Abbott (NYSE: ABT) today announced results from long-term open-label extensions of the PREMIER and DE019 Phase 3 studies, which evaluated HUMIRA® (adalimumab) plus methotrexate (MTX) for up to eight years in patients with early moderate to severe rheumatoid arthritis (RA) and up to 10 years in patients with long-standing moderate to severe RA, respectively. In both studies, patients were assessed for disease activity, improvement in physical function and inhibition of radiographic progression, including the percentage of patients with no further radiographic progression (change in modified total Sharp score of less than or equal to 0.5). These results were presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Chicago.
"Treating patients with RA requires consideration of managing outcomes beyond the signs and symptoms of the disease; for example, it is critically important to improve and maintain physical function to the greatest extent possible, and to inhibit joint damage, as assessed by radiographic progression," said Arthur Kavanaugh, M.D., Professor of Medicine, University of California San Diego, Division of Rheumatology, Allergy and Immunology. "DE019 and PREMIER provide additional longer term data that support the value of treating both early and long-standing moderate to severe RA with TNF inhibitors such as adalimumab."
DE019 and PREMIER are among the longest open-label extension trials in RA. HUMIRA now has eight years of clinical response, radiographic inhibition and physical function data in early moderate to severe RA and 10 years of data in patients with long-standing RA. The results of these long-term extension studies add to the breadth of evidence that rheumatologists have when managing their patients with a chronic, painful and potentially debilitating disease such as RA.
"The ability to inhibit the progression of the disease and improve physical function is the current benchmark for RA treatment," said John Leonard, M.D., senior vice president, Pharmaceuticals Research and Development, Abbott. "When RA is not treated effectively, the radiographic consequences are irreversible and potentially can be devastating for patients. HUMIRA has accumulated an extensive body of long-term radiographic inhibition data in both early and long-standing RA."