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TDM解析を基盤とした、リウマチ治療における生物学的製剤適正使用法の確立研究

基于TDM分析建立生物制剂在风湿病治疗中正确使用的研究

基本信息

批准号：
19K16445
负责人：
傳田将也
金额：
$ 2.66万
依托单位：
Kyoto University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Early-Career Scientists
财政年份：
2019
资助国家：
日本
起止时间：
2019-04-01 至 2020-03-31
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-19K16445/
关键词：
関節リウマチ生物学的製剤インフリキシマブ二次無効 TDM 抗体医薬

项目摘要

本研究では、関節リウマチ治療に用いられる生物学的製剤の血中濃度と治療効果の相関を明らかにすることを目的としている。生物学的製剤の一つであるインフリキシマブを用いた関節リウマチ治療で、血清中インフリキマブ濃度と治療効果に相関があることは近年明らかになりつつある。しかしながら関節リウマチが臨床的寛解に達した患者において、インフリキマブ投与中止・減量後の再燃リスク因子は明らかになっていない。そこで再燃リスク因子の解明を指向し、インフリキシマブ投与中止・減量時の当該薬物濃度および治療効果に影響を及ぼす抗薬物抗体の発現量と、中止・減量後の疾患活動性に関する相関探索研究を立案し、研究を行った。研究方法としては、京都大学医学部附属病院リウマチセンターで収集している関節リウマチ患者データと大学院医科学研究科薬剤学分野が利用するインフリキマブ濃度測定法であるn-SMOL法を組み合わせ実施した。今年度の検討で、インフリキマブによる治療で効果があった群と効果がなかった群の2群に分類し、血中濃度を確認したところ、効果を示した群で血中濃度が高いことが明らかになった。この結果から、治療効果とインフリキマブ血中濃度に関してROC曲線を作成し、効果を示す血中濃度の算出を行い、効果を示す血中濃度以上の群とそれ以下の群に分類し、治療効果の推移を追跡した。その結果、両群とも一度は寛解に到達するが、血中濃度が高い群では寛解を維持し、低い群では再燃する傾向が明らかになった。さらに抗薬物抗体の発現が陽性と陰性の群を比較したところ、陰性群で治療効果を示す割合が大きいことを明らかにした。

In this study, we used biological methods to treat the disease. The results showed that there was no significant difference between the two groups. The first step of biology is to treat the disease in order to treat the disease, and to treat the disease in the serum. This is the first time to know that the patient is suffering from the disease, and that the patient will be reignited after the dose is measured. It is necessary to determine the direction of the reburning factor, the dose of the drug, the dose of the drug, the effect of the dose and the level of the antibody against the substance. After stopping the dose, the disease activity test has been established, the study has been put on file and the study has been conducted. Research methods: the clinical data of the affiliated Hospital of Kyoto University, the affiliated Hospital of Kyoto University, the Department of Medical Science of Kyoto University, the Department of Medical Scientific Research of the University, the Department of Medical Scientific Research, the Department of Medical Science, the Department of Medical Scientific Research, the Department of Medical Scientific Research, the Department of Medical Science, the Department of Medical Science, the Department of Medical Science This year, the results of this year's health care program show that the population is divided into two groups, the blood concentration is high, the blood concentration is high, and the blood temperature is high. The results showed that the levels of ROC in blood were calculated, the results showed that the levels above the levels in blood were classified into groups, and the results of treatment were classified into different groups. According to the results of the experiment, the results showed that the temperature of the group was significantly higher than that of the control group, and that of the group with high level of blood temperature was significantly higher than that of the group with high level of blood temperature, and that of the group with low temperature was significantly higher than that of the control group. The anti-substance antibody shows that the sex is more common in the sex group than in the sex group, and the results show that there is a gap between the two groups.