NEW YORK (Reuters Health)—Certolizumab pegol, a humanized anti-TNF antibody fragment conjugated to polyethylene glycol, is effective for treating early rheumatoid arthritis (RA) with poor prognostic factors, according to results from the C-OPERA study.
Certolizumab is approved in the U.S. and other countries for treating inflammatory diseases, including RA, but its effectiveness in methotrexate-naïve early RA has not been reported before.
Dr. Tatsuya Atsumi from Hokkaido University in Sapporo, Japan, and colleagues in the Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA) study analyzed one-year results of certolizumab treatment in 316 patients with early RA, 159 of whom received certolizumab plus methotrexate and 157 of which received placebo plus methotrexate.
Seventy-three patients (46.5%) in the placebo patients and 111 (69.8%) in the certolizumab patients completed the 52-week double-blind phase of the study, the researchers report in Annals of the Rheumatic Diseases, online July 2.
The primary endpoint, joint damage progression as assessed by the change from baseline in the modified Total Sharp Score (mTSS) at week 52, was significantly better with certolizumab plus methotrexate than with placebo plus methotrexate (0.36 vs. 1.58, p<0.001).
Significantly more patients in the certolizumab group (82.9%) than in the placebo group (70.7%) showed minimal or no joint damage progression (mTSS change <=0.5).
Clinical response rates were also significantly greater in the certolizumab patients, who showed higher ACR/EULAR remission rates, DAS28 remission rates and ACR responses.
Most of the discontinuations in the placebo group were due to lack of efficacy, and there were no clinically relevant differences between groups in the overall incidence of adverse events and serious adverse events.
More than 40% of both groups developed abnormal liver tests, almost all of which resolved by temporarily discontinuing or reducing the methotrexate dose.
“These efficacy and safety findings from C-OPERA in methotrexate-naive early RA suggest that certolizumab pegol could be used as possible first-line treatment concomitantly with methotrexate in patients with poor prognostic factors, as typified by high-titer anti-CCP antibody,” the researchers conclude. “Patients with higher disease activity, functional disability, or bone erosion in the early stages of RA will have a higher chance of preventing joint damage and disease progression.”
Dr. Atsumi did not respond to a request for comments.
Otsuka Pharmaceutical Co., Astellas Pharma, and UCB Pharma sponsored the study, employed two of the authors, and had various relationships with 13 other authors.