Humanized Monoclonal Antibody Shows Promise In RA.(Brief Article)

2001 DEC 19 - (NewsRx.com & NewsRx.net) -- Results from the Phase II clinical trial called ARMADA (Anti-TNF Research Study Program of the Monoclonal Antibody D2E7 in Patients with Rheumatoid Arthritis), suggest that Abbott Laboratories' D2E7 (adalimumab), in development for rheumatoid arthritis (RA), reduces the signs and symptoms of moderate-to-severe rheumatoid arthritis.

D2E7 is the first fully human monoclonal antibody in development. D2E7 is an investigational agent designed to block the activity of tumor necrosis factor alpha (TNF-alpha), which contributes to the inflammation in autoimmune diseases such as RA.

"In this study, D2E7 showed promise in reducing the signs and symptoms of rheumatoid arthritis," said Edward Keystone, MD, director, Center for Advanced Therapeutics, University of Toronto, Canada, and lead investigator in the D2E7 studies. "Developing potential new treatment options for RA, a debilitating joint disease, is critical."

Two hundred seventy-one patients were enrolled in the ARMADA Trial, a 24-week, double-blind, placebo-controlled Phase II study. Participants had active RA despite current treatment with methotrexate (MTX), a disease modifying antirheumatic drug (DMARD). All patients had failed between one and four DMARDs prior to MTX therapy. All patients continued on MTX and were randomized to receive either D2E7 (n=209) at 20, 40, or 80 mg doses or placebo (n=62) administered by subcutaneous injection every other week for 24 weeks.

Results were measured using American College of Rheumatology (ACR) criteria. ACR 20, ACR 50, and ACR 70 represent the percentage of improvement (20%, 50%, and 70%) in tender and swollen joint count and other relevant clinical measures such as pain scale and physician assessment of disease activity.

Among patients receiving 40 mg of D2E7 every other week, 65.7% achieved ACR 20 versus 14.5% in the placebo group, 53.7% achieved ACR 50 versus 8.1% in the placebo ...