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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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Clinical and epidemiological research
Extended report
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
  1. Tatsuya Atsumi1,
  2. Kazuhiko Yamamoto2,
  3. Tsutomu Takeuchi3,
  4. Hisashi Yamanaka4,
  5. Naoki Ishiguro5,
  6. Yoshiya Tanaka6,
  7. Katsumi Eguchi7,
  8. Akira Watanabe8,
  9. Hideki Origasa9,
  10. Shinsuke Yasuda1,
  11. Yuji Yamanishi10,
  12. Yasuhiko Kita11,
  13. Tsukasa Matsubara12,
  14. Masahiro Iwamoto13,
  15. Toshiharu Shoji14,
  16. Toshiyuki Okada15,
  17. Désirée van der Heijde16,
  18. Nobuyuki Miyasaka17,
  19. Takao Koike1,18
  1. 1Hokkaido University Graduate School of Medicine, Sapporo, Japan
  2. 2The University of Tokyo, Tokyo, Japan
  3. 3Keio University School of Medicine, Tokyo, Japan
  4. 4Tokyo Women's Medical University, Tokyo, Japan
  5. 5Faculty of Medicine, Nagoya University Graduate School, Nagoya, Japan
  6. 6University of Occupational and Environmental Health, Kitakyushu, Japan
  7. 7Sasebo Chuo Hospital, Nagasaki, Japan
  8. 8Tohoku University, Sendai, Japan
  9. 9University of Toyama School of Medicine, Toyama, Japan
  10. 10Hiroshima Rheumatology Clinic, Hiroshima, Japan
  11. 11Yokohama Rosai Hospital, Yokohama, Japan
  12. 12Matsubara Mayflower Hospital, Kato, Japan
  13. 13Jichi Medical University, Tochigi, Japan
  14. 14UCB Pharma, Tokyo, Japan
  15. 15Astellas Pharma Inc., Tokyo, Japan
  16. 16Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands
  17. 17Tokyo Medical and Dental University, Tokyo, Japan
  18. 18NTT Sapporo Medical Centre, Sapporo, Japan
  1. Correspondence to Professor Tatsuya Atsumi, Division of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan; at3tat{at}med.hokudai.ac.jp

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.

Trial registration number (NCT01451203).

  • Early Rheumatoid Arthritis
  • Anti-TNF
  • Rheumatoid Arthritis
  • Inflammation
  • Disease Activity

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/annrheumdis-2015-207511

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