Nov. 15, 2007 A potential new therapy called certolizumab pegol, when used in combination with methotrexate, may be safe and effective at treating active rheumatoid arthritis, according to research presented recently at the American College of Rheumatology Annual Scientific Meeting in Boston.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 2.1 million Americans have RA, most of them women.
Investigators followed 982 adult patients in a Phase III, multicenter, double-blind, placebo-controlled, 52-week study. Primary endpoints were clinical improvement according to a composite measure of disease activity, the ACR20, at week 24 and an improvement in the radiographic findings in joint x-rays (Sharp score) from the start to the end of the study.
Secondary endpoints included ACR20 at week 52 and the more demanding ACR 50/ACR70 response rates at weeks 24 and 52. The ACR 20/50/70 scoring criteria measures improvement in tender and swollen joint count and improvement in at least three of the following five criteria: pain; level of disability; overall self-assessment; overall physician assessment; and acute phase reactant (e.g., C-reactive protein).
Patients received certolizumab pegol in three 400 mg doses given every two weeks, followed by doses of 200 mg or 400 mg every two weeks, or placebo. All patients were taking methotrexate therapy. Patients receiving certolizumab at either dose combined with methotrexate had significant improvement compared to patients taking only methotrexate, with up to 60% an ACR20 response and at least 20% an ACR70 response at weeks 24 and 52. Adverse events, including injection site reactions, were reported in both groups, the majority of which were considered mild to moderate.
“A unique aspect of certolizumab pegol is the rapid attainment of the high hurdle ACR50 and ACR70 responses by 12-16 weeks, compared to other TNF inhibitors which achieve these responses by about 24 weeks or more,” said Edward Keystone, MD, University of Toronto, and lead investigator in the study. “Whether this is a reflection of the rapid entry of the pegylated molecule in the joint, remains unclear.”
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