RT Journal Article
SR Electronic
T1 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
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 75
OP 83
DO 10.1136/annrheumdis-2015-207511
VO 75
IS 1
A1 Atsumi, Tatsuya
A1 Yamamoto, Kazuhiko
A1 Takeuchi, Tsutomu
A1 Yamanaka, Hisashi
A1 Ishiguro, Naoki
A1 Tanaka, Yoshiya
A1 Eguchi, Katsumi
A1 Watanabe, Akira
A1 Origasa, Hideki
A1 Yasuda, Shinsuke
A1 Yamanishi, Yuji
A1 Kita, Yasuhiko
A1 Matsubara, Tsukasa
A1 Iwamoto, Masahiro
A1 Shoji, Toshiharu
A1 Okada, Toshiyuki
A1 van der Heijde, Désirée
A1 Miyasaka, Nobuyuki
A1 Koike, Takao
YR 2016
UL http://ard.bmj.com/content/75/1/75.abstract
AB 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.Trial registration number (NCT01451203).