Activation of CD4+ T cells that trigger and maintain the inflammatory process in the rheumatoid joint following interaction with an antigen is one theory about the propagation of rheumatoid arthritis (RA). (read more on the pathophysiology of RA) Blocking the receptors on antigen presenting cells and thereby preventing activation of the T-cell may have therapeutic benefit in RA. In this study, the safety and efficacy of two such agents, CTLA4Ig and LEA29Y, are assessed.

214 RA patients with a mean duration of disease of 3.4 years received CTLA4Ig or LEA29Y at 0.5, 2, or 10 mg/kg doses or placebo administered intravenously. Patients received infusions on days 1, 15, 29, and 57 and were evaluated by ACR20 criteria on day 85. NSAIDS or steroid use was permitted.

Results were as follows:

These data suggest that CTLA4Ig and LEA29Y are both safe and efficacious.

Editorial Comment: The surface molecule B7 on antigen presenting cells interacts with its T cell ligands CD28 and CD152 (CTLA-4) to provide an important co-stimulatory molecule in T cell activation. CTLA4Ig and LEA29Y are soluble ligands of B7 designed to block this pathway. The data from this study is encouraging with the ACR20 responses in the highest dosing group similar to those seen in the studies with TNF inhibitors, etanercept and infliximab. The study suffers from a high placebo response. These results will need to be confirmed in larger studies, but add credibility to anti-T cell therapy in RA.

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