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

Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

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

Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi et al.

Modern Rheumatology, 2016, 26(4), 473-480

Permalink : https://hdl.handle.net/2115/62845

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アクセス権	open access
URI	https://hdl.handle.net/2115/62845
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 ; Yamamoto, Kazuhiko ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Tanaka, Yoshiya ; Eguchi, Katsumi ; Watanabe, Akira ; Origasa, Hideki ; Kobayashi, Mariko ; Shoji, Toshiharu ; Togo, Osamu ; Miyasaka, Nobuyuki ; Koike, Takao
e-Rad_Researcher 50179610 著者名 Takeuchi, Tsutomu
e-Rad_Researcher 80191394 著者名 Yamamoto, Kazuhiko
e-Rad_Researcher 10166754 著者名 Yamanaka, Hisashi
e-Rad_Researcher 20212871 著者名 Ishiguro, Naoki
e-Rad_Researcher 30248562 著者名 Tanaka, Yoshiya
e-Rad_Researcher 30128160 著者名 Eguchi, Katsumi
e-Rad_Researcher 70220861 著者名 Watanabe, Akira
e-Rad_Researcher 20245038 著者名 Origasa, Hideki
著者名 Kobayashi, Mariko
著者名 Shoji, Toshiharu
著者名 Togo, Osamu
e-Rad_Researcher 30157622 著者名 Miyasaka, Nobuyuki
e-Rad_Researcher 80146795 著者名 Koike, Takao
言語	英語
キーワード	Certolizumab pegol
	Loading dose
	Randomized controlled trial
	Rheumatoid arthritis
	Tumor necrosis factor-alpha inhibitor
発行日	2016
出版者	Taylor & Francis
収録物名	Modern Rheumatology
巻(号)	26(4)
ページ	473-480
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.
資源タイプ	学術雑誌論文
出版タイプ	Version of Record
権利情報	Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
PISSN	1439-7595
NCID	AA1157187X
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.3109/14397595.2015.1109182