Methotrexate in polymyalgia rheumatica: preliminary results of an open, randomized study

J Rheumatol. 1996 Apr;23(4):624-8.


Objective: Steroids are the only treatment of polymyalgia rheumatica (PMR). We report the effects of methotrexate (MTX) plus prednisone versus prednisone alone in PMR.

Methods: Twenty-four patients with recent onset PMR were studied in a randomized prospective study lasting one year. Patients were given MTX (MTX arm) 10 mg intramuscularly plus prednisone every week, or prednisone alone (Pred arm). After 6 months an attempt was made to stop prednisone, and to use the lowest possible dose over the next 6 months.

Results: At the 12th month, all patients were in clinical remission, acute phase reactants were in the normal range in both arms of the study, 6 patients were no longer taking steroids in the MTX arm versus 0/12 in the Pred arm, and the amount of prednisone in the 2 groups was statistically different (1.84 versus 3.2 g; p < 0.0001). In addition, bone mineral density was significantly decreased in the Pred arm, but not in the MTX arm.

Conclusion: The MTX regimen allowed the use of much less prednisone over one year to obtain full control of PMR with no loss of efficacy. It also allowed sparing of bone in elderly patients at increased risk of osteoporotic fractures.

Publication types

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

MeSH terms

  • Aged
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use*
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / therapeutic use*
  • Blood Sedimentation
  • Bone Density / drug effects
  • C-Reactive Protein / metabolism
  • Creatinine / metabolism
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Hydroxyproline / metabolism
  • Injections, Intramuscular
  • Male
  • Methotrexate / administration & dosage
  • Methotrexate / therapeutic use*
  • Osteocalcin / metabolism
  • Polymyalgia Rheumatica / drug therapy*
  • Polymyalgia Rheumatica / metabolism
  • Prednisone / administration & dosage
  • Prednisone / therapeutic use*
  • Prospective Studies


  • Anti-Inflammatory Agents
  • Antirheumatic Agents
  • Osteocalcin
  • C-Reactive Protein
  • Creatinine
  • Hydroxyproline
  • Prednisone
  • Methotrexate