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| CTLA-4Ig | |
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OP0070 A PHASE IIB, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND CLINICAL EFFICACY OF TWO DIFFERENT DOSES OF CTLA4IG ADMINISTERED INTRAVENOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS CTLA4Ig binds the CD80 and CD86 receptors on antigen presenting cell, preventing T cell proliferation and cytokine generation. The purpose of this study was to test the sagety and efficacy of CTLA4Ig treatment in patients with rheumatoid arthritis. All patients had active disease despite receiving methotrexate. Methods: Patients were randomized to receive monthly infusions of either 2 mg/kg CTLA4Ig (n=115) or 10 mg/kg CTLA4Ig (n=105) or placebo (n=119). ACR 20/50/70 were the primary outcome measurements evaluated at 6 months of treatment. Stable steroids and NSAIDS were allowed, but no DMARD use was permitted. Results: Both the 2 and 10 mg/kg doses showed an increasing positive response through month 6 compared with the placebo group. Biomarkers showed a similar dose response pattern. The control group had a higher number of patients compared to both CTLA4Ig treatment groups discontinue the study, primarily due to lack of efficacy. All 3 groups were comparable in terms of global safety. Summary: CTLA4Ig appears to be well tolerated and efficacious in patients with active RA while receiving methotrexate. Editorial Comments: This study builds upon the initial trial of CTLA-4Ig (see ACR 2001 highlights) in which the agent was shown to have efficacy in RA as monotherapy. Similar results were seen in this trial in patients who had active disease despite treatment with methotrexate. This is one of the few T cell directed therapies which has been shown to be efficacious in RA. | |
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