单克隆抗体药物的治疗药物监测研究进展

Advances in Therapeutic Drug Monitoring of Monoclonal Antibody Drugs

单克隆抗体药物是当前药物研发的重要领域之一,在自身免疫性疾病和肿瘤治疗领域的应用较为广泛。然而,治疗效果个体差异较大以及治疗期间响应丢失的临床问题日益显著,其机制同抗体药物的体内暴露和免疫原性特征密切相关。基于治疗药物监测的方式来指导给药方案调整,将有助于实现个体化给药,特别是在肿瘤坏死因子抑制剂中的应用,治疗药物监测已被证明有助于治疗决策。笔者从单抗药物的药动学特征出发,综述近年来单抗药物的体内暴露和临床疗效之间相关性的临床研究,为单抗药物开展治疗药物监测提供理论依据和研究方向。

Monoclonal antibody（ m Ab） drugs currently are an important field in drug development and playing a wide role in the treatment of autoimmune diseases and tumor. However,interindividual variability of therapeutic response and loss of response during treatment become serious problems in clinic,and the underlying mechanisms are believed to be closely related to drug exposure in patients and immunogenicity. Therapeutic drug monitoring（ TDM） of m Ab drugs has the potential to guide more effective dosing in individual patients and it has been proved to be helpful when making treatment decisions particularly for tumor necrosis factor inhibitors.This review is to summarize the pharmacokinetic profiles and exposure-response relationship of m Ab drugs,so as to provide theoretical basis and research direction for the application of TDM in m Ab drugs.