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


CONCLUSIONS
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.
Ferraccioli
G
G
Department of Internal Medicine, Udine School of Medicine, Italy.
Salaffi
F
F
De Vita
S
S
Casatta
L
L
Bartoli
E
E
D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001799:Blood Sedimentation; D015519:Bone Density / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D003404:Creatinine / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006909:Hydroxyproline / Q000378:metabolism; D007273:Injections, Intramuscular; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use*; D015675:Osteocalcin / Q000378:metabolism; D011111:Polymyalgia Rheumatica / Q000188:drug therapy* / Q000378:metabolism; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies
D000893:Anti-Inflammatory Agents; D018501:Antirheumatic Agents; D015675:Osteocalcin; D002097:C-Reactive Protein; D003404:Creatinine; D006909:Hydroxyproline; D011241:Prednisone; D008727:Methotrexate