THU0224 Randomized Double-Blind Comparative Effectiveness in RA Patients with Active Disease Despite Methotrexate (MTX): A Comparison of Conventional Disease-Modifying Anti-Rheumatic Drugs with a Biological

Background Double-blind placebo controlled trials have demonstrated the efficacy of 16 different therapies in RA patients with active disease despite MTX. However, there have been no blinded trials comparing conventional combination therapy to biologicals in this population. This gap in knowledge is important since biologicals are substantially more expensive than conventional therapy and have different toxicities. We compared two treatment strategies, adding conventional oral DMARDs or adding a biological, etanercept, in patients with active disease despite MTX followed by switch to the other treatment when clinically indicated. Methods This investigator-initiated multinational double-blind non-inferiority trial randomized 353 patients with active RA despite MTX to treatment with triple DMARD therapy (MTX, sulfasalazine and hydroxychloroquine) or etanercept + MTX. Treatment continued for 48 wks, with blinded treatment switch at 24 wks for patients in either group if their disease activity had failed to improve by a clinically significant amount (ΔDAS28 of