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阿尼氟单抗用于成人系统性红斑狼疮的评估。

An evaluation of anifrolumab for use in adults with systemic lupus erythematosus.

作者信息

Ahmed Abdullah Ali, Osman Naureen, Furie Richard

机构信息

Rheumatology, Stony Brook University the State University of New York, Stony Brook, NY, USA.

Rheumatology, Northwell Health, Great Neck, NY, USA.

出版信息

Expert Rev Clin Immunol. 2022 Nov;18(11):1095-1106. doi: 10.1080/1744666X.2022.2123793. Epub 2022 Sep 12.

Abstract

INTRODUCTION

Type 1 interferons play a key role in the pathogenesis of systemic lupus erythematosus (SLE). An important clinical question is whether inhibiting the type 1 interferon pathway reduce the disease activity in SLE patients. This review evaluates the safety and efficacy of the monoclonal antibody against the type 1 interferon alpha receptor, anifrolumab, in patients with SLE.

AREAS COVERED

Key terms (SLE, type 1 interferon, anifrolumab) were used to query the PubMed database for phase 1, 2 and 3 clinical trials of anifrolumab for SLE patients. Phase 1 studies showed anifrolumab has non-linear pharmacokinetics and the optimal safe dose is 300 mg given intravenously every four weeks. The MUSE (phase 2) and the TULIP-2 (phase 3) trials showed that anifrolumab when added to standard therapy significantly reduced disease activity in SLE patients. Common adverse events associated with anifrolumab were upper respiratory and urinary infections as well as shingles.

EXPERT OPINION

Anifrolumab is an exciting new therapeutic for SLE patients. Additional analyses of the combined TULIP-1 and TULIP-2 datasets as well as future studies with anifrolumab will generate yet more data in SLE. No doubt anifrolumab will be studied in other diseases where type I interferons play an important role.

摘要

引言

1型干扰素在系统性红斑狼疮(SLE)的发病机制中起关键作用。一个重要的临床问题是,抑制1型干扰素通路是否能降低SLE患者的疾病活动度。本综述评估了抗1型干扰素α受体单克隆抗体阿尼鲁单抗在SLE患者中的安全性和疗效。

涵盖领域

使用关键词(SLE、1型干扰素、阿尼鲁单抗)在PubMed数据库中查询阿尼鲁单抗用于SLE患者的1期、2期和3期临床试验。1期研究表明,阿尼鲁单抗具有非线性药代动力学,最佳安全剂量为每四周静脉注射300mg。MUSE(2期)和TULIP-2(3期)试验表明,在标准治疗基础上加用阿尼鲁单抗可显著降低SLE患者的疾病活动度。与阿尼鲁单抗相关的常见不良事件为上呼吸道感染、泌尿系统感染以及带状疱疹。

专家观点

阿尼鲁单抗对SLE患者来说是一种令人兴奋的新疗法。对TULIP-1和TULIP-2数据集合并后的进一步分析以及未来对阿尼鲁单抗的研究将在SLE中产生更多数据。毫无疑问,阿尼鲁单抗将在I型干扰素起重要作用的其他疾病中进行研究。

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