A 2 year, open ended trial of methotrexate in systemic lupus erythematosus

J Rheumatol. 1994 Sep;21(9):1674-7.


Objective: To investigate a possible role for methotrexate (MTX) in the treatment of patients with systemic lupus erythematosus (SLE) who require unacceptably high doses of glucocorticosteroids (GCS) for control of their disease.

Methods: Twelve patients with SLE participated in this open ended prospective study. Patients with active renal or central nervous system (CNS) disease were excluded as were patients with liver disease. Serological variables, SLE disease activity index, joint count, and prednisone dose were serially evaluated. Data were analyzed using paired t test and contingency table analysis.

Results: Arthritis was the major persistent problem in 7 patients: 1 patient had recurrent pleuropericarditis, 2 patients had refractory cutaneous lupus rashes and 2 had vasculitis. Three patients discontinued MTX because of side effects. The remaining 9 patients have been treated from 7-26 months. In 6 patients the GCS dose was reduced by an average of 42%. In 1 patient symptoms subsided and joint count was reduced without change in the GCS dose. GCS dosage was increased in 2 patients: 1 with recurrent serositis, 1 with persistent vasculitis. No apparent effect on anti-dsDNA antibodies, complement or erythrocyte sedimentation rate (ESR) was noted.

Conclusion: MTX appears to be useful in selected patients with SLE, especially those with persistent synovitis.

Publication types

  • Clinical Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antibodies, Antinuclear / blood
  • Arthritis / drug therapy
  • Arthritis / etiology
  • Blood Sedimentation
  • Complement System Proteins / analysis
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Lupus Erythematosus, Systemic / blood
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lupus Erythematosus, Systemic / immunology
  • Male
  • Methotrexate / administration & dosage
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Prednisone / administration & dosage
  • Prednisone / therapeutic use
  • Prospective Studies
  • Synovitis / drug therapy
  • Synovitis / etiology
  • Vasculitis / drug therapy
  • Vasculitis / etiology


  • Antibodies, Antinuclear
  • Complement System Proteins
  • Prednisone
  • Methotrexate