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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

rly, improvements in American College of Rheumatology (ACR) 20, ACR 50 and ACR 70 scores were reported at week 10 and were sustained through week 26. Additionally, by week 26 of the study, more than half of patients demonstrated a clinical improvement, as evaluated by the EULAR response criteria, with 48.3 percent of patients previously treated with etanercept and 57.1 percent of patients previously treated with adalimumab achieving a EULAR response.  

Patients in the study also sustained improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ), improving 0.223 from baseline levels (p<0.001). HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and other activities of daily living), scoring their responses from 0 to 3.  

About the RESTART Study

The Phase 4 multicenter, open-label, assessor-blinded, active switch study evaluated 197 patients with moderate to severe rheumatoid arthritis who had an inadequate response, assessed as having a DAS28 score of at least 3.6 and at least 6 swollen and 6 tender joints, to treatment with etanercept (N=120) or adalimumab (N=77). Patients were assigned to receive REMICADE 3 mg/kg at weeks 0, 2 and 6, typically 1 and 2 weeks following their last dose of etanercept or adalimumab, respectively.  Dosage was increased by 2 mg/kg at 14 and/or 22 weeks for those who did not achieve or lost response. Improvements from baseline were assessed at weeks 10 and 26 evaluating EULAR response (the primary endpoint at week 10) and improvement in arthritis symptoms (ACR response), disease activity (DAS28 scores) and physical function (HAQ scores).

Treatment with REMICADE was generally well-tolerated with no new safety signals reported. At least one adverse event (AE) was reported in 70.4 percent of patients, with at least one serious AE report
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SOURCE Centocor Ortho Biotech, Inc.
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