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银屑病关节炎的新治疗模式:美国食品药品监督管理局批准的新疗法最新进展

New treatment paradigms in psoriatic arthritis: an update on new therapeutics approved by the U.S. Food and Drug Administration.

作者信息

Felquer Maria L Acosta, Soriano Enrique R

机构信息

aRheumatology Unit, Internal Medical Services, Hospital Italiano de Buenos Aires, Insituto Universitario Hospital Italiano de Buenos Aires bFundacion P.M. Catoggio, para el progreso de la Reumatologia, Buenos Aires, Argentina.

出版信息

Curr Opin Rheumatol. 2015 Mar;27(2):99-106. doi: 10.1097/BOR.0000000000000151.

Abstract

PURPOSE OF REVIEW

The purpose of this study is to give an overview of the new treatments approved by the U.S. Food and Drug Administration (FDA) for use in psoriatic arthritis (PsA).

RECENT FINDINGS

FDA has approved three new drugs for PsA: Certolizumab-pegol: a PEGylated Fc-free tumour necrosis factor inhibitor (TNFi); ustekinumab: an anti interleukin (IL)-12 and IL-23 mAb; and apremilast and oral phosphodiesterase 4 inhibitor. On well designed and extensive developing programmes, all three drugs proved to be effective for the treatment of most PsA manifestations, including peripheral arthritis, skin involvement, enthesitis, dactylitis, quality of life and radiographic progression in patients failing traditional disease modifying drugs (DMARDs) and TNFi. Safety profile of all three drugs seems to be reassuring until now, although long-term data are still not available. Although Certolizumab-pegol is likely to be placed among the other TNFi, ustekinumab and apremilast, due to lower efficacy on arthritis, are being more frequently used as second-line therapy after TNFi failure, especially among rheumatologists.

SUMMARY

There are new therapeutic options approved for the treatment of PsA. For the first time, well proved effective therapies with a different mechanism of action than the inhibition of TNF alpha are available for the treatment of this progressive disease.

摘要

综述目的

本研究旨在概述美国食品药品监督管理局(FDA)批准用于治疗银屑病关节炎(PsA)的新疗法。

最新发现

FDA已批准三种用于PsA的新药:赛妥珠单抗聚乙二醇化制剂:一种聚乙二醇化无Fc结构的肿瘤坏死因子抑制剂(TNFi);优特克单抗:一种抗白细胞介素(IL)-12和IL-23单克隆抗体;以及阿普斯特,一种口服磷酸二酯酶4抑制剂。在精心设计且广泛开展的研发项目中,这三种药物均被证明对大多数PsA表现有效,包括外周关节炎、皮肤受累、肌腱端炎、指(趾)炎、生活质量以及对传统改善病情抗风湿药(DMARDs)和TNFi治疗无效患者的影像学进展。尽管目前仍缺乏长期数据,但这三种药物的安全性至今看来令人放心。尽管赛妥珠单抗聚乙二醇化制剂可能会被归类于其他TNFi药物,但由于其对关节炎的疗效较低,优特克单抗和阿普斯特在TNFi治疗失败后更常被用作二线治疗药物,尤其是在风湿病学家中。

总结

有新的治疗方案被批准用于治疗PsA。首次有了经充分验证且作用机制不同于抑制肿瘤坏死因子α的有效疗法可用于治疗这种进展性疾病。

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