Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: Safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries

The Journal of Rheumatology, 10/20/2010

Gibofsky A et al. – The RADIUS registries provide a better understanding of the safety of etanercept in patients with RA in the US practice setting.

Methods

  • Adults ? 18 years of age who fulfilled 1987 American Rheumatism Association criteria for RAwere eligible for enrollment in 2 prospective, 5-year, multicenter, observational registries
  • RADIUS 1 (Rheumatoid Arthritis DMARD Intervention and Utilization Study) enrolled patients with RA who required change in treatment [either an addition or a switch of a biologic or nonbiologic disease-modifying antirheumatic drug (DMARD)]
  • In RADIUS 2, patients with RA required to start etanercept therapy at entry
  • Patients seen at frequency determined by their rheumatologist

Results

  • SAE, SIE, and EMI occurred at rates comparable to those seen in clinical trials
  • No unexpected safety signals were observed
  • Rates for SAE, SIE, and EMI in etanercept-treated patients comparable to rates observed in patients receiving methotrexate monotherapy and did not increase with greater exposure to etanercept therapy

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