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Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis

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タイトル: Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis
著者: Takeuchi, Tsutomu 著作を一覧する
Yamamoto, Kazuhiko 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
Tanaka, Yoshiya 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
Kobayashi, Mariko 著作を一覧する
Shoji, Toshiharu 著作を一覧する
Togo, Osamu 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
Loading dose
Randomized controlled trial
Rheumatoid arthritis
Tumor necrosis factor-alpha inhibitor
発行日: 2016年
出版者: Taylor & Francis
誌名: Modern Rheumatology
巻: 26
号: 4
開始ページ: 473
終了ページ: 480
出版社 DOI: 10.3109/14397595.2015.1109182
抄録: Objectives: To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Methods: Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. Results: In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Conclusions: Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile.
資料タイプ: article
URI: http://hdl.handle.net/2115/62845
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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