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ACR: Adalimumab (D2E7) in Patients with Active RA on Methotrexate (MTX) By Claire Sowerbutt Special to DG News SAN FRANCISCO, CA -- November 13, 2001 -- Adalimumab, a new fully human anti-tumor necrosis factor antibody, demonstrated superior efficacy to methotrexate in a study of 271 patients with active rheumatoid arthritis who had shown an inadequate response to methotrexate. The data, presented yesterday (Nov. 12) at the 65th Annual Meeting of the American College of Rheumatology (ACR), show that 65.7 percent of patients treated with adalimumab demonstrated significant improvement in signs and symptoms of rheumatoid arthritis (RA), while 53.7 percent of patients had an extremely good response as defined by standard RA evaluation criteria. The mean age of patients was 55.1 years, 76.8 percent of the study cohort was female, and 81 percent were RF positive. "The relatively large number of patients that substantially improved with adalimumab, despite the previous use of methotrexate, suggests adalimumab is a viable treatment regimen for rheumatoid arthritis," said Edward Keystone, MD, from University of Toronto, in Toronto, Ontario, Canada. The overproduction of tumor necrosis factor (TNF) in the body can lead to joint inflammation and destruction. Adalimumab selectively binds up the excess circulating TNF and removes it from the body. The purpose of the double-blind, placebo-controlled trial was to examine the efficacy of adalimumab administered subcutaneously every two weeks to patients who were partial responders to methotrexate. The study drug was administered subcutaneously at doses of 20, 40 or 80 mg over a 24-week treatment period. Injection site reactions occurred in 15.2 percent of the patients treated with adalimumab, compared to 3.2 percent in patients treated with placebo. While there were 18 withdrawals from the study, nine were from the placebo group and nine from the adalimumab arm. Of the total number of withdrawals, eight were related to adverse events and 10 for lack of efficacy or administrative reasons. "The method of administration, i.e., a subcutaneous injection once every two weeks, makes adalimumab easier to use than current biological therapies that antagonize the activity of TNF," Dr. Keystone explained. "The fully human nature of adalimumab is expected to result in fewer side effects and sustained benefit for the patient," he concluded. E-mail this page to a friend or colleague! To print, use this version