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The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression

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Title: The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression
Authors: Atsumi, Tatsuya Browse this author →KAKEN DB
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, Hideki Browse this author →KAKEN DB
Yasuda, Shinsuke Browse this author →KAKEN DB
Yamanishi, Yuji Browse this author
Kita, Yasuhiko Browse this author
Matsubara, Tsukasa Browse this author
Iwamoto, Masahiro Browse this author →KAKEN DB
Shoji, Toshiharu Browse this author
Okada, Toshiyuki Browse this author
van der Heijde, Désirée Browse this author
Miyasaka, Nobuyuki Browse this author →KAKEN DB
Koike, Takao Browse this author →KAKEN DB
Issue Date: Jan-2016
Publisher: BMJ Publishing Group
Journal Title: Annals of the rheumatic diseases
Volume: 75
Issue: 1
Start Page: 75
End Page: 83
Publisher DOI: 10.1136/annrheumdis-2015-207511
Abstract: Objectives: To evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTX-naive, early rheumatoid arthritis (RA) with poor prognostic factors, compared with MTX alone. Methods: MTX-naive, early RA patients with <= 12 months persistent disease, high anti-cyclic citrullinated peptide, and either rheumatoid factor positive and/or presence of bone erosions were enrolled in this multicentre, double-blind, randomised placebo (PBO)-controlled study. Patients were randomised 1: 1 to CZP+MTX or PBO+MTX for 52 weeks. Primary endpoint was inhibition of radiographic progression (change from baseline in modified Total Sharp Score (mTSS CFB)) at week 52. Secondary endpoints were mTSS CFB at week 24, and clinical remission rates at weeks 24 and 52. Results: 316 patients randomised to CZP+MTX (n=159) or PBO+MTX (n=157) had comparable baseline characteristics reflecting features of early RA (mean disease duration: 4.0 vs 4.3 months; Disease Activity Score 28-joint assessment (DAS28)) (erythrocyte sedimentation rate (ESR)): 5.4 vs 5.5; mTSS: 5.2 vs 6.0). CZP+MTX group showed significantly greater inhibition of radiographic progression relative to PBO+MTX at week 52 (mTSS CFB=0.36 vs 1.58; p<0.001) and week 24 (mTSS CFB=0.26 vs 0.86; p=0.003). Clinical remission rates (Simple Disease Activity Index, Boolean and DAS28 (ESR)) of the CZP+MTX group were significantly higher compared with those of the PBO +MTX group, at weeks 24 and 52. Safety results in both groups were similar, with no new safety signals observed with addition of CZP to MTX. Conclusions: In MTX-naive early RA patients with poor prognostic factors, CZP+MTX significantly inhibited structural damage and reduced RA signs and symptoms, demonstrating the efficacy of CZP in these patients.
Rights: This article has been accepted for publication in "Atsumi T, et al. Ann Rheum Dis 2016;75:75–83" following peer review and can also be viewed on the journal's website at http://ard.bmj.com/
http://creativecommons.org/licenses/by-nc/4.0/
Type: article
URI: http://hdl.handle.net/2115/60633
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: 渥美 達也

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