Methotrexate is steroid sparing in acute sarcoidosis: results of a double blind, randomized trial.
OBJECTIVE
Methotrexate has been steroid sparing for some patients with chronic sarcoidosis. We wished to determine whether methotrexate can be steroid sparing in the first year of corticosteroid therapy in sarcoidosis.


METHODS
Patients with new onset, symptomatic disease within four weeks of starting on prednisone were randomized to receive either methotrexate or placebo for the next year. They were seen monthly and prednisone dosage was tapered following a pre-determined schedule.


RESULTS
Of 24 patients enrolled, only 15 received at least six months of therapy. Since methotrexate appears to take six months to be effective, only patients who completed six or more months of therapy were evaluated. The amount of prednisone per day decreased for both groups: methotrexate (First 6 months: Median 26 (Range 15-37) mg/day); Second 6 months 8 (1-22) mg/day, p < 0.01) and placebo (First 6 Months 28 (24-33) mg/day; Second 6 months 16 (11-22) mg/day, p < 0.02), with less prednisone used for the methotrexate patients versus placebo in the last six months (p < 0.01). There was also less weight gain for those patients receiving methotrexate. There was no difference in toxicity between methotrexate and placebo. The difference between methotrexate versus placebo was not seen when all patients (including the dropouts) were analyzed.


CONCLUSIONS
Methotrexate can be a steroid sparing agent in acute sarcoidosis.
Baughman
R P
RP
Department of Internal Medicine, University of Cincinnati Medical Center, Ohio 45267-0564, USA.
Winget
D B
DB
Lower
E E
EE
D000328:Adult; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D011241:Prednisone / Q000008:administration & dosage* / Q000627:therapeutic use; D012507:Sarcoidosis / Q000188:drug therapy*; D017565:Sarcoidosis, Pulmonary / Q000188:drug therapy; D016896:Treatment Outcome
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011241:Prednisone; D008727:Methotrexate