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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.


ABSTRACT: 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.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.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.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.NCT01451203.

SUBMITTER: Atsumi T 

PROVIDER: S-EPMC5738604 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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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 T   Tanaka Yoshiya Y   Yamamoto Kazuhiko K   Takeuchi Tsutomu T   Yamanaka Hisashi H   Ishiguro Naoki N   Eguchi Katsumi K   Watanabe Akira A   Origasa Hideki H   Yasuda Shinsuke S   Yamanishi Yuji Y   Kita Yasuhiko Y   Matsubara Tsukasa T   Iwamoto Masahiro M   Shoji Toshiharu T   Togo Osamu O   Okada Toshiyuki T   van der Heijde Désirée D   Miyasaka Nobuyuki N   Koike Takao T  

Annals of the rheumatic diseases 20170202 8


<h4>Objectives</h4>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.<h4>Methods</h4>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 an  ...[more]

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