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Fostamatinib proven to be safe but not effective
Date:1/27/2011

In a previous study, rheumatoid arthritis (RA) patients who failed to respond to methotrexate were shown to experience positive results with fostamatinib disodium (R788), an oral spleen tyrosine kinase (Syk) inhibitor that is thought to block immune cell signaling involved with bone and cartilage destruction. In the current study, RA patients who failed to respond to biologic agents were studied. In contrast to the prior study, however, fostamatinib was not effective in this group of patients, although the drug did appear to be safe. Results of this phase II trial are published in the February issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).

Patients with RA experience inflammation, pain and swelling of their joints that often limits daily activities and can lead to permanent disability. The National Arthritis Data Workgroup estimates that 1.3 million (0.6%) of adults in the U.S. have RA, affecting two to three times as many women as men. While many RA patients are successfully treated with disease-modifying anti-rheumatic drugs (DMARDs), those with moderate to severe RA may find that newer biologically-based therapies that inhibit cytokine activity, block T cell stimulation, or modify B cell biology slow disease progression, especially when combined with methotrexate (MTX). However, there remains a subgroup of the RA patient population who do not respond to DMARDs or current biologic therapies.

The three-month double-blind, placebo-controlled trial of R788, led by Mark Genovese, M.D., from Stanford University, enrolled 219 patients with active RA who failed to respond to one or more biologic therapies (TNF inhibitor, anakinra, abatacept, or rituximab). Patients were randomly assigned in a 2:1 ratio to receive 100 mg of R788 or placebo, respectively. Efficacy and safety were evaluated over three months. Researchers evaluated changes in the disease activity score (DAS); inflammation and joint da
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Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Source:Eurekalert

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