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

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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 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
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, Origasa 著作を一覧する
Iwai, Koichi 著作を一覧する
Sakamaki, Yoshiharu 著作を一覧する
van der Heijde, Désirée 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
Randomized controlled trial
Rheumatoid arthritis
Tumor necrosis factor-alpha inhibitor
発行日: 2014年
出版者: Informa Healthcare
誌名: Modern Rheumatology
巻: 24
号: 4
開始ページ: 552
終了ページ: 560
出版社 DOI: 10.3109/14397595.2013.843764
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.
資料タイプ: article
URI: http://hdl.handle.net/2115/62838
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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