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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

Authors :
Tsukasa Matsubara
Tatsuya Atsumi
Yuji Yamanishi
Katsumi Eguchi
Tsutomu Takeuchi
Naoki Ishiguro
Masahiro Iwamoto
Nobuyuki Miyasaka
Désirée van der Heijde
Y Kita
Kazuhiko Yamamoto
Akira Watanabe
Yoshiya Tanaka
Hideki Origasa
Hisashi Yamanaka
Shinsuke Yasuda
T. Shoji
T. Okada
Takao Koike
Source :
Annals of the Rheumatic Diseases, Annals of the Rheumatic Diseases, 75(1), 75-83
Publication Year :
2015
Publisher :
BMJ, 2015.

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

Details

ISSN :
14682060 and 00034967
Volume :
75
Database :
OpenAIRE
Journal :
Annals of the Rheumatic Diseases
Accession number :
edsair.doi.dedup.....59f637ce3eb2c1d31350373aac25b5ec
Full Text :
https://doi.org/10.1136/annrheumdis-2015-207511