2022 Fiscal Year Final Research Report
Basic and clinical analysis of anti-drug antibody against therapeutic antibody
Project/Area Number |
19H03389
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Research Category |
Grant-in-Aid for Scientific Research (B)
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Allocation Type | Single-year Grants |
Section | 一般 |
Review Section |
Basic Section 47060:Clinical pharmacy-related
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Research Institution | Kyoto University |
Principal Investigator |
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Co-Investigator(Kenkyū-buntansha) |
中川 俊作 京都大学, 医学研究科, 助教 (50721916)
橋本 求 京都大学, 医学研究科, 特定講師 (60512845)
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Project Period (FY) |
2019-04-01 – 2023-03-31
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Keywords | 抗体医薬品 / 体内動態 / 個別化医療 / リアルワールドデータ |
Outline of Final Research Achievements |
Unlike conventional low-molecular-weight drugs, therapeutic antibody has immunogenicity, and anti-drug antibodies are produced in the body. In this study, we clarified the characteristics of anti-drug antibodies against various therapeutic antibodies, investigated the effects on clinical efficacy and on the pharmacokinetics of therapeutic antibodies in patients with autoimmune diseases. Although the production of anti-drug antibodies is observed in many therapeutic antibodies, their characteristics varied, such as reducing the blood concentration of therapeutic antibody, some not, and others depending on the measurement method. The clinical effect has stronger correlation with the blood concentration of therapeutic antibody. In addition, biotransformation of therapeutic antibodies was also discovered.
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Free Research Field |
臨床薬理学
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Academic Significance and Societal Importance of the Research Achievements |
本研究は抗薬物抗体の実態解明を進め、抗体医薬品の適正使用を推進する上で重要な知見を提供すると考える。さらに、抗体医薬品の新たなバイオトランスフォーメーションを発見し、体内動態に対する深い理解に基づく患者個別の最適化医療の実現に繋がる有用な情報であると考える。
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