Introduction: De novo donor-specific antibodies (dnDSA) directed against HLA are a major contributing factor to the chronic deterioration of renal allograft function. Several factors, including the degree of HLA matching, younger recipient age, and past sensitization events have been shown to increase the risk for the development of dnDSA. The development of dnDSA is also strongly associated with modifications in the immunosuppressive regimen, non-adherence, and under-immunosuppression.

Areas covered: Tacrolimus is widely used after solid organ transplantation (SOT) and in recent years, both a high intra-patient variability in tacrolimus exposure and low tacrolimus exposure have been found to be associated with a higher risk of dnDSA development in kidney transplant recipients. This article provides an overview of current findings published in the recent 5 years regarding the relationship between tacrolimus exposure and variation therein and the development of dnDSA.

Expert opinion: In this review, we describe how combining data on tacrolimus intra-patient variability and mean pre-dose concentration may be an effective tool to identify kidney transplant recipients who are at higher risk of developing dnDSA.

简介：针对HLA的新生供体特异性抗体（dn DSA）是导致肾脏同种异体移植功能长期恶化的主要因素。已经显示出多种因素，包括HLA匹配程度，较年轻的接受者年龄和过去的致敏事件，这些因素会增加dn DSA发生的风险。dn DSA的发展也与免疫抑制方案的修改，不依从性和免疫抑制不足密切相关。

覆盖区域：他克莫司在实体器官移植（SOT）后被广泛使用，并且近年来，他克莫司暴露的高患者体内变异性和他克莫司暴露的低暴露均被发现与肾脏移植中dn DSA发展的较高风险相关收件人。本文概述了最近5年中发表的有关他克莫司暴露及其变化与dn DSA发展之间关系的最新发现。

专家意见：在这篇综述中，我们描述了如何将他克莫司患者体内变异性和平均给药前浓度的数据结合起来可能是一种有效的工具，以识别出罹患dn DSA风险较高的肾脏移植接受者。