Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial.

摘要: Objective To evaluate the safety, efficacy, and pharmacokinetics of 50 mg etanercept administered subcutaneously once weekly in adult patients with active rheumatoid arthritis (RA). Methods Four hundred twenty RA were randomized to receive, a blinded manner, study drug for up 16 weeks: 214 received weekly, 153 25 twice 53 placebo 8 weeks followed by weeks. Efficacy safety assessed at 16. Pharmacokinetic analyses performed on serum samples from selected sites. The primary efficacy end point was achievement American College Rheumatology (ACR) 20% improvement criteria (ACR20 response) week 8. Results An ACR20 response achieved 50% receiving 49% 19% group (P Conclusion Safety, comparable between 2 dosing regimens. Thus, clinical outcomes are be expected when treated either as or weekly.