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Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate : 52-week results from an open-label extension of the HIKARI study

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タイトル: Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate : 52-week results from an open-label extension of the HIKARI study
著者: Tanaka, Yoshiya 著作を一覧する
Yamamoto, Kazuhiko 著作を一覧する
Takeuchi, Tsutomu 著作を一覧する
Yamanaka, Hisashi 著作を一覧する
Ishiguro, Naoki 著作を一覧する
Eguchi, Katsumi 著作を一覧する
Watanabe, Akira 著作を一覧する
Origasa, Hideki 著作を一覧する
Shoji, Toshiharu 著作を一覧する
Miyasaka, Nobuyuki 著作を一覧する
Koike, Takao 著作を一覧する
キーワード: Certolizumab pegol
Monotherapy
Rheumatoid arthritis
TNF α
TNF inhibitor
発行日: 2014年
出版者: Informa Healthcare
誌名: Modern Rheumatology
巻: 24
号: 5
開始ページ: 725
終了ページ: 733
出版社 DOI: 10.3109/14397595.2013.865822
抄録: Objectives. To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients who could not receive methotrexate (MTX). Methods. HIKARI double-blind (DB) patients were entered into an open-label extension (OLE) study. Patients withdrawn at 16 weeks due to lack of efficacy and DB completers without a 24-week American College of Rheumatology (ACR)20 response received CZP 200 mg every 2 weeks (Q2W). DB completers with 24-week ACR20 responses were randomized to CZP 200 mg Q2W or CZP 400 mg every 4 weeks. Results. The ACR20/ACR50/ACR70 response rates of DB completers (n = 98) were 82.7%/56.1%/34.7% at OLE entry, and 83.7%/65.3%/48.0% at 52 weeks, respectively. Other clinical, functional, and radiographic outcomes were sustained during long-term administration of CZP, even without MTX. No new unexpected adverse events were observed during long-term CZP treatment. The efficacy and safety of CZP treatment were similar between the two dosing schedules. Conclusions. Long-term CZP administration is efficacious and safe for RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules. The choice between two maintenace regimens adds flexibility in administration schedules for RA patients and physicians.
資料タイプ: article
URI: http://hdl.handle.net/2115/62842
出現コレクション:雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

提供者: 小池 隆夫

 

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