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阿达木单抗治疗重度银屑病和银屑病关节炎:一项针对30例曾接受其他生物制剂治疗患者的开放标签研究。

Adalimumab for severe psoriasis and psoriatic arthritis: an open-label study in 30 patients previously treated with other biologics.

作者信息

Papoutsaki Marina, Chimenti Maria-Sole, Costanzo Antonio, Talamonti Marina, Zangrilli Arianna, Giunta Alessandro, Bianchi Luca, Chimenti Sergio

机构信息

Department of Dermatology, University of Rome Tor Vergata, Rome, Italy.

出版信息

J Am Acad Dermatol. 2007 Aug;57(2):269-75. doi: 10.1016/j.jaad.2006.12.003. Epub 2007 Jun 18.

Abstract

BACKGROUND

Psoriasis is a chronic, genetically determined, immune-mediated, inflammatory skin disease affecting approximately 2% to 3% of the Caucasian population. Previously reported data demonstrated adalimumab to be an efficacious treatment of psoriatic arthritis and plaque-type psoriasis. Adalimumab is a fully human monoclonal antibody IgG1 against tumor necrosis factor alpha.

OBJECTIVE

To evaluate the efficacy and safety of adalimumab, in the treatment of psoriasis patients whose disease is refractory to treatment with other biologic agents.

PATIENTS AND METHODS

Thirty patients affected by plaque-type psoriasis with or without psoriatic arthritis, unresponsive to conventional and biologic systemic treatments were enrolled. Adalimumab was administered in monotherapy, at a dosage of 40 mg, subcutaneously, once a week.

RESULTS

At week 12, 26 of 30 patients (87%) achieved Psoriasis Area and Severity Index (PASI) 75; at week 24, 25 of 30 patients (83%) achieved PASI 75. Concerning psoriatic arthritis, at week 24, the mean Health Assessment Questionnaire score improved from 0.99 to 0.2, Ritchie articular index from 10.15 to 2, and Pain Visual Assessment Score from 6.32 to 1.2. Furthermore, therapy with adalimumab considerably enhanced patients' quality of life as assessed by two measures (Dermatology Life Quality Index, Psoriasis Disability Index). Adalimumab was generally safe and well tolerated.

LIMITATIONS

This is not a randomized placebo-controlled study and is restricted to a small number of patients.

CONCLUSIONS

In our experience, although preliminary, monotherapy with adalimumab 40 mg weekly proved to be an effective and safe treatment for the management of plaque-type psoriasis and psoriatic arthritis, with a rapid onset of action in patients whose disease had been refractory to both conventional and biologic agents.

摘要

背景

银屑病是一种慢性、由基因决定的、免疫介导的炎症性皮肤病,影响约2%至3%的白种人人口。先前报道的数据表明阿达木单抗是治疗银屑病关节炎和斑块型银屑病的有效药物。阿达木单抗是一种针对肿瘤坏死因子α的全人单克隆抗体IgG1。

目的

评估阿达木单抗治疗对其他生物制剂治疗无效的银屑病患者的疗效和安全性。

患者和方法

纳入30例斑块型银屑病患者,伴有或不伴有银屑病关节炎,对传统和生物全身治疗无反应。阿达木单抗单药治疗,剂量为40mg,皮下注射,每周一次。

结果

在第12周时,30例患者中有26例(87%)达到银屑病面积和严重程度指数(PASI)改善75%;在第24周时,30例患者中有25例(83%)达到PASI改善75%。关于银屑病关节炎,在第24周时,健康评估问卷平均得分从0.99提高到0.2,里奇关节指数从10.15提高到2,疼痛视觉评估得分从6.32提高到1.2。此外,通过两种测量方法(皮肤病生活质量指数、银屑病残疾指数)评估,阿达木单抗治疗显著提高了患者的生活质量。阿达木单抗总体安全且耐受性良好。

局限性

这不是一项随机安慰剂对照研究,且限于少数患者。

结论

根据我们的经验,尽管是初步的,但每周一次40mg阿达木单抗单药治疗被证明是治疗斑块型银屑病和银屑病关节炎的有效且安全的方法,对传统药物和生物制剂均难治的患者起效迅速。

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