2010 Fiscal Year Final Research Report
A epidemiological study of long-term safety of biological disease-modifying antirheumatic drugs for patients with rheumatoid arthritis and risk factors for adverse drug reactions.
| Project/Area Number |
20390158
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (B)
|
| Allocation Type | Single-year Grants |
|---|
| Section | 一般 |
|---|
| Research Field |
Applied pharmacology
|
|---|
| Research Institution | Tokyo Medical and Dental University |
|---|
Principal Investigator |
HARIGAI Masayoshi Tokyo Medical and Dental University, 大学院・医歯学総合研究科, 寄附講座教員 (20238207)
|
|---|
| Co-Investigator(Kenkyū-buntansha) |
MIYASAKA Nobuyuki 東京医科歯科大学, 大学院・医歯学総合研究科, 教授 (30157622)
KOIKE Ryuji 東京医科歯科大学, 医学部附属病院, 准教授 (50250220)
NANKI Toshihiro 東京医科歯科大学, 大学院・医歯学総合研究科, 准教授 (00282749)
ATSUMI Tatsuya 北海道大学, 大学院・医学研究科, 准教授 (20301905)
TAKENO Mitsuhiro 横浜市立大学, 医学(系)研究科・大学院, 准教授 (50236494)
KAMEDA Hideto 慶應義塾大学, 医学部, 講師 (00265795)
SAITO Kazuyoshi 産業医科大学, 医学部, 准教授 (30279327)
FUJII Takao 京都大学, 大学院・医学研究科, 准教授 (70255462)
TSUTANI Kiichiro 東京大学, 大学院薬学系研究科, 特任教授 (80142040)
SAWADA Tetsuji 東京医科大学, 医学部, 准教授 (50235470)
TAMURA Naoto 順天堂大学, 医学部, 准教授 (20227284)
TOHMA Shigeto 国立病院機構, 相模原病院, 部長 (50207528)
KAWAKAMI Atsushi 長崎大学, 大学院・医歯薬学総合研究科, 教授 (90325639)
HAYASHI Taichi 筑波大学, 大学院・人間総合科学研究科, 講師 (00466674)
|
|---|
| Co-Investigator(Renkei-kenkyūsha) |
NAKAMURA Takahiro 防衛医科大学校, 医学教育部, 准教授 (60415255)
|
|---|
| Project Period (FY) |
2008 – 2010
|
| Keywords | 生物学的製剤 / TNF阻害薬 / 関節リウマチ / 薬剤疫学 / 安全性 / 患者登録システム / 重篤有害事象 |
|---|
| Research Abstract |
We implemented this project to clarify mid- to long-term safety of biological disease modifying antirheumatic drugs (biologics) in Japanese RA patients and to evaluate benefit-risk balance of these drugs. In the REAL study, we identified the use of tumor necrosis factor (TNF) inhibitors as a significant risk factor for serious infection in Japanese RA patients. SECURE study revealed that risks for all malignancies, non-hematopoietic malignancies, and hematopoietic malignancies were not increased in Japanese RA patients given TNF inhibitors. We also performed pharmacoeconomical study to calculate the medical cost for serious adverse events which were observed in the REAL study. These data provided solid and useful evidences for mid- to long-term safety of biologics in Japanese RA patients.
|
