Objective: The objective of this study was to evaluate the efficacy and steroid-sparing effect of methotrexate (MTX) in patients with active polymyalgia rheumatica (PMR) undergoing prednisone therapy.

Methods: A meta-analysis of randomized controlled trial (RCT) was conducted to compare the efficacy and steroid-sparing effect of MTX with those of placebo in patients with PMR.

Results: Four RCTs (97 patients and 97 controls) were used in this meta-analysis. The remission rate was significantly higher in the MTX group than in the placebo group (odds ratio (OR) = 5.699, 95% confidence interval (CI) = 2.401 - 13.53, p < 0.001). The relapse rate appeared lower in the MTX group than in the placebo group, albeit without significance (OR = 0.377, 95% CI = 0.093 - 1.526, p = 0.171). The cumulative steroid dosage was also significantly lower in the MTX group than in the placebo group (standard mean difference (SMD) = -1.636, 95% CI = -2.864 - 0.407, p = 0.009), which suggested the steroid-sparing role of MTX in PMR therapy. All studies showed the same pattern of SMDs in the cumulative steroid dose, but there was variability in the meta-analysis results for the cumulative steroid dose owing to the disparity in the extent of the effect.

Conclusions: MTX in conjunction with prednisone was more successful than prednisone alone for treating PMR, and the use of MTX was correlated with a decreased average steroid dose.