OP0111 A PILOT STUDY OF THE SAFETY AND EFFICACY OF ALEFACEPT IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON METHOTREXATE
M Schneider, H Stahl, AK Vaishnaw, T Podrebarac, J Braun

Memory-effector T-cells have been shown to play a role in the pathogenesis of rheumatoid arthritis (RA). Alefacept is a human LFA-3/IgG1 fusion protein that selectively targets this population of T cells by binding the CD2 receptor on T cells. It is currently approved for the treatment of plaque psoriasis. The purpose of this 6-month, placebo-controlled, double blind study was to assess the safety and efficacy of alefacept in patients with active RA despite treatment with methotrexate.

Methods: 36 patients with active RA were randomized to receive weekly bolus injections of either Alefacept (3.75 mg or 7.5 mg) or placebo for 12 weeks in addition to their methotrexate treatment. Stable doses of NSAIDs and steroids were allowed but no additional DMARDs were permitted. ACR responses were the primary endpoints.

Results: The table below shows the percent of patient achieving ACR responses measured at 14 weeks and 6 months.

Circulating CD4+ and CD8+ T cells were reduced during treatment with levels returning during follow-up. Of interest, all patients receiving alefacept 3.75 mg that achieved ACR 20 response by week 14, maintained the response with an additional 25% of patients becoming responders during the follow-up period.

Conclusion: Alefacept in combination with methotrexate appears to be safe and efficacious in this small group of RA patients with active disease and with an unsuccessful response to methotrexate alone

Editorial Comment: This is an extremely small trial and thus it is difficult to draw definite conclusions. The lack of dose response between the 3.75 mg and 7.5 mg group is troubling. Also it seems odd that the ACR response continues of improve off therapy with the exception of the ACR 20 response in the 7.5 mg group, while the ACR 50 response increases. Further larger trials are needed.

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