Thematic stream: inflammatory arthritis (PP01–PP31)PP01. Autoinflammatory Synovitis in Familial Mediterranean Fever is Characterized by Numerous Neutrophils Lacking Myeloperoxidase and Lysozyme, Macrophages, Mast Cells and B Cells, Up-Regulation of Galectin-1, P65 (REL A)/NF-ΚB and Inos, but not COX-2

Background: Recent recommendations have established clinical remission ideally or low disease activity (LDA) as therapeutic targets in all patients with rheumatoid arthritis (RA). Controlled studies of biologic agents have primarily assessed treatment effects in patients with severe RA; patients with moderate disease activity, whoconstitute a larger group, have received far less attention. In Period 1 of the PRESERVE trial, the proportion of subjects with moderately active RA achieving LDA or remission were evaluated after treatment with etanercept 50mg once weekly (QW) plus methotrexate for 36 weeks.Methods: Subjects with DAS28 >3.2 and ≤5.1 despite stable doses of oral methotrexate received open-label etanercept 50mg QW plus methotrexate (screening dose permitted to be titrated up to 25 mg/wk through week 28) for 36 weeks.Results: 834 subjects received treatment and were analyzed. Subjects were mostly female (83%), Caucasian (74%), RFþ (73%), and aCCPþ (78%), with a mean age of 48 years and disease duration of 7 years. Mean baseline DAS28 was 4.4; SDAI, 19.1; ESR, 22.2 mm/hr; and CRP, 12.3 mg/L. Efficacy results from Period 1 are shown in the table. The most commonly reported adverse events (AEs) were headache (6.1%), nasopharyngitis (5.4%), and upper respiratory tract infection (4.4%). Twenty-two subjects (2.6%) discontinued due to AEs.Conclusions: Substantial proportions of subjects with moderately active RA who received etanercept 50mg QW plus methotrexate for 36 weeks achieved LDA (85%-86%), DAS28 remission (67%), or SDAI remission (25%). Therefore, these ambitious goals can be achieved realistically in a high percentage of patients with moderate disease activity.