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New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement
Date:11/8/2010

ATLANTA, Nov. 8, 2010 /PRNewswire/ -- Patients with active moderate to severe rheumatoid arthritis (RA) inadequately responding to either etanercept (Enbrel®) or adalimumab (Humira®) and who were actively switched to REMICADE® (infliximab) demonstrated significant improvement from baseline at week 10, and sustained response through week 26 in an open label study. These week 26 results from the RESTART study were presented for the first time at the largest rheumatology medical meeting in the United States.

"These findings offer new insights into actively switching patients not responding to one TNF blocker to another therapy in the class, and in this case REMICADE," said Roy Fleischmann, MD, University of Texas/Southwestern Medical Center and lead investigator. "The data from the RESTART study show that there are patients switched to REMICADE who demonstrate immediate benefits, including improvements in disease activity and physical function."  

Patients who had an inadequate response (as measured by Disease Activity Score (DAS) 28 of at least 3.6 and at least 6 swollen and 6 tender joints) while receiving methotrexate and either etanercept or adalimumab were maintained on their stable dose of methotrexate and were actively switched to REMICADE 3 mg/kg. Patients who did not achieve or lost response had their dose titrated by 2 mg/kg.  At week 10, nearly half of REMICADE-treated patients (49.7 percent) achieved clinical response as evaluated by the European League Against Rheumatism (EULAR) response criteria. The EULAR response criteria are based on the assessment of disease activity using the DAS28 score, a statistically-derived index consisting of number of tender joints, number of swollen joints, erythrocyte sedimentation rate and global assessments of disease activity.  

At week 26, improvements were sustained (51.8 percent) with REMICADE maintenance dosing.  Simila
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SOURCE Centocor Ortho Biotech, Inc.
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