Newswise — Rituximab, a genetically-engineered antibody, has proven to be an effective adjunct therapy for patients with rheumatoid arthritis who have not responded adequately to one or more anti-TNF inhibitors, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Diego, California.

TNF inhibitor therapy has often proven successful in reducing joint inflammation in patients with rheumatoid rthritis. However, for some patients, this therapy, even when combined with methotrexate, has not brought about the desired decrease in disease activity. To further evaluate the efficacy and safety of rituximab, a monoclonal antibody usually used to treat non-Hodgkin's lymphoma, as an alternative in these patients, researchers conducted a six-month study following 520 patients who had not responded adequately to methotrexate and anti-TNF therapy.

Rheumatoid arthritis patients on stable doses of methotrexate whom had previously failed the TNF inhibitors, etanercept, infliximab or adalimumab, were randomly selected to receive either a single course of 1000 mg of rituximab or placebo given intravenously on days one and 15. All patients received a corticosteroid prior to each infusion and took a brief course of oral glucocorticoids between the two injections. Every four weeks for six months, patients were evaluated for evidence of toxicity efficacy and for efficacy using an assessment tool designed to identify improvement in their arthritis (as measured by standard criteria of disease activity developed by the American College of Rheumatology).

For the patients taking rituximab, the medication proved to be well tolerated and highly effective compared to those receiving placebo and methotrexate. The most common adverse effects were infusion-related and easily managed.

"While TNF blockers are an extremely beneficial therapy, there are patients who fail to respond or have toxicity to these therapies," said Stanley B. Cohen, MD, Radiant Research-Dallas, Dallas, Texas, and an investigator in the study. "For those patients, adding rituximab to the treatment management plan may spell the difference in success."

The American College of Rheumatology is the professional organization for rheumatologists and health professionals who share a dedication to healing, preventing disability and curing arthritis and related rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see http://www.rheumatology.org/annual.

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ACR Annual Scientific Meeting