A new strategy for treating rheumatoid arthritis patients has been announced by pharmaceutical companies Genentech, Inc., and Biogen Idec, Inc. Positive results have been obtained from interim analyses of ongoing open-label extension studies of Rituxan (Rituximab) therapy in patients with rheumatoid arthritis who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies (etanercept, infliximab, or adalimumab).

   Interim findings show that a greater proportion of patients achieved an American College of Rheumatology (ACR) 20, 50, or 70 response following treatment with a subsequent course of Rituxan, in combination with methotrexate, compared to outcomes after their first course. These findings, along with data on physical function and mental and physical health measures, along with a preliminary safety analysis of TNF antagonist use following Rituxan treatment, were presented at the most recent annual scientific meeting of the ACR.

   In open-label extension studies that evaluated the long-term desired effects and safety of a subsequent course of Rituxan treatment, 155 patients received Rituxan (1000 mg i.v. infusion on days 1 and 15) in combination with a stable dose of methotrexate. After 16 weeks or more, patients who had received placebo in the original studies were also eligible to enter the extension study and receive one or more courses of Rituxan.

   At 24 weeks, following a subsequent course of treatment with Rituxan and methotrexate, interim study findings showed that patients who responded to a first course of Rituxan treatment also benefited from a subsequent course. Compared to the original baseline, 72 percent achieved ACR 20 after a subsequent course, versus 65 percent after the first course; 42 percent achieved ACR 50 after a subsequent course, versus 33 percent after the first course; and 21 percent achieved ACR 70 after a subsequent course, versus 12 percent after the first course.

   Among all patients in the extension study who received a subsequent course of Rituxan treatment after a previous exposure to at least one TNF antagonist, the rate of serious adverse events (grade 3 or 4) was approximately 11 percent; and serious infections occurred in 2 percent of patients. The companies recognize the importance of and will continue to monitor the long-term safety of Rituxan in rheumatoid arthritis.

   "These interim data show that patients who received a subsequent course of Rituxan experienced comparable or improved rheumatoid arthritis symptom relief compared to outcomes after their first course," said Mark Genovese, M.D., Associate Professor of Medicine, Immunology and Rheumatology, Stanford University Medical Center. "The analysis also showed that additional Rituxan treatment in this study was not associated with an increase in infections or adverse events, including infusion reaction."

   In addition to rheumatoid arthritis, Rituxan is being studied in other autoimmune diseases with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis, multiple sclerosis, and ANCA-associated vasculitis.

   "The results of these most recent studies involving rheumatoid arthritis patients are most encouraging," commented Virginia Ladd, president of the American Autoimmune Related Diseases Association. "According to one study, almost 2 million Americans suffer from rheumatoid arthritis. It also encouraging that attention is being given to the millions of other autoimmune disease patients as well. Help cant come too soon!"

--Adapted from news release, Genentech and Biogen Idec, Nov 11, 2006