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一项关于每周使用阿达木单抗治疗化脓性汗腺炎疗效的前瞻性开放标签临床试验。

A prospective open-label clinical trial of efficacy of the every week administration of adalimumab in the treatment of hidradenitis suppurativa.

作者信息

Sotiriou Elena, Goussi Christina, Lallas Aimilios, Chovarda Eleni, Apalla Zoe, Lazaridou Elisabeth, Ioannides Demetris

机构信息

First Dermatology Department, Aristotle University Thessaloniki, Thessaloniki, Greece.

出版信息

J Drugs Dermatol. 2012 May;11(5 Suppl):s15-20.

Abstract

BACKGROUND

Hidradenitis suppurativa (HS) is a debilitating disease refractory to treatment. As its impact on patients' quality of life is strong, it requires effective treatment.

OBJECTIVES

To evaluate the efficacy and safety of adalimumab using a higher dosage regimen for HS treatment and establish the recurrence-free interval after treatment discontinuation.

MATERIAL AND METHODS

Patients with moderate to severe HS were treated with 80 mg adalimumab at baseline, followed by 40 mg every week for 24 weeks. Subsequently, patients entered an observational period for another 24 weeks. Clinical evaluation took place every 4 weeks during the study period. Sartorius scoring system was used as assessment tool regarding disease activity. At the same time points patients evaluated disease activity by Visual Analogue Scale (VAS). They completed a Dermatology Life Quality Index (DLQI) questionnaire at baseline and at weeks 24 and 48.

RESULTS

Fifteen patients completed the study. Significant reduction in Sartorius score was obtained by week 24 with a marked improvement during the first month. Mean time to relapse was 11 weeks after treatment cessation, but even at the final visit Sartorius score was significantly lower than at baseline. VAS score and DLQI showed a significant decrease at week 24. There was significant worsening at week 48, however both scores remained significantly lower than baseline levels.

CONCLUSIONS

Our study data demonstrate the significant efficacy of the once weekly regimen, as well as its benefit regarding time to recurrence. However, the question if benefit outweighs the risk of a long-term anti-TNF-α antagonist's administration needs still to be answered.

摘要

背景

化脓性汗腺炎(HS)是一种难治性的使人衰弱的疾病。由于其对患者生活质量有很大影响,因此需要有效的治疗方法。

目的

评估使用更高剂量方案的阿达木单抗治疗HS的疗效和安全性,并确定停药后的无复发间隔时间。

材料与方法

中度至重度HS患者在基线时接受80mg阿达木单抗治疗,随后每周40mg,持续24周。随后,患者进入另一个24周的观察期。在研究期间每4周进行一次临床评估。使用 Sartorius评分系统作为疾病活动度的评估工具。在相同时间点,患者通过视觉模拟量表(VAS)评估疾病活动度。他们在基线时以及第24周和第48周完成了皮肤病生活质量指数(DLQI)问卷。

结果

15名患者完成了研究。到第24周时,Sartorius评分显著降低,第一个月有明显改善。治疗停止后平均复发时间为11周,但即使在最后一次访视时,Sartorius评分仍显著低于基线水平。第24周时VAS评分和DLQI显著下降。然而在第48周时出现显著恶化,不过两个评分仍显著低于基线水平。

结论

我们的研究数据证明了每周一次方案的显著疗效,以及其在复发时间方面的益处。然而,长期使用抗TNF-α拮抗剂的益处是否超过风险这个问题仍有待解答。

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