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Title: Rituximab Effective for Tumor Necrosis Factor Nonresponders: Presented at ACR

"Rituximab Effective for Tumor Necrosis Factor Nonresponders: Presented at ACR"

By Bruce Sylvester SAN DIEGO, CA -- November 16, 2005 -- Rituximab is effective as adjunct therapy with methotrexate for patients with rheumatoid arthritis who have not responded adequately to antitumor necrosis (TNF) inhibitors, researchers reported here at the American College of Rheumatology Annual Scientific Meeting (ACR). The findings, from the Randomized Evaluation of Long-term Efficacy of Rituximab in RA (REFLEX), was presented at a press briefing on November 14[^th.

"TNF blockers have led to a revolution in treatment, but about 25% of patients have an inadequate response or toxicity issues," said Stanley B. Cohen, MD, medical director, Radiant Research, Dallas, Texas. "So we need to do something else for this large group of patients. Adding rituximab could be it."

The investigators conducted a 6-month study, enrolling and following 520 patients. Subjects received stable doses of methotrexate and were randomized to either a single course of 1000 mg of rituximab or placebo given intravenously on days 1 and 15.

All subjects received corticosteroid treatment before each infusion and a brief course of oral glucocorticoids between the 2 injections.

The investigators evaluated all subjects every 4 weeks for 6 months, examining for toxicity and for efficacy (as measured by standard criteria of disease activity developed by the American College of Rheumatology -- ACR 20/50/70).

ACR 20 was achieved by 51% of the rituximab group and 18% of placebo subjects. ACR 50 was achieved by 27% of rituximab patients and 5% of placebo patients. ACR 70 was achieved by 12% and 1% of subjects, respectively.

All differences in scores between the rituximab and placebo groups were statistically significant.

Rituximab was generally well tolerated.

The authors concluded that these results confirm rituximab is highly effective and well tolerated when given in combination with methotrexate in patients with active rheumatoid arthritis who have inadequate responses to 1 or more anti-TNF therapies.

Based on the REFLEX data, a supplemental Biologics License Application was submitted to the United States Food and Drug Administration by Biogen Idec, which discovered Rituxican, and Genentech, which comarkets the drug in the United States. The companies announced that the FDA accepted and granted Priority Review status to the sBLA on October 31^st. Rituximab is currently approved for treatment of non-Hodgkin's lymphoma.

The study was supported by Roche.

[Presentation title: Efficacy and Safety of Rituximab in Active R A Patients Who Experienced an Inadequate Response to One or More Anti- T N F a Therapies ( R E F L E X Study). Abstract 1830]

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