3)和 45.7%(n=16;95% CI 28.4-63.1)的患者达到 PGA 评分 0 或 1。阿达木单抗耐受性良好,未报告严重不良事件。

局限性

这是一项开放标签的非对照研究。

结论

对于未对依那西普产生充分反应或依那西普剂量减少后失去反应的银屑病患者,阿达木单抗可作为一种替代治疗药物。

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