Adverse experience with methotrexate during 176 weeks of a longterm prospective trial in patients with rheumatoid arthritis

J Rheumatol. 1990 Dec;17(12):1628-35.


Adverse experience occurred with a high frequency in a longterm (greater than 3 years), prospective, double blind, followed by an open trial of methotrexate (MTX) therapy in 45 patients with rheumatoid arthritis (RA). Adverse experiences occurred in 96% of patients, and the discontinuation rate was 44% over 176 weeks. No hepatic or pulmonary fibrosis occurred. Unusual toxicities included weight loss (2 patients), systemic fungal infections (2 patients), and transient noncirrhotic ascites (1 patient). Baseline white blood cell counts and creatinine may help predict adverse experiences. The full dose-toxicity spectrum of MTX RA is not yet fully defined.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / epidemiology
  • Creatine / blood
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Evaluation
  • Female
  • Humans
  • Leukocyte Count
  • Male
  • Methotrexate / adverse effects*
  • Methotrexate / therapeutic use
  • Prospective Studies
  • Time Factors


  • Creatine
  • Methotrexate