タケウチ　ツトム   TAKEUCHI Tsutomu   竹内　勤    所属   埼玉医科大学  医学部 学長室    職種   学長
論文種別	学術雑誌(原著)
言語種別	英語
査読の有無	査読あり
表題	Population Pharmacokinetics of ozoralizumab in patients with rheumatoid arthritis.
掲載誌名	正式名：Journal of Clinical Pharmacology 略　 称：JCP
掲載区分	国外
出版社	Weily
著者・共著者	Takeuchi T, Chino Y, Mano Y, Kawanishi M, Sato Y, Uchida S, and Tanaka Y.
発行年月	2023/11/01
概要	Ozoralizumab inhibits the TNFα physiological activity while maintaining long-term plasma retention owing to its human serum albumin-binding ability. A population pharmacokinetic (PK) model was developed using data from 494 Japanese patients with rheumatoid arthritis in Phase II/III and Phase III trials. Body weight, sex, anti-drug antibody status, estimated glomerular filtration rate, and concomitant methotrexate use were identified as covariates for apparent clearance. Body weight had the greatest effect on the PK of ozoralizumab, while the other covariates had minor effects. We developed a population PK model that adequately described the ozoralizumab PK in Japanese patients with rheumatoid arthritis, and none of the evaluated covariates showed clinically relevant effects on the PK of ozoralizumab.