A prospective study of the long-term efficacy and toxicity of low-dose methotrexate in rheumatoid arthritis

Clin Exp Rheumatol. 1995 Jan-Feb;13(1):23-8.


Objective: To determine the long-term efficacy and safety of weekly low-dose methotrexate (MTX) in rheumatoid arthritis (RA).

Methods: Fifty-one patients receiving MTX for RA were prospectively studied over a mean treatment period of 36 months. Standard clinical and laboratory measures of disease activity were assessed by the same investigator at baseline, and at 3, 6, 12, 24 and 36 months.

Results: The overall probability of continuing to take MTX was 80.3% at 12 months, 74.5% at 24 months, and 70.5% at 36 months. Of the 36 patients who completed 36 months of therapy, a significant improvement was noted compared to baseline in all of the clinical disease variables and acute phase reactants, with a steroid-sparing effect. There were no significant differences in these parameters between the 36-month visit and the 24- or 12-month visit. Adverse events occurred frequently (80.3%), but only 15.6% of the patients discontinued MTX permanently. Four patients (7.9%) withdrew due to a lack of efficacy.

Conclusion: Our findings indicate that MTX remains effective over 36 months of therapy, with an acceptable toxicity profile.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / physiopathology
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Methotrexate / administration & dosage*
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use
  • Middle Aged
  • Prednisone / therapeutic use
  • Prospective Studies
  • Time Factors
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Prednisone
  • Methotrexate