Genentech announced data from the ADACTA study which showed that adult rheumatoid arthritis (RA) patients who received Actemra (tocilizumab) as single-agent therapy (without other DMARDs) experienced a significantly greater improvement in disease activity (DAS28 score reduction ) after 24 weeks compared to patients who received adalimumab as single-agent therapy. The results of ADACTA will be presented at the annual European League Against Rheumatism (EULAR) conference in Berlin.
RA patients are often treated with a number of medicines, combining protein-based biologic therapies with methotrexate (MTX). However, about one in three patients on a biologic treatment such as Actemra or adalimumab receive it as a single agent, also known as biologic monotherapy, largely due to intolerance to MTX.
“Since there are a number of therapies approved for patients with RA, it is important for them and their healthcare provider to have the information they need to choose the best individual treatment option,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “This study showed that for patients requiring biologic monotherapy, Actemra was more effective than adalimumab, meaning that patients were more likely to experience DAS28 remission, greater improvement in joint pain and swelling, and an improved quality of life.”
Results from ADACTA showed that after 24 weeks of treatment, adult patients with severe active RA and intolerance or inadequate response to MTX:
• achieved a mean improvement in disease activity (DAS28 score reduction) of 3.3 with Actemra versus 1.8 with adalimumab
• had a DAS28 remission rate of 40% with Actemra versus 11% with adalimumab (DAS28 <2.6)
• achieved ACR20, 50 and 702 responses of 65%, 47%, and 33% with Actemra versus 49%, 28%, and 18% with adalimumab
Differences on all of these endpoints were statistically significant. Adverse event profiles in the two treatment groups were comparable and Actemra safety data in ADACTA was consistent with previous Actemra RA clinical trials. Changes in laboratory values, including transaminase elevations (liver enzymes), LDL elevations (a type of cholesterol) and neutrophil reductions (white blood cells), occurred in both arms, with the proportion of patients with abnormal values higher in the Actemra arm.
RA is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.
Date: June 5, 2012