Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital.
Graduate School of Pharmaceutical Sciences, Kyoto University.
Biol Pharm Bull. 2022;45(7):843-846. doi: 10.1248/bpb.b22-00006.
In recent years, many antibody drugs that play an important role in the pharmacotherapy of several diseases have been developed. Antibody drugs exhibit immunogenicity in vivo leading to the development of antibodies against the antibody drug (anti-drug antibody). Nonetheless, other factors also affect the pharmacokinetics of antibody drugs. Recently, therapeutic drug monitoring (TDM) of infliximab was introduced for personalized medicine. However, the usefulness of TDM in antibody therapy remains unclear. In addition to intervention studies, real-world data analysis is important. Unlike small-molecule drugs, antibody drugs do not have a uniform molecular weight; therefore, using the conventional analysis methods, it is impossible to determine the true pharmacokinetic outcomes of these agents. To analyze structural changes of antibody drugs in the body, new technologies are necessary. In the future, along with the development of new drugs, the establishment of novel analytical methods is essential to facilitate the promotion of personalized medicine.
近年来，许多在多种疾病的药物治疗中发挥重要作用的抗体药物已经被开发出来。抗体药物在体内表现出免疫原性，导致针对抗体药物的抗体（抗药物抗体）的产生。然而，其他因素也会影响抗体药物的药代动力学。最近，英夫利昔单抗的治疗药物监测（TDM）被引入个性化医疗。然而，TDM 在抗体治疗中的实用性仍不清楚。除了干预性研究，真实世界的数据分析也很重要。与小分子药物不同，抗体药物没有统一的分子量；因此，使用传统的分析方法，不可能确定这些药物的真实药代动力学结果。为了分析抗体药物在体内的结构变化，需要新的技术。未来，随着新药的发展，建立新的分析方法对于促进个性化医疗是必要的。
