Long-term prospective study of methotrexate in the treatment of rheumatoid arthritis. 84-month update

Arthritis Rheum. 1992 Feb;35(2):129-37. doi: 10.1002/art.1780350202.


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

Methods: Eighty-four-month open prospective trial at a single academic rheumatology center.

Results: Twenty-six patients were enrolled in a prospective study of the long-term efficacy of MTX in RA; a significant improvement had been demonstrated after 36 months of therapy. Twelve patients remained in the study at the 84-month visit; the mean weekly dosage of MTX was 10.2 mg. A significant improvement was still noted at 84 months in the number of painful joints, number of swollen joints, joint pain index, joint swelling index, and physician and patient global assessments. A 50% improvement in the joint pain index and joint swelling index was observed in more than 80% of the 12 patients still enrolled. A significant reduction in prednisone dosage was achieved; of 14 patients taking prednisone at entry, 7 had discontinued prednisone completely. Fourteen patients withdrew from the study: 10 between 0 and 36 months, and 4 between 36 and 84 months. Toxicity in 3 patients and visit noncompliance in 1 patient were the reasons for withdrawal between 36 and 84 months. At 84 months, 46% of the patients remained in the study; 11.5% had discontinued due to MTX toxicity.

Conclusion: The effectiveness of MTX in the treatment of RA continues to be demonstrated in this prospective study, after 84 months of treatment.

Publication types

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

MeSH terms

  • Aged
  • Arthritis, Rheumatoid / complications
  • Arthritis, Rheumatoid / diagnostic imaging
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / physiopathology
  • Biopsy
  • Drug Administration Schedule
  • Humans
  • Liver / pathology
  • Liver Cirrhosis / chemically induced
  • Male
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Pain / physiopathology
  • Prednisone / administration & dosage
  • Prospective Studies
  • Pulmonary Fibrosis / etiology
  • Radiography
  • Treatment Outcome


  • Prednisone
  • Methotrexate