| 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)
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