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	Efficacy and pharmacokinetics of ozoralizumab, an anti-TNFα NANOBODY® compound, in patients with rheumatoid arthritis: 52-week results from the OHZORA and NATSUZORA trials.
掲載誌名	正式名：Arthritis Research and Therapy
掲載区分	国外
出版社	Springer Nature
巻・号・頁	25,60頁
著者・共著者	Takeuchi T, Chino Y, Kawanishi M, Nakanishi M, Watase H, Mano Y, Sato Y, Uchida S, and Tanaka Y.
発行年月	2023/04/13
概要	Introduction Ozoralizumab (OZR), a tumor necrosis factor alpha (TNFα) inhibitor, is a NANOBODY® compound that binds to TNFα and human serum albumin. The main objective of this study was to analyze the pharmacokinetics (PK) of the drug and its correlation with clinical efficacy in patients with rheumatoid arthritis (RA). Results The maximum plasma concentration (Cmax) was reached in 6 days in both the 30 and 80 mg groups, with an elimination half-life of 18 days. The Cmax and area under the plasma concentration–time curve increased in a dose-dependent manner, and the trough concentration reached steady state by week 16. The receiver operating characteristic analysis of the effect of trough concentration on the American College of Rheumatology 20% and 50% improvement rates was retrospectively performed, and a cutoff trough concentration of approximately 1 μg/mL at week 16 was obtained in both trials. Conclusions OZR showed a long half-life and favorable PK properties.