Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis : The HIKARI randomized, placebo-controlled trial

Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Origasa; Iwai, Koichi; Sakamaki, Yoshiharu; van der Heijde, Désirée; Miyasaka, Nobuyuki; Koike, Takao

Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis : The HIKARI randomized, placebo-controlled trial

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

Modern Rheumatology, 2014, 24(4), 552-560

Permalink : https://hdl.handle.net/2115/62838

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アクセス権	open access
URI	https://hdl.handle.net/2115/62838
タイトル	Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis : The HIKARI randomized, placebo-controlled trial
著者	Yamamoto, Kazuhiko ; Takeuchi, Tsutomu ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Tanaka, Yoshiya ; Eguchi, Katsumi ; Watanabe, Akira ; Origasa, Origasa ; Iwai, Koichi ; Sakamaki, Yoshiharu ; van der Heijde, Désirée ; Miyasaka, Nobuyuki ; Koike, Takao
e-Rad_Researcher 80191394 著者名 Yamamoto, Kazuhiko
e-Rad_Researcher 50179610 著者名 Takeuchi, Tsutomu
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, Origasa
著者名 Iwai, Koichi
著者名 Sakamaki, Yoshiharu
著者名 van der Heijde, Désirée
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
	Monotherapy
	Randomized controlled trial
	Rheumatoid arthritis
	Tumor necrosis factor-alpha inhibitor
発行日	2014
出版者	Informa Healthcare
収録物名	Modern Rheumatology
巻(号)	24(4)
ページ	552-560
抄録	Objective. This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered. Methods. A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks. Results. ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) and Week 24 (63.8% vs. 11.4%). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2% vs. 20.0%; without [monotherapy], 59.3% vs. 8.2%) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2% (CZP) and 2.6% (placebo); one CZP patient died of dissecting aortic aneurysm. Conclusion. CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression.
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-NoDerivs 3.0 Unported
PISSN	1439-7595
関連情報 (isIdenticalTo)	出版社版DOI https://doi.org/10.3109/14397595.2013.843764