Etanercept and methotrexate combination therapy

Clin Exp Rheumatol. Nov-Dec 1999;17(6 Suppl 18):S69-72.


Tumor necrosis factor (TNF) is a major proinflammatory cytokine in the rheumatoid joint. TNF activity can be neutralized by administration of a recombinant version of its soluble p75 TNF receptor linked to the Fc portion of human immunoglobulin IgG1 (etanercept). The present study examined the combination of etanercept with methotrexate (MTX) in a group of patients with rheumatoid arthritis (RA) who had persistent activity despite monotherapy with MTX. The etanercept-MTX group had a significantly better outcome than the placebo-MTX group using American College of Rheumatology (ACR) criteria. At 6 months, 71% of the patients in the etanercept-MTX group had an ACR 20% response (versus 27% in the placebo-MTX group). In the etanercept-MTX group, 39% had an ACR 50% response (versus 3% in the placebo-MTX group), and 15% in the etanercept-MTX group versus 0% in the placebo-MTX group met the robust ACR 70% response. The present study indicates that etanercept is a novel and robust drug in combination with MTX for the treatment of RA.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / physiopathology
  • Drug Therapy, Combination
  • Female
  • Humans
  • Isoxazoles / therapeutic use*
  • Leflunomide
  • Male
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Antirheumatic Agents
  • Isoxazoles
  • Leflunomide
  • Methotrexate