学術雑誌論文 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

76 ( 8 )  , pp.1348 - 1356 , 2017-08 , BMJ Publishing Group
ISSN:0003-4967
内容記述
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.
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https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/67068/2/annrheumdis-2017-August-76-8-1348-inline-supplementary-material-1.pdf

https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/67068/1/1348.full.pdf

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