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Responses to the combination therapy in this phase 3 clinical trial were seen as early as one week into the study.
A combination of certolizumab pegol (Cimzia) and methotrexate (MTX) significantly inhibits structural damages and safely reduces signs and symptoms of rheumatoid arthritis (RA) among early RA patients new to MTX who have poor prognostic factors, according to a phase 3 clinical trial from Japan.
At one year, almost twice as many patients on the certolizumab (CZP) combo were in remission compared to those on MTX monotherapy-and most had no progression of bone erosions with low rates of serious adverse events (SAEs).
Responses were seen as early as one week into the trial.
Japanese investigators say these results support CZP-MTX as a first-line treatment for MTX-naÃ¯ve patients with early RA.
The multi-center Certolizumab–Optimal Prevention of joint damage for Early RA (C-OPERA) study is the first to test the dual therapy in patients who have had RA for less than a year and have negative risk factors-such as high anti-cyclic citrullinated peptide (anti-CCP) and the presence of rheumatoid factor (RF) and/or bone erosions.
C-OPERA evenly randomized 316 patients in a double-blind fashion to subcutaneous CZP plus oral MTX or to placebo plus MTX for one year then continued for another year as an open label trial with MTX monotherapy.
The patients, 81% women with a mean age of 49 years, all had high titers of anti-CCP antibodies and were RF-positive; half had confirmed bone erosions.
Among the CZP/MTX patients completing the trial (n=111) 57.9% show remission by American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria compared to 33.8% of the trial completers on MTX alone (n=73).
ACR responses were higher throughout the year-long trial, with significant differences seen as early as one week.
There were similar remission rates according to disease activity in 28 joints (DAS28) and health assessment-disability questionnaire (HAQ-DI) scores.
Less than 9% of the patients experienced SAEs, mostly respiratory infections, with no clinically relevant differences between the groups in either adverse events or SAEs.
Atsumi T, Yamamoto K, Takeuchi T, et al.,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.Ann Rheum Dis doi:10.1136/annrheumdis-2015-207511. Online first. July 2, 2015.