HUSCAP logo Hokkaido Univ. logo

Hokkaido University Collection of Scholarly and Academic Papers >
Graduate School of Medicine / Faculty of Medicine >
Peer-reviewed Journal Articles, etc >

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

This item is licensed under: Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported

Files in This Item:
112_ModRheumatol24_552.pdf807.73 kBPDFView/Open
Please use this identifier to cite or link to this item:http://hdl.handle.net/2115/62838

Title: Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis : The HIKARI randomized, placebo-controlled trial
Authors: Yamamoto, Kazuhiko Browse this author →KAKEN DB
Takeuchi, Tsutomu Browse this author →KAKEN DB
Yamanaka, Hisashi Browse this author →KAKEN DB
Ishiguro, Naoki Browse this author →KAKEN DB
Tanaka, Yoshiya Browse this author →KAKEN DB
Eguchi, Katsumi Browse this author →KAKEN DB
Watanabe, Akira Browse this author →KAKEN DB
Origasa, Origasa Browse this author →KAKEN DB
Iwai, Koichi Browse this author
Sakamaki, Yoshiharu Browse this author
van der Heijde, Désirée Browse this author
Miyasaka, Nobuyuki Browse this author →KAKEN DB
Koike, Takao Browse this author →KAKEN DB
Keywords: Certolizumab pegol
Monotherapy
Randomized controlled trial
Rheumatoid arthritis
Tumor necrosis factor-alpha inhibitor
Issue Date: 2014
Publisher: Informa Healthcare
Journal Title: Modern Rheumatology
Volume: 24
Issue: 4
Start Page: 552
End Page: 560
Publisher DOI: 10.3109/14397595.2013.843764
Abstract: 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.
Rights: https://creativecommons.org/licenses/by-nc-nd/3.0/
Type: article
URI: http://hdl.handle.net/2115/62838
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

Export metadata:

OAI-PMH ( junii2 , jpcoar )

MathJax is now OFF:


 

 - Hokkaido University