Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation : 2-year results of the C-OPERA study, a phase III randomised trial

• Atsumi, Tatsuya

• Tanaka, Yoshiya

• Yamamoto, Kazuhiko

• Takeuchi, Tsutomu

• Yamanaka, Hisashi

• Ishiguro, Naoki

• Eguchi, Katsumi

• Watanabe, Akira

• Origasa, Hideki

• Yasuda, Shinsuke

• Yamanishi, Yuji

• Kita, Yasuhiko

• Matsubara, Tsukasa

• Iwamoto, Masahiro

• Shoji, Toshiharu

• Togo, Osamu

• Okada, Toshiyuki

• van der Heijde, Désirée

• Miyasaka, Nobuyuki

• Koike, Takao

抄録

Objectives: To investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone. Methods: MTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP. Results: 34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (p<0.001)). Remission rates decreased after CZP discontinuation; however, higher rates were maintained through week 104 in CZP+MTX→MTX versus PBO+MTX→MTX (41.5% vs 29.3% (p=0.026), 34.6% vs 24.2% (p=0.049) and 41.5% vs 33.1% (p=0.132) at week 104 in SDAI, Boolean and DAS28(erythrocyte sedimentation rate) remission. CZP retreated patients due to flare (n=28) showed rapid clinical improvement. The incidence of overall adverse events was similar between groups. Conclusions: In MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2 years, even after stopping CZP.

収録刊行物

• Annals of the rheumatic diseases

  Annals of the rheumatic diseases 76 (8), 1348-1356, 2017-08

  BMJ Publishing Group

詳細情報

• CRID: 1050001202569955584
• NII論文ID: 120006337768
• HANDLE: 2115/67068
• ISSN: 00034967
• 本文言語コード: en
• 資料種別: journal article
• データソース種別:
  • IRDB
  • CiNii Articles