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AURORA 和 BLISS 试验述评:是否将改变狼疮肾炎的治疗?

A review of the AURORA and BLISS trials: will it revolutionize the treatment of lupus nephritis?

机构信息

Department of Medicine, University of Toronto.

Toronto General Hospital, University Health Network.

出版信息

Curr Opin Nephrol Hypertens. 2022 May 1;31(3):278-282. doi: 10.1097/MNH.0000000000000792. Epub 2022 Mar 4.

Abstract

PURPOSE OF REVIEW

Renal involvement in patients with systemic lupus erythematosus can lead to significant complications including end-stage renal disease. Treatment of lupus nephritis has evolved over the last several decades, but despite this evolution, many patients fail to achieve remission and often progress to end-stage kidney disease or carry a burden of adverse side effects related to treatment.

RECENT FINDINGS

The recent findings from AURORA 1 and BLISS LN trials led the FDA to approve voclosporin and belimumab for the treatment of lupus nephritis. The AURORA 1 trial demonstrated that voclosporin, a second-generation calcineurin inhibitor, effectively lowers proteinuria in patients with lupus nephritis, when added to mycophenolate mofetil with a better safety profile, compared with other calcineurin inhibitors. The BLISS LN trial revealed better control of disease and lower risk of progression to end stage kidney disease (ESKD) and relapses in patients treated with belimumab in addition to standard therapy.

SUMMARY

Both voclosporin and belimumab are costly and have not shown any early evidence to revolutionize practice in the management of lupus nephritis. Until more data are made available with future studies or other cost-effective treatment options become available, the widespread adoption and utility of these novel agents remains limited.

摘要

目的综述

系统性红斑狼疮患者的肾脏受累可导致严重并发症,包括终末期肾病。狼疮肾炎的治疗在过去几十年中不断发展,但尽管如此,许多患者仍无法缓解,且常进展至终末期肾病,或因治疗相关的不良反应而背负沉重负担。

最新发现

AURORA 1 和 BLISS LN 试验的最新发现促使 FDA 批准 voclosporin 和 belimumab 用于狼疮肾炎的治疗。AURORA 1 试验表明,第二代钙调磷酸酶抑制剂 voclosporin 与其他钙调磷酸酶抑制剂相比,在添加霉酚酸酯时可更有效地降低狼疮肾炎患者的蛋白尿,且安全性更好。BLISS LN 试验显示,在标准治疗的基础上添加 belimumab 可更好地控制疾病,降低进展为终末期肾病(ESKD)和复发的风险。

总结

voclosporin 和 belimumab 均价格昂贵,且在狼疮肾炎的治疗中尚无任何早期证据可彻底改变实践。在未来的研究提供更多数据或出现其他具有成本效益的治疗选择之前,这些新型药物的广泛应用和实用性仍然有限。

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