Rituximab Receives FDA Approval for Treatment of Rheumatoid Arthritis

The Food and Drug Administration (FDA) has now approved rituximab (Rituxan^®) in combination with methotrexate for the treatment of rheumatoid arthritis (RA) in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Rituximab is an anti-CD20 B-cell depleting monoclonal antibody. B-cells have been found to play a role in the pathogenesis of rheumatoid arthritis by perpetuating the inflammatory process in joints. FDA approval is based on the efficacy and safety data (summarized previously) from two clinical trials, the DANCER Study and the RELEX Study. Overall, using ACR response criteria, patients receiving rituximab in combination with methotrexate had significantly greater improvements in their disease activity than those receiving placebo or methotrexate alone.