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

Tatsuya Atsumi, Kazuhiko Yamamoto, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Yoshiya Tanaka, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Shinsuke Yasuda, Yuji Yamanishi, Yasuhiko Kita, Tsukasa Matsubara, Masahiro Iwamoto, Toshiharu Shoji, Toshiyuki Okada, Désirée Van Der Heijde, Nobuyuki Miyasaka, Takao Koike

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    Abstract

    Objectives To evaluate efficacy and safety of combination therapy using certolizumab pegol (CZP) and methotrexate (MTX) as first-line treatment for MTXnaive, 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.

    Original languageEnglish
    Pages (from-to)75-83
    Number of pages9
    JournalAnnals of the rheumatic diseases
    Volume75
    Issue number1
    DOIs
    Publication statusPublished - 2016 Jan 1

    ASJC Scopus subject areas

    • Immunology and Allergy
    • Rheumatology
    • Immunology
    • Biochemistry, Genetics and Molecular Biology(all)

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    Atsumi, T., Yamamoto, K., Takeuchi, T., Yamanaka, H., Ishiguro, N., Tanaka, Y., Eguchi, K., Watanabe, A., Origasa, H., Yasuda, S., Yamanishi, Y., Kita, Y., Matsubara, T., Iwamoto, M., Shoji, T., Okada, T., Van Der Heijde, D., Miyasaka, N., & Koike, T. (2016). The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naïve early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression. Annals of the rheumatic diseases, 75(1), 75-83. https://doi.org/10.1136/annrheumdis-2015-207511