The efficacy and toxicity of a constant low dose of methotrexate as a treatment for intractable rheumatoid arthritis: an open prospective study

J Rheumatol. 1991 Jul;18(7):978-83.


Ninety-two patients with intractable rheumatoid arthritis (RA) participated in an open prospective study of the longterm efficacy and toxicity of methotrexate (MTX), administered orally at a constant dosage of 7.5 mg/week. Twenty-four patients (25%) had to be withdrawn from the study within the first 12 months because of inefficacy or adverse reactions with a fatal outcome in 2 patients. In the remaining 68 patients, the mean duration of therapy was 19 months. Sixty-three of 92 patients (68%) experienced significant clinical improvement after one year, 23 (25%) were in clinical remission. Twenty-three of these patients initially responded well but relapsed after a median of 15 months of therapy. In 5 patients (5%) the disease activity remained status quo. Toxicity was noted at some time in 51 patients (54%), consisting of clinical side effects in 37 patients (40%) and biological abnormalities in 36 patients (39%), including 9 patients (10%) with blood and bone marrow toxicity, in whom renal function at start was normal. Two of these latter 9 patients had a fatal outcome because of an unexpected renal deterioration due to intercurrent disease. Thus, MTX at this constant low dose appears to be a temporarily valuable therapy for intractable RA. Careful monitoring is necessary in view of the potentially dangerous side effects.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / physiopathology
  • Blood Sedimentation
  • Bone Marrow Diseases / chemically induced
  • Bone Marrow Diseases / mortality
  • C-Reactive Protein / analysis
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Hematologic Diseases / chemically induced
  • Humans
  • Kidney Failure, Chronic / chemically induced
  • Liver / drug effects
  • Male
  • Methotrexate / administration & dosage*
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use
  • Middle Aged
  • Prospective Studies


  • C-Reactive Protein
  • Methotrexate